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Label wording by medicine and country: a table

What official product information says about sexual side effects, and about side effects that continue after stopping, by medicine and country.

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What this page is

This page is a record of what official product information says, medicine by medicine and country by country. It covers two things: sexual side effects, and side effects that continue after the medicine is stopped.

Each row is one document for one medicine in one country or region. It can be the text for professionals, the patient leaflet, or a related document such as a regulator’s safety notice. The row says what kind of document it is and whose words they are.

A row gives the words of the text and the section they stand in, the document with a link to it, the date the document prints, and the day we checked it.

This is a record, not a comparison of countries. The rows stand in one fixed order, whatever the texts say. A row speaks for its own document and for no other: texts for two products in the same country can differ, and then each has a row of its own.

What a text means for a patient is not on this page. Where a medicine has a page of its own, its rows link to it.

How it was checked

We opened each text on the day shown in its row under “Checked”. Every quotation was copied from the text as it stands. Spelling, punctuation and misprints are the document’s own.

A second, separate check followed. Each quoted source was opened again, and every quotation was compared with it character by character. Where the two differed, the row was corrected from the source or left out.

Where we could not open a text, the row says so and gives the reason. That says nothing about what the text contains. Where a text we opened has no sentence about sexual side effects continuing after the medicine is stopped, the row says that too. The words we searched for are in the JSON file.

Nothing is carried over from one country to another. We do not work out what one country’s text says from another’s.

Australia’s rows are different. We read each text on the site of its regulator, the TGA. The TGA’s terms of access let a reader download, display, print and copy a single copy. For other uses they refer the reader to the medicine’s sponsor, whom we have not asked. So Australia’s rows are summarised in our own words, not quoted. Each of those rows says so, and each summary was checked against the notes we took while reading.

Where a text is in another language than this page, the row shows the original, with our translation under it. Where the body that issued the text has published its own version in this page’s language, the row shows that version and says so. Each of our translations was checked a second time against the original. They are there to help, and are never the official text.

A text can change after the day we checked it. The “Checked” date tells you how fresh a row is.

If you find an error, write to contact@sidefxhub.com. We will open the source again and correct the row if it is wrong.

How to quote it

Every row has an address of its own: the address of this page, then # and the row’s name. The row for sertraline in the United Kingdom, for example, is #sertraline-uk. The country name at the start of a row is a link to that address. Row names never change, and they are the same in every language of this page.

For the words of an official text, name the document and its date. Both are in the row. For the record as a whole, name SIDEfxHUB and give the address of this page. Say which day the text was checked.

What you may reuse, and on what terms, stands above the first table.

The record as a file

The whole record can be downloaded. The files hold every row of this page, and their addresses do not change.

  • label-ledger.json holds everything: each document, its passages in the original, the official language versions, our translations and our summaries in seven languages, the dates, and what we searched for or tried.
  • label-ledger.csv is a table with one line for each passage. A document with no passage has one line. Import it as text: the quotations are exact, so a cell can begin with a hyphen or a bullet.
  • label-ledger.csv-metadata.json describes the columns of the CSV file for software, and carries the terms of reuse.

The columns of the CSV file

  • record_id: the row’s name on this page.
  • medicine: the medicine, by its international name.
  • jurisdiction: the country or region, as our short code, such as uk or eu.
  • iso: the same as an ISO country code. The European Union is EU.
  • kind: the kind of document: professional, patient-leaflet or regulator-communication.
  • issuer: for a regulator-communication, whose words it is: regulator, company or government.
  • access: whether we opened the text: opened, could-not-open or no-product.
  • access_reason: why a text could not be opened.
  • document: the document’s own title.
  • product: the product the text belongs to, with its form and its holder.
  • source_type: the kind of place where we read the text, such as the regulator’s database or the holder’s site.
  • source_name: the name of that place.
  • passage_key: the name of the passage within its row.
  • passage_kind: what the passage is: sexual-persistence, sexual-side-effects, general-persistence, qualification or regulator-statement.
  • in_warnings: for a sexual-persistence passage, whether it stands in a warnings section of the text.
  • qualifies: for a qualification, the passage it qualifies.
  • section: the headings the passage stands under, as printed.
  • quote_lang: the language of the quotation.
  • quote: the exact words of the text.
  • quote_en: the quotation in English.
  • quote_en_by: whose English that is: original, official or ours.
  • summary_en: our summary in English, where a text is summarised and not quoted.
  • summary_reason: why the text is summarised.
  • text_date: the date the document prints.
  • text_date_kind: what kind of date that is, such as a revision or a publication.
  • since: since when the sentence has been on record, where a dated official document says so.
  • since_scope: whether that date holds for the country’s texts or for this product’s text.
  • since_basis: the rows of the documents that say so.
  • source_url: the address of the document.
  • checked: the day we last opened the source, or tried to.
  • changed: the day the substance of the row last changed.
  • verified: the result of the second check.
  • anchor: the row’s address on this page.

Countries and regions

United Kingdom
Report a side effect: MHRA
Address checked
European Union
Report a side effect: EMA
Address checked
United States
Report a side effect: FDA
Address checked
Canada
Report a side effect: Health Canada
Address checked
Australia
Report a side effect: TGA
Address could not be re-checked on
New Zealand
Report a side effect: Medsafe
Address checked
Germany
Report a side effect: BfArM
Address checked
France
Report a side effect: ANSM
Address checked
Italy
Report a side effect: AIFA
Address checked
Spain
Report a side effect: AEMPS
Address checked
Brazil
Report a side effect: ANVISA
Address checked
India
Report a side effect: PvPI (Indian Pharmacopoeia Commission)
Address could not be re-checked on
Ireland
Report a side effect: HPRA
Address checked
Saudi Arabia
Report a side effect: SFDA
Address could not be re-checked on
Malaysia
Report a side effect: NPRA
Address checked

The whole record as a file: JSON · CSV

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You may reuse this page and its data files under CC BY 4.0 (Creative Commons Attribution 4.0 International) if you credit SIDEfxHUB and give this page's address.

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The texts quoted here, in the original or in our translation, are quoted, not licensed by us. The licence covers our compilation: the selection, the dates, the checks and the explanations.

Sertraline

For the SSRI antidepressant sertraline (Zoloft, Lustral), the product information we read in the United Kingdom says there have been reports of long-lasting sexual dysfunction where symptoms continued after SSRIs were stopped. This is known as post-SSRI sexual dysfunction (PSSD). The EU medicines regulator set the wording of this warning in 2019 for ten medicines, sertraline among them, and a government answer in Parliament says UK product information for all SSRIs was updated in 2019 to carry it.

Sertraline: what each text says about sexual side effects, and about side effects that continue after stopping.
Country or regionWhat the text saysDocumentDates
United KingdomText for professionals · LustralSertraline: the page about it

Sexual side effects that continue after stopping4.4 Special warnings and precautions for use · Sexual dysfunctionSelective serotonin reuptake inhibitors (SSRIs) may cause symptoms of sexual dysfunction (see section 4.8). There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs.On record since 2019, according to a government answer in parliament, 13 May 2025. That document is about the whole class of medicines. It does not name sertraline.

Sexual side effects, as listed4.8 Undesirable effects · Table 1 · Reproductive system and breast disorders · Very Common (≥1/10)ejaculation failure

Sexual side effects, as listed4.8 Undesirable effects · Table 1 · Reproductive system and breast disorders · Common (≥1/100 to <1/10)menstruation irregular∗, erectile dysfunction

Sexual side effects, as listed4.8 Undesirable effects · Table 1 · Reproductive system and breast disorders · Uncommon (≥1/1,000 to <1/100)sexual dysfunction (see section 4.4), menorrhagia, vaginal haemorrhage, female sexual dysfunction (see section 4.4)

Sexual side effects, as listed4.8 Undesirable effects · Table 1 · Reproductive system and breast disorders · Rare (≥1/10,000 to <1/1,000)galactorrhoea*, atrophic vulvovaginitis, genital discharge, balanoposthitis∗§, gynaecomastia∗, priapism*

Text for professionals Summary of Product Characteristics (SmPC): Lustral 100mg film coated tabletsLustral 100 mg film coated tablets, Viatris Products Limited · Read in a compendium of product information: emcText revisedChecked
United KingdomPatient leaflet · LustralSertraline: the page about it

Sexual side effects that continue after stopping2. What you need to know before you take Lustral · Warnings and precautions · Sexual problems:Medicines like Lustral (so called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.On record since 2019, according to a government answer in parliament, 13 May 2025. That document is about the whole class of medicines. It does not name sertraline.

Patient leaflet Package leaflet: Information for the user. Lustral® 50 mg film coated tablets, Lustral® 100 mg film coated tablets. SertralineLustral 50 mg and 100 mg film coated tablets, Viatris Products Limited · Read in a compendium of product information: emcText revisedChecked
United KingdomGovernment answer in parliamentSertraline: the page about it

Sexual side effects that continue after stoppingAnswerThe Medicines and Healthcare products Regulatory Agency (MHRA) approved product information provided to healthcare professionals and patients for all selective serotonin reuptake inhibitors (SSRIs) was updated in 2019 to inform them that reports had been received of long-lasting sexual dysfunction where symptoms continue despite discontinuation of the SSRI.

That document is about the whole class of medicines. It does not name sertraline.

Contains Parliamentary information licensed under the Open Parliament Licence v3.0.

Government answer in parliament Written question UIN 50758, House of Commons: "Selective Serotonin Reuptake Inhibitors: Sexual Dysfunction"Read on the parliament's siteAnsweredChecked
United KingdomDocument from the regulatorSertraline: the page about it

Sexual side effects that continue after stoppingNews storyThe CHM has also recommended updates to the PILs for certain antidepressants to better reflect patient feedback and emerging evidence on the potential for sexual dysfunction that may continue after stopping treatment.

This document does not say which medicines it means. It does not name sertraline.

Document from the regulator Patient and family experiences inform antidepressant safety information reviewRead on the regulator's site: GOV.UKPublishedChecked
United KingdomDocument from the regulatorSertraline: the page about it

Sexual side effects that continue after stoppingNews Roundup · Patient and family experiences inform antidepressant safety information reviewThe CHM advised updates to the PILs for some antidepressants on the risk of sexual dysfunction where symptoms continue after stopping treatment to better reflect the views of patients and evolving data.

This document does not say which medicines it means. It does not name sertraline.

Document from the regulator MHRA Safety Roundup: December 2025Read on the regulator's site: GOV.UKPublishedChecked
European UnionDocument from the regulatorSertraline: the page about it

Sexual side effects that continue after stopping3. Serotonin and noradrenaline reuptake inhibitors (SNRI); selective serotonin reuptake inhibitors (SSRI) – Persistent sexual dysfunction after drug withdrawal (EPITT no 19277) · Summary of product characteristics · 4.4. Special warnings and precautions for use · Sexual dysfunctionThere have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRI.On record since 2019, according to EMA, 11 June 2019.

Sexual side effects that continue after stopping3. Serotonin and noradrenaline reuptake inhibitors (SNRI); selective serotonin reuptake inhibitors (SSRI) – Persistent sexual dysfunction after drug withdrawal (EPITT no 19277) · Package leaflet · 2. What you need to know before you take [Invented name] · Warnings and precautionsIn some cases, these symptoms have continued after stopping treatment.On record since 2019, according to EMA, 11 June 2019.

The wording is for ten medicines: citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, desvenlafaxine, duloxetine, milnacipran and venlafaxine.

This is wording for national product texts. There is no single EU product text for this medicine.

Document from the regulator New product information wording – Extracts from PRAC recommendations on signals. Adopted at the 13-16 May 2019 PRACRead on the regulator's site: European Medicines AgencyPublishedChecked
European UnionDocument from the regulatorSertraline: the page about it

Sexual side effects that continue after stopping1.3. Serotonin and noradrenaline reuptake inhibitors (SNRI); selective serotonin reuptake inhibitors (SSRI) – Persistent sexual dysfunction after drug withdrawal · Summary of product characteristics · 4.4. Special warnings and precautions for use · Sexual dysfunctionThere have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRI.

Sexual side effects that continue after stopping1.3. Serotonin and noradrenaline reuptake inhibitors (SNRI); selective serotonin reuptake inhibitors (SSRI) – Persistent sexual dysfunction after drug withdrawal · Package leaflet · 2. What you need to know before you take [Invented name] · Warnings and precautionsIn some cases, these symptoms have continued after stopping treatment.

The wording is for ten medicines: citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, desvenlafaxine, duloxetine, milnacipran and venlafaxine.

Document from the regulator PRAC recommendations on signals. Adopted at the 13-16 May 2019 PRAC meetingRead on the regulator's site: European Medicines AgencyPublishedChecked
United StatesText for professionals · ZoloftSertraline: the page about it

Sexual side effects, as listed5 WARNINGS AND PRECAUTIONS · 5.11 Sexual DysfunctionUse of SSRIs, including ZOLOFT, may cause symptoms of sexual dysfunction [see Adverse Reactions (6.1)]. In male patients, SSRI use may result in ejaculatory delay or failure, decreased libido, and erectile dysfunction. In female patients, SSRI use may result in decreased libido and delayed or absent orgasm.

This text has no sentence about sexual side effects continuing after the medicine is stopped.

On 13 October 2026 we searched the labels in the FDA's open database. A sentence about sexual dysfunction continuing after stopping stood on none of the 423 labels that name sertraline.

Text for professionals ZOLOFT (sertraline hydrochloride) tablets, for oral use; ZOLOFT (sertraline hydrochloride) oral solution: Full Prescribing InformationZoloft tablets 25 mg, 50 mg and 100 mg, and oral solution 20 mg/mL, Viatris Specialty LLC · Read in the government's medicines database: DailyMedText revisedChecked
United StatesPatient leaflet · ZoloftSertraline: the page about it

Sexual side effects, as listedWhat is the most important information I should know about ZOLOFT?Sexual problems (dysfunction). Taking selective serotonin reuptake inhibitors (SSRIs), including ZOLOFT, may cause sexual problems.

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Patient leaflet MEDICATION GUIDE: ZOLOFT (ZOH-loft) (sertraline hydrochloride) Tablets and Oral SolutionZoloft tablets 25 mg, 50 mg and 100 mg, and oral solution 20 mg/mL, Viatris Specialty LLC · Read in the government's medicines database: DailyMedText revisedChecked
United StatesDocument from the regulator · ZoloftSertraline: the page about it

What the regulator said09/20/2021 (SUPPL-100) · 5 Warnings and Precautions · 5.11 Sexual Dysfunction(Newly added subsection)

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Document from the regulator Drug Safety-related Labeling Changes (SrLC): ZOLOFT (NDA-019839) (SERTRALINE HYDROCHLORIDE)Zoloft tablets, Viatris · Read in the regulator's own database: Drug Safety-related Labeling Changes (SrLC)PublishedChecked
CanadaText for professionals · ZoloftSertraline: the page about it

Sexual side effects that continue after stopping7 WARNINGS AND PRECAUTIONS · Reproductive Health: Female and Male Potential · FunctionSexual Dysfunction: Selective serotonin reuptake inhibitors (SSRIs) may cause symptoms of sexual dysfunction. Patients should be informed that there have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs.

Sexual side effects, as listed8 ADVERSE REACTIONS · 8.2 Clinical Trial Adverse Reactions · DepressionThe most commonly observed adverse events associated with the use of ZOLOFT were: gastrointestinal complaints; including nausea, diarrhea/loose stools and dyspepsia; male sexual dysfunction (primarily ejaculatory delay) (see 7 WARNINGS AND PRECAUTIONS); insomnia and somnolence; tremor; increased sweating and dry mouth; and dizziness.

Text for professionals PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION: ZOLOFT, Sertraline Hydrochloride CapsulesZoloft capsules 25 mg, 50 mg and 100 mg, BGP Pharma ULC · Read in the regulator's own database: Drug Product DatabaseText revisedChecked
CanadaPatient leaflet · ZoloftSertraline: the page about it

Sexual side effects, as listedSerious side effects and what to do about them · COMMONSexual dysfunction: low sex drive, not being able to ejaculate, delayed ejaculation, erectile dysfunction

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Patient leaflet PATIENT MEDICATION INFORMATION: ZOLOFT, Sertraline Hydrochloride CapsulesZoloft capsules 25 mg, 50 mg and 100 mg, BGP Pharma ULC · Read in the regulator's own database: Drug Product DatabaseText revisedChecked
CanadaDocument from the regulatorSertraline: the page about it

Sexual side effects that continue after stoppingConclusions and actionsHealth Canada will work with manufacturers to update the product safety information for all SSRIs and SNRIs to recommend that healthcare professionals inform patients about the potential risk of long lasting (possibly weeks to years) sexual symptoms persisting after stopping SSRI or SNRI treatment.

The same text also saysConclusions and actionsHealth Canada's review could not confirm, nor rule out, a causal link between stopping SSRI or SNRI treatment and persistent sexual dysfunction.

This document is about a whole class of medicines and names sertraline among them.

Document from the regulator Summary Safety Review - Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin-norepinephrine Reuptake Inhibitors (SNRIs) - Assessing the Potential Risk of Sexual Dysfunction despite Treatment DiscontinuationRead on the regulator's site: Drug and Health Product PortalPublishedChecked
CanadaDocument from the regulatorSertraline: the page about it

Sexual side effects that continue after stoppingProduct monograph updates · Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs)The Warnings and Precautions section of the Canadian product monographs for SSRIs (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, vilazodone and vortioxetine) and SNRIs (desvenlafaxine, duloxetine, levomilnacipran and venlafaxine) has been, or will be, updated with new safety information concerning reports of long-lasting sexual dysfunction where the symptoms have continued despite treatment discontinuation.

This document is about a whole class of medicines and names sertraline among them.

Document from the regulator Health Product InfoWatch, December 2021Read on the regulator's site: Government of Canada PublicationsPublishedChecked
AustraliaText for professionals · ZOLOFTSertraline: the page about it

Sexual side effects that continue after stopping4.4 Special warnings and precautions for use · Sexual DysfunctionSection 4.4 of Australia's product information for Zoloft has a warning headed sexual dysfunction. It says there are reports of sexual dysfunction that lasted a long time, with symptoms going on after SSRIs were stopped.Summarised, not quoted, because of the TGA's access terms.

Sexual side effects, as listedSection 4.8 · Reproductive system and breast disorders · CommonSection 4.8 lists ejaculation disorder and sexual dysfunction as common side effects and points back to section 4.4.Summarised, not quoted, because of the TGA's access terms.

The regulator's site asks readers to accept its terms before it shows this text.

Text for professionals AUSTRALIAN PRODUCT INFORMATION ZOLOFT (sertraline hydrochloride) tabletZOLOFT, Viatris · Read in the regulator's own database: TGA eBSText revisedChecked
AustraliaPatient leaflet · ZOLOFTSertraline: the page about it

Sexual side effects that continue after stoppingLess serious side effectsAustralia's consumer medicine information for Zoloft lists sexual dysfunction among the less serious side effects. It says medicines like this one may cause sexual problems, and that in some cases these have carried on after treatment stopped.Summarised, not quoted, because of the TGA's access terms.

The regulator's site asks readers to accept its terms before it shows this text.

Patient leaflet Consumer Medicine InformationZOLOFT, Viatris · Read in the regulator's own database: TGA eBSText revisedChecked
AustraliaDocument from the regulatorSertraline: the page about it

We could not open this text on 13 October 2026: the site did not answer. This says nothing about what the text contains.

Document from the regulatorWe tried: www.tga.gov.au/news/safety-updates/updated-warnings-about-persistent-sexual-dysfunction-antidepressantsTried
New ZealandText for professionals · SetronaSertraline: the page about it

Sexual side effects that continue after stopping4.4. Special warnings and precautions for use · Sexual dysfunctionSelective serotonin reuptake inhibitors (SSRIs) may cause symptoms of sexual dysfunction (see section 4.8). There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs.

The originator product is not in the list we read. This is another product from that list.

Text for professionals New Zealand Data Sheet, SETRONASetrona 50 mg and 100 mg film coated tablets, Douglas Pharmaceuticals Ltd · Read in the regulator's own database: MedsafeText revisedChecked
New ZealandPatient leaflet · SetronaSertraline: the page about it

Sexual side effects that continue after stoppingBefore you take SETRONA · Before you start to take itMedicines like SETRONA may cause symptoms of sexual dysfunction (see “Side effects” section). In some cases, these symptoms have continued after stopping treatment.

The originator product is not in the list we read. This is another product from that list.

Patient leaflet Consumer Medicine Information, SETRONASetrona 50 mg and 100 mg tablets, Douglas Pharmaceuticals Ltd · Read in the regulator's own database: MedsafeText revisedChecked
New ZealandDocument from the regulatorSertraline: the page about it

Sexual side effects that continue after stopping3.2.2 Serotonin reuptake inhibitors and persistent sexual dysfunctionThe Committee considered the European product information on this issue and determined, based on their review of the available information, that updates to the data sheets regarding the risk of persistent sexual dysfunction are necessary.

The same text also says3.2.2 Serotonin reuptake inhibitors and persistent sexual dysfunctionThe Committee considered the strength of the evidence to be low and it is difficult to draw conclusions from the available data.

What the regulator said3.2.2 Serotonin reuptake inhibitors and persistent sexual dysfunction · Recommendation 5The Committee recommended that Medsafe writes to the sponsors of serotonin reuptake inhibitors requesting updates to New Zealand data sheets.

That document is about the whole class of medicines. It does not name sertraline.

Document from the regulator Minutes of the 179th Medicines Adverse Reactions Committee Meeting, 12 September 2019Read on the regulator's site: MedsafeAdoptedChecked
New ZealandDocument from the regulatorSertraline: the page about it

Sexual side effects that continue after stopping3.2.3 Update on sexual dysfunction (post SSRI sexual dysfunction, PSSD) following discontinuation of serotonin reuptake inhibitors · BackgroundA warning that long-lasting symptoms of sexual dysfunction following discontinuing of treatment with selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs) have been reported, is currently listed in section 4.4 of the data sheets for these medicines.

That document is about the whole class of medicines. It does not name sertraline.

Document from the regulator Minutes of the 206th Medicines Adverse Reactions Committee Meeting, 11 June 2026Read on the regulator's site: MedsafeAdoptedChecked
New ZealandDocument from the regulatorSertraline: the page about it

Sexual side effects that continue after stoppingCARM ID: 138298 · Reaction description and data sheet informationThe Arrow Sertraline data sheet states that selective serotonin reuptake inhibitors (SSRIs)/serotonin norepinephrine reuptake inhibitors (SNRIs) may cause symptoms of sexual dysfunction. There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRI.

Document from the regulator Gathering knowledge from adverse reaction reports: March 2021Read on the regulator's site: MedsafePublishedChecked
GermanyText for professionals · ZoloftSertraline: the page about it

Sexual side effects that continue after stopping4.4 Besondere Warnhinweise und Vorsichtsmaßnahmen für die Anwendung · Sexuelle FunktionsstörungEs wurden lang anhaltende sexuelle Funktionsstörungen berichtet, bei denen die Symptome trotz der Absetzung von SSRIs bestehen blieben.Original text: German. Our translation:Long-lasting sexual dysfunction has been reported in which the symptoms continued despite the SSRIs being stopped.

This is the copy in a compendium of product information. The regulator's database asks visitors to accept its terms first, which we did not do.

Text for professionals FachinformationZoloft Filmtabletten, Viatris Pharma GmbH · Read in a compendium of product information: fachinfo.deText revisedChecked
GermanyPatient leaflet · ZoloftSertraline: the page about it

Sexual side effects that continue after stopping2. Was sollten Sie vor der Einnahme von Zoloft beachten? · Warnhinweise und Vorsichtsmaßnahmen · Sexuelle ProblemeIn bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen.Original text: German. Our translation:In certain cases these symptoms continued after treatment was ended.

This is the copy in a compendium of product information. The regulator's database asks visitors to accept its terms first, which we did not do.

Patient leaflet Gebrauchsinformation: Information für AnwenderZoloft 50 mg und 100 mg, Filmtabletten, Viatris Pharma GmbH · Read in a compendium of product information: PatientenInfo-ServiceText revisedChecked
GermanyDocument from the regulatorSertraline: the page about it

Sexual side effects that continue after stoppingPRAC-Meldungen · Neufassung des Wortlauts der Produktinformationen – Auszüge aus den Empfehlungen des PRAC zu Signalen · Serotonin- und Noradrenalin-Wiederaufnahmehemmer (SNRI); selektive Serotonin-Wiederaufnahmehemmer (SSRI) – persistierende sexuelle Funktionsstörung nach Absetzen von Arzneimitteln (EPITT Nr. 19277)Es wurden lang anhaltende sexuelle Funktionsstörungen berichtet, bei denen die Symptome trotz der Absetzung von SSRI/SNRI bestehen blieben.Original text: German. Our translation:Long-lasting sexual dysfunction has been reported in which the symptoms continued despite the SSRI/SNRI being stopped.

The wording is for ten medicines: citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, desvenlafaxine, duloxetine, milnacipran and venlafaxine.

Document from the regulator Bulletin zur Arzneimittelsicherheit – Informationen aus BfArM und PEI, Ausgabe 2 | Juni 2019Read on the regulator's site: BfArMPublishedChecked
FranceText for professionals · ZOLOFTSertraline: the page about it

Sexual side effects that continue after stopping4.4. Mises en garde spéciales et précautions d'emploi · Dysfonction sexuelleDes cas de dysfonction sexuelle dont les symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS ont été rapportés.Original text: French. Our translation:Cases of sexual dysfunction in which the symptoms continued despite stopping treatment with SSRIs have been reported.

The text itself prints no date of revision.

Text for professionals Résumé des Caractéristiques du ProduitZOLOFT 50 mg, gélule, VIATRIS UP · Read in the government's medicines database: Base de données publique des médicamentsUpdated by the regulatorChecked
FrancePatient leaflet · ZOLOFTSertraline: the page about it

Sexual side effects that continue after stopping2. QUELLES SONT LES INFORMATIONS A CONNAITRE AVANT DE PRENDRE ZOLOFT 50 mg, gélule ? · Avertissements et précautions · Dysfonction sexuelleDans certains cas, ces symptômes se sont prolongés après l’arrêt du traitement.Original text: French. Our translation:In some cases, these symptoms continued after treatment was stopped.

The text itself prints no date of revision.

Patient leaflet Notice patientZOLOFT 50 mg, gélule, VIATRIS UP · Read in the government's medicines database: Base de données publique des médicamentsUpdated by the regulatorChecked
FranceDocument from the regulatorSertraline: the page about it

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Document from the regulator Xeljanz® (tofacitinib), Fenspiride (Pneumorel), ibuprofène et kétoprofène : retour d’information sur le PRAC de mai 2019Read on the regulator's site: ANSMPublishedChecked
ItalyText for professionals · ZoloftSertraline: the page about it

Sexual side effects that continue after stopping4.4 Avvertenze speciali e precauzioni di impiego · Disfunzione sessualeSono stati segnalati casi di disfunzione sessuale a lungo termine con persistenza dei sintomi dopo l’interruzione dell’uso di SSRI.Original text: Italian. Our translation:Cases of long-term sexual dysfunction have been reported, with the symptoms persisting after the use of SSRIs was stopped.

The text itself prints no date of revision.

Text for professionals Riassunto delle Caratteristiche del ProdottoZoloft 25 mg, 50 mg e 100 mg compresse rivestite con film, Viatris Pharma S.r.l. · Read in the regulator's own database: Banca Dati FarmaciMade available by the regulatorChecked
ItalyPatient leaflet · ZoloftSertraline: the page about it

Sexual side effects that continue after stopping2. Cosa deve sapere prima di prendere Zoloft · Avvertenze e precauzioni · Problemi sessuali:In alcuni casi, si è osservata la persistenza di questi sintomi dopo l’interruzione del trattamento.Original text: Italian. Our translation:In some cases, these symptoms have been seen to persist after treatment was stopped.

The text itself prints no date of revision.

Patient leaflet Foglio illustrativo: informazioni per l’utilizzatoreZoloft 25 mg, 50 mg e 100 mg compresse rivestite con film, Viatris Pharma S.r.l. · Read in the regulator's own database: Banca Dati FarmaciMade available by the regulatorChecked
SpainText for professionals · BesitranSertraline: the page about it

Sexual side effects that continue after stopping4.4. Advertencias y precauciones especiales de empleo · Disfunción sexualSe han notificado casos de disfunción sexual de larga duración en los que los síntomas persisten a pesar de la suspensión del ISRS.Original text: Spanish. Our translation:Cases of long-lasting sexual dysfunction have been reported in which the symptoms persist despite the SSRI being stopped.

Text for professionals Ficha técnicaBesitran 50 mg comprimidos recubiertos con película, Viatris Healthcare Limited · Read in the regulator's own database: CIMAText revisedChecked
SpainPatient leaflet · BesitranSertraline: the page about it

Sexual side effects that continue after stopping2. Qué necesita saber antes de empezar a tomar Besitran · Advertencias y precauciones · Problemas sexuales:En algunos casos, estos síntomas persisten después de suspender el tratamiento.Original text: Spanish. Our translation:In some cases, these symptoms persist after treatment is stopped.

Patient leaflet Prospecto: información para el usuarioBesitran 50 mg comprimidos recubiertos con película, Viatris Healthcare Limited · Read in the regulator's own database: CIMAText revisedChecked
SpainDocument from the regulatorSertraline: the page about it

Sexual side effects that continue after stoppingInformación sobre seguridad · Nueva información de seguridad procedente de la evaluación periódica de los datos de farmacovigilancia · Inhibidores selectivos de la recaptación de serotonina (SRS)/serotonina y noradrenalina (ISRN): persistencia de disfunción sexualEn pacientes a tratamiento con inhibidores de la recaptación de serotonina y noradrenalina, o con inhibidores selectivos de la recaptación de serotonina, se han notificado casos de disfunción sexual de larga duración en los que los síntomas persisten a pesar de la interrupción del tratamiento. Se incorporará este hallazgo a las advertencias de estos medicamentos.Original text: Spanish. Our translation:In patients treated with serotonin and noradrenaline reuptake inhibitors, or with selective serotonin reuptake inhibitors, cases of long-lasting sexual dysfunction have been reported in which the symptoms persist despite treatment being stopped. This finding will be added to the warnings of these medicines.

That document is about the whole class of medicines. It does not name sertraline.

Spelling and punctuation are the document's own.

Document from the regulator Boletín mensual de la AEMPS sobre medicamentos de uso humano. Mayo de 2019Read on the regulator's site: AEMPSPublishedChecked
BrazilText for professionals · ZoloftSertraline: the page about it

Sexual side effects that continue after stopping5. ADVERTÊNCIAS E PRECAUÇÕES · Disfunção sexualInibidores seletivos da recaptação da serotonina (ISRSs) podem causar sintomas de disfunção sexual (vide item 9. Reações Adversas). Houve relatos de disfunção sexual de longa duração onde os sintomas continuaram apesar da descontinuação dos ISRSs.Original text: Portuguese. Our translation:Selective serotonin reuptake inhibitors (SSRIs) may cause symptoms of sexual dysfunction (see item 9. Adverse reactions). There have been reports of long-lasting sexual dysfunction where the symptoms continued despite the SSRIs being stopped.

This is the holder's own copy. The regulator's database refused our requests (it blocks by country; we asked from Denmark).

Text for professionals ZOLOFT® cloridrato de sertralina: bula do profissional de saúde (VPS)Zoloft comprimidos revestidos 50 mg e 100 mg, Viatris Farmacêutica do Brasil Ltda. · Read on the holder's own site: Viatris Farmacêutica do Brasil Ltda.Last change listedChecked
BrazilPatient leaflet · ZoloftSertraline: the page about it

Sexual side effects that continue after stopping4. O QUE DEVO SABER ANTES DE USAR ESTE MEDICAMENTO?Medicamentos inibidores seletivos da recaptação da serotonina, como o Zoloft®, podem causar sintomas de disfunção sexual. Houve relatos de disfunção sexual de longa duração onde os sintomas continuaram apesar da descontinuação destes medicamentos.Original text: Portuguese. Our translation:Selective serotonin reuptake inhibitor medicines, such as Zoloft®, may cause symptoms of sexual dysfunction. There have been reports of long-lasting sexual dysfunction where the symptoms continued despite these medicines being stopped.

This is the holder's own copy. The regulator's database refused our requests (it blocks by country; we asked from Denmark).

Patient leaflet ZOLOFT® cloridrato de sertralina: bula do paciente (VP)Zoloft comprimidos revestidos 50 mg e 100 mg, Viatris Farmacêutica do Brasil Ltda. · Read on the holder's own site: Viatris Farmacêutica do Brasil Ltda.Last change listedChecked
IndiaText for professionals · DaxidSertraline: the page about it

We could not open this text on 13 October 2026: this regulator publishes no database of such texts; the holder publishes no text. This says nothing about what the text contains.

Text for professionalsDaxid 25 mg, 50 mg, 100 mg tablets, Viatris IndiaWe tried: cdsco.gov.in/opencms/opencms/en/Notifications/Prescribing-Information/Tried

Citalopram

For the SSRI antidepressant citalopram (Celexa, Cipramil), the product information we read in the United Kingdom says there have been reports of long-lasting sexual dysfunction where symptoms continued after SSRIs or SNRIs were stopped. This is known as post-SSRI sexual dysfunction (PSSD). The EU medicines regulator set the wording of this warning in 2019 for ten medicines, citalopram among them, and a government answer in Parliament says UK product information for all SSRIs was updated in 2019 to carry it.

Citalopram: what each text says about sexual side effects, and about side effects that continue after stopping.
Country or regionWhat the text saysDocumentDates
United KingdomText for professionals · CipramilCitalopram: the page about it

Sexual side effects that continue after stopping4.4 Special warnings and precautions for use · Sexual dysfunctionSelective serotonin reuptake inhibitors (SSRIs/serotonin norepinephrine reuptake inhibitors (SNRIs) may cause symptoms of sexual dysfunction (see section 4.8). There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRI.On record since 2019, according to a government answer in parliament, 13 May 2025. That document is about the whole class of medicines. It does not name citalopram.

Sexual side effects, as listed4.8 Undesirable effects · Psychiatric disorders · CommonAgitation, libido decreased, anxiety, nervousness, confusional state, abnormal orgasm (female), abnormal dreams, apathy

Sexual side effects, as listed4.8 Undesirable effects · Psychiatric disorders · UncommonAggression, depersonalisation, hallucination, mania, libido increased

Sexual side effects, as listed4.8 Undesirable effects · Reproductive system and breast disorders · CommonImpotence, ejaculation disorder, ejaculation failure

Sexual side effects, as listed4.8 Undesirable effects · Reproductive system and breast disorders · Not knownFemale: Metrorrhagia, postpartum haemorrhage2 Male: Priapism Galactorrhoea

The same text also says4.8 Undesirable effectsAdverse effects observed with citalopram are in general mild and transient. They are most frequent during the first one or two weeks of treatment and usually attenuate subsequently.

A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.

Text for professionals Summary of Product Characteristics (SmPC): Cipramil 20 mg film-coated tabletsCipramil 20 mg film-coated tablets, Lundbeck Limited · Read in a compendium of product information: emcText revisedChecked
United KingdomPatient leaflet · CipramilCitalopram: the page about it

Sexual side effects that continue after stopping2. What you need to know before you take Cipramil · Warnings and precautions · Please note:Medicines like Cipramil (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.On record since 2019, according to a government answer in parliament, 13 May 2025. That document is about the whole class of medicines. It does not name citalopram.

Sexual side effects, as listed4. Possible side effects · Common side effects (may affect up to 1 in 10 people)Decreased sex drive

Sexual side effects, as listed4. Possible side effects · Common side effects (may affect up to 1 in 10 people)For men, problems with ejaculation and erection

Sexual side effects, as listed4. Possible side effects · Common side effects (may affect up to 1 in 10 people)For women, failing to reach an orgasm

Sexual side effects, as listed4. Possible side effects · Rare (may affect up to 1 in 1000 people)Increased sex drive

Sexual side effects, as listed4. Possible side effects · Some patient have reported (frequency not known)In men, painful erections

The same text also says4. Possible side effectsThe following side effects are often mild and usually disappear after a few days’ treatment.

Patient leaflet Package leaflet: Information for the user. Cipramil® 20 mg film-coated tablets. citalopram (as hydrobromide)Cipramil 20 mg film-coated tablets, Lundbeck Limited · Read in a compendium of product information: emcText revisedChecked
United KingdomGovernment answer in parliamentCitalopram: the page about it

Sexual side effects that continue after stoppingAnswerThe Medicines and Healthcare products Regulatory Agency (MHRA) approved product information provided to healthcare professionals and patients for all selective serotonin reuptake inhibitors (SSRIs) was updated in 2019 to inform them that reports had been received of long-lasting sexual dysfunction where symptoms continue despite discontinuation of the SSRI.

That document is about the whole class of medicines. It does not name citalopram.

Contains Parliamentary information licensed under the Open Parliament Licence v3.0.

Government answer in parliament Written question UIN 50758, House of Commons: "Selective Serotonin Reuptake Inhibitors: Sexual Dysfunction"Read on the parliament's siteAnsweredChecked
European UnionDocument from the regulatorCitalopram: the page about it

Sexual side effects that continue after stopping3. Serotonin and noradrenaline reuptake inhibitors (SNRI); selective serotonin reuptake inhibitors (SSRI) – Persistent sexual dysfunction after drug withdrawal (EPITT no 19277) · Summary of product characteristics · 4.4. Special warnings and precautions for use · Sexual dysfunctionThere have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRI.On record since 2019, according to EMA, 11 June 2019.

Sexual side effects that continue after stopping3. Serotonin and noradrenaline reuptake inhibitors (SNRI); selective serotonin reuptake inhibitors (SSRI) – Persistent sexual dysfunction after drug withdrawal (EPITT no 19277) · Package leaflet · 2. What you need to know before you take [Invented name] · Warnings and precautionsIn some cases, these symptoms have continued after stopping treatment.On record since 2019, according to EMA, 11 June 2019.

The wording is for ten medicines: citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, desvenlafaxine, duloxetine, milnacipran and venlafaxine.

This is wording for national product texts. There is no single EU product text for this medicine.

Document from the regulator New product information wording – Extracts from PRAC recommendations on signals. Adopted at the 13-16 May 2019 PRACRead on the regulator's site: European Medicines AgencyPublishedChecked
European UnionDocument from the regulatorCitalopram: the page about it

Sexual side effects that continue after stopping1.3. Serotonin and noradrenaline reuptake inhibitors (SNRI); selective serotonin reuptake inhibitors (SSRI) – Persistent sexual dysfunction after drug withdrawal · Summary of product characteristics · 4.4. Special warnings and precautions for use · Sexual dysfunctionThere have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRI.

Sexual side effects that continue after stopping1.3. Serotonin and noradrenaline reuptake inhibitors (SNRI); selective serotonin reuptake inhibitors (SSRI) – Persistent sexual dysfunction after drug withdrawal · Package leaflet · 2. What you need to know before you take [Invented name] · Warnings and precautionsIn some cases, these symptoms have continued after stopping treatment.

The wording is for ten medicines: citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, desvenlafaxine, duloxetine, milnacipran and venlafaxine.

Document from the regulator PRAC recommendations on signals. Adopted at the 13-16 May 2019 PRAC meetingRead on the regulator's site: European Medicines AgencyPublishedChecked
United StatesText for professionals · CelexaCitalopram: the page about it

Sexual side effects, as listed5 WARNINGS AND PRECAUTIONS · 5.10 Sexual DysfunctionUse of SSRIs, including CELEXA, may cause symptoms of sexual dysfunction [see Adverse Reactions (6.1)]. In male patients, SSRI use may result in ejaculatory delay or failure, decreased libido, and erectile dysfunction. In female patients, SSRI use may result in decreased libido and delayed or absent orgasm.

The same text also says5 WARNINGS AND PRECAUTIONS · 5.10 Sexual DysfunctionWhen evaluating changes in sexual function, obtaining a detailed history (including timing of symptom onset) is important because sexual symptoms may have other causes, including the underlying psychiatric disorder.

This text has no sentence about sexual side effects continuing after the medicine is stopped.

This text names sexual side effects in several places that this row does not show. Together those passages are too long to reproduce here. The document link in this row opens the text. That they are not shown says nothing about how common these side effects are.

On 14 October 2026 we searched the labels in openFDA, the FDA's open database. A sentence about sexual dysfunction continuing after stopping stood on none of the 320 labels in that database that name citalopram.

Text for professionals CELEXA (citalopram) tablets, for oral use: Full Prescribing InformationCelexa film-coated tablets 10 mg, 20 mg and 40 mg, Allergan, Inc. · Read in the government's medicines database: DailyMedText revisedChecked
United StatesPatient leaflet · CelexaCitalopram: the page about it

Sexual side effects, as listedWhat are the possible side effects of CELEXA?Sexual problems (dysfunction). Taking selective serotonin reuptake inhibitors (SSRIs), including CELEXA, may cause sexual problems.

Sexual side effects, as listedWhat are the possible side effects of CELEXA? · Sexual problems (dysfunction) · Symptoms in males may include:Delayed ejaculation or inability to have an ejaculation

Sexual side effects, as listedWhat are the possible side effects of CELEXA? · Sexual problems (dysfunction) · Symptoms in males may include:Decreased sex drive

Sexual side effects, as listedWhat are the possible side effects of CELEXA? · Sexual problems (dysfunction) · Symptoms in males may include:Problems getting or keeping an erection

Sexual side effects, as listedWhat are the possible side effects of CELEXA? · Sexual problems (dysfunction) · Symptoms in females may include:Decreased sex drive

Sexual side effects, as listedWhat are the possible side effects of CELEXA? · Sexual problems (dysfunction) · Symptoms in females may include:Delayed orgasm or inability to have an orgasm

Sexual side effects, as listedWhat are the possible side effects of CELEXA?The most common side effect of CELEXA is delayed ejaculation.

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Patient leaflet MEDICATION GUIDE: CELEXA® (Suh-leks-uh) (citalopram) Tablets, for oral useCelexa film-coated tablets 10 mg, 20 mg and 40 mg, Allergan, Inc. · Read in the government's medicines database: DailyMedText revisedChecked
CanadaText for professionals · CelexaCitalopram: the page about it

Sexual side effects that continue after stopping7. Warnings and Precautions · Reproductive Health · FunctionSelective serotonin reuptake inhibitors (SSRIs) may cause symptoms of sexual dysfunction. Patients should be informed that there have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs.

Sexual side effects that continue after stopping8. Adverse Reactions · 8.2. Clinical Trial Adverse Reactions · Male and Female Sexual Dysfunction with SSRIsFurthermore, there have been reports of long-lasting sexual dysfunction where these symptoms have continued despite discontinuation of SSRIs.

The same text also says8. Adverse Reactions · 8.2. Clinical Trial Adverse Reactions · Male and Female Sexual Dysfunction with SSRIsThis is a difficult area to study because patients may not spontaneously report symptoms of this nature, and therefore, it is thought that sexual side effects with SSRIs may be underestimated.

This text names sexual side effects in several places that this row does not show. Together those passages are too long to reproduce here. The document link in this row opens the text. That they are not shown says nothing about how common these side effects are.

Text for professionals Product Monograph Including Patient Medication Information: CELEXA®, citalopram hydrobromide, TabletsCelexa tablets 10 mg, 20 mg and 40 mg, Lundbeck Canada Inc. · Read in the regulator's own database: Drug Product DatabaseText approvedChecked
CanadaPatient leaflet · CelexaCitalopram: the page about it

Sexual side effects that continue after stoppingOther warnings you should know about:Effects on Sexual Function: Taking medicines like CELEXA may cause symptoms of sexual dysfunction. In some cases these symptoms have continued after stopping CELEXA treatment.

Sexual side effects, as listedPossible side effects from using CELEXA · Side effects may include:Ejaculation disorder

Patient leaflet Patient Medication Information: CELEXA®, Citalopram Hydrobromide TabletsCelexa tablets 10 mg, 20 mg and 40 mg, Lundbeck Canada Inc. · Read in the regulator's own database: Drug Product DatabaseText revisedChecked
CanadaDocument from the regulatorCitalopram: the page about it

Sexual side effects that continue after stoppingConclusions and actionsHealth Canada will work with manufacturers to update the product safety information for all SSRIs and SNRIs to recommend that healthcare professionals inform patients about the potential risk of long lasting (possibly weeks to years) sexual symptoms persisting after stopping SSRI or SNRI treatment.

The same text also saysConclusions and actionsHealth Canada's review could not confirm, nor rule out, a causal link between stopping SSRI or SNRI treatment and persistent sexual dysfunction.

This document is about a whole class of medicines and names citalopram among them.

Document from the regulator Summary Safety Review - Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin-norepinephrine Reuptake Inhibitors (SNRIs) - Assessing the Potential Risk of Sexual Dysfunction despite Treatment DiscontinuationRead on the regulator's site: Drug and Health Product PortalPublishedChecked
CanadaDocument from the regulatorCitalopram: the page about it

Sexual side effects that continue after stoppingProduct monograph updates · Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs)The Warnings and Precautions section of the Canadian product monographs for SSRIs (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, vilazodone and vortioxetine) and SNRIs (desvenlafaxine, duloxetine, levomilnacipran and venlafaxine) has been, or will be, updated with new safety information concerning reports of long-lasting sexual dysfunction where the symptoms have continued despite treatment discontinuation.

The same text also saysProduct monograph updates · Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) · Key messages for healthcare professionals:Health Canada’s review could not confirm, nor rule out, a causal link between discontinuing SSRI or SNRI treatment and persistent sexual dysfunction.

This document is about a whole class of medicines and names citalopram among them.

Document from the regulator Health Product InfoWatch, December 2021Read on the regulator's site: Government of Canada PublicationsPublishedChecked
AustraliaText for professionals · CIPRAMILCitalopram: the page about it

Sexual side effects that continue after stopping4.4 Special warnings and precautions for use · Sexual dysfunctionSection 4.4 of Australia's product information for Cipramil has a warning headed sexual dysfunction. It says there are reports of sexual dysfunction that lasted a long time, with symptoms going on after SSRIs or SNRIs were stopped.Summarised, not quoted, because of the TGA's access terms.

The regulator's site asks readers to accept its terms before it shows this text.

Text for professionals AUSTRALIAN PRODUCT INFORMATION – CIPRAMIL (CITALOPRAM HYDROBROMIDE) FILM-COATED TABLETSCIPRAMIL, Lundbeck Australia Pty Ltd · Read in the regulator's own database: TGA eBSText revisedChecked
AustraliaPatient leaflet · CIPRAMILCitalopram: the page about it

Sexual side effects that continue after stoppingSection 2 · WarningsAustralia's consumer medicine information for Cipramil says medicines like this one may cause sexual problems, and that in some cases these have carried on after treatment stopped.Summarised, not quoted, because of the TGA's access terms.

The regulator's site asks readers to accept its terms before it shows this text.

Patient leaflet CIPRAMIL Consumer Medicine InformationCIPRAMIL, Lundbeck Australia Pty Ltd · Read in the regulator's own database: TGA eBSText revisedChecked
New ZealandText for professionals · CipramilCitalopram: the page about it

Sexual side effects that continue after stopping4.4 Special warnings and precautions for use · Warnings · Sexual dysfunctionSelective serotonin reuptake inhibitors (SSRIs)/serotonin norepinephrine reuptake inhibitors (SNRIs) may cause symptoms of sexual dysfunction (see Section 4.8 Undesirable effects). There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRI.

This text names sexual side effects in several places that this row does not show. Together those passages are too long to reproduce here. The document link in this row opens the text. That they are not shown says nothing about how common these side effects are.

Text for professionals New Zealand Data Sheet, CipramilCipramil 20 mg film-coated tablets, Pharmacy Retailing t/a Healthcare Logistics · Read in the regulator's own database: MedsafeText revisedChecked
New ZealandPatient leaflet · CipramilCitalopram: the page about it

Sexual side effects that continue after stoppingWhile you are taking it · Things you must doMedicines like Cipramil may cause symptoms of sexual dysfunction (see section "Side effects"). In some cases, these symptoms have continued after stopping treatment.

Sexual side effects, as listedSide effects · Tell your doctor if you notice any of the following and they worry you:sexual disturbances (decreased sexual drive, problems with orgasm; problems with ejaculation or erection)

The same text also saysSide effectsThe side effects of Cipramil are, in general, mild and disappear after a short period of time.

Patient leaflet Consumer Medicine Information (CMI), CipramilCipramil 20 mg film-coated tablets, Pharmacy Retailing t/a Healthcare Logistics · Read in the regulator's own database: MedsafeText revisedChecked
New ZealandDocument from the regulatorCitalopram: the page about it

Sexual side effects that continue after stopping3.2.2 Serotonin reuptake inhibitors and persistent sexual dysfunctionThe Committee considered the European product information on this issue and determined, based on their review of the available information, that updates to the data sheets regarding the risk of persistent sexual dysfunction are necessary.

The same text also says3.2.2 Serotonin reuptake inhibitors and persistent sexual dysfunctionThe Committee considered the strength of the evidence to be low and it is difficult to draw conclusions from the available data.

What the regulator said3.2.2 Serotonin reuptake inhibitors and persistent sexual dysfunction · Recommendation 5The Committee recommended that Medsafe writes to the sponsors of serotonin reuptake inhibitors requesting updates to New Zealand data sheets.

That document is about the whole class of medicines. It does not name citalopram.

Document from the regulator Minutes of the 179th Medicines Adverse Reactions Committee Meeting, 12 September 2019Read on the regulator's site: MedsafeAdoptedChecked
New ZealandDocument from the regulatorCitalopram: the page about it

Sexual side effects that continue after stopping3.2.3 Update on sexual dysfunction (post SSRI sexual dysfunction, PSSD) following discontinuation of serotonin reuptake inhibitors · BackgroundA warning that long-lasting symptoms of sexual dysfunction following discontinuing of treatment with selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs) have been reported, is currently listed in section 4.4 of the data sheets for these medicines.

The same text also says3.2.3 Update on sexual dysfunction (post SSRI sexual dysfunction, PSSD) following discontinuation of serotonin reuptake inhibitors · DiscussionIt was highlighted that this makes it difficult to confirm a causal relationship with SSRIs/SNRIs

That document is about the whole class of medicines. It does not name citalopram.

Document from the regulator Minutes of the 206th Medicines Adverse Reactions Committee Meeting, 11 June 2026Read on the regulator's site: MedsafeAdoptedChecked
GermanyPatient leaflet · CipramilCitalopram: the page about it

Sexual side effects that continue after stopping2. Was sollten Sie vor der Einnahme von Cipramil beachten? · Warnhinweise und VorsichtsmaßnahmenIn bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen.Original text: German. Our translation:In certain cases these symptoms continued after treatment was ended.

Sexual side effects, as listed4. Welche Nebenwirkungen sind möglich? · Häufig (kann bis zu 1 von 10 Behandelten betreffen)Störungen der Sexualfunktion, wie Ejakulationsstörungen, ausbleibende Ejakulation, Impotenz, Minderung des sexuellen Interesses, bei Frauen OrgasmusstörungenOriginal text: German. Our translation:Disorders of sexual function, such as ejaculation disorders, absent ejaculation, impotence, reduced sexual interest, and in women orgasm disorders

Sexual side effects, as listed4. Welche Nebenwirkungen sind möglich? · Nicht bekannt (Häufigkeit auf Grundlage der verfügbaren Daten nicht abschätzbar)Männer: Schmerzhafte ErektionenOriginal text: German. Our translation:Men: painful erections

The same text also says4. Welche Nebenwirkungen sind möglich?Die Nebenwirkungen sind im Allgemeinen leicht und klingen gewöhnlich nach wenigen Behandlungswochen ab. Sie sollten auch wissen, dass viele dieser Symptome auch auf Ihre Krankheit zurückzuführen sein können und daher abklingen, wenn Sie beginnen, sich besser zu fühlen.Original text: German. Our translation:The side effects are generally mild and usually subside after a few weeks of treatment. You should also know that many of these symptoms may also be due to your illness and will therefore subside when you begin to feel better.

This is the copy in a compendium of product information. The regulator's database asks visitors to accept its terms first, which we did not do.

Patient leaflet Gebrauchsinformation: Information für PatientenCipramil 20 mg, Filmtabletten, Lundbeck GmbH · Read in a compendium of product information: PatientenInfo-ServiceText revisedChecked
GermanyText for professionals · CipramilCitalopram: the page about it

We could not open this text on 14 October 2026: the site asks for a login; the site asks visitors to accept its terms first, which we did not do. This says nothing about what the text contains.

Text for professionalsCipramil, Lundbeck GmbHWe tried: www.fachinfo.de/Tried
GermanyText for professionals · Citalopram-ratiopharm®Citalopram: the page about it

Sexual side effects that continue after stopping4.4 Besondere Warnhinweise und Vorsichtsmaßnahmen für die Anwendung · Sexuelle FunktionsstörungEs wurden lang anhaltende sexuelle Funktionsstörungen berichtet, bei denen die Symptome trotz der Absetzung von SSRI/SNRI bestehen blieben.Original text: German. Our translation:Long-lasting sexual dysfunction has been reported in which the symptoms continued despite the SSRI/SNRI being stopped.

Sexual side effects, as listed4.8 Nebenwirkungen · Psychiatrische Erkrankungen · HäufigAgitiertheit, verringerte Libido, Ängstlichkeit, Nervosität, Verwirrtheit, Frauen: Orgasmusstörungen, anormale Träume, ApathieOriginal text: German. Our translation:Agitation, decreased libido, anxiety, nervousness, confusion, women: orgasm disorders, abnormal dreams, apathy

Sexual side effects, as listed4.8 Nebenwirkungen · Psychiatrische Erkrankungen · SeltenGesteigerte LibidoOriginal text: German. Our translation:Increased libido

Sexual side effects, as listed4.8 Nebenwirkungen · Erkrankungen der Geschlechtsorgane und der Brustdrüse · HäufigImpotenz, Ejakulationsstörungen, ausbleibende Ejakulation, DysmenorrhöOriginal text: German. Our translation:Impotence, ejaculation disorders, absent ejaculation, dysmenorrhoea

Sexual side effects, as listed4.8 Nebenwirkungen · Erkrankungen der Geschlechtsorgane und der Brustdrüse · Nicht bekanntFrauen: Metrorrhagie, postpartale Hämorrhagie2; Männer: Priapismus; GalaktorrhöOriginal text: German. Our translation:Women: metrorrhagia, postpartum haemorrhage2; men: priapism; galactorrhoea

The same text also says4.8 NebenwirkungenDie unter Citalopram beobachteten Nebenwirkungen sind im Allgemeinen leicht und vorübergehend. Sie treten am häufigsten in den ersten ein oder zwei Behandlungswochen auf und klingen anschließend im Allgemeinen wieder ab.Original text: German. Our translation:The side effects observed with citalopram are generally mild and transient. They occur most often in the first one or two weeks of treatment and generally subside afterwards.

This is the holder's own copy. The regulator's database asks visitors to accept its terms first, which we did not do.

A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.

Text for professionals FachinformationCitalopram-ratiopharm® 10 mg / 20 mg / 40 mg Filmtabletten, ratiopharm GmbH · Read on the holder's own site: ratiopharm GmbHText revisedChecked
GermanyDocument from the regulatorCitalopram: the page about it

Sexual side effects that continue after stoppingPRAC-Meldungen · Neufassung des Wortlauts der Produktinformationen – Auszüge aus den Empfehlungen des PRAC zu Signalen · Serotonin- und Noradrenalin-Wiederaufnahmehemmer (SNRI); selektive Serotonin-Wiederaufnahmehemmer (SSRI) – persistierende sexuelle Funktionsstörung nach Absetzen von Arzneimitteln (EPITT Nr. 19277)Es wurden lang anhaltende sexuelle Funktionsstörungen berichtet, bei denen die Symptome trotz der Absetzung von SSRI/SNRI bestehen blieben.Original text: German. Our translation:Long-lasting sexual dysfunction has been reported in which the symptoms continued despite the SSRI/SNRI being stopped.

The wording is for ten medicines: citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, desvenlafaxine, duloxetine, milnacipran and venlafaxine.

Document from the regulator Bulletin zur Arzneimittelsicherheit – Informationen aus BfArM und PEI, Ausgabe 2 | Juni 2019Read on the regulator's site: BfArMPublishedChecked
FranceText for professionals · SEROPRAMCitalopram: the page about it

Sexual side effects that continue after stopping4.4. Mises en garde spéciales et précautions d'emploi · Dysfonction sexuelleDes cas de dysfonction sexuelle dont les symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS/IRSN ont été rapportés.Original text: French. Our translation:Cases of sexual dysfunction in which the symptoms continued despite stopping treatment with SSRIs/SNRIs have been reported.

Sexual side effects, as listed4.8. Effets indésirables · Affections psychiatriques · FréquentAgitation, baisse de la libido, anxiété, nervosité, confusion, anorgasmie chez la femme, rêves anormauxOriginal text: French. Our translation:Agitation, decreased libido, anxiety, nervousness, confusion, anorgasmia in women, abnormal dreams

Sexual side effects, as listed4.8. Effets indésirables · Affections des organes de reproduction et du sein · FréquentChez l’homme : impuissance, troubles de l’éjaculationOriginal text: French. Our translation:In men: impotence, ejaculation disorders

Sexual side effects, as listed4.8. Effets indésirables · Affections des organes de reproduction et du sein · Fréquence indéterminéeGalactorrhée Chez la femme : métrorragie, hémorragie du post-partum3 Chez l’homme : priapismeOriginal text: French. Our translation:Galactorrhoea In women: metrorrhagia, postpartum haemorrhage3 In men: priapism

The same text also says4.8. Effets indésirablesLes effets indésirables observés durant le traitement par citalopram sont en général d’intensité peu sévère et transitoires et sont plus fréquemment observés durant la première voire les deux premières semaines du traitement et s'estompent par la suite en intensité et en fréquence.Original text: French. Our translation:The adverse effects observed during treatment with citalopram are in general mild in intensity and transient, are seen more often during the first week, or even the first two weeks, of treatment, and then fade in intensity and in frequency.

The text itself prints no date of revision.

A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.

Text for professionals Résumé des Caractéristiques du ProduitSEROPRAM 20 mg, comprimé pelliculé sécable, LUNDBECK SAS · Read in the government's medicines database: Base de données publique des médicamentsUpdated by the regulatorChecked
FrancePatient leaflet · SEROPRAMCitalopram: the page about it

Sexual side effects that continue after stopping2. QUELLES SONT LES INFORMATIONS A CONNAITRE AVANT DE PRENDRE SEROPRAM 20 mg, comprimé pelliculé sécable ? · Avertissements et précautionsDans certains cas, ces symptômes se sont prolongés après l’arrêt du traitement.Original text: French. Our translation:In some cases, these symptoms continued after treatment was stopped.

Sexual side effects, as listed4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Fréquemment (de 1 à 10 personnes sur 100) :Diminution de la libido,Original text: French. Our translation:Decreased libido,

Sexual side effects, as listed4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Fréquemment (de 1 à 10 personnes sur 100) :Troubles de l’orgasme chez la femme,Original text: French. Our translation:Orgasm disorders in women,

Sexual side effects, as listed4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Fréquemment (de 1 à 10 personnes sur 100) :Troubles de l’éjaculation et de l’érection chez l’homme,Original text: French. Our translation:Ejaculation and erection disorders in men,

Sexual side effects, as listed4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Effets indésirables dont on ne connaît pas la fréquence :Erections douloureuses,Original text: French. Our translation:Painful erections,

Sexual side effects, as listed4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Effets indésirables dont on ne connaît pas la fréquence :Erection douloureuse et qui dure dans le temps,Original text: French. Our translation:Painful erection that goes on for a long time,

The same text also says4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?Les effets indésirables disparaissent habituellement après quelques semaines de traitement. Certains effets indésirables peuvent être des symptômes de la maladie pour laquelle vous êtes traité, qui par conséquent s’amélioreront quand vous commencerez à aller mieux.Original text: French. Our translation:The side effects usually disappear after a few weeks of treatment. Some side effects may be symptoms of the illness you are being treated for, and will therefore improve when you start to feel better.

The text itself prints no date of revision.

Patient leaflet Notice patientSEROPRAM 20 mg, comprimé pelliculé sécable, LUNDBECK SAS · Read in the government's medicines database: Base de données publique des médicamentsUpdated by the regulatorChecked
ItalyText for professionals · SeropramCitalopram: the page about it

Sexual side effects that continue after stopping4.4 Avvertenze speciali e precauzioni di impiego · Disfunzione sessualeSono stati segnalati casi di disfunzione sessuale a lungo termine con persistenza dei sintomi dopo l’interruzione dell’uso di SSRI/SNRI.Original text: Italian. Our translation:Cases of long-term sexual dysfunction have been reported, with the symptoms persisting after the use of SSRIs/SNRIs was stopped.

Sexual side effects, as listed4.8 Effetti indesiderati · Disturbi psichiatrici · ComuneAgitazione, riduzione della libido, ansia, nervosismo, stato confusionale, orgasmo anormale (donne), disturbi dell’attività oniricaOriginal text: Italian. Our translation:Agitation, decreased libido, anxiety, nervousness, confusional state, abnormal orgasm (women), disturbed dreaming

Sexual side effects, as listed4.8 Effetti indesiderati · Patologie dell’apparato riproduttivo e della mammella · ComuneImpotenza, disturbi di eiaculazione, mancata eiaculazioneOriginal text: Italian. Our translation:Impotence, ejaculation disorders, failure to ejaculate

Sexual side effects, as listed4.8 Effetti indesiderati · Patologie dell’apparato riproduttivo e della mammella · Non notaGalattorrea Donne: metrorragia, emorragia postpartum2 Uomini: priapismoOriginal text: Italian. Our translation:Galactorrhoea Women: metrorrhagia, postpartum haemorrhage2 Men: priapism

The same text also says4.8 Effetti indesideratiGli effetti indesiderati osservati con citalopram sono in generale, di lieve entità e di tipo transitorio. Essi si manifestano soprattutto nella prima o seconda settimana di terapia, per poi attenuarsi successivamente.Original text: Italian. Our translation:The adverse effects observed with citalopram are in general mild and transient. They appear mostly in the first or second week of treatment and then lessen.

The text itself prints no date of revision.

A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.

Text for professionals Riassunto delle caratteristiche del prodottoSeropram compresse rivestite con film, Lundbeck Italia S.p.A. · Read in the regulator's own database: Banca Dati FarmaciMade available by the regulatorChecked
ItalyPatient leaflet · SeropramCitalopram: the page about it

Sexual side effects that continue after stopping2. Cosa deve sapere prima di prendere SEROPRAM · Avvertenze e precauzioniIn alcuni casi, si è osservata la persistenza di questi sintomi dopo l’interruzione del trattamento.Original text: Italian. Our translation:In some cases, these symptoms have been seen to persist after treatment was stopped.

Sexual side effects, as listed4. Possibili effetti indesiderati · Comuni (possono interessare fino a 1 su 10 persone):agitazione, riduzione del desiderio sessuale (libido), ansia, nervosismo, confusione (stato confusionale), orgasmo anormale nelle donne, sogni anomali (disturbi dell’attività onirica);Original text: Italian. Our translation:agitation, reduced sexual desire (libido), anxiety, nervousness, confusion (confusional state), abnormal orgasm in women, abnormal dreams (disturbed dreaming);

Sexual side effects, as listed4. Possibili effetti indesiderati · Comuni (possono interessare fino a 1 su 10 persone):disturbi sessuali nell’uomo (impotenza, disturbi di eiaculazione, mancata eiaculazione)Original text: Italian. Our translation:sexual disorders in men (impotence, ejaculation disorders, failure to ejaculate)

Sexual side effects, as listed4. Possibili effetti indesiderati · Frequenza non nota (la cui frequenza non può essere definita sulla base dei dati disponibili):erezione prolungata e dolorosa (priapismo)Original text: Italian. Our translation:prolonged and painful erection (priapism)

The same text also says4. Possibili effetti indesideratiGli effetti indesiderati si manifestano soprattutto nella prima o seconda settimana di terapia, per poi successivamente scomparire.Original text: Italian. Our translation:The side effects appear mostly in the first or second week of treatment and then disappear.

The text itself prints no date of revision.

A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.

Patient leaflet Foglio illustrativo: informazioni per il pazienteSeropram compresse rivestite con film, Lundbeck Italia S.p.A. · Read in the regulator's own database: Banca Dati FarmaciMade available by the regulatorChecked
SpainText for professionals · SeropramCitalopram: the page about it

Sexual side effects that continue after stopping4.4. Advertencias y precauciones especiales de empleo · Disfunción sexualSe han notificado casos de disfunción sexual de larga duración en los que los síntomas persisten a pesar de la suspensión del ISRS/IRSN.Original text: Spanish. Our translation:Cases of long-lasting sexual dysfunction have been reported in which the symptoms persist despite the SSRI/SNRI being stopped.

Sexual side effects, as listed4.8. Reacciones adversas · Trastornos psiquiátricos · FrecuenteAgitación, disminución de la libido, ansiedad, nerviosismo, estado de confusión, mujeres: orgasmos anormales, sueños anormalesOriginal text: Spanish. Our translation:Agitation, decreased libido, anxiety, nervousness, confusional state, women: abnormal orgasms, abnormal dreams

Sexual side effects, as listed4.8. Reacciones adversas · Trastornos del aparato reproductor y de la mama · FrecuenteImpotencia, trastornos de la eyaculación, insuficiencia eyaculatoriaOriginal text: Spanish. Our translation:Impotence, ejaculation disorders, ejaculation failure

Sexual side effects, as listed4.8. Reacciones adversas · Trastornos del aparato reproductor y de la mama · No conocidaGalactorrea Mujeres: metrorragia, hemorragia posparto2 Hombres: priapismoOriginal text: Spanish. Our translation:Galactorrhoea Women: metrorrhagia, postpartum haemorrhage2 Men: priapism

The same text also says4.8. Reacciones adversasLas reacciones adversas observadas con citalopram son generalmente de intensidad leve y transitoria. Son más frecuentes durante la primera o las dos primeras semanas del tratamiento, y posteriormente, normalmente, van desapareciendo.Original text: Spanish. Our translation:The adverse reactions observed with citalopram are generally mild in intensity and transient. They are most frequent during the first one or two weeks of treatment, and afterwards they normally fade away.

A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.

Text for professionals Ficha técnicaSeropram 30 mg comprimidos recubiertos con película, Lundbeck España, SA · Read in the regulator's own database: CIMAText revisedChecked
SpainPatient leaflet · SeropramCitalopram: the page about it

Sexual side effects that continue after stopping2. Qué necesita saber antes de empezar a tomar Seropram · Advertencias y precaucionesEn algunos casos, estos síntomas persisten después de suspender el tratamiento.Original text: Spanish. Our translation:In some cases, these symptoms persist after treatment is stopped.

Sexual side effects, as listed4. Posibles efectos adversos · Efectos adversos frecuentes (Pueden afectar hasta 1 de cada 10 personas):Disminución de la conducta sexual.Original text: Spanish. Our translation:Decrease in sexual behaviour.

Sexual side effects, as listed4. Posibles efectos adversos · Efectos adversos frecuentes (Pueden afectar hasta 1 de cada 10 personas):Los hombres pueden experimentar problemas con la eyaculación y erección.Original text: Spanish. Our translation:Men may experience problems with ejaculation and erection.

Sexual side effects, as listed4. Posibles efectos adversos · Efectos adversos frecuentes (Pueden afectar hasta 1 de cada 10 personas):Las mujeres pueden experimentar dificultad para alcanzar el orgasmo.Original text: Spanish. Our translation:Women may experience difficulty reaching orgasm.

Sexual side effects, as listed4. Posibles efectos adversos · Frecuencia no conocida (no puede estimarse a partir de los datos disponibles):Erecciones dolorosas.Original text: Spanish. Our translation:Painful erections.

The same text also says4. Posibles efectos adversosLos siguientes efectos adversos son generalmente leves y normalmente desaparecen después de algunos días de tratamiento.Original text: Spanish. Our translation:The following side effects are generally mild and normally disappear after a few days of treatment.

Patient leaflet Prospecto: información para el usuarioSeropram 30 mg Comprimidos recubiertos con película, Lundbeck España, SA · Read in the regulator's own database: CIMAText revisedChecked
SpainDocument from the regulatorCitalopram: the page about it

Sexual side effects that continue after stoppingInformación sobre seguridad · Nueva información de seguridad procedente de la evaluación periódica de los datos de farmacovigilancia · Inhibidores selectivos de la recaptación de serotonina (SRS)/serotonina y noradrenalina (ISRN): persistencia de disfunción sexualEn pacientes a tratamiento con inhibidores de la recaptación de serotonina y noradrenalina, o con inhibidores selectivos de la recaptación de serotonina, se han notificado casos de disfunción sexual de larga duración en los que los síntomas persisten a pesar de la interrupción del tratamiento. Se incorporará este hallazgo a las advertencias de estos medicamentos.Original text: Spanish. Our translation:In patients treated with serotonin and noradrenaline reuptake inhibitors, or with selective serotonin reuptake inhibitors, cases of long-lasting sexual dysfunction have been reported in which the symptoms persist despite treatment being stopped. This finding will be added to the warnings of these medicines.

That document is about the whole class of medicines. It does not name citalopram.

Spelling and punctuation are the document's own.

Document from the regulator Boletín mensual de la AEMPS sobre medicamentos de uso humano. Mayo de 2019Read on the regulator's site: AEMPSPublishedChecked
BrazilText for professionals · DenylCitalopram: the page about it

Sexual side effects, as listed9. REAÇÕES ADVERSAS · Distúrbios psiquiátricos · ComumAgitação, diminuição da libido, ansiedade, nervosismo, confusão, sonhos anormais, orgasmo anormal em mulheresOriginal text: Portuguese. Our translation:Agitation, decreased libido, anxiety, nervousness, confusion, abnormal dreams, abnormal orgasm in women

Sexual side effects, as listed9. REAÇÕES ADVERSAS · Distúrbios do sistema reprodutor e mamas · ComumImpotência, alterações da ejaculação, falha da ejaculaçãoOriginal text: Portuguese. Our translation:Impotence, ejaculation disorders, ejaculation failure

Sexual side effects, as listed9. REAÇÕES ADVERSAS · Distúrbios do sistema reprodutor e mamas · DesconhecidoGalactorréia Mulheres: metrorragia, Hemorragia pós-parto² Homens: priapismoOriginal text: Portuguese. Our translation:Galactorrhoea Women: metrorrhagia, postpartum haemorrhage² Men: priapism

The same text also says9. REAÇÕES ADVERSASAs reações adversas observadas com citalopram são em geral moderadas e transitórias. As reações adversas são mais frequentes durante a primeira ou segunda semana de tratamento e, geralmente, diminuem de intensidade e frequência com a continuação do tratamento.Original text: Portuguese. Our translation:The adverse reactions observed with citalopram are in general moderate and transient. Adverse reactions are most frequent during the first or second week of treatment and generally decrease in intensity and frequency as treatment continues.

This text has no sentence about sexual side effects continuing after the medicine is stopped.

This is the holder's own copy. The regulator's database refused our requests (it blocks by country; we asked from Denmark).

The originator product's text could not be opened. This is the text of another product, the one named in this row.

A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.

Text for professionals DENYL® bromidrato de citalopram: bula para o profissional de saúdeDenyl comprimidos revestidos 20 mg, Cristália Produtos Químicos Farmacêuticos Ltda. · Read on the holder's own site: Cristália Produtos Químicos Farmacêuticos Ltda.Last change listedChecked
BrazilText for professionals · CipramilCitalopram: the page about it

We could not open this text on 14 October 2026: the site refused our requests (it blocks by country; we asked from Denmark); the holder publishes no text. This says nothing about what the text contains.

Text for professionalsCipramil, Lundbeck Brasil Ltda.We tried: consultas.anvisa.gov.br/#/bulario/Tried
BrazilPatient leaflet · DenylCitalopram: the page about it

Sexual side effects, as listed8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE CAUSAR? · Reação comum - ocorre entre 1% e 10% (> 1/100 e ≤ 1/10) dos pacientes que utilizam este medicamento:diminuição do desejo sexualOriginal text: Portuguese. Our translation:decreased sexual desire

Sexual side effects, as listed8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE CAUSAR? · Reação comum - ocorre entre 1% e 10% (> 1/100 e ≤ 1/10) dos pacientes que utilizam este medicamento:homens podem apresentar problemas de ereção e ejaculação,e mulheres podem apresentar dificuldade para chegar ao orgasmoOriginal text: Portuguese. Our translation:men may have problems with erection and ejaculation, and women may have difficulty reaching orgasm

Sexual side effects, as listed8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE CAUSAR? · Alguns pacientes já apresentaram (frequência desconhecida):ereção dolorosa (priapismo)Original text: Portuguese. Our translation:painful erection (priapism)

The same text also says8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE CAUSAR?Os seguintes efeitos adversos descritos a seguir são geralmente ligeiros e desaparecem habitualmente após alguns dias de tratamento.Original text: Portuguese. Our translation:The adverse effects described below are generally mild and usually disappear after a few days of treatment.

This text has no sentence about sexual side effects continuing after the medicine is stopped.

This is the holder's own copy. The regulator's database refused our requests (it blocks by country; we asked from Denmark).

Patient leaflet DENYL® bromidrato de citalopram: bula para o pacienteDenyl comprimidos revestidos 20 mg, Cristália Produtos Químicos Farmacêuticos Ltda. · Read on the holder's own site: Cristália Produtos Químicos Farmacêuticos Ltda.Last change listedChecked
BrazilPatient leaflet · AlcytamCitalopram: the page about it

Sexual side effects, as listed8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Reação comum (ocorre entre 1% e 10% (> 1/100 e < 1/10) dos pacientes que utilizam este medicamento):diminuição do desejo sexualOriginal text: Portuguese. Our translation:decreased sexual desire

Sexual side effects, as listed8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Reação comum (ocorre entre 1% e 10% (> 1/100 e < 1/10) dos pacientes que utilizam este medicamento):homens podem apresentar problemas de ereção e ejaculação, e mulheres podem apresentar dificuldade para chegar ao orgasmoOriginal text: Portuguese. Our translation:men may have problems with erection and ejaculation, and women may have difficulty reaching orgasm

Sexual side effects, as listed8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Alguns pacientes já apresentaram (frequência desconhecida):ereção dolorosa (priapismo)Original text: Portuguese. Our translation:painful erection (priapism)

The same text also says8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?Os seguintes efeitos adversos descritos a seguir são geralmente ligeiros e desaparecem habitualmente após alguns dias de tratamento.Original text: Portuguese. Our translation:The adverse effects described below are generally mild and usually disappear after a few days of treatment.

This text has no sentence about sexual side effects continuing after the medicine is stopped.

This is the holder's own copy. The regulator's database refused our requests (it blocks by country; we asked from Denmark).

Patient leaflet ALCYTAM® bromidrato de citalopram: bula para pacienteAlcytam comprimido revestido 20 mg, Torrent do Brasil Ltda. · Read on the holder's own site: Torrent do Brasil Ltda.Text approvedChecked
BrazilPatient leaflet · CipramilCitalopram: the page about it

We could not open this text on 14 October 2026: the site refused our requests (it blocks by country; we asked from Denmark); the holder publishes no text. This says nothing about what the text contains.

Patient leafletCipramil, Lundbeck Brasil Ltda.We tried: consultas.anvisa.gov.br/#/bulario/Tried
IndiaText for professionalsCitalopram: the page about it

We could not open this text on 14 October 2026: this regulator publishes no database of such texts. This says nothing about what the text contains.

Text for professionalsWe tried: cdsco.gov.in/opencms/opencms/en/Notifications/Prescribing-Information/Tried

Escitalopram

For the SSRI antidepressant escitalopram (Lexapro, Cipralex), the product information we read in the United Kingdom says there have been reports of long-lasting sexual dysfunction where symptoms continued after SSRIs or SNRIs were stopped. This is known as post-SSRI sexual dysfunction (PSSD). The EU medicines regulator set the wording of this warning in 2019 for ten medicines, escitalopram among them, and a government answer in Parliament says UK product information for all SSRIs was updated in 2019 to carry it.

Escitalopram: what each text says about sexual side effects, and about side effects that continue after stopping.
Country or regionWhat the text saysDocumentDates
United KingdomText for professionals · CipralexEscitalopram: the page about it

Sexual side effects that continue after stopping4.4 Special warnings and precautions for use · Sexual dysfunctionSelective serotonin reuptake inhibitors (SSRIs)/serotonin norepinephrine reuptake inhibitors (SNRIs) may cause symptoms of sexual dysfunction (see section 4.8). There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRI.On record since 2019, according to a government answer in parliament, 13 May 2025. That document is about the whole class of medicines. It does not name escitalopram.

Sexual side effects, as listed4.8 Undesirable effects · Psychiatric disorders · CommonAnxiety, restlessness, abnormal dreams libido decreased Female: anorgasmia

Sexual side effects, as listed4.8 Undesirable effects · Reproductive system and breast disorders · CommonMale: ejaculation disorder, impotence

Sexual side effects, as listed4.8 Undesirable effects · Reproductive system and breast disorders · Not knownGalactorrhoea Male: priapism Postpartum haemorrhage3

The same text also says4.8 Undesirable effectsAdverse reactions are most frequent during the first or second week of treatment and usually decrease in intensity and frequency with continued treatment.

A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.

Text for professionals Summary of Product Characteristics (SmPC): Cipralex 10 mg film-coated tabletsCipralex 5 mg, 10 mg and 20 mg film-coated tablets, Lundbeck Limited · Read in a compendium of product information: emcText revisedChecked
United KingdomPatient leaflet · CipralexEscitalopram: the page about it

Sexual side effects that continue after stopping2. What you need to know before you take Cipralex · Warning and Precautions · Please noteMedicines like Cipralex (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.On record since 2019, according to a government answer in parliament, 13 May 2025. That document is about the whole class of medicines. It does not name escitalopram.

Sexual side effects, as listed4. POSSIBLE SIDE EFFECTS · Common (may affect up to 1 in 10 people):Sexual disturbances (delayed ejaculation, problems with erection, decreased sexual drive and women may experience difficulties achieving orgasm)

Sexual side effects, as listed4. POSSIBLE SIDE EFFECTS · Not known (frequency cannot be estimated from the available data):Painful erections (priapism)

The same text also says4. POSSIBLE SIDE EFFECTSThe side effects usually disappear after a few weeks of treatment. Please be aware that many of the effects may also be symptoms of your illness and therefore will improve when you start to get better.

Patient leaflet PACKAGE LEAFLET: INFORMATION FOR THE USER. Cipralex 5 mg film-coated tablets, Cipralex 10 mg film-coated tablets, Cipralex 20 mg film-coated tablets. escitalopramCipralex 5 mg, 10 mg and 20 mg film-coated tablets, Lundbeck Limited · Read in a compendium of product information: emcText revisedChecked
United KingdomGovernment answer in parliamentEscitalopram: the page about it

Sexual side effects that continue after stoppingAnswerThe Medicines and Healthcare products Regulatory Agency (MHRA) approved product information provided to healthcare professionals and patients for all selective serotonin reuptake inhibitors (SSRIs) was updated in 2019 to inform them that reports had been received of long-lasting sexual dysfunction where symptoms continue despite discontinuation of the SSRI.

That document is about the whole class of medicines. It does not name escitalopram.

Contains Parliamentary information licensed under the Open Parliament Licence v3.0.

Government answer in parliament Written question UIN 50758, House of Commons: "Selective Serotonin Reuptake Inhibitors: Sexual Dysfunction"Read on the parliament's siteAnsweredChecked
European UnionDocument from the regulatorEscitalopram: the page about it

Sexual side effects that continue after stopping3. Serotonin and noradrenaline reuptake inhibitors (SNRI); selective serotonin reuptake inhibitors (SSRI) – Persistent sexual dysfunction after drug withdrawal (EPITT no 19277) · Summary of product characteristics · 4.4. Special warnings and precautions for use · Sexual dysfunctionThere have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRI.On record since 2019, according to EMA, 11 June 2019.

Sexual side effects that continue after stopping3. Serotonin and noradrenaline reuptake inhibitors (SNRI); selective serotonin reuptake inhibitors (SSRI) – Persistent sexual dysfunction after drug withdrawal (EPITT no 19277) · Package leaflet · 2. What you need to know before you take [Invented name] · Warnings and precautionsIn some cases, these symptoms have continued after stopping treatment.On record since 2019, according to EMA, 11 June 2019.

The wording is for ten medicines: citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, desvenlafaxine, duloxetine, milnacipran and venlafaxine.

This is wording for national product texts. There is no single EU product text for this medicine.

Document from the regulator New product information wording – Extracts from PRAC recommendations on signals. Adopted at the 13-16 May 2019 PRACRead on the regulator's site: European Medicines AgencyPublishedChecked
European UnionDocument from the regulatorEscitalopram: the page about it

Sexual side effects that continue after stopping1.3. Serotonin and noradrenaline reuptake inhibitors (SNRI); selective serotonin reuptake inhibitors (SSRI) – Persistent sexual dysfunction after drug withdrawal · Summary of product characteristics · 4.4. Special warnings and precautions for use · Sexual dysfunctionThere have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRI.

Sexual side effects that continue after stopping1.3. Serotonin and noradrenaline reuptake inhibitors (SNRI); selective serotonin reuptake inhibitors (SSRI) – Persistent sexual dysfunction after drug withdrawal · Package leaflet · 2. What you need to know before you take [Invented name] · Warnings and precautionsIn some cases, these symptoms have continued after stopping treatment.

The wording is for ten medicines: citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, desvenlafaxine, duloxetine, milnacipran and venlafaxine.

Document from the regulator PRAC recommendations on signals. Adopted at the 13-16 May 2019 PRAC meetingRead on the regulator's site: European Medicines AgencyPublishedChecked
United StatesText for professionals · LexaproEscitalopram: the page about it

Sexual side effects, as listed5 WARNINGS AND PRECAUTIONS · 5.11 Sexual DysfunctionUse of SSRIs, including Lexapro, may cause symptoms of sexual dysfunction [see Adverse Reactions (6.1)]. In male patients, SSRI use may result in ejaculatory delay or failure, decreased libido, and erectile dysfunction. In female patients, SSRI use may result in decreased libido and delayed or absent orgasm.

The same text also says5 WARNINGS AND PRECAUTIONS · 5.11 Sexual DysfunctionWhen evaluating changes in sexual function, obtaining a detailed history (including timing of symptom onset) is important because sexual symptoms may have other causes, including the underlying psychiatric disorder.

This text has no sentence about sexual side effects continuing after the medicine is stopped.

This text names sexual side effects in several places that this row does not show. Together those passages are too long to reproduce here. The document link in this row opens the text. That they are not shown says nothing about how common these side effects are.

On 14 October 2026 we searched the labels in openFDA, the FDA's open database. A sentence about sexual dysfunction continuing after stopping stood on none of the 332 labels in that database that name escitalopram.

Text for professionals Lexapro® (escitalopram) tablets, for oral use; Lexapro® (escitalopram) oral solution: Full Prescribing InformationLexapro film-coated tablets 5 mg, 10 mg and 20 mg, and oral solution 1 mg per mL, Allergan, Inc. · Read in the government's medicines database: DailyMedText revisedChecked
United StatesPatient leaflet · LexaproEscitalopram: the page about it

Sexual side effects, as listedWhat are the possible side effects of Lexapro?Sexual problems (dysfunction). Taking Lexapro may cause sexual problems.

Sexual side effects, as listedWhat are the possible side effects of Lexapro? · Sexual problems (dysfunction) · Symptoms in males may include:delayed ejaculation or inability to have an ejaculation

Sexual side effects, as listedWhat are the possible side effects of Lexapro? · Sexual problems (dysfunction) · Symptoms in males may include:decreased sex drive

Sexual side effects, as listedWhat are the possible side effects of Lexapro? · Sexual problems (dysfunction) · Symptoms in males may include:problems getting or keeping an erection

Sexual side effects, as listedWhat are the possible side effects of Lexapro? · Sexual problems (dysfunction) · Symptoms in females may include:decreased sex drive

Sexual side effects, as listedWhat are the possible side effects of Lexapro? · Sexual problems (dysfunction) · Symptoms in females may include:delayed orgasm or inability to have an orgasm

Sexual side effects, as listedWhat are the possible side effects of Lexapro? · The most common side effects of Lexapro include:decreased sex drive

Sexual side effects, as listedWhat are the possible side effects of Lexapro? · The most common side effects of Lexapro include:delayed ejaculation

Sexual side effects, as listedWhat are the possible side effects of Lexapro? · The most common side effects of Lexapro include:delayed orgasm or inability to have an orgasm

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Patient leaflet MEDICATION GUIDE: Lexapro® (leks-a-pro) (escitalopram) tablets oral solutionLexapro film-coated tablets 5 mg, 10 mg and 20 mg, and oral solution 1 mg per mL, Allergan, Inc. · Read in the government's medicines database: DailyMedText revisedChecked
CanadaText for professionals · CipralexEscitalopram: the page about it

Sexual side effects that continue after stopping7 WARNINGS AND PRECAUTIONS · Reproductive Health: Female and Male Potential · FunctionSelective serotonin reuptake inhibitors (SSRIs) may cause symptoms of sexual dysfunction. Patients should be informed that there have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs.

Sexual side effects that continue after stopping8 ADVERSE REACTIONS · 8.2 Clinical Trial Adverse Reactions · Male and Female Sexual Dysfunction with SSRIsFurthermore, there have been reports of long-lasting sexual dysfunction where these symptoms have continued despite discontinuation of SSRIs.

The same text also says8 ADVERSE REACTIONS · 8.2 Clinical Trial Adverse Reactions · Male and Female Sexual Dysfunction with SSRIsThis is a difficult area to study because patients may not spontaneously report symptoms of this nature, and therefore, it is thought that sexual side effects with SSRIs may be underestimated.

This text names sexual side effects in several places that this row does not show. Together those passages are too long to reproduce here. The document link in this row opens the text. That they are not shown says nothing about how common these side effects are.

Text for professionals PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION: CIPRALEX, escitalopram oxalate (as escitalopram), TabletsCipralex tablets 5, 10, 15 and 20 mg escitalopram (base), Lundbeck Canada Inc. · Read in the regulator's own database: Drug Product DatabaseText revisedChecked
CanadaPatient leaflet · CipralexEscitalopram: the page about it

Sexual side effects that continue after stoppingOther warnings you should know about:Effects on Sexual Function: Taking medicines like CIPRALEX may cause symptoms of sexual dysfunction. In some cases these symptoms have continued after stopping CIPRALEX treatment.

Sexual side effects, as listedWhat are possible side effects from using CIPRALEX? · Side effects may include:decreased interest in sex

Sexual side effects, as listedWhat are possible side effects from using CIPRALEX? · Side effects may include:decreased ability to reach orgasm

Sexual side effects, as listedWhat are possible side effects from using CIPRALEX? · Side effects may include:erectile dysfunction

Patient leaflet PATIENT MEDICATION INFORMATION: CIPRALEX, escitalopram oxalate tabletsCipralex tablets 5, 10, 15 and 20 mg escitalopram (base), Lundbeck Canada Inc. · Read in the regulator's own database: Drug Product DatabaseText revisedChecked
CanadaDocument from the regulatorEscitalopram: the page about it

Sexual side effects that continue after stoppingConclusions and actionsHealth Canada will work with manufacturers to update the product safety information for all SSRIs and SNRIs to recommend that healthcare professionals inform patients about the potential risk of long lasting (possibly weeks to years) sexual symptoms persisting after stopping SSRI or SNRI treatment.

The same text also saysConclusions and actionsHealth Canada's review could not confirm, nor rule out, a causal link between stopping SSRI or SNRI treatment and persistent sexual dysfunction.

This document is about a whole class of medicines and names escitalopram among them.

Document from the regulator Summary Safety Review - Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin-norepinephrine Reuptake Inhibitors (SNRIs) - Assessing the Potential Risk of Sexual Dysfunction despite Treatment DiscontinuationRead on the regulator's site: Drug and Health Product PortalPublishedChecked
CanadaDocument from the regulatorEscitalopram: the page about it

Sexual side effects that continue after stoppingProduct monograph updates · Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs)The Warnings and Precautions section of the Canadian product monographs for SSRIs (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, vilazodone and vortioxetine) and SNRIs (desvenlafaxine, duloxetine, levomilnacipran and venlafaxine) has been, or will be, updated with new safety information concerning reports of long-lasting sexual dysfunction where the symptoms have continued despite treatment discontinuation.

The same text also saysProduct monograph updates · Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) · Key messages for healthcare professionals:Health Canada’s review could not confirm, nor rule out, a causal link between discontinuing SSRI or SNRI treatment and persistent sexual dysfunction.

This document is about a whole class of medicines and names escitalopram among them.

Document from the regulator Health Product InfoWatch, December 2021Read on the regulator's site: Government of Canada PublicationsPublishedChecked
AustraliaText for professionals · LEXAPROEscitalopram: the page about it

Sexual side effects that continue after stoppingSection 4.4 · Sexual DysfunctionSection 4.4 of Australia's product information for Lexapro has a warning headed sexual dysfunction. It says there are reports of sexual dysfunction that lasted a long time, with symptoms going on after SSRIs or SNRIs were stopped.Summarised, not quoted, because of the TGA's access terms.In this product's text since 2023, according to the text for professionals, 23 August 2023.

The regulator's site asks readers to accept its terms before it shows this text.

Text for professionals AUSTRALIAN PRODUCT INFORMATION – LEXAPRO (ESCITALOPRAM OXALATE) FILM-COATED TABLETS AND ORAL SOLUTIONLEXAPRO, Lundbeck Australia Pty Ltd · Read in the regulator's own database: TGA eBSText revisedChecked
AustraliaPatient leaflet · LEXAPROEscitalopram: the page about it

Sexual side effects that continue after stoppingSection 2 · WarningsAustralia's consumer medicine information for Lexapro tablets says medicines like this one may cause sexual problems, and that in some cases these have carried on after treatment stopped.Summarised, not quoted, because of the TGA's access terms.

The regulator's site asks readers to accept its terms before it shows this text.

Patient leaflet Lexapro Tablets, Consumer Medicine InformationLEXAPRO, Lundbeck Australia Pty Ltd · Read in the regulator's own database: TGA eBSText revisedChecked
New ZealandText for professionals · LexaproEscitalopram: the page about it

Sexual side effects that continue after stopping4.4 Special warnings and precautions for use · Warnings · Sexual dysfunctionSelective serotonin reuptake inhibitors (SSRIs)/serotonin norepinephrine reuptake inhibitors (SNRIs) may cause symptoms of sexual dysfunction (see Section 4.8 Undesirable effects). There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRI.

This text names sexual side effects in several places that this row does not show. Together those passages are too long to reproduce here. The document link in this row opens the text. That they are not shown says nothing about how common these side effects are.

Text for professionals New Zealand Data Sheet, LexaproLexapro 10 mg and 20 mg film-coated tablets, Pharmacy Retailing t/a Healthcare Logistics · Read in the regulator's own database: MedsafeText revisedChecked
New ZealandPatient leaflet · LexaproEscitalopram: the page about it

Sexual side effects that continue after stoppingWhile you are taking it · Things you must doMedicines like Lexapro may cause symptoms of sexual dysfunction (see section "Side effects"). In some cases, these symptoms have continued after stopping treatment.

Sexual side effects, as listedSide effects · Tell your doctor if you notice any of the following and they worry you:sexual disturbances (decreased sexual drive; problems with ejaculation or erection; women may experience difficulties achieving orgasm)

The same text also saysSide effectsThe side effects of Lexapro are, in general, mild and disappear after a short period of time.

Patient leaflet Consumer Medicine Information, LexaproLexapro 10 mg and 20 mg film-coated tablets, Pharmacy Retailing t/a Healthcare Logistics · Read in the regulator's own database: MedsafeText revisedChecked
New ZealandDocument from the regulatorEscitalopram: the page about it

Sexual side effects that continue after stopping3.2.2 Serotonin reuptake inhibitors and persistent sexual dysfunctionThe Committee considered the European product information on this issue and determined, based on their review of the available information, that updates to the data sheets regarding the risk of persistent sexual dysfunction are necessary.

The same text also says3.2.2 Serotonin reuptake inhibitors and persistent sexual dysfunctionThe Committee considered the strength of the evidence to be low and it is difficult to draw conclusions from the available data.

What the regulator said3.2.2 Serotonin reuptake inhibitors and persistent sexual dysfunction · Recommendation 5The Committee recommended that Medsafe writes to the sponsors of serotonin reuptake inhibitors requesting updates to New Zealand data sheets.

That document is about the whole class of medicines. It does not name escitalopram.

Document from the regulator Minutes of the 179th Medicines Adverse Reactions Committee Meeting, 12 September 2019Read on the regulator's site: MedsafeAdoptedChecked
New ZealandDocument from the regulatorEscitalopram: the page about it

Sexual side effects that continue after stopping3.2.3 Update on sexual dysfunction (post SSRI sexual dysfunction, PSSD) following discontinuation of serotonin reuptake inhibitors · BackgroundA warning that long-lasting symptoms of sexual dysfunction following discontinuing of treatment with selective serotonin reuptake inhibitors (SSRIs) and serotonin and noradrenaline reuptake inhibitors (SNRIs) have been reported, is currently listed in section 4.4 of the data sheets for these medicines.

The same text also says3.2.3 Update on sexual dysfunction (post SSRI sexual dysfunction, PSSD) following discontinuation of serotonin reuptake inhibitors · DiscussionIt was highlighted that this makes it difficult to confirm a causal relationship with SSRIs/SNRIs

That document is about the whole class of medicines. It does not name escitalopram.

Document from the regulator Minutes of the 206th Medicines Adverse Reactions Committee Meeting, 11 June 2026Read on the regulator's site: MedsafeAdoptedChecked
GermanyPatient leaflet · CipralexEscitalopram: the page about it

Sexual side effects that continue after stopping2. Was sollten Sie vor der Einnahme von Cipralex beachten? · Warnhinweise und VorsichtsmaßnahmenIn bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen.Original text: German. Our translation:In certain cases these symptoms continued after treatment was ended.

Sexual side effects, as listed4. Welche Nebenwirkungen sind möglich? · Häufig (kann bis zu 1 von 10 Behandelten betreffen):Störungen der Sexualfunktion (verzögerte Ejakulation, Erektionsstörungen, Minderung des sexuellen Interesses und bei Frauen Orgasmusstörungen)Original text: German. Our translation:Disorders of sexual function (delayed ejaculation, erection problems, reduced sexual interest and, in women, orgasm problems)

Sexual side effects, as listed4. Welche Nebenwirkungen sind möglich? · Nicht bekannt (Häufigkeit auf Grundlage der verfügbaren Daten nicht abschätzbar):Schmerzhafte Erektionen (Priapismus)Original text: German. Our translation:Painful erections (priapism)

The same text also says4. Welche Nebenwirkungen sind möglich?Die Nebenwirkungen klingen gewöhnlich nach wenigen Behandlungswochen ab. Sie sollten auch wissen, dass viele dieser Symptome auch auf Ihre Krankheit zurückzuführen sein können und daher abklingen, wenn Sie beginnen, sich besser zu fühlen.Original text: German. Our translation:The side effects usually wear off after a few weeks of treatment. You should also know that many of these symptoms can also be due to your illness and so wear off when you begin to feel better.

This is the copy in a compendium of product information. The regulator's database asks visitors to accept its terms first, which we did not do.

Patient leaflet Gebrauchsinformation: Information für AnwenderCipralex 10 mg Filmtabletten, H. Lundbeck A/S · Read in a compendium of product information: PatientenInfo-ServiceText revisedChecked
GermanyText for professionals · CipralexEscitalopram: the page about it

We could not open this text on 14 October 2026: the site asks for a login; the site asks visitors to accept its terms first, which we did not do. This says nothing about what the text contains.

Text for professionalsCipralex, H. Lundbeck A/SWe tried: www.fachinfo.de/Tried
GermanyText for professionals · Escitalopram-ratiopharm®Escitalopram: the page about it

Sexual side effects that continue after stopping4.4 Besondere Warnhinweise und Vorsichtsmaßnahmen für die Anwendung · Sexuelle FunktionsstörungEs wurden lang anhaltende sexuelle Funktionsstörungen berichtet, bei denen die Symptome trotz der Absetzung von SSRI/SNRI bestehen blieben.Original text: German. Our translation:Long-lasting sexual dysfunction has been reported in which the symptoms continued despite the SSRI/SNRI being stopped.

Sexual side effects, as listed4.8 Nebenwirkungen · Psychiatrische Erkrankungen · HäufigÄngstlichkeit, Ruhelosigkeit, anormale Träume, verringerte Libido Frauen: AnorgasmieOriginal text: German. Our translation:Anxiety, restlessness, abnormal dreams, decreased libido Women: anorgasmia

Sexual side effects, as listed4.8 Nebenwirkungen · Erkrankungen der Geschlechtsorgane und der Brustdrüse · HäufigMänner: Ejakulationsstörungen, ImpotenzOriginal text: German. Our translation:Men: ejaculation disorders, impotence

Sexual side effects, as listed4.8 Nebenwirkungen · Erkrankungen der Geschlechtsorgane und der Brustdrüse · Nicht bekanntGalaktorrhö, postpartale Hämorrhagie3 Männer: PriapismusOriginal text: German. Our translation:Galactorrhoea, postpartum haemorrhage3 Men: priapism

The same text also says4.8 NebenwirkungenAm häufigsten treten Nebenwirkungen in der ersten oder zweiten Behandlungswoche auf und nehmen normalerweise bei fortgesetzter Behandlung an Intensität und Häufigkeit ab.Original text: German. Our translation:Side effects occur most often in the first or second week of treatment and normally decrease in intensity and frequency with continued treatment.

This is the holder's own copy. The regulator's database asks visitors to accept its terms first, which we did not do.

A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.

Text for professionals FachinformationEscitalopram-ratiopharm® 5 mg / 10 mg / 15 mg / 20 mg Filmtabletten, ratiopharm GmbH · Read on the holder's own site: ratiopharm GmbHText revisedChecked
GermanyDocument from the regulatorEscitalopram: the page about it

Sexual side effects that continue after stoppingPRAC-Meldungen · Neufassung des Wortlauts der Produktinformationen – Auszüge aus den Empfehlungen des PRAC zu Signalen · Serotonin- und Noradrenalin-Wiederaufnahmehemmer (SNRI); selektive Serotonin-Wiederaufnahmehemmer (SSRI) – persistierende sexuelle Funktionsstörung nach Absetzen von Arzneimitteln (EPITT Nr. 19277)Es wurden lang anhaltende sexuelle Funktionsstörungen berichtet, bei denen die Symptome trotz der Absetzung von SSRI/SNRI bestehen blieben.Original text: German. Our translation:Long-lasting sexual dysfunction has been reported in which the symptoms continued despite the SSRI/SNRI being stopped.

The wording is for ten medicines: citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, desvenlafaxine, duloxetine, milnacipran and venlafaxine.

Document from the regulator Bulletin zur Arzneimittelsicherheit – Informationen aus BfArM und PEI, Ausgabe 2 | Juni 2019Read on the regulator's site: BfArMPublishedChecked
FranceText for professionals · SEROPLEXEscitalopram: the page about it

Sexual side effects that continue after stopping4.4. Mises en garde spéciales et précautions d'emploi · Dysfonction sexuelleDes cas de dysfonction sexuelle dont les symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS/IRSN ont été rapportés.Original text: French. Our translation:Cases of sexual dysfunction in which the symptoms continued despite stopping treatment with SSRIs/SNRIs have been reported.

Sexual side effects, as listed4.8. Effets indésirables · Affections psychiatriques · FréquentAnxiété, impatiences, rêves anormaux, baisse de la libido Chez la femme : anorgasmieOriginal text: French. Our translation:Anxiety, restlessness, abnormal dreams, decreased libido In women: anorgasmia

Sexual side effects, as listed4.8. Effets indésirables · Affections des organes de reproduction et du sein · FréquentChez l’homme : troubles de l’éjaculation, impuissanceOriginal text: French. Our translation:In men: ejaculation disorders, impotence

Sexual side effects, as listed4.8. Effets indésirables · Affections des organes de reproduction et du sein · Fréquence indéterminéeGalactorrhée Chez l’homme : priapisme Hémorragie du post-partum3Original text: French. Our translation:Galactorrhoea In men: priapism Postpartum haemorrhage3

The same text also says4.8. Effets indésirablesLes effets indésirables sont surtout notés durant la première ou la seconde semaine du traitement et s'estompent habituellement par la suite en intensité et en fréquence.Original text: French. Our translation:The adverse effects are noted above all during the first or second week of treatment and usually fade afterwards in intensity and frequency.

The text itself prints no date of revision.

Texts for other products in this country do not all say the same. We searched them for sentences about sexual side effects continuing after stopping and did not read them whole. This row shows the product named, and no other.

A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.

Text for professionals Résumé des Caractéristiques du ProduitSEROPLEX 10 mg, comprimé pelliculé sécable, H. LUNDBECK A/S · Read in the government's medicines database: Base de données publique des médicamentsUpdated by the regulatorChecked
FrancePatient leaflet · SEROPLEXEscitalopram: the page about it

Sexual side effects that continue after stopping2. QUELLES SONT LES INFORMATIONS A CONNAITRE AVANT DE PRENDRE SEROPLEX 10 mg, comprimé pelliculé sécable ? · Avertissements et précautionsDans certains cas, ces symptômes se sont prolongés après l’arrêt du traitement.Original text: French. Our translation:In some cases, these symptoms continued after treatment was stopped.

Sexual side effects, as listed4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Fréquemment (peut concerner jusqu’à 1 patient sur 10) :Troubles sexuels (éjaculation retardée, troubles de l’érection, baisse de la libido, troubles de l’orgasme chez la femme).Original text: French. Our translation:Sexual disorders (delayed ejaculation, erection problems, decreased libido, orgasm problems in women).

Sexual side effects, as listed4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Fréquence indéterminée (fréquence ne pouvant pas être estimée à partir des données disponibles) :Erections douloureuses (priapisme).Original text: French. Our translation:Painful erections (priapism).

The same text also says4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?Ces effets indésirables s’estompent habituellement après quelques semaines de traitement. Sachez que certains de ces effets peuvent aussi être des symptômes liés à votre maladie qui s’amélioreront ainsi quand vous commencerez à vous sentir mieux.Original text: French. Our translation:These side effects usually fade after a few weeks of treatment. Be aware that some of these effects may also be symptoms of your illness, which will improve when you begin to feel better.

The text itself prints no date of revision.

Patient leaflet Notice patientSEROPLEX 10 mg, comprimé pelliculé sécable, H. LUNDBECK A/S · Read in the government's medicines database: Base de données publique des médicamentsUpdated by the regulatorChecked
ItalyText for professionals · CipralexEscitalopram: the page about it

Sexual side effects that continue after stopping4.4 Avvertenze speciali e precauzioni di impiego · Disfunzione sessualeSono stati segnalati casi di disfunzione sessuale a lungo termine con persistenza dei sintomi dopo l’interruzione dell’uso di SSRI/SNRI.Original text: Italian. Our translation:Cases of long-term sexual dysfunction have been reported, with the symptoms persisting after the use of SSRIs/SNRIs was stopped.

Sexual side effects, as listed4.8 Effetti indesiderati · Disturbi psichiatrici · ComuneAnsia, irrequietezza, sogni anomali, riduzione della libido Donne: anorgasmiaOriginal text: Italian. Our translation:Anxiety, restlessness, abnormal dreams, decreased libido Women: anorgasmia

Sexual side effects, as listed4.8 Effetti indesiderati · Patologie del sistema riproduttivo e della mammella · ComuneUomini: disturbi di eiaculazione, impotenzaOriginal text: Italian. Our translation:Men: ejaculation disorders, impotence

Sexual side effects, as listed4.8 Effetti indesiderati · Patologie del sistema riproduttivo e della mammella · Non notaGalattorea Uomini: priapismo emorragia postpartum3Original text: Italian. Our translation:Galactorrhoea Men: priapism postpartum haemorrhage3

The same text also says4.8 Effetti indesideratiLe reazioni avverse si manifestano più frequentemente durante la prima o seconda settimana di trattamento, per poi diminuire d’intensità e frequenza con la continuazione del trattamento.Original text: Italian. Our translation:Adverse reactions occur most frequently during the first or second week of treatment and then decrease in intensity and frequency as treatment continues.

The text itself prints no date of revision.

A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.

Text for professionals Riassunto delle caratteristiche del prodottoCipralex 5 mg, 10 mg, 15 mg e 20 mg compresse rivestite con film, H. Lundbeck A/S · Read in the regulator's own database: Banca Dati FarmaciMade available by the regulatorChecked
ItalyPatient leaflet · CipralexEscitalopram: the page about it

Sexual side effects that continue after stopping2. Cosa deve sapere prima di prendere Cipralex · Avvertenze e precauzioniIn alcuni casi, si è osservata la persistenza di questi sintomi dopo l’interruzione del trattamentoOriginal text: Italian. Our translation:In some cases, these symptoms have been seen to persist after treatment was stopped

Sexual side effects, as listed4. Possibili effetti indesiderati · Comune (può interessare fino a 1 persona su 10):disturbi sessuali (ritardata eiaculazione, problemi di erezione, diminuzione degli impulsi sessuali e le donne possono avere difficoltà nel raggiungere l’orgasmo)Original text: Italian. Our translation:sexual disorders (delayed ejaculation, erection problems, reduced sexual drive, and women may have difficulty reaching orgasm)

Sexual side effects, as listed4. Possibili effetti indesiderati · Non nota (la frequenza non può essere stimata sulla base dei dati disponibili):erezioni dolorose (priapismo)Original text: Italian. Our translation:painful erections (priapism)

The same text also says4. Possibili effetti indesideratiGli effetti indesiderati solitamente scompaiono dopo alcune settimane di trattamento.Original text: Italian. Our translation:The side effects usually disappear after a few weeks of treatment.

The text itself prints no date of revision.

Patient leaflet Foglio illustrativo: informazioni per l’utilizzatoreCipralex 5 mg, 10 mg, 15 mg e 20 mg compresse rivestite con film, H. Lundbeck A/S · Read in the regulator's own database: Banca Dati FarmaciMade available by the regulatorChecked
SpainText for professionals · CipralexEscitalopram: the page about it

Sexual side effects that continue after stopping4.4. Advertencias y precauciones especiales de empleo · Disfunción sexualSe han notificado casos de disfunción sexual de larga duración en los que los síntomas persisten a pesar de la suspensión del ISRS/IRSN.Original text: Spanish. Our translation:Cases of long-lasting sexual dysfunction have been reported in which the symptoms persist despite the SSRI/SNRI being stopped.

Sexual side effects, as listed4.8. Reacciones adversas · Trastornos psiquiátricos · FrecuenteAnsiedad, inquietud, sueños anormales libido disminuida Mujeres: anorgasmiaOriginal text: Spanish. Our translation:Anxiety, restlessness, abnormal dreams decreased libido Women: anorgasmia

Sexual side effects, as listed4.8. Reacciones adversas · Trastornos del aparato reproductor y de la mama · FrecuenteHombres: trastorno de la eyaculación, impotenciaOriginal text: Spanish. Our translation:Men: ejaculation disorder, impotence

Sexual side effects, as listed4.8. Reacciones adversas · Trastornos del aparato reproductor y de la mama · DesconocidaGalactorrea Hombres: priapismo Hemorragia posparto3Original text: Spanish. Our translation:Galactorrhoea Men: priapism Postpartum haemorrhage3

The same text also says4.8. Reacciones adversasLas reacciones adversas son más frecuentes durante la primera o segunda semana del tratamiento y habitualmente disminuyen en intensidad y frecuencia con el tratamiento continuado.Original text: Spanish. Our translation:Adverse reactions are most frequent during the first or second week of treatment and usually decrease in intensity and frequency with continued treatment.

A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.

Text for professionals Ficha técnicaCipralex 10 mg comprimidos recubiertos con película, Lundbeck España, S.A. · Read in the regulator's own database: CIMAText revisedChecked
SpainPatient leaflet · CipralexEscitalopram: the page about it

Sexual side effects that continue after stopping2. Qué necesita saber antes de empezar a tomar Cipralex · Advertencias y precaucionesEn algunos casos, estos síntomas persisten después de suspender el tratamiento.Original text: Spanish. Our translation:In some cases, these symptoms persist after treatment is stopped.

Sexual side effects, as listed4. Posibles efectos adversos · Frecuente (puede afectar hasta 1 de cada 10 personas):Alteraciones sexuales (retraso de la eyaculación, problemas con la erección, disminución de la conducta sexual y las mujeres pueden experimentar dificultades para alcanzar el orgasmo).Original text: Spanish. Our translation:Sexual disturbances (delayed ejaculation, problems with erection, reduced sexual behaviour, and women may have difficulty reaching orgasm).

Sexual side effects, as listed4. Posibles efectos adversos · Desconocido (no se puede determinar la frecuencia a partir de los datos disponibles):Erecciones dolorosas (priapismo).Original text: Spanish. Our translation:Painful erections (priapism).

The same text also says4. Posibles efectos adversosLos efectos adversos normalmente desaparecen después de pocas semanas de tratamiento.Original text: Spanish. Our translation:The side effects usually disappear after a few weeks of treatment.

Patient leaflet Prospecto: información para el usuarioCipralex 10 mg comprimidos recubiertos con película, Lundbeck España, S.A. · Read in the regulator's own database: CIMAText revisedChecked
SpainDocument from the regulatorEscitalopram: the page about it

Sexual side effects that continue after stoppingInformación sobre seguridad · Nueva información de seguridad procedente de la evaluación periódica de los datos de farmacovigilancia · Inhibidores selectivos de la recaptación de serotonina (SRS)/serotonina y noradrenalina (ISRN): persistencia de disfunción sexualEn pacientes a tratamiento con inhibidores de la recaptación de serotonina y noradrenalina, o con inhibidores selectivos de la recaptación de serotonina, se han notificado casos de disfunción sexual de larga duración en los que los síntomas persisten a pesar de la interrupción del tratamiento. Se incorporará este hallazgo a las advertencias de estos medicamentos.Original text: Spanish. Our translation:In patients treated with serotonin and noradrenaline reuptake inhibitors, or with selective serotonin reuptake inhibitors, cases of long-lasting sexual dysfunction have been reported in which the symptoms persist despite treatment being stopped. This finding will be added to the warnings of these medicines.

That document is about the whole class of medicines. It does not name escitalopram.

Spelling and punctuation are the document's own.

Document from the regulator Boletín mensual de la AEMPS sobre medicamentos de uso humano. Mayo de 2019Read on the regulator's site: AEMPSPublishedChecked
BrazilText for professionals · EscenaEscitalopram: the page about it

Sexual side effects, as listed9. REAÇÕES ADVERSAS · Distúrbios psiquiátricos · ComumAnsiedade, inquietude, sonhos anormais, diminuição da libido, anorgasmia femininaOriginal text: Portuguese. Our translation:Anxiety, restlessness, abnormal dreams, decreased libido, female anorgasmia

Sexual side effects, as listed9. REAÇÕES ADVERSAS · Distúrbios do sistema reprodutor e mama · ComumHomens: distúrbios da ejaculação e impotênciaOriginal text: Portuguese. Our translation:Men: ejaculation disorders and impotence

Sexual side effects, as listed9. REAÇÕES ADVERSAS · Distúrbios do sistema reprodutor e mama · DesconhecidoGalactorreia Mulheres: hemorragia pós-parto3 Homens: priapismoOriginal text: Portuguese. Our translation:Galactorrhoea Women: postpartum haemorrhage3 Men: priapism

The same text also says9. REAÇÕES ADVERSASAs reações adversas são mais frequentes durante a primeira ou segunda semana de tratamento e, geralmente, diminuem de intensidade e frequência com a continuação do tratamento.Original text: Portuguese. Our translation:Adverse reactions are most frequent during the first or second week of treatment and generally decrease in intensity and frequency as treatment continues.

This text has no sentence about sexual side effects continuing after the medicine is stopped.

This is the holder's own copy. The regulator's database refused our requests (it blocks by country; we asked from Denmark).

The originator product's text could not be opened. This is the text of another product, the one named in this row.

A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.

Text for professionals Escena® oxalato de escitalopram: bula para o profissional de saúdeEscena comprimidos revestidos 10 mg e 20 mg, Cristália Produtos Químicos Farmacêuticos Ltda. · Read on the holder's own site: Cristália Produtos Químicos Farmacêuticos Ltda.Last change listedChecked
BrazilText for professionals · LexaproEscitalopram: the page about it

We could not open this text on 14 October 2026: the site refused our requests (it blocks by country; we asked from Denmark); the holder publishes no text. This says nothing about what the text contains.

Text for professionalsLexapro, Lundbeck Brasil Ltda.We tried: consultas.anvisa.gov.br/#/bulario/Tried
BrazilPatient leaflet · EscenaEscitalopram: the page about it

Sexual side effects, as listed8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Reação comum - ocorre entre 1% e 10% (> 1/100 e ≤ 1/10) dos pacientes que utilizam este medicamento:Distúrbios sexuais (retardo ejaculatório, dificuldades de ereção, diminuição do desejo sexual e, em mulheres, dificuldades para chegar ao orgasmo)Original text: Portuguese. Our translation:Sexual disorders (delayed ejaculation, erection difficulties, reduced sexual desire and, in women, difficulty reaching orgasm)

Sexual side effects, as listed8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Desconhecida (frequência não pode ser estimada a partir dos dados disponíveis):Ereção dolorosa (priapismo)Original text: Portuguese. Our translation:Painful erection (priapism)

The same text also says8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?Os efeitos adversos são geralmente amenos e desaparecem espontaneamente após alguns dias de tratamento.Original text: Portuguese. Our translation:The side effects are generally mild and disappear on their own after a few days of treatment.

This text has no sentence about sexual side effects continuing after the medicine is stopped.

This is the holder's own copy. The regulator's database refused our requests (it blocks by country; we asked from Denmark).

Patient leaflet Escena® oxalato de escitalopram: bula para o pacienteEscena comprimidos revestidos 10 mg e 20 mg, Cristália Produtos Químicos Farmacêuticos Ltda. · Read on the holder's own site: Cristália Produtos Químicos Farmacêuticos Ltda.Last change listedChecked
BrazilPatient leaflet · EspranEscitalopram: the page about it

Sexual side effects, as listed8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Reação comum - ocorre entre 1% e 10% (> 1/100 e ≤ 1/10) dos pacientes que utilizam este medicamento:Distúrbios sexuais (retardo ejaculatório, dificuldades de ereção, diminuição do desejo sexual e, em mulheres, dificuldades para chegar ao orgasmo)Original text: Portuguese. Our translation:Sexual disorders (delayed ejaculation, erection difficulties, reduced sexual desire and, in women, difficulty reaching orgasm)

Sexual side effects, as listed8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Desconhecida (frequência não pode ser estimada a partir dos dados disponíveis):Ereção dolorosa (priapismo)Original text: Portuguese. Our translation:Painful erection (priapism)

The same text also says8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?Os efeitos adversos são geralmente amenos e desaparecem espontaneamente após alguns dias de tratamento.Original text: Portuguese. Our translation:The side effects are generally mild and disappear on their own after a few days of treatment.

This text has no sentence about sexual side effects continuing after the medicine is stopped.

This is the holder's own copy. The regulator's database refused our requests (it blocks by country; we asked from Denmark).

Patient leaflet ESPRAN® oxalato de escitalopram: bula para pacienteEspran comprimidos revestidos 10 mg, 15 mg e 20 mg, Torrent do Brasil Ltda. · Read on the holder's own site: Torrent do Brasil Ltda.Text approvedChecked
BrazilPatient leaflet · LexaproEscitalopram: the page about it

We could not open this text on 14 October 2026: the site refused our requests (it blocks by country; we asked from Denmark); the holder publishes no text. This says nothing about what the text contains.

Patient leafletLexapro, Lundbeck Brasil Ltda.We tried: consultas.anvisa.gov.br/#/bulario/Tried
IndiaText for professionals · S-CITADEPEscitalopram: the page about it

This text has no sentence about sexual side effects continuing after the medicine is stopped.

This is the holder's own copy. This regulator publishes no database of such texts.

This text names sexual side effects in several places that this row does not show. Together those passages are too long to reproduce here. The document link in this row opens the text. That they are not shown says nothing about how common these side effects are.

Text for professionals S-CITADEP TabletsS-CITADEP tablets, Cipla Ltd. · Read on the holder's own site: Cipla (ciplamed.com)Text revisedChecked
IndiaText for professionals · NexitoEscitalopram: the page about it

We could not open this text on 14 October 2026: the holder publishes no text; this regulator publishes no database of such texts. This says nothing about what the text contains.

Text for professionalsNexito 5 mg, 10 mg, 15 mg, 20 mg tablets, Sun Pharmaceutical Industries Ltd.We tried: sunpharma.com/india-products/Tried

Fluoxetine

For the SSRI antidepressant fluoxetine (Prozac), the product information we read in the United Kingdom, that of a generic product, says there have been reports of long-lasting sexual dysfunction where symptoms continued after SSRIs were stopped. This is known as post-SSRI sexual dysfunction (PSSD). The EU medicines regulator set the wording of this warning in 2019 for ten medicines, fluoxetine among them, and a government answer in Parliament says UK product information for all SSRIs was updated in 2019 to carry it. In the United States, the Prozac text for professionals says that symptoms of sexual dysfunction occasionally persist after fluoxetine is stopped. That sentence stands in the section on adverse reactions, not in a warning, and not every fluoxetine label there has it.

Fluoxetine: what each text says about sexual side effects, and about side effects that continue after stopping.
Country or regionWhat the text saysDocumentDates
United KingdomText for professionals · FluoxetineFluoxetine: the page about it

Sexual side effects that continue after stopping4.4 Special warnings and precautions for use · Sexual dysfunctionSelective serotonin reuptake inhibitors (SSRI) may cause symptoms of sexual dysfunction (see section 4.8). There have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs.On record since 2019, according to a government answer in parliament, 13 May 2025. That document is about the whole class of medicines. It does not name fluoxetine.

Sexual side effects, as listed4.8 Undesirable effects · b) Tabulated list of adverse reactions · Psychiatric disorders · CommonAnxiety Nervousness Restlessness Tension Libido decreased3 Sleep disorder Abnormal dreams4

Sexual side effects, as listed4.8 Undesirable effects · b) Tabulated list of adverse reactions · Psychiatric disorders · UncommonDepersonalisation Elevated mood Euphoric mood Thinking abnormal Orgasm abnormal5 Bruxism Suicidal thoughts and behaviour 6

Sexual side effects, as listed4.8 Undesirable effects · b) Tabulated list of adverse reactions · Reproductive system and breast disorders · CommonGynaecological bleeding14 Erectile dysfunction Ejaculation disorder15

Sexual side effects, as listed4.8 Undesirable effects · b) Tabulated list of adverse reactions · Reproductive system and breast disorders · UncommonSexual dysfunction16

Sexual side effects that continue after stopping4.8 Undesirable effects · b) Tabulated list of adverse reactions · footnote 16Occasionally persisting after treatment discontinuation

Sexual side effects, as listed4.8 Undesirable effects · b) Tabulated list of adverse reactions · Reproductive system and breast disorders · RareGalactorrhoea, Hyperprolactinaemia Priapism

The same text also says4.8 Undesirable effects · a) Summary of the safety profileUndesirable effects may decrease in intensity and frequency with continued treatment and do not generally lead to cessation of therapy.

Sexual side effects, as listed4.8 Undesirable effects · d) Paediatric populationIsolated cases of adverse events potentially indicating delayed sexual maturation or sexual dysfunction have been reported from paediatric clinical use (see also section 5.3).

The originator product is not in the list we read. This is another product from that list.

Texts for other products in this country do not all say the same. We searched them for sentences about sexual side effects continuing after stopping and did not read them whole. This row shows the product named, and no other.

A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.

Text for professionals Summary of Product Characteristics (SmPC): Fluoxetine 10 mg hard capsulesFluoxetine 10 mg hard capsules, Brown & Burk UK Ltd · Read in a compendium of product information: emcText revisedChecked
United KingdomPatient leaflet · FluoxetineFluoxetine: the page about it

Sexual side effects that continue after stopping2. What you need to know before you take Fluoxetine · Sexual dysfunctionMedicines like Fluoxetine (so called SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.On record since 2019, according to a government answer in parliament, 13 May 2025. That document is about the whole class of medicines. It does not name fluoxetine.

Sexual side effects, as listed4. Possible side effects · Some patients have had:prolonged and painful erection;

Sexual side effects, as listed4. Possible side effects · Common (may affect up to 1 in 10 people)decreased sex drive or sexual problems (including difficulty maintaining an erection for sexual activity)

Sexual side effects that continue after stopping4. Possible side effects · Uncommon (may affect up to 1 in 100 people)sexual problems, including orgasm problems, occasionally persisting after treatment discontinuation

The same text also says4. Possible side effectsMost of these side effects are likely to disappear with continued treatment.

The originator product is not in the list we read. This is another product from that list.

Patient leaflet Package Leaflet: Information for the patient. Fluoxetine 10 mg hard capsules. fluoxetineFluoxetine 10 mg hard capsules, Brown & Burk UK Ltd · Read in a compendium of product information: emcText revisedChecked
United KingdomGovernment answer in parliamentFluoxetine: the page about it

Sexual side effects that continue after stoppingAnswerThe Medicines and Healthcare products Regulatory Agency (MHRA) approved product information provided to healthcare professionals and patients for all selective serotonin reuptake inhibitors (SSRIs) was updated in 2019 to inform them that reports had been received of long-lasting sexual dysfunction where symptoms continue despite discontinuation of the SSRI.

That document is about the whole class of medicines. It does not name fluoxetine.

Contains Parliamentary information licensed under the Open Parliament Licence v3.0.

Government answer in parliament Written question UIN 50758, House of Commons: "Selective Serotonin Reuptake Inhibitors: Sexual Dysfunction"Read on the parliament's siteAnsweredChecked
European UnionDocument from the regulatorFluoxetine: the page about it

Sexual side effects that continue after stopping3. Serotonin and noradrenaline reuptake inhibitors (SNRI); selective serotonin reuptake inhibitors (SSRI) – Persistent sexual dysfunction after drug withdrawal (EPITT no 19277) · Summary of product characteristics · 4.4. Special warnings and precautions for use · Sexual dysfunctionThere have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRI.On record since 2019, according to EMA, 11 June 2019.

Sexual side effects that continue after stopping3. Serotonin and noradrenaline reuptake inhibitors (SNRI); selective serotonin reuptake inhibitors (SSRI) – Persistent sexual dysfunction after drug withdrawal (EPITT no 19277) · Package leaflet · 2. What you need to know before you take [Invented name] · Warnings and precautionsIn some cases, these symptoms have continued after stopping treatment.On record since 2019, according to EMA, 11 June 2019.

The wording is for ten medicines: citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, desvenlafaxine, duloxetine, milnacipran and venlafaxine.

This is wording for national product texts. There is no single EU product text for this medicine.

Document from the regulator New product information wording – Extracts from PRAC recommendations on signals. Adopted at the 13-16 May 2019 PRACRead on the regulator's site: European Medicines AgencyPublishedChecked
European UnionDocument from the regulatorFluoxetine: the page about it

Sexual side effects that continue after stopping1.3. Serotonin and noradrenaline reuptake inhibitors (SNRI); selective serotonin reuptake inhibitors (SSRI) – Persistent sexual dysfunction after drug withdrawal · Summary of product characteristics · 4.4. Special warnings and precautions for use · Sexual dysfunctionThere have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs/SNRI.

Sexual side effects that continue after stopping1.3. Serotonin and noradrenaline reuptake inhibitors (SNRI); selective serotonin reuptake inhibitors (SSRI) – Persistent sexual dysfunction after drug withdrawal · Package leaflet · 2. What you need to know before you take [Invented name] · Warnings and precautionsIn some cases, these symptoms have continued after stopping treatment.

The wording is for ten medicines: citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, desvenlafaxine, duloxetine, milnacipran and venlafaxine.

Document from the regulator PRAC recommendations on signals. Adopted at the 13-16 May 2019 PRAC meetingRead on the regulator's site: European Medicines AgencyPublishedChecked
United StatesText for professionals · ProzacFluoxetine: the page about it

Sexual side effects, as listed5 WARNINGS AND PRECAUTIONS · 5.17 Sexual DysfunctionUse of SSRIs, including PROZAC, may cause symptoms of sexual dysfunction [see Adverse Reactions (6.1)]. In male patients, SSRI use may result in ejaculatory delay or failure, decreased libido, and erectile dysfunction. In female patients, SSRI use may result in decreased libido and delayed or absent orgasm.

The same text also says5 WARNINGS AND PRECAUTIONS · 5.17 Sexual DysfunctionWhen evaluating changes in sexual function, obtaining a detailed history (including timing of symptom onset) is important because sexual symptoms may have other causes, including the underlying psychiatric disorder.

Sexual side effects that continue after stopping6 ADVERSE REACTIONS · 6.1 Clinical Trials Experience · Male and female sexual dysfunction with SSRIsSymptoms of sexual dysfunction occasionally persist after discontinuation of fluoxetine treatment.In this product's text since 2011, according to FDA, 15 June 2011.

The same text also says6 ADVERSE REACTIONS · 6.1 Clinical Trials Experience · Male and female sexual dysfunction with SSRIsThere are no adequate and well-controlled studies examining sexual dysfunction with fluoxetine treatment.

The date given is for this product. Texts for other products carry other dates.

An official list of medicines we read shows this product as discontinued or no longer marketed, and the text in this row is still this product's own.

This text names sexual side effects in several places that this row does not show. Together those passages are too long to reproduce here. The document link in this row opens the text. That they are not shown says nothing about how common these side effects are.

On 14 October 2026 we searched the labels in openFDA, the FDA's open database. The sentence about sexual dysfunction persisting after stopping, which this row shows, stood on 388 of the 439 labels in that database that contain fluoxetine. Five of the 388 are labels of the combination of olanzapine with fluoxetine. On those 388 labels the sentence stood among the adverse reactions and in no warnings section.

Text for professionals PROZAC (fluoxetine capsules) for oral use: Full Prescribing InformationProzac capsules ("Pulvules") 10 mg, 20 mg and 40 mg, Dista Products Company · Read in the government's medicines database: DailyMedText revisedChecked
United StatesPatient leaflet · ProzacFluoxetine: the page about it

Sexual side effects, as listedWhat is the most important information I should know about PROZAC?Sexual problems (dysfunction). Taking selective serotonin reuptake inhibitors (SSRIs), including PROZAC, may cause sexual problems.

Sexual side effects, as listedWhat is the most important information I should know about PROZAC? · Sexual problems (dysfunction) · Symptoms in males may include:Delayed ejaculation or inability to have an ejaculation

Sexual side effects, as listedWhat is the most important information I should know about PROZAC? · Sexual problems (dysfunction) · Symptoms in males may include:Decreased sex drive

Sexual side effects, as listedWhat is the most important information I should know about PROZAC? · Sexual problems (dysfunction) · Symptoms in males may include:Problems getting or keeping an erection

Sexual side effects, as listedWhat is the most important information I should know about PROZAC? · Sexual problems (dysfunction) · Symptoms in females may include:Decreased sex drive

Sexual side effects, as listedWhat is the most important information I should know about PROZAC? · Sexual problems (dysfunction) · Symptoms in females may include:Delayed orgasm or inability to have an orgasm

Sexual side effects, as listedWhat are the possible side effects of PROZAC? · Common possible side effects in people who take PROZAC include:sexual problems

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Patient leaflet Medication Guide: PROZAC® (PRO-zac) (fluoxetine capsules) for oral useProzac capsules ("Pulvules") 10 mg, 20 mg and 40 mg, Dista Products Company · Read in the government's medicines database: DailyMedText revisedChecked
United StatesDocument from the regulator · ProzacFluoxetine: the page about it

Sexual side effects that continue after stoppingADVERSE REACTIONS · section 6.1, Clinical Trials ExperienceAdded text related to occasional persistence of sexual dysfunction following discontinuation of fluoxetine treatment.

Document from the regulator SUPPLEMENT APPROVAL: NDA 18-936/S-096, NDA 21-235/S-018Prozac capsules for oral use, Eli Lilly and Company · Read in the regulator's own database: Drugs@FDAText approvedChecked
CanadaText for professionals · APO-FLUOXETINEFluoxetine: the page about it

Sexual side effects that continue after stopping7 WARNINGS AND PRECAUTIONS · Reproductive Health: Female and Male Potential · FunctionSelective serotonin reuptake inhibitors (SSRIs) may cause symptoms of sexual dysfunction (see 8.2 Clinical Trial Adverse Reactions). Patients should be informed that there have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of SSRIs.

Sexual side effects that continue after stopping8 ADVERSE REACTIONS · 8.2 Clinical Trial Adverse Reactions · Male and Female Sexual Dysfunction with SSRIsSymptoms of sexual dysfunction occasionally persisting after discontinuation of fluoxetine treatment have been observed in spontaneous reports.

The same text also says8 ADVERSE REACTIONS · 8.2 Clinical Trial Adverse Reactions · Male and Female Sexual Dysfunction with SSRIsThere are no adequate and well-controlled studies examining sexual dysfunction with fluoxetine treatment.

An official list of medicines we read shows the originator product as cancelled, revoked or archived. This is the text of another product, the one named in this row.

This text names sexual side effects in several places that this row does not show. Together those passages are too long to reproduce here. The document link in this row opens the text. That they are not shown says nothing about how common these side effects are.

Text for professionals PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION: APO-FLUOXETINE, Fluoxetine Capsules, Fluoxetine Oral SolutionAPO-FLUOXETINE capsules 10 mg and 20 mg and oral solution 20 mg/5 mL, Apotex Inc. · Read in the regulator's own database: Drug Product DatabaseText revisedChecked
CanadaPatient leaflet · APO-FLUOXETINEFluoxetine: the page about it

Sexual side effects that continue after stoppingOther warnings you should know about:Effects on Sexual Function: Taking medicines like APO-FLUOXETINE may cause symptoms of sexual dysfunction. In some cases these symptoms have continued after stopping APO-FLUOXETINE treatment.

Sexual side effects, as listedWhat are possible side effects from using APO-FLUOXETINE? · What are possible side effects from using APO-FLUOXETINE?low sex drive

Sexual side effects, as listedSerious side effects and what to do about them · UNKNOWNIncrease in the hormone prolactin: In women: breast discomfort, leakage of milk from the breasts, missed periods, or other problems with your menstrual cycle. In men: decreased body and facial hair, breast swelling, difficulty in getting or maintaining erections, or other sexual dysfunction

An official list of medicines we read shows the originator product as cancelled, revoked or archived. This is the text of another product, the one named in this row.

A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.

Patient leaflet PATIENT MEDICATION INFORMATION: APO-FLUOXETINE, Fluoxetine Capsules, Fluoxetine Oral SolutionAPO-FLUOXETINE capsules 10 mg and 20 mg and oral solution 20 mg/5 mL, Apotex Inc. · Read in the regulator's own database: Drug Product DatabaseText revisedChecked
CanadaDocument from the regulatorFluoxetine: the page about it

Sexual side effects that continue after stoppingConclusions and actionsHealth Canada will work with manufacturers to update the product safety information for all SSRIs and SNRIs to recommend that healthcare professionals inform patients about the potential risk of long lasting (possibly weeks to years) sexual symptoms persisting after stopping SSRI or SNRI treatment.

The same text also saysConclusions and actionsHealth Canada's review could not confirm, nor rule out, a causal link between stopping SSRI or SNRI treatment and persistent sexual dysfunction.

This document is about a whole class of medicines and names fluoxetine among them.

Document from the regulator Summary Safety Review - Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin-norepinephrine Reuptake Inhibitors (SNRIs) - Assessing the Potential Risk of Sexual Dysfunction despite Treatment DiscontinuationRead on the regulator's site: Drug and Health Product PortalPublishedChecked
CanadaDocument from the regulatorFluoxetine: the page about it

Sexual side effects that continue after stoppingProduct monograph updates · Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs)The Warnings and Precautions section of the Canadian product monographs for SSRIs (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, vilazodone and vortioxetine) and SNRIs (desvenlafaxine, duloxetine, levomilnacipran and venlafaxine) has been, or will be, updated with new safety information concerning reports of long-lasting sexual dysfunction where the symptoms have continued despite treatment discontinuation.

The same text also saysProduct monograph updates · Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) · Key messages for healthcare professionals:Health Canada’s review could not confirm, nor rule out, a causal link between discontinuing SSRI or SNRI treatment and persistent sexual dysfunction.

This document is about a whole class of medicines and names fluoxetine among them.

Document from the regulator Health Product InfoWatch, December 2021Read on the regulator's site: Government of Canada PublicationsPublishedChecked
AustraliaText for professionals · APO-FLUOXETINEFluoxetine: the page about it

Sexual side effects that continue after stoppingSection 4.4 · Sexual dysfunctionSection 4.4 of Australia's product information for APO-Fluoxetine has a warning headed sexual dysfunction. It says there are reports of sexual dysfunction that lasted a long time, with symptoms going on after SSRIs or SNRIs were stopped.Summarised, not quoted, because of the TGA's access terms.

Sexual side effects that continue after stoppingSection 4.8 · Urogenital System · UncommonIn section 4.8, the list of side effects of the urogenital system has sexual dysfunction among the uncommon ones, and adds in brackets that it occasionally persists after treatment is stopped.Summarised, not quoted, because of the TGA's access terms.

The regulator's site asks readers to accept its terms before it shows this text.

The originator product is not in the list we read. This is another product from that list.

Text for professionals AUSTRALIAN PRODUCT INFORMATION APO-FLUOXETINE (FLUOXETINE HYDROCHLORIDE)APO-FLUOXETINE, Arrotex Pharmaceuticals Pty Ltd · Read in the regulator's own database: TGA eBSText revisedChecked
AustraliaPatient leaflet · APO-FLUOXETINEFluoxetine: the page about it

Sexual side effects that continue after stoppingSection 6 · Less serious side effects · General symptoms:Australia's consumer medicine information for APO-Fluoxetine lists sexual problems among its side effects: a lower sex drive, and trouble with erection, ejaculation or orgasm. It says that in some cases these have carried on after treatment stopped.Summarised, not quoted, because of the TGA's access terms.

The regulator's site asks readers to accept its terms before it shows this text.

The originator product is not in the list we read. This is another product from that list.

Patient leaflet APO-FLUOXETINE Consumer Medicine InformationAPO-FLUOXETINE, Arrotex Pharmaceuticals Pty Ltd · Read in the regulator's own database: TGA eBSText revisedChecked
New ZealandText for professionals · Arrow - FluoxetineFluoxetine: the page about it

Sexual side effects, as listed4.8 Undesirable effects · b. Adverse reactions from clinical trials · Nervous system disorders · Commonabnormal dreams, libido decreased, sleep disorder, thinking abnormal, chills;

Sexual side effects that continue after stopping4.8 Undesirable effects · b. Adverse reactions from clinical trials · Reproductive system and breast disordersCommon: abnormal ejaculation (male only), gynaecological bleeding (female only), impotence (male only); Uncommon: anorgasmia, breast pain, sexual dysfunction (occasionally persisting after treatment discontinuation); Rare: priapism (male only).

The same text also says4.8 Undesirable effects · b. Adverse reactions from clinical trialsIt is important to emphasise that, although the events reported did occur during treatment with fluoxetine, they were not necessarily caused by it.

The originator product is not in the list we read. This is another product from that list.

This sentence stands in the list of adverse reactions. The warnings section of this text has no entry on sexual function.

A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.

Text for professionals New Zealand Data Sheet, Arrow - FluoxetineArrow - Fluoxetine 20 mg capsules, Teva Pharma (New Zealand) Limited · Read in the regulator's own database: MedsafeText revisedChecked
New ZealandText for professionals · FluoxFluoxetine: the page about it

Sexual side effects, as listed4.8 Undesirable effects · Nervous system disorders · Common:abnormal dreams, libido decreased, sleep disorder, thinking abnormal, chills

Sexual side effects that continue after stopping4.8 Undesirable effects · Reproductive system and breast disordersabnormal ejaculation (male only), gynaecological bleeding (female only), impotence (male only) anorgasmia, breast pain, sexual dysfunction (occasionally persisting after treatment discontinuation) priapism (male only)

The same text also says4.8 Undesirable effectsIt is important to emphasise that, although the events reported did occur during treatment with fluoxetine, they were not necessarily caused by it.

This sentence stands in the list of adverse reactions. The warnings section of this text has no entry on sexual function.

A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.

Text for professionals New Zealand Data Sheet, FLUOXFluox capsules and dispersible tablets (20 mg fluoxetine), Viatris Ltd · Read in the regulator's own database: MedsafeText revisedChecked
New ZealandPatient leaflet · Arrow-FluoxetineFluoxetine: the page about it

Sexual side effects that continue after stoppingSide effectssexual disturbances (decreased sexual drive, problems with orgasm, ejaculation or erection). In some cases, these symptoms have continued after stopping treatment.

The same text also saysSide effectsSide effects vary from patient to patient and often lessen with continued use.

The originator product is not in the list we read. This is another product from that list.

Another product's leaflet reads differently. This row shows the product named, and no other.

Patient leaflet Consumer Medicine Information, Arrow-FluoxetineArrow-Fluoxetine capsules 20 mg and dispersible tablets, Teva Pharma (New Zealand) Limited · Read in the regulator's own database: MedsafeText revisedChecked
New ZealandPatient leaflet · FluoxFluoxetine: the page about it

Sexual side effects that continue after stoppingBefore you take Fluox · Before you start to take it:Medicines like Fluox may cause symptoms of sexual dysfunction (see Side Effects section). In some cases, these symptoms have continued after stopping treatment.

Sexual side effects that continue after stoppingSide effectssexual function problems: such as delayed ejaculation, problems with erection, decreased sex drive or difficulties achieving orgasm (In some cases, these symptoms have continued after stopping treatment)

The same text also saysSide effectsThis medicine may have unwanted side effects in a few people.

Patient leaflet New Zealand Consumer Medicine Information, FLUOXFluox capsules 20 mg and dispersible tablets 20 mg, Viatris Ltd · Read in the regulator's own database: MedsafeText revisedChecked
GermanyText for professionals · Fluoxetin-ratiopharm®Fluoxetine: the page about it

Sexual side effects that continue after stopping4.4 Besondere Warnhinweise und Vorsichtsmaßnahmen für die Anwendung · Sexuelle FunktionsstörungEs wurden lang anhaltende sexuelle Funktionsstörungen berichtet, bei denen die Symptome trotz der Absetzung von SSRI bestehen blieben.Original text: German. Our translation:Long-lasting sexual dysfunction has been reported in which the symptoms continued despite the SSRI being stopped.

Sexual side effects, as listed4.8 Nebenwirkungen · Psychiatrische Erkrankungen · HäufigAngst, Nervosität Ruhelosigkeit Angespanntheit verminderte Libido3 Schlafstörung abnormale Träume4Original text: German. Our translation:Anxiety, nervousness restlessness tension decreased libido3 sleep disorder abnormal dreams4

Sexual side effects, as listed4.8 Nebenwirkungen · Psychiatrische Erkrankungen · GelegentlichDepersonalisation, gehobene Stimmung, euphorische Stimmung, abnormales Denken abnormaler Orgasmus5 Zähneknirschen, suizidale Gedanken und suizidales Verhalten6Original text: German. Our translation:Depersonalisation, elevated mood, euphoric mood, abnormal thinking abnormal orgasm5 teeth grinding, suicidal thoughts and suicidal behaviour6

Sexual side effects, as listed4.8 Nebenwirkungen · Erkrankungen der Geschlechtsorgane und der Brustdrüse · Häufiggynäkologische Blutung14 Erektile Dysfunktion Ejakulationsstörung15Original text: German. Our translation:gynaecological bleeding14 Erectile dysfunction Ejaculation disorder15

Sexual side effects, as listed4.8 Nebenwirkungen · Erkrankungen der Geschlechtsorgane und der Brustdrüse · Gelegentlichsexuelle Dysfunktion16Original text: German. Our translation:sexual dysfunction16

Sexual side effects that continue after stopping4.8 Nebenwirkungen · Tabellarische Zusammenfassung der Nebenwirkungen · Fußnote 16Gelegentlich anhaltend nach Absetzung der TherapieOriginal text: German. Our translation:Occasionally persisting after the therapy is stopped

Sexual side effects, as listed4.8 Nebenwirkungen · Erkrankungen der Geschlechtsorgane und der Brustdrüse · SeltenGalaktorrhoe, Hyperprolaktinämie, PriapismusOriginal text: German. Our translation:Galactorrhoea, hyperprolactinaemia, priapism

The same text also says4.8 Nebenwirkungen · Zusammenfassung des SicherheitsprofilsSchweregrad und Häufigkeit von Nebenwirkungen können im Verlauf der Behandlung abnehmen und führen im Allgemeinen nicht zu einem Abbruch der Behandlung.Original text: German. Our translation:The severity and frequency of side effects may decrease in the course of treatment and do not generally lead to treatment being stopped.

Sexual side effects, as listed4.8 Nebenwirkungen · Kinder und JugendlicheEinzelfälle von Nebenwirkungen, die möglicherweise auf eine verzögerte sexuelle Entwicklung oder Störung der Sexualfunktion hinweisen, wurden während der klinischen Anwendung bei Kindern und Jugendlichen berichtet (siehe auch Abschnitt 5.3).Original text: German. Our translation:Isolated cases of side effects that may point to delayed sexual development or a disorder of sexual function were reported during clinical use in children and adolescents (see also section 5.3).

This is the holder's own copy. The regulator's database asks visitors to accept its terms first, which we did not do.

The originator product's text could not be opened. This is the text of another product, the one named in this row.

A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.

Text for professionals FachinformationFluoxetin-ratiopharm® 20 mg Hartkapseln, ratiopharm GmbH · Read on the holder's own site: ratiopharm GmbHText revisedChecked
GermanyText for professionals · FluctinFluoxetine: the page about it

We could not open this text on 14 October 2026: the holder publishes no text; the site asks for a login. This says nothing about what the text contains.

Text for professionalsFluctin, LillyWe tried: www.lilly.com/de/arzneimittel/aktuellTried
GermanyPatient leaflet · Fluoxetin-ratiopharm®Fluoxetine: the page about it

Sexual side effects that continue after stopping2. Was sollten Sie vor der Einnahme von Fluoxetin-ratiopharm® beachten? · Warnhinweise und Vorsichtsmaßnahmen · Sexuelle FunktionsstörungIn bestimmten Fällen blieben diese Symptome nach Beendigung der Behandlung bestehen.Original text: German. Our translation:In certain cases these symptoms continued after treatment was ended.

Sexual side effects, as listed4. Welche Nebenwirkungen sind möglich? · Einige Patienten hattenverlängerte und schmerzhafte Erektion;Original text: German. Our translation:prolonged and painful erection;

Sexual side effects, as listed4. Welche Nebenwirkungen sind möglich? · Häufig (kann bis zu 1 von 10 Behandelten betreffen)Verminderter Sexualtrieb oder sexuelle Probleme (einschließlich Schwierigkeit, eine Erektion zur sexuellen Aktivität aufrecht zu halten)Original text: German. Our translation:Reduced sex drive or sexual problems (including difficulty keeping an erection for sexual activity)

Sexual side effects that continue after stopping4. Welche Nebenwirkungen sind möglich? · Gelegentlich (kann bis zu 1 von 100 Behandelten betreffen)Sexuelle Funktionsstörungen, einschließlich Orgasmusprobleme, die gelegentlich nach Beendigung der Behandlung bestehen bleibenOriginal text: German. Our translation:Sexual dysfunction, including orgasm problems, which occasionally persists after treatment has ended

The same text also says4. Welche Nebenwirkungen sind möglich?Die meisten dieser Nebenwirkungen gehen wahrscheinlich vorüber, während Sie Ihr Arzneimittel weiter einnehmen.Original text: German. Our translation:Most of these side effects are likely to pass while you go on taking your medicine.

This is the holder's own copy. The regulator's database asks visitors to accept its terms first, which we did not do.

The originator product's text could not be opened. This is the text of another product, the one named in this row.

Patient leaflet Gebrauchsinformation: Information für PatientenFluoxetin-ratiopharm® 20 mg Hartkapseln, ratiopharm GmbH · Read on the holder's own site: ratiopharm GmbHText revisedChecked
GermanyPatient leaflet · FluctinFluoxetine: the page about it

We could not open this text on 14 October 2026: the holder publishes no text; the site asks for a login. This says nothing about what the text contains.

Patient leafletFluctin, LillyWe tried: www.lilly.com/de/arzneimittel/aktuellTried
GermanyDocument from the regulatorFluoxetine: the page about it

Sexual side effects that continue after stoppingPRAC-Meldungen · Neufassung des Wortlauts der Produktinformationen – Auszüge aus den Empfehlungen des PRAC zu Signalen · Serotonin- und Noradrenalin-Wiederaufnahmehemmer (SNRI); selektive Serotonin-Wiederaufnahmehemmer (SSRI) – persistierende sexuelle Funktionsstörung nach Absetzen von Arzneimitteln (EPITT Nr. 19277)Es wurden lang anhaltende sexuelle Funktionsstörungen berichtet, bei denen die Symptome trotz der Absetzung von SSRI/SNRI bestehen blieben.Original text: German. Our translation:Long-lasting sexual dysfunction has been reported in which the symptoms continued despite the SSRI/SNRI being stopped.

The wording is for ten medicines: citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, desvenlafaxine, duloxetine, milnacipran and venlafaxine.

Document from the regulator Bulletin zur Arzneimittelsicherheit – Informationen aus BfArM und PEI, Ausgabe 2 | Juni 2019Read on the regulator's site: BfArMPublishedChecked
FranceText for professionals · PROZACFluoxetine: the page about it

Sexual side effects that continue after stopping4.4. Mises en garde spéciales et précautions d'emploi · Dysfonction sexuelleDes cas de dysfonction sexuelle dont les symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS ont été rapportés.Original text: French. Our translation:Cases of sexual dysfunction in which the symptoms continued despite stopping treatment with SSRIs have been reported.

Sexual side effects, as listed4.8. Effets indésirables · Affections psychiatriques · FréquentAnxiété. Nervosité. Impatiences. Tension. Baisse de la libido3. Troubles du sommeil. Rêves anormaux4.Original text: French. Our translation:Anxiety. Nervousness. Restlessness. Tension. Decreased libido3. Sleep disorders. Abnormal dreams4.

Sexual side effects, as listed4.8. Effets indésirables · Affections psychiatriques · Peu fréquentDépersonnalisation. Exaltation. Euphorie. Pensées anormales. Orgasmes anormaux5. Bruxisme. Pensées et comportement suicidaires6.Original text: French. Our translation:Depersonalisation. Elation. Euphoria. Abnormal thoughts. Abnormal orgasms5. Bruxism. Suicidal thoughts and behaviour6.

Sexual side effects, as listed4.8. Effets indésirables · Affections des organes de reproduction et du sein · FréquentSaignements gynécologiques14. Dysfonction érectile. Troubles de l’éjaculation15.Original text: French. Our translation:Gynaecological bleeding14. Erectile dysfunction. Ejaculation disorders15.

Sexual side effects, as listed4.8. Effets indésirables · Affections des organes de reproduction et du sein · Peu fréquentTroubles sexuels16.Original text: French. Our translation:Sexual disorders16.

Sexual side effects that continue after stopping4.8. Effets indésirables · b. Tableau récapitulatif des effets indésirables · note 16Pouvant parfois persister après arrêt du traitementOriginal text: French. Our translation:May sometimes persist after treatment is stopped

Sexual side effects, as listed4.8. Effets indésirables · Affections des organes de reproduction et du sein · RareGalactorrhée. Hyperprolactinémie Priapisme.Original text: French. Our translation:Galactorrhoea. Hyperprolactinaemia Priapism.

The same text also says4.8. Effets indésirables · a. Résumé du profil de sécuritéLes effets indésirables peuvent diminuer en intensité et en fréquence lors de la poursuite du traitement et ne nécessitent généralement pas l’arrêt du traitement.Original text: French. Our translation:The adverse effects may decrease in intensity and frequency as treatment continues and do not generally require treatment to be stopped.

Sexual side effects, as listed4.8. Effets indésirables · d. Population pédiatriqueDes cas isolés d’effets indésirables suggérant des retards de maturation sexuelle ou une dysfonction sexuelle ont été rapportés lors de l’utilisation clinique en pédiatrie (voir également rubrique 5.3).Original text: French. Our translation:Isolated cases of adverse effects suggesting delayed sexual maturation or sexual dysfunction have been reported during paediatric clinical use (see also section 5.3).

The text itself prints no date of revision.

An official list of medicines we read shows this product as discontinued or no longer marketed, and the text in this row is still this product's own.

Texts for other products in this country do not all say the same. The ones we read are on the full record.

A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.

Text for professionals Résumé des Caractéristiques du ProduitPROZAC 20 mg, gélule, LILLY France · Read in the government's medicines database: Base de données publique des médicamentsUpdated by the regulatorChecked
FranceText for professionals · FLUOXETINE ACCORDFluoxetine: the page about it

Sexual side effects that continue after stopping4.4. Mises en garde spéciales et précautions d'emploi · Dysfonction sexuelleDes cas de dysfonction sexuelle dont les symptômes se sont prolongés malgré l’arrêt du traitement par des ISRS ont été rapportés.Original text: French. Our translation:Cases of sexual dysfunction in which the symptoms continued despite stopping treatment with SSRIs have been reported.

Sexual side effects, as listed4.8. Effets indésirables · Affections psychiatriques · FréquentAnxiété. Nervosité. Impatiences. Tension. Baisse de la libido3. Troubles du sommeil. Rêves anormaux4.Original text: French. Our translation:Anxiety. Nervousness. Restlessness. Tension. Decreased libido3. Sleep disorders. Abnormal dreams4.

Sexual side effects, as listed4.8. Effets indésirables · Affections psychiatriques · Peu fréquentDépersonnalisation. Exaltation. Euphorie. Pensées anormales. Orgasmes anormaux5. Bruxisme. Pensées et comportement suicidaires6.Original text: French. Our translation:Depersonalisation. Elation. Euphoria. Abnormal thoughts. Abnormal orgasms5. Bruxism. Suicidal thoughts and behaviour6.

Sexual side effects, as listed4.8. Effets indésirables · Affections des organes de reproduction et du sein · FréquentSaignements gynécologiques14. Dysfonction érectile. Troubles de l’éjaculation15.Original text: French. Our translation:Gynaecological bleeding14. Erectile dysfunction. Ejaculation disorders15.

Sexual side effects, as listed4.8. Effets indésirables · Affections des organes de reproduction et du sein · Peu fréquentTroubles sexuels16.Original text: French. Our translation:Sexual disorders16.

Sexual side effects that continue after stopping4.8. Effets indésirables · b. Tableau récapitulatif des effets indésirables · note 16Pouvant parfois persister après arrêt du traitementOriginal text: French. Our translation:May sometimes persist after treatment is stopped

Sexual side effects, as listed4.8. Effets indésirables · Affections des organes de reproduction et du sein · RareGalactorrhée. Hyperprolactinémie. Priapisme.Original text: French. Our translation:Galactorrhoea. Hyperprolactinaemia. Priapism.

The same text also says4.8. Effets indésirables · a. Résumé du profil de sécuritéLes effets indésirables peuvent diminuer en intensité et en fréquence lors de la poursuite du traitement et ne nécessitent généralement pas l’arrêt du traitement.Original text: French. Our translation:The adverse effects may decrease in intensity and frequency as treatment continues and do not generally require treatment to be stopped.

Sexual side effects, as listed4.8. Effets indésirables · d. Population pédiatriqueDes cas isolés d’effets indésirables suggérant des retards de maturation sexuelle ou une dysfonction sexuelle ont été rapportés lors de l’utilisation clinique en pédiatrie (voir également rubrique 5.3).Original text: French. Our translation:Isolated cases of adverse effects suggesting delayed sexual maturation or sexual dysfunction have been reported during paediatric clinical use (see also section 5.3).

The text itself prints no date of revision.

A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.

Text for professionals Résumé des Caractéristiques du ProduitFLUOXETINE ACCORD 20 mg, gélule, ACCORD HEALTHCARE France SAS · Read in the government's medicines database: Base de données publique des médicamentsUpdated by the regulatorChecked
FrancePatient leaflet · PROZACFluoxetine: the page about it

Sexual side effects that continue after stopping2. QUELLES SONT LES INFORMATIONS A CONNAITRE AVANT DE PRENDRE PROZAC 20 mg, gélule ? · Avertissements et précautions · Dysfonction sexuelleDans certains cas, ces symptômes se sont prolongés après l’arrêt du traitement.Original text: French. Our translation:In some cases, these symptoms continued after treatment was stopped.

Sexual side effects, as listed4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Certains patients ont présenté :Une érection prolongée et douloureuse ;Original text: French. Our translation:A prolonged and painful erection;

Sexual side effects, as listed4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Fréquents (pouvant affecter jusqu’à 1 patient sur 10)baisse du désir sexuel ou problèmes sexuels (tels que difficultés à conserver une érection suffisante pour une activité sexuelle),Original text: French. Our translation:decreased sexual desire or sexual problems (such as difficulty keeping an erection sufficient for sexual activity),

Sexual side effects that continue after stopping4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Peu fréquents (pouvant affecter jusqu’à 1 patient sur 100)troubles sexuels, incluant des troubles de l’orgasme, pouvant parfois persister après arrêt du traitementOriginal text: French. Our translation:sexual disorders, including orgasm disorders, which may sometimes persist after treatment is stopped

The same text also says4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?La plupart de ces effets indésirables disparaissent avec la poursuite du traitement.Original text: French. Our translation:Most of these side effects disappear as treatment continues.

The text itself prints no date of revision.

An official list of medicines we read shows this product as discontinued or no longer marketed, and the text in this row is still this product's own.

Patient leaflet Notice patientPROZAC 20 mg, gélule, LILLY France · Read in the government's medicines database: Base de données publique des médicamentsUpdated by the regulatorChecked
FrancePatient leaflet · FLUOXETINE ACCORDFluoxetine: the page about it

Sexual side effects that continue after stopping2. QUELLES SONT LES INFORMATIONS A CONNAITRE AVANT DE PRENDRE FLUOXETINE ACCORD 20 mg, gélule ? · Avertissements et précautions · Dysfonction sexuelleDans certains cas, ces symptômes se sont prolongés après l’arrêt du traitement.Original text: French. Our translation:In some cases, these symptoms continued after treatment was stopped.

Sexual side effects, as listed4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Certains patients ont présenté :Une érection prolongée et douloureuse ;Original text: French. Our translation:A prolonged and painful erection;

Sexual side effects, as listed4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Fréquents (pouvant affecter jusqu’à 1 patient sur 10)baisse du désir sexuel ou problèmes sexuels (tels que difficultés à conserver une érection suffisante pour une activité sexuelle),Original text: French. Our translation:decreased sexual desire or sexual problems (such as difficulty keeping an erection sufficient for sexual activity),

Sexual side effects that continue after stopping4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Peu fréquents (pouvant affecter jusqu’à 1 patient sur 100)troubles sexuels, incluant des troubles de l’orgasme, pouvant parfois persister après arrêt du traitement,Original text: French. Our translation:sexual disorders, including orgasm disorders, which may sometimes persist after treatment is stopped,

The same text also says4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?La plupart de ces effets indésirables disparaissent avec la poursuite du traitement.Original text: French. Our translation:Most of these side effects disappear as treatment continues.

The text itself prints no date of revision.

Patient leaflet Notice patientFLUOXETINE ACCORD 20 mg, gélule, ACCORD HEALTHCARE France SAS · Read in the government's medicines database: Base de données publique des médicamentsUpdated by the regulatorChecked
ItalyText for professionals · ProzacFluoxetine: the page about it

Sexual side effects that continue after stopping4.4 Avvertenze speciali e precauzioni di impiego · Disfunzione sessualeSono stati segnalati casi di disfunzione sessuale a lungo termine con persistenza dei sintomi dopo l’interruzione dell’uso di SSRI.Original text: Italian. Our translation:Cases of long-term sexual dysfunction have been reported, with the symptoms persisting after the use of SSRIs was stopped.

Sexual side effects, as listed4.8 Effetti indesiderati · b. Tabella riassuntiva delle reazioni avverse · Disturbi psichiatrici · ComuneAnsia Nervosismo Irrequietezza Tensione Diminuzione della libido3 Disturbi del sonno Sogni anormali4Original text: Italian. Our translation:Anxiety Nervousness Restlessness Tension Decreased libido3 Sleep disorders Abnormal dreams4

Sexual side effects, as listed4.8 Effetti indesiderati · b. Tabella riassuntiva delle reazioni avverse · Disturbi psichiatrici · Non comuneDepersonalizzazione Umore elevato Umore euforico Pensiero anormale Orgasmo anormale5 Bruxismo Ideazioni e comportamento suicidario6Original text: Italian. Our translation:Depersonalisation Elevated mood Euphoric mood Abnormal thinking Abnormal orgasm5 Bruxism Suicidal ideation and behaviour6

Sexual side effects, as listed4.8 Effetti indesiderati · b. Tabella riassuntiva delle reazioni avverse · Patologie dell'apparato riproduttivo e della mammella · ComuneSanguinamento a carico dell'apparato riproduttivo femminile14 Disfunzione erettile Disturbo dell’eiaculazione15Original text: Italian. Our translation:Bleeding of the female reproductive system14 Erectile dysfunction Ejaculation disorder15

Sexual side effects, as listed4.8 Effetti indesiderati · b. Tabella riassuntiva delle reazioni avverse · Patologie dell'apparato riproduttivo e della mammella · Non comuneDisfunzione di natura sessuale16Original text: Italian. Our translation:Dysfunction of a sexual nature16

Sexual side effects that continue after stopping4.8 Effetti indesiderati · b. Tabella riassuntiva delle reazioni avverse · nota 16Occasionalmente persistente dopo sospensione del trattamento.Original text: Italian. Our translation:Occasionally persistent after treatment is stopped.

Sexual side effects, as listed4.8 Effetti indesiderati · b. Tabella riassuntiva delle reazioni avverse · Patologie dell'apparato riproduttivo e della mammella · RaroGalattorrea Iperprolattinemia PriapismoOriginal text: Italian. Our translation:Galactorrhoea Hyperprolactinaemia Priapism

The same text also says4.8 Effetti indesiderati · a. Sommario del profilo di sicurezzaGli effetti indesiderati possono diminuire di intensità e frequenza con il trattamento continuato e generalmente non portano ad una interruzione della terapia.Original text: Italian. Our translation:The undesirable effects may decrease in intensity and frequency with continued treatment and do not generally lead to therapy being stopped.

Sexual side effects, as listed4.8 Effetti indesiderati · d. Popolazione pediatrica (vedere paragrafi 4.4 e 5.1)Nell’impiego clinico in pediatria sono stati riportati casi isolati di eventi avversi potenzialmente indicanti una ritardata maturazione sessuale o una disfunzione sessuale (vedere anche paragrafo 5.3).Original text: Italian. Our translation:In paediatric clinical use, isolated cases have been reported of adverse events potentially indicating delayed sexual maturation or sexual dysfunction (see also section 5.3).

The text itself prints no date of revision.

An official list of medicines we read shows this product as discontinued or no longer marketed, and the text in this row is still this product's own.

Texts for other products in this country do not all say the same. The ones we read are on the full record.

A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.

Text for professionals Riassunto delle caratteristiche del prodottoProzac 20 mg capsule rigide, Eli Lilly Italia S.p.A. · Read in the regulator's own database: Banca Dati FarmaciMade available by the regulatorChecked
ItalyText for professionals · Fluoxetina EGFluoxetine: the page about it

Sexual side effects that continue after stopping4.4 Avvertenze speciali e precauzioni d’impiego · Disfunzione sessualeSono stati segnalati casi di disfunzione sessuale a lungo termine con persistenza dei sintomi dopo l’interruzione dell’uso di SSRI/SNRI.Original text: Italian. Our translation:Cases of long-term sexual dysfunction have been reported, with the symptoms persisting after the use of SSRIs/SNRIs was stopped.

Sexual side effects, as listed4.8 Effetti indesiderati · b) Elenco delle reazioni avverse · Disturbi psichiatrici · Comune:ansia, nervosismo, irrequietezza, tensione, diminuzione della libido 3, disturbi del sonno, sogni anormali 4Original text: Italian. Our translation:anxiety, nervousness, restlessness, tension, decreased libido 3, sleep disorders, abnormal dreams 4

Sexual side effects, as listed4.8 Effetti indesiderati · b) Elenco delle reazioni avverse · Disturbi psichiatrici · Non comune:depersonalizzazione, alterazioni del pensiero, umore elevato, euforia, orgasmo anormale 5, bruxismo, idea suicida e comportamento suicida 6Original text: Italian. Our translation:depersonalisation, changes in thinking, elevated mood, euphoria, abnormal orgasm 5, bruxism, suicidal ideas and suicidal behaviour 6

Sexual side effects, as listed4.8 Effetti indesiderati · b) Elenco delle reazioni avverse · Patologie dell’apparato riproduttivo e della mammella · Comune:emorragia ginecologica 13, disfunzione erettile, problemi nell’eiaculazione 14Original text: Italian. Our translation:gynaecological bleeding 13, erectile dysfunction, ejaculation problems 14

Sexual side effects, as listed4.8 Effetti indesiderati · b) Elenco delle reazioni avverse · Patologie dell’apparato riproduttivo e della mammella · Non comune:disfunzione sessualeOriginal text: Italian. Our translation:sexual dysfunction

Sexual side effects, as listed4.8 Effetti indesiderati · b) Elenco delle reazioni avverse · Patologie dell’apparato riproduttivo e della mammella · Raro:galattorrea, iperprolattinemia, priapismoOriginal text: Italian. Our translation:galactorrhoea, hyperprolactinaemia, priapism

The same text also says4.8 Effetti indesiderati · a) Sintesi del profilo di sicurezzaGli effetti indesiderati possono diminuire di intensità e frequenza con il trattamento continuato e generalmente non portano ad una interruzione della terapia.Original text: Italian. Our translation:The undesirable effects may decrease in intensity and frequency with continued treatment and do not generally lead to therapy being stopped.

Sexual side effects, as listed4.8 Effetti indesiderati · d) Popolazione pediatrica (vedere paragrafi 4.4 e 5.1)Nell’uso clinico pediatrico sono stati riportati casi isolati di eventi avversi che potenzialmente indicano ritardo della maturazione sessuale o disfunzioni sessuali (vedere anche paragrafo 5.3).Original text: Italian. Our translation:In paediatric clinical use, isolated cases have been reported of adverse events that potentially indicate delayed sexual maturation or sexual dysfunction (see also section 5.3).

The text itself prints no date of revision.

A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.

Text for professionals Riassunto delle caratteristiche del prodottoFluoxetina EG 20 mg capsule rigide, EG S.p.A. · Read in the regulator's own database: Banca Dati FarmaciMade available by the regulatorChecked
ItalyPatient leaflet · ProzacFluoxetine: the page about it

Sexual side effects that continue after stopping2. Cosa deve sapere prima di prendere Prozac capsule rigide · Avvertenze e precauzioni · Disfunzione sessualeIn alcuni casi, si è osservata la persistenza di questi sintomi dopo l’interruzione del trattamento.Original text: Italian. Our translation:In some cases, these symptoms have been seen to persist after treatment was stopped.

Sexual side effects, as listed4. Possibili effetti indesiderati · Alcuni pazienti hanno presentato:erezione prolungata e dolorosa;Original text: Italian. Our translation:prolonged and painful erection;

Sexual side effects, as listed4. Possibili effetti indesiderati · Comuni (che possono interessare fino a 1 paziente su 10)ridotto desiderio sessuale e problemi sessuali (inclusa la difficoltà a mantenere un’erezione per l’attività sessuale)Original text: Italian. Our translation:reduced sexual desire and sexual problems (including difficulty keeping an erection for sexual activity)

Sexual side effects that continue after stopping4. Possibili effetti indesiderati · Non comuni (che possono interessare fino a 1 paziente su 100)problemi sessuali, inclusi problemi di orgasmo, occasionalmente persistenti dopo l’interruzione del trattamentoOriginal text: Italian. Our translation:sexual problems, including orgasm problems, occasionally persisting after treatment is stopped

The same text also says4. Possibili effetti indesideratiÈ probabile che la maggior parte di questi effetti indesiderati sparisca continuando il trattamento.Original text: Italian. Our translation:Most of these side effects are likely to disappear as treatment continues.

The text itself prints no date of revision.

An official list of medicines we read shows this product as discontinued or no longer marketed, and the text in this row is still this product's own.

Patient leaflet Foglio illustrativo: informazioni per l’utilizzatoreProzac 20 mg capsule rigide, Eli Lilly Italia S.p.A. · Read in the regulator's own database: Banca Dati FarmaciMade available by the regulatorChecked
ItalyPatient leaflet · Fluoxetina EGFluoxetine: the page about it

Sexual side effects that continue after stopping2. Cosa deve sapere prima di prendere Fluoxetina EG · Avvertenze e precauzioniIn alcuni casi, si è osservata la persistenza di questi sintomi dopo l’interruzione del trattamento.Original text: Italian. Our translation:In some cases, these symptoms have been seen to persist after treatment was stopped.

Sexual side effects, as listed4. Possibili effetti indesiderati · Effetti indesiderati comuni (possono interessare fino a 1 persona su 10):problemi sessuali, tra cui difficoltà a mantenere l'erezione per un'attività sessuale (disfunzione erettile), eiaculazione precoce o eiaculazione ritardata (disturbi dell'eiaculazione), diminuzione del desiderio sessuale (libido diminuita);Original text: Italian. Our translation:sexual problems, including difficulty keeping an erection for sexual activity (erectile dysfunction), premature or delayed ejaculation (ejaculation disorders), decreased sexual desire (decreased libido);

Sexual side effects, as listed4. Possibili effetti indesiderati · Effetti indesiderati non comuni (possono interessare fino a 1 persona su 100):problemi di orgasmo;Original text: Italian. Our translation:orgasm problems;

Sexual side effects, as listed4. Possibili effetti indesiderati · Effetti indesiderati non comuni (possono interessare fino a 1 persona su 100):problemi nell’attività sessuali (disfunzione sessuale);Original text: Italian. Our translation:problems with sexual activity (sexual dysfunction);

Sexual side effects, as listed4. Possibili effetti indesiderati · Effetti indesiderati rari (possono interessare fino a 1 persona su 1.000):erezione dolorosa persistente (priapismo);Original text: Italian. Our translation:persistent painful erection (priapism);

Sexual side effects, as listed4. Possibili effetti indesiderati · Uso nei bambini e negli adolescenti al di sotto di 18 anni d’etàmaturità sessuale ritardata o disfunzione sessuale;Original text: Italian. Our translation:delayed sexual maturity or sexual dysfunction;

The text itself prints no date of revision.

Patient leaflet Foglio illustrativo: informazioni per l’utilizzatoreFluoxetina EG 20 mg capsule rigide, EG S.p.A. · Read in the regulator's own database: Banca Dati FarmaciMade available by the regulatorChecked
SpainText for professionals · fluoxetina cinfaFluoxetine: the page about it

Sexual side effects that continue after stopping4.4. Advertencias y precauciones especiales de empleo · Disfunción sexualSe han notificado casos de disfunción sexual de larga duración en los que los síntomas persisten a pesar de la suspensión del ISRS.Original text: Spanish. Our translation:Cases of long-lasting sexual dysfunction have been reported in which the symptoms persist despite the SSRI being stopped.

Sexual side effects, as listed4.8. Reacciones adversas · Resumen tabulado de reacciones adversas · Trastornos psiquiátricos · FrecuentesAnsiedad Nerviosismo Inquietud Tensión Disminución de la libido3 Trastornos del sueño Sueños anormales4Original text: Spanish. Our translation:Anxiety Nervousness Restlessness Tension Decreased libido3 Sleep disorders Abnormal dreams4

Sexual side effects, as listed4.8. Reacciones adversas · Resumen tabulado de reacciones adversas · Trastornos psiquiátricos · Poco frecuentesDespersonalización Estado elevado del ánimo Estado eufórico del ánimo Pensamiento anormal Orgasmo normal5 Bruxismo Comportamientos y pensamientos suicidas6Original text: Spanish. Our translation:Depersonalisation Elevated mood Euphoric mood Abnormal thinking Abnormal orgasm5 Bruxism Suicidal behaviour and thoughts6

Sexual side effects, as listed4.8. Reacciones adversas · Resumen tabulado de reacciones adversas · Trastornos del aparato reproductor y de la mama · FrecuentesHemorragia ginecológica14 Disfunción eréctil Trastorno de la eyaculación15Original text: Spanish. Our translation:Gynaecological bleeding14 Erectile dysfunction Ejaculation disorder15

Sexual side effects, as listed4.8. Reacciones adversas · Resumen tabulado de reacciones adversas · Trastornos del aparato reproductor y de la mama · Poco frecuentesDisfunción sexualOriginal text: Spanish. Our translation:Sexual dysfunction

Sexual side effects, as listed4.8. Reacciones adversas · Resumen tabulado de reacciones adversas · Trastornos del aparato reproductor y de la mama · RarasGalactorrea Hiperprolactinemia PriapismoOriginal text: Spanish. Our translation:Galactorrhoea Hyperprolactinaemia Priapism

The same text also says4.8. Reacciones adversas · Resumen del perfil de seguridadLas reacciones adversas pueden disminuir en intensidad y frecuencia con el tratamiento continuado y no conducen generalmente a la interrupción del tratamiento.Original text: Spanish. Our translation:The adverse reactions may decrease in intensity and frequency with continued treatment and do not generally lead to treatment being stopped.

Sexual side effects, as listed4.8. Reacciones adversas · Población pediátrica (ver secciones 4.4 y 5.1)Han sido notificados de la experiencia clínica en pediatría casos aislados de efectos adversos indicando potencialmente un retraso en la maduración sexual o disfunción sexual (ver también sección 5.3).Original text: Spanish. Our translation:From clinical experience in children, isolated cases have been reported of adverse effects potentially indicating delayed sexual maturation or sexual dysfunction (see also section 5.3).

An official list of medicines we read shows the originator product as cancelled, revoked or archived. This is the text of another product, the one named in this row.

Texts for other products in this country do not all say the same. We searched them for sentences about sexual side effects continuing after stopping and did not read them whole. This row shows the product named, and no other.

Spelling and punctuation are the document's own.

A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.

Text for professionals Ficha técnicafluoxetina cinfa 20 mg cápsulas duras EFG, Laboratorios Cinfa, S.A. · Read in the regulator's own database: CIMAText revisedChecked
SpainPatient leaflet · fluoxetina cinfaFluoxetine: the page about it

Sexual side effects that continue after stopping2. Qué necesita saber antes de empezar a tomar fluoxetina cinfa · Advertencias y precauciones · Disfunción sexualEn algunos casos, estos síntomas persisten después de suspender el tratamiento.Original text: Spanish. Our translation:In some cases, these symptoms persist after treatment is stopped.

Sexual side effects, as listed4. Posibles efectos adversos · Algunos pacientes han padecido:Erección prolongada y dolorosa.Original text: Spanish. Our translation:Prolonged and painful erection.

Sexual side effects, as listed4. Posibles efectos adversos · Frecuentes (pueden afectar hasta 1 de cada 10 personas)Disminución del deseo sexual o problemas sexuales (incluyendo dificultad para mantener una erección durante la actividad sexual).Original text: Spanish. Our translation:Decreased sexual desire or sexual problems (including difficulty keeping an erection during sexual activity).

Sexual side effects that continue after stopping4. Posibles efectos adversos · Poco frecuentes (pueden afectar hasta 1 de cada 100 personas)Problemas sexuales, incluyendo problemas de orgasmo, persistiendo ocasionalmente después de la interrupción del tratamiento.Original text: Spanish. Our translation:Sexual problems, including orgasm problems, occasionally persisting after treatment is stopped.

The same text also says4. Posibles efectos adversosLa mayoría de estos efectos adversos tienden a desaparecer con la continuación del tratamiento.Original text: Spanish. Our translation:Most of these side effects tend to disappear as treatment continues.

An official list of medicines we read shows the originator product as cancelled, revoked or archived. This is the text of another product, the one named in this row.

Patient leaflet Prospecto: información para el usuariofluoxetina cinfa 20 mg cápsulas duras EFG, Laboratorios Cinfa, S.A. · Read in the regulator's own database: CIMAText revisedChecked
SpainDocument from the regulatorFluoxetine: the page about it

Sexual side effects that continue after stoppingInformación sobre seguridad · Nueva información de seguridad procedente de la evaluación periódica de los datos de farmacovigilancia · Inhibidores selectivos de la recaptación de serotonina (SRS)/serotonina y noradrenalina (ISRN): persistencia de disfunción sexualEn pacientes a tratamiento con inhibidores de la recaptación de serotonina y noradrenalina, o con inhibidores selectivos de la recaptación de serotonina, se han notificado casos de disfunción sexual de larga duración en los que los síntomas persisten a pesar de la interrupción del tratamiento. Se incorporará este hallazgo a las advertencias de estos medicamentos.Original text: Spanish. Our translation:In patients treated with serotonin and noradrenaline reuptake inhibitors, or with selective serotonin reuptake inhibitors, cases of long-lasting sexual dysfunction have been reported in which the symptoms persist despite treatment being stopped. This finding will be added to the warnings of these medicines.

That document is about the whole class of medicines. It does not name fluoxetine.

Spelling and punctuation are the document's own.

Document from the regulator Boletín mensual de la AEMPS sobre medicamentos de uso humano. Mayo de 2019Read on the regulator's site: AEMPSPublishedChecked
BrazilText for professionals · FluoxetinFluoxetine: the page about it

Sexual side effects, as listed9. REAÇÕES ADVERSAS · Reação comum (> 1/100 e < 1/10):diminuição da libido (incluindo perda da libido)Original text: Portuguese. Our translation:decreased libido (including loss of libido)

Sexual side effects, as listed9. REAÇÕES ADVERSAS · Reação comum (> 1/100 e < 1/10):distúrbios da ejaculação (incluindo falha na ejaculação, disfunção da ejaculação, ejaculação precoce, retardo na ejaculação e ejaculação retrógrada)Original text: Portuguese. Our translation:ejaculation disorders (including ejaculation failure, ejaculation dysfunction, premature ejaculation, delayed ejaculation and retrograde ejaculation)

Sexual side effects, as listed9. REAÇÕES ADVERSAS · Reação comum (> 1/100 e < 1/10):disfunção erétilOriginal text: Portuguese. Our translation:erectile dysfunction

Sexual side effects, as listed9. REAÇÕES ADVERSAS · Reação incomum (> 1/1.000 e <1/100):alteração do orgasmo (incluindo anorgasmia)Original text: Portuguese. Our translation:change in orgasm (including anorgasmia)

Sexual side effects, as listed9. REAÇÕES ADVERSAS · Reação incomum (> 1/1.000 e <1/100):aumento da libidoOriginal text: Portuguese. Our translation:increased libido

Sexual side effects, as listed9. REAÇÕES ADVERSAS · Relatos pós-comercialização:priapismoOriginal text: Portuguese. Our translation:priapism

Sexual side effects that continue after stopping9. REAÇÕES ADVERSAS · Relatos pós-comercialização:disfunção sexual (ocasionalmente persistindo após a descontinuação do uso)Original text: Portuguese. Our translation:sexual dysfunction (occasionally persisting after use is stopped)

This is the holder's own copy. The regulator's database refused our requests (it blocks by country; we asked from Denmark).

The originator product's text could not be opened. This is the text of another product, the one named in this row.

Text for professionals Fluoxetin (cloridrato de fluoxetina): bula para o profissional de saúdeFluoxetin cápsula dura 20 mg, Cristália Produtos Químicos Farmacêuticos Ltda. · Read on the holder's own site: Cristália Produtos Químicos Farmacêuticos Ltda.The text prints no dateChecked
BrazilText for professionals · ProzacFluoxetine: the page about it

We could not open this text on 14 October 2026: the site refused our requests (it blocks by country; we asked from Denmark); the holder publishes no text. This says nothing about what the text contains.

Text for professionalsProzac, Eli Lilly do Brasil Ltda.We tried: consultas.anvisa.gov.br/#/bulario/Tried
BrazilPatient leaflet · FluoxetinFluoxetine: the page about it

Sexual side effects, as listed8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Reação comum (ocorre entre 1% e 10% dos pacientes que utilizam este medicamento):diminuição da libido [incluindo perda da libido (desejo sexual)]Original text: Portuguese. Our translation:decreased libido [including loss of libido (sexual desire)]

Sexual side effects, as listed8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Reação comum (ocorre entre 1% e 10% dos pacientes que utilizam este medicamento):distúrbios da ejaculaçãoOriginal text: Portuguese. Our translation:ejaculation disorders

Sexual side effects, as listed8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Reação comum (ocorre entre 1% e 10% dos pacientes que utilizam este medicamento):disfunção erétil (dificuldade de obtenção e/ou manutenção da ereção do pênis)Original text: Portuguese. Our translation:erectile dysfunction (difficulty getting and/or keeping an erection of the penis)

Sexual side effects, as listed8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Reação incomum (ocorre entre 0,1% e 1% dos pacientes que utilizam este medicamento):alteração do orgasmo [incluindo anorgasmia (incapacidade de ter orgasmo)]Original text: Portuguese. Our translation:change in orgasm [including anorgasmia (inability to have an orgasm)]

Sexual side effects, as listed8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Reação incomum (ocorre entre 0,1% e 1% dos pacientes que utilizam este medicamento):aumento da libido (aumento do desejo sexual)Original text: Portuguese. Our translation:increased libido (increased sexual desire)

Sexual side effects, as listed8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Relatos pós-comercialização:priapismo (ereção do pênis prolongada ou dolorida)Original text: Portuguese. Our translation:priapism (prolonged or painful erection of the penis)

Sexual side effects that continue after stopping8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Relatos pós-comercialização:disfunção sexual (ocasionalmente persistindo após a descontinuação do uso)Original text: Portuguese. Our translation:sexual dysfunction (occasionally persisting after use is stopped)

This is the holder's own copy. The regulator's database refused our requests (it blocks by country; we asked from Denmark).

Patient leaflet Fluoxetin (cloridrato de fluoxetina): bula para o pacienteFluoxetin cápsula dura 20 mg, Cristália Produtos Químicos Farmacêuticos Ltda. · Read on the holder's own site: Cristália Produtos Químicos Farmacêuticos Ltda.The text prints no dateChecked
BrazilPatient leaflet · ProzacFluoxetine: the page about it

We could not open this text on 14 October 2026: the site refused our requests (it blocks by country; we asked from Denmark); the holder publishes no text. This says nothing about what the text contains.

Patient leafletProzac, Eli Lilly do Brasil Ltda.We tried: consultas.anvisa.gov.br/#/bulario/Tried
IndiaText for professionalsFluoxetine: the page about it

We could not open this text on 14 October 2026: this regulator publishes no database of such texts. This says nothing about what the text contains.

Text for professionalsWe tried: cdsco.gov.in/opencms/opencms/en/Notifications/Prescribing-Information/Tried

Finasteride

For the 5α-reductase inhibitor finasteride (Propecia), the product information we read in the United Kingdom, in the United States, in Canada, in Australia, in New Zealand, in Germany, in France, in Italy, in Spain, in Brazil and in India, in some places that of another product, lists sexual dysfunction that continued after treatment was stopped. In each of those texts it stands among side effects reported once the medicine was in general use. Several add that these reports come from a group of unknown size, so how often this happens, and whether finasteride is the cause, cannot always be established. Patients call lasting effects after finasteride post-finasteride syndrome (PFS). The wording a European Commission decision set for the EU in 2025 is about mood and thoughts of suicide, and has no sentence about sexual side effects continuing after the medicine is stopped.

Finasteride: what each text says about sexual side effects, and about side effects that continue after stopping.
Country or regionWhat the text saysDocumentDates
United KingdomText for professionals · PropeciaFinasteride: the page about it

Sexual side effects, as listed4.8 Undesirable effects · Psychiatric disorders: · Uncommon*:Decreased libido.

Sexual side effects, as listed4.8 Undesirable effects · Reproductive system and breast disorders: · Uncommon*:Erectile dysfunction, ejaculation disorder (including decreased volume of ejaculate).

Sexual side effects that continue after stopping4.8 Undesirable effectsIn addition, the following have been reported in post-marketing use: persistence of sexual dysfunction (decreased libido, erectile dysfunction and ejaculation disorder) after discontinuation of treatment with 'Propecia'; male breast cancer (see 4.4 Special warnings and precautions for use).

The same text also says4.8 Undesirable effectsThe frequency of adverse reactions reported during post-marketing use cannot be determined as they are derived from spontaneous reports.

Sexual side effects, as listed4.8 Undesirable effectsIn these studies, the following drug-related adverse experiences were reported in ≥1% of men treated with 'Propecia': decreased libido ('Propecia', 1.8% vs. placebo, 1.3%) and erectile dysfunction (1.3%, 0.7%). In addition, decreased volume of ejaculate was reported in 0.8% of men treated with 'Propecia' and 0.4% of men treated with placebo. Resolution of these side effects occurred in men who discontinued therapy with 'Propecia' and in many who continued therapy. The effect of 'Propecia' on ejaculate volume was measured in a separate study and was not different from that seen with placebo.

Sexual side effects, as listed4.8 Undesirable effectsDrug-related sexual undesirable effects were more common in the finasteride 1 mg-treated men than the placebo-treated men, with frequencies during the first 12 months of 3.8% vs 2.1%, respectively. The incidence of these effects decreased to 0.6% in finasteride 1 mg-treated men over the following four years. Approximately 1% of men in each treatment group discontinued due to drug-related sexual adverse experiences in the first 12 months, and the incidence declined thereafter.

This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text.

Texts for other products in this country do not all say the same. The ones we read are on the full record.

Text for professionals Summary of Product Characteristics (SmPC): Propecia 1 mg Film-Coated TabletsPropecia 1 mg film-coated tablets, Organon Pharma (UK) Limited · Read in a compendium of product information: emcText revisedChecked
United KingdomText for professionals · ProscarFinasteride: the page about it

Sexual side effects, as listed4.8 Undesirable effectsThe most frequent adverse reactions are impotence and decreased libido. These adverse reactions occur early in the course of therapy and resolve with continued treatment in the majority of patients.

Sexual side effects, as listed4.8 Undesirable effects · Psychiatric disorders · Common:decreased libido

Sexual side effects that continue after stopping4.8 Undesirable effects · Psychiatric disorders · Unknown:decreased libido that may continue after discontinuation of therapy, depression, anxiety, suicidal ideation

Sexual side effects, as listed4.8 Undesirable effects · Reproductive system and breast disorders · Common:impotence

Sexual side effects, as listed4.8 Undesirable effects · Reproductive system and breast disorders · Uncommon:ejaculation disorder, breast tenderness, breast enlargement.

Sexual side effects that continue after stopping4.8 Undesirable effects · Reproductive system and breast disorders · Unknown:testicular pain, haematospermia, sexual dysfunction (erectile dysfunction and ejaculation disorder) which may continue after discontinuation of treatment; male infertility and/or poor seminal quality. Normalization or improvement of seminal quality has been reported after discontinuation of finasteride.

The same text also says4.8 Undesirable effectsThe frequency of adverse reactions reported during post-marketing use cannot be determined as they are derived from spontaneous reports.

Sexual side effects, as listed4.8 Undesirable effects · Investigations · Common:decreased volume of ejaculate

Sexual side effects, as listed4.8 Undesirable effects · Medical Therapy of Prostatic Symptoms (MTOPS)The MTOPS study compared finasteride 5 mg/day (n=768), doxazosin 4 or 8 mg/day (n=756), combination therapy of finasteride 5 mg/day and doxazosin 4 or 8 mg/day (n=786), and placebo (n=737). In this study, the safety and tolerability profile of the combination therapy was generally consistent with the profiles of the individual components. The incidence of ejaculation disorder in patients receiving combination therapy was comparable to the sum of incidences of this adverse experience for the two monotherapies.

A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.

Text for professionals Summary of Product Characteristics (SmPC): Proscar 5mg film-coated TabletsProscar 5 mg film-coated tablets, Organon Pharma (UK) Limited · Read in a compendium of product information: emcText revisedChecked
United KingdomPatient leaflet · PropeciaFinasteride: the page about it

Sexual side effects, as listed4. Possible side effects · Uncommon: may affect up to 1 in 100 peopleyou may be unable to have an erection (impotence)

Sexual side effects, as listed4. Possible side effects · Uncommon: may affect up to 1 in 100 peopleyou may have less desire to have sex

Sexual side effects, as listed4. Possible side effects · Uncommon: may affect up to 1 in 100 peopleyou may have problems with ejaculation, for example a decrease in the amount of semen released during sex. This decrease in the amount of semen does not appear to affect normal sexual function

The same text also says4. Possible side effectsSome of the side effects are temporary with continued treatment or disappeared when treatment is stopped.

Sexual side effects that continue after stopping4. Possible side effects · Frequency unknown:persistent difficulty having an erection after discontinuation of treatmentOn record since 2010, according to MHRA, April 2024.

Sexual side effects that continue after stopping4. Possible side effects · Frequency unknown:persistent decrease in sex drive after discontinuation of treatment

Sexual side effects that continue after stopping4. Possible side effects · Frequency unknown:persistent problems with ejaculation after discontinuation of treatment

This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text.

Patient leaflet Package Leaflet: Information for the user. Propecia® 1 mg film-coated Tablets. finasteridePropecia 1 mg film-coated tablets, Organon Pharma (UK) Limited · Read in a compendium of product information: emcText revisedChecked
United KingdomPatient leaflet · ProscarFinasteride: the page about it

Sexual side effects, as listed4. Possible side effects · Other side effects may include:You may be unable to have an erection (impotence)

Sexual side effects, as listed4. Possible side effects · Other side effects may include:You may have less desire to have sex

Sexual side effects, as listed4. Possible side effects · Other side effects may include:You may have problems with ejaculation, for example a decrease in the amount of semen released during sex. This decrease in the amount of semen does not appear to affect normal sexual function.

The same text also says4. Possible side effectsThese side effects above may disappear after a while if you continue taking Proscar. If not, they usually resolve after stopping Proscar.

Sexual side effects that continue after stopping4. Possible side effects · Other side effects reported in some men are:An inability to have an erection which may continue after stopping the medicationOn record since 2010, according to MHRA, April 2024.

Sexual side effects that continue after stopping4. Possible side effects · Other side effects reported in some men are:Decrease in sex drive that may continue after stopping the medication

Sexual side effects that continue after stopping4. Possible side effects · Other side effects reported in some men are:Problems with ejaculation that may continue after stopping the medication

Patient leaflet PACKAGE LEAFLET: INFORMATION FOR THE USER. PROSCAR® 5 mg film-coated tablets (finasteride)Proscar 5 mg film-coated tablets, Organon Pharma (UK) Limited · Read in a compendium of product information: emcText revisedChecked
United KingdomDocument from the regulatorFinasteride: the page about it

What the regulator said3.3 Warnings on sexual and psychiatric risks in the product information · Sexual side effects and finasterideIn 2010, the product information was updated to clarify that persistence of erectile dysfunction after stopping treatment had been reported in post-marketing use. In 2013, the product information was further updated to include ‘decreased libido’ and ‘ejaculation disorder’.

Sexual side effects that continue after stopping10. Annexes · Annex 1 · Patient card for finasteride 1mg:Decreased sex drive and erectile dysfunction have also been reported (which in some cases continued after treatment was stopped).

Sexual side effects that continue after stopping10. Annexes · Annex 1 · Patient card for finasteride 5mg:Decreased sex drive and erectile dysfunction have also been reported (which in some cases continued after treatment was stopped).

Document from the regulator Safety review of Finasteride. Public Assessment ReportRead on the regulator's site: GOV.UKPublishedChecked
United KingdomDocument from the regulatorFinasteride: the page about it

Sexual side effects that continue after stoppingAdvice for Healthcare Professionals:finasteride is associated with depression, suicidal ideation and sexual dysfunction which may persist after treatment is stopped

What the regulator saidAdvice for Healthcare Professionals:inform patients of the risks at point of prescribing and advise patients to read the Finasteride patient cards and the patient leaflet for finasteride which are both supplied in the 1 mg and 5 mg packs

What the regulator saidAdvice for Healthcare Professionals:the product information for finasteride 1 mg will be updated with a warning that sexual dysfunction may contribute to mood disorders, and that sexual dysfunction has also been reported without mood alterations

Document from the regulator Drug Safety Update: "Finasteride and Dutasteride – updated safety warnings for psychiatric side effects and sexual dysfunction"Read on the regulator's site: GOV.UKPublishedChecked
United KingdomDocument from the regulatorFinasteride: the page about it

What the regulator saidReview of persistent sexual dysfunction and psychiatric side effects with finasterideThe PEAG noted that the product information for finasteride contains information regarding the potential for persistent sexual side effects after discontinuation with finasteride and depression and suicidal ideation. However, these side effects are not well known by prescribers and patients and therefore a Drug Safety Update article was recommended.

Sexual side effects that continue after stoppingAdvice for healthcare professionals:patients have reported that sexual dysfunction (including decreased libido and erectile dysfunction) has persisted even after treatment was stopped

What the regulator saidAdvice for healthcare professionals:a patient card will be introduced in all finasteride packs, which will highlight the risk of sexual side effects and psychiatric side effects reported with finasteride to increase awareness among patients and prescribers

Sexual side effects that continue after stoppingAdvice for healthcare professionals to give to patients and caregivers:in some cases sexual dysfunction has persisted in patients even after they have stopped taking finasteride

Document from the regulator Drug Safety Update: "Finasteride: reminder of the risk psychiatric side effects and of sexual side effects (which may persist after discontinuation of treatment)"Read on the regulator's site: GOV.UKPublishedChecked
United KingdomDocument from the regulatorFinasteride: the page about it

Sexual side effects, as listedSexual dysfunctionHealthcare professionals are reminded that adverse reactions related to sexual function have been reported in association with finasteride. These include decreased libido, erectile dysfunction, and ejaculation disorders (such as decreased volume of ejaculate).

This text has no sentence about sexual side effects continuing after the medicine is stopped.

The regulator has marked this document as superseded.

Document from the regulator Drug Safety Update: "Finasteride: rare reports of depression and suicidal thoughts"Read on the regulator's site: GOV.UKPublishedChecked
United KingdomDocument from the regulatorFinasteride: the page about it

Sexual side effects that continue after stoppingMen on finasteride asked to stay vigilant for possible psychiatric and sexual side effectsIn some cases, sexual dysfunction has persisted in patients even after they have stopped taking finasteride.

Document from the regulator Press release: "Men on finasteride asked to stay vigilant for possible psychiatric and sexual side effects"Read on the regulator's site: GOV.UKPublishedChecked
United KingdomDocument from the regulatorFinasteride: the page about it

What the regulator saidMHRA strengthens safety warnings for finasteride and dutasterideExisting UK patient alert cards for finasteride, introduced in 2024, remain in place. These cards highlight the risks of sexual dysfunction, depression and suicidal thoughts and advise patients on what action to take if side effects occur.

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Document from the regulator Press release: "MHRA strengthens safety warnings for finasteride and dutasteride"Read on the regulator's site: GOV.UKPublishedChecked
United KingdomCompany letter to health professionals, on the regulator's siteFinasteride: the page about it

What the regulator saidSummary of the safety concern:A Patient Alert Card is available in the package of medicinal products containing finasteride to highlight the risks of depressed mood, depression, suicidal ideation and sexual dysfunction reported with finasteride.

This text has no sentence about sexual side effects continuing after the medicine is stopped.

The letter opens by saying it was written in agreement with the regulator. The words are the company's, and it is not the product's own text.

Company letter to health professionals, on the regulator's site Direct Healthcare Professional Communication (DHPC): "Finasteride and dutasteride - Updated safety warnings for psychiatric side effects and sexual dysfunction"Read on the regulator's site: GOV.UKPublishedChecked
United KingdomGovernment answer in parliamentFinasteride: the page about it

What the regulator saidAnswerThe MHRA has recently completed an extensive safety review into finasteride, with the subsequent updates to the product information having been implemented, and the development of a patient alert card is underway.

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Contains Parliamentary information licensed under the Open Parliament Licence v3.0.

Government answer in parliament Written question UIN 20625, House of Commons: "Finasteride"Read on the parliament's siteAnsweredChecked
United KingdomGovernment answer in parliamentFinasteride: the page about it

Sexual side effects that continue after stoppingAnswerThe MHRA is currently reviewing the existing warnings in relation to sexual dysfunction which may continue after stopping anti-depressant medication, and recently completed an extensive safety review of finasteride and persistent sexual dysfunction, including after stopping treatment with finasteride.

Contains Parliamentary information licensed under the Open Parliament Licence v3.0.

Government answer in parliament Written question UIN 23846, House of Commons: "Antidepressants: Side Effects"Read on the parliament's siteAnsweredChecked
United KingdomGovernment answer in parliamentFinasteride: the page about it

What the regulator saidAnswerPatient alert cards are being introduced in all finasteride packs to reiterate these warnings.

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Contains Parliamentary information licensed under the Open Parliament Licence v3.0.

Government answer in parliament Written question UIN HL2471, House of Lords: "Finasteride: Side Effects"Read on the parliament's siteAnsweredChecked
European UnionDocument from the regulatorFinasteride: the page about it

This text has no sentence about sexual side effects continuing after the medicine is stopped.

This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text.

This is wording for national product texts. There is no single EU product text for this medicine.

Document from the regulator Finasteride- and dutasteride-containing medicinal products, Article 31 referral: Annex III Amendments to relevant sections of the Product InformationRead on the regulator's site: European Medicines AgencyThe text prints no dateChecked
European UnionDocument from the regulatorFinasteride: the page about it

What the regulator saidMeasures to minimise risk of suicidal thoughts with finasteride and dutasteride medicinesThe product information for finasteride 1 mg tablets will now also alert patients about the need to seek medical advice if they experience problems with sexual function (such as decreased sex drive or erectile dysfunction), which are known side effects of the medicine and may contribute to mood changes.

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Document from the regulator Measures to minimise risk of suicidal thoughts with finasteride and dutasteride medicinesRead on the regulator's site: European Medicines AgencyPublishedChecked
European UnionDocument from the regulatorFinasteride: the page about it

What the regulator saidScientific conclusions · Grounds for PRAC recommendationPRAC concluded that sexual dysfunction (a known adverse drug reaction of finasteride) may have a potential contributory role in suicidal ideation in some patients being treated with finasteride 1 mg for oral use and recommended this to be reflected in the product information of these medicinal products.

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Document from the regulator Finasteride- and dutasteride-containing medicinal products, Article 31 referral: Annex II Scientific conclusionsRead on the regulator's site: European Medicines AgencyThe text prints no dateChecked
United StatesText for professionals · PropeciaFinasteride: the page about it

Sexual side effects that continue after stopping6 ADVERSE REACTIONS · 6.2 Postmarketing ExperienceReproductive System: sexual dysfunction that continued after discontinuation of treatment, including erectile dysfunction, libido disorders, ejaculation disorders, and orgasm disorders; male infertility and/or poor seminal quality (normalization or improvement of seminal quality has been reported after discontinuation of finasteride); testicular pain; hematospermia.

The same text also says6 ADVERSE REACTIONS · 6.2 Postmarketing ExperienceThe following adverse reactions have been identified during post approval use of PROPECIA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:

This sentence stands in the list of adverse reactions. The warnings section of this text has no entry on sexual function.

Texts for other products in this country do not all say the same. The ones we read are on the full record.

This text names sexual side effects in several places that this row does not show. Together those passages are too long to reproduce here. The document link in this row opens the text. That they are not shown says nothing about how common these side effects are.

On 14 October 2026 we searched the labels in openFDA, the FDA's open database. A sentence that sexual dysfunction continued after treatment was stopped stood on 151 of the 181 labels in that database that name finasteride, and on each of them among the adverse reactions, in no warnings section. Of the 30 without it, 10 are hair products with labels in the Drug Facts style, 5 are listings of compounded solutions for the skin, 2 have no text on adverse reactions, and 13 are older labels of 5 mg tablets with an earlier list of adverse reactions.

A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.

Text for professionals PROPECIA® (finasteride) tablets for oral use: Full Prescribing InformationPropecia tablets 1 mg, Organon LLC · Read in the government's medicines database: DailyMedText revisedChecked
United StatesText for professionals · ProscarFinasteride: the page about it

Sexual side effects that continue after stopping6 ADVERSE REACTIONS · 6.2 Postmarketing Experiencesexual dysfunction that continued after discontinuation of treatment, including erectile dysfunction, decreased libido and ejaculation disorders (e.g. reduced ejaculate volume). These events were reported rarely in men taking PROSCAR for the treatment of BPH. Most men were older and were taking concomitant medications and/or had co-morbid conditions. The independent role of PROSCAR in these events is unknown.

The same text also says6 ADVERSE REACTIONS · 6.2 Postmarketing ExperienceThe following additional adverse events have been reported in postmarketing experience with PROSCAR. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:

Sexual side effects that continue after stopping6 ADVERSE REACTIONS · 6.2 Postmarketing ExperienceThe following additional adverse event related to sexual dysfunction that continued after discontinuation of treatment has been reported in postmarketing experience with finasteride at lower doses used to treat male pattern baldness. Because the event is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate its frequency or establish a causal relationship to drug exposure: orgasm disorders

This text names sexual side effects in several places that this row does not show. Together those passages are too long to reproduce here. The document link in this row opens the text. That they are not shown says nothing about how common these side effects are.

Text for professionals PROSCAR® (finasteride) Tablets: Full Prescribing InformationProscar tablets 5 mg, Organon LLC · Read in the government's medicines database: DailyMedText revisedChecked
United StatesPatient leaflet · PropeciaFinasteride: the page about it

Sexual side effects, as listedWhat are the possible side effects of PROPECIA? · The most common side effects of PROPECIA include:decrease in sex drive

Sexual side effects, as listedWhat are the possible side effects of PROPECIA? · The most common side effects of PROPECIA include:trouble getting or keeping an erection

Sexual side effects, as listedWhat are the possible side effects of PROPECIA? · The most common side effects of PROPECIA include:a decrease in the amount of semen

Sexual side effects that continue after stoppingWhat are the possible side effects of PROPECIA? · The following have been reported in general use with PROPECIA:decrease in sex drive that continued after stopping the medication;

Sexual side effects that continue after stoppingWhat are the possible side effects of PROPECIA? · The following have been reported in general use with PROPECIA:problems with ejaculation that continued after stopping medication;

Sexual side effects that continue after stoppingWhat are the possible side effects of PROPECIA? · The following have been reported in general use with PROPECIA:difficulty in achieving an erection that continued after stopping the medication;

Patient leaflet Patient Information PROPECIA (Pro-pee-sha) (finasteride) TabletsPropecia tablets 1 mg, Organon LLC · Read in the government's medicines database: DailyMedText revisedChecked
United StatesPatient leaflet · ProscarFinasteride: the page about it

Sexual side effects, as listedWhat are the possible side effects of PROSCAR? · The most common side effects of PROSCAR include:trouble getting or keeping an erection (impotence)

Sexual side effects, as listedWhat are the possible side effects of PROSCAR? · The most common side effects of PROSCAR include:decrease in sex drive

Sexual side effects, as listedWhat are the possible side effects of PROSCAR? · The most common side effects of PROSCAR include:decreased volume of ejaculate

Sexual side effects, as listedWhat are the possible side effects of PROSCAR? · The most common side effects of PROSCAR include:ejaculation disorders

Sexual side effects that continue after stoppingWhat are the possible side effects of PROSCAR? · The following have been reported in general use with PROSCAR and/or finasteride at lower doses:trouble getting or keeping an erection that continued after stopping the medication

Sexual side effects that continue after stoppingWhat are the possible side effects of PROSCAR? · The following have been reported in general use with PROSCAR and/or finasteride at lower doses:problems with ejaculation that continued after stopping the medication

Sexual side effects that continue after stoppingWhat are the possible side effects of PROSCAR? · The following have been reported in general use with PROSCAR and/or finasteride at lower doses:decrease in sex drive that continued after stopping the medication

Patient leaflet Patient Information about PROSCAR® (Prahs-car)Proscar tablets 5 mg, Organon LLC · Read in the government's medicines database: DailyMedText revisedChecked
United StatesDocument from the regulator · PropeciaFinasteride: the page about it

Sexual side effects that continue after stoppingSUPPLEMENT APPROVALS-021 is a “Changes Being Effected” sNDA that provides for the addition of the adverse reaction “erectile dysfunction that continued after discontinuation of treatment”, to the Postmarketing Experience section of the package insert and to the patient labeling.

Document from the regulator SUPPLEMENT APPROVAL: NDA 020788/S-020, S-021, S-023Propecia Tablet, 1 mg, Merck Sharp & Dohme Corp. · Read in the regulator's own database: Drugs@FDAText approvedChecked
United StatesDocument from the regulator · ProscarFinasteride: the page about it

What the regulator saidSUPPLEMENT APPROVALThese supplemental new drug applications, provides for revisions to the ADVERSE REACTIONS, Postmarketing Experience section of the labeling related to depression, erectile dysfunction, decreased libido, and male infertility and/or poor seminal quality, as well as a modification of the WARNINGS and PRECAUTIONS section concerning the consideration of other urological conditions when prescribing Proscar.

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Document from the regulator SUPPLEMENT APPROVAL: NDA 020180/S-040, S-041, S-042Proscar 5 mg Tablets, Merck Sharp & Dohme Corp. · Read in the regulator's own database: Drugs@FDAText approvedChecked
United StatesDocument from the regulator · ProscarFinasteride: the page about it

Sexual side effects that continue after stoppingSUPPLEMENT APPROVALThis “Prior Approval” supplemental new drug application provides for changes to the ADVERSE REACTIONS, Postmarketing Experience section of the labeling related to sexual dysfunction that continued after discontinuation of treatment.

Document from the regulator SUPPLEMENT APPROVAL: NDA 020180/S-043Proscar 5 mg Tablets, Merck Sharp & Dohme Corp. · Read in the regulator's own database: Drugs@FDAText approvedChecked
United StatesDocument from the regulator · PropeciaFinasteride: the page about it

What the regulator saidSUPPLEMENT APPROVALThis information pertains to the risk of suicidal ideation and behavior, additional risk of sexual dysfunction and psychoneurocognitive adverse events with use of Propecia.

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Document from the regulator SUPPLEMENT APPROVAL: NDA 020788/S-030Propecia tablets, 1mg, Organon LLC · Read in the regulator's own database: Drugs@FDAText approvedChecked
United StatesDocument from the regulatorFinasteride: the page about it

A general sentence about side effects that may continue. It does not name sexual function.Review and discussionMost of the reports FDA has received state the adverse events continued to persist after product discontinuation.

The same text also saysReview and discussionThere were 32 cases reported to the FDA Adverse Event Reporting System between 2019 and 2024. Absorption of finasteride through the skin into the bloodstream is expected, and the reports describe adverse events that are consistent with those reported in association with the approved oral finasteride products, such as erectile dysfunction, anxiety, suicidal ideation, brain fog, depression, fatigue, insomnia, decreased libido and testicular pain following the use of compounded topical products with finasteride alone or in combination with other active ingredients.

This text has no sentence about sexual side effects continuing after the medicine is stopped.

The text itself prints no date of revision.

Document from the regulator FDA alerts health care providers, compounders and consumers of potential risks associated with compounded topical finasteride productsRead on the regulator's site: U.S. Food and Drug AdministrationUpdated by the regulatorChecked
CanadaText for professionals · PropeciaFinasteride: the page about it

Sexual side effects that continue after stopping8 ADVERSE REACTIONS · 8.5 Post-Market Adverse ReactionsPsychiatric disorders: mood alterations and depression, decreased libido that continued after discontinuation of treatment.

Sexual side effects that continue after stopping8 ADVERSE REACTIONS · 8.5 Post-Market Adverse ReactionsReproductive system and breast disorders: sexual dysfunction (erectile dysfunction and ejaculation disorders) that continued after discontinuation of treatment, breast tenderness and enlargement, male breast cancer, testicular pain, hematospermia, male infertility and/or poor seminal quality.

The same text also says8 ADVERSE REACTIONS · 8.5 Post-Market Adverse ReactionsBecause these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.

This sentence stands in the list of adverse reactions. The warnings section of this text has no entry on sexual function.

Texts for other products in this country do not all say the same. The ones we read are on the full record.

This text names sexual side effects in several places that this row does not show. Together those passages are too long to reproduce here. The document link in this row opens the text. That they are not shown says nothing about how common these side effects are.

A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.

Text for professionals PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION: PrPROPECIA® finasteride tablets, Film-coated Tablets 1 mg, USPPropecia film-coated tablets 1 mg, Organon Canada Inc. · Read in the regulator's own database: Drug Product DatabaseText revisedChecked
CanadaText for professionals · ProscarFinasteride: the page about it

Sexual side effects that continue after stopping8 ADVERSE REACTIONS · 8.5 Post-Market Adverse ReactionsPsychiatric disorders: mood alterations and depression, decreased libido that continued after discontinuation of treatment.

Sexual side effects that continue after stopping8 ADVERSE REACTIONS · 8.5 Post-Market Adverse ReactionsReproductive system and breast disorders: sexual dysfunction (erectile dysfunction and ejaculation disorders) that continued after discontinuation of treatment, male breast cancer, testicular pain, hematospermia, male infertility and/or poor seminal quality.

The same text also says8 ADVERSE REACTIONS · 8.5 Post-Market Adverse ReactionsBecause these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.

This sentence stands in the list of adverse reactions. The warnings section of this text has no entry on sexual function.

This text names sexual side effects in several places that this row does not show. Together those passages are too long to reproduce here. The document link in this row opens the text. That they are not shown says nothing about how common these side effects are.

A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.

Text for professionals PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION: PrPROSCAR® finasteride tablets, Film-coated Tablets 5 mg, USPProscar film-coated tablets 5 mg, Organon Canada Inc. · Read in the regulator's own database: Drug Product DatabaseText revisedChecked
CanadaPatient leaflet · PropeciaFinasteride: the page about it

Sexual side effects that continue after stoppingWhat are possible side effects from using PROPECIA? · Side effects may include:difficulty in achieving an erection that continued after stopping the medication;

Sexual side effects, as listedWhat are possible side effects from using PROPECIA? · Side effects may include:difficulty in achieving an erection;

Sexual side effects, as listedWhat are possible side effects from using PROPECIA? · Side effects may include:less desire to have sex;

Sexual side effects, as listedWhat are possible side effects from using PROPECIA? · Side effects may include:problems with ejaculation, such as a decrease in the amount of semen released during sex;

Patient leaflet PATIENT MEDICATION INFORMATION: PrPROPECIA® Finasteride tabletsPropecia film-coated tablets 1 mg, Organon Canada Inc. · Read in the regulator's own database: Drug Product DatabaseText revisedChecked
CanadaPatient leaflet · ProscarFinasteride: the page about it

Sexual side effects, as listedOther warnings you should know aboutCombination therapy of PROSCAR and doxazosin may increase the chances of dizziness, postural hypotension (dizziness upon standing), weakness, impotence and abnormal ejaculation.

Sexual side effects, as listedWhat are possible side effects from using PROSCAR? · Side effects may include:impotence (an inability to have an erection);

Sexual side effects, as listedWhat are possible side effects from using PROSCAR? · Side effects may include:less desire to have sex;

Sexual side effects that continue after stoppingWhat are possible side effects from using PROSCAR? · Side effects may include:problems with ejaculation that continued after stopping the medication;

Sexual side effects, as listedWhat are possible side effects from using PROSCAR? · Side effects may include:problems with ejaculation, such as a decrease in the amount of semen released during sex;

A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.

Patient leaflet PATIENT MEDICATION INFORMATION: PrPROSCAR® Finasteride tabletsProscar film-coated tablets 5 mg, Organon Canada Inc. · Read in the regulator's own database: Drug Product DatabaseText revisedChecked
CanadaDocument from the regulatorFinasteride: the page about it

What the regulator saidKey MessagesHealth Canada will work with the manufacturers to enhance the existing product safety information in the Canadian product monograph (CPM) for all finasteride-containing products and dutasteride-containing products to also include a warning about the risk of sexual dysfunction.

The same text also saysOverviewThe risk of sexual dysfunction with the use of finasteride and dutasteride is known and labelled in the CPM for all finasteride-containing products and dutasteride-containing products.

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Document from the regulator Summary Safety Review - Finasteride and Dutasteride - Assessing the Potential Risk of Sexual DysfunctionRead on the regulator's site: Drug and Health Product PortalThe text prints no dateChecked
CanadaDocument from the regulatorFinasteride: the page about it

What the regulator saidMONTHLY RECAP OF HEALTH PRODUCT SAFETY INFORMATION · Finasteride and dutasterideHealth Canada will work with the manufacturers to enhance the product safety information in the Canadian product monograph for all finasteride-containing products and dutasteride-containing products to include a warning about the risk of sexual dysfunction.

The same text also saysMONTHLY RECAP OF HEALTH PRODUCT SAFETY INFORMATIONThe following is a list of health product advisories, type I drug recalls and summaries of completed safety reviews published in May 2026 by Health Canada.

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Document from the regulator Health Product InfoWatch, June 2026Read on the regulator's site: Government of Canada PublicationsPublishedChecked
AustraliaText for professionals · PROPECIAFinasteride: the page about it

Sexual side effects that continue after stoppingSection 4.8 · Post-marketing experienceIn section 4.8, under post-marketing experience, Australia's product information for Propecia lists a lower sex drive, and sexual dysfunction (erection and ejaculation problems), each as having gone on after the treatment was stopped.Summarised, not quoted, because of the TGA's access terms.

The same text also saysSection 4.8 · Post-marketing experienceThe text says these reports come from a group of unknown size, so how often this happens, and whether the medicine is the cause, cannot always be established.Summarised, not quoted, because of the TGA's access terms.

The regulator's site asks readers to accept its terms before it shows this text.

This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text.

Texts for other products in this country do not all say the same. The ones we read are on the full record.

Text for professionals AUSTRALIAN PRODUCT INFORMATION PROPECIA (finasteride) TabletsPROPECIA, Organon Pharma Pty Ltd · Read in the regulator's own database: TGA eBSText revisedChecked
AustraliaText for professionals · PROSCARFinasteride: the page about it

Sexual side effects that continue after stoppingSection 4.8 · Post-Marketing ExperienceIn section 4.8, under post-marketing experience, Australia's product information for Proscar lists a lower sex drive, and sexual dysfunction (erection and ejaculation problems), each as having gone on after the treatment was stopped.Summarised, not quoted, because of the TGA's access terms.

The same text also saysSection 4.8 · Post-Marketing ExperienceThe text says these reports are for Proscar or for finasteride at lower doses, and come from a group of unknown size, so how often this happens, and whether the medicine is the cause, cannot always be established.Summarised, not quoted, because of the TGA's access terms.

The regulator's site asks readers to accept its terms before it shows this text.

This sentence stands in the list of adverse reactions. The warnings section of this text has no entry on sexual function.

Text for professionals AUSTRALIAN PRODUCT INFORMATION PROSCAR (finasteride) TabletsPROSCAR, Organon Pharma Pty Ltd · Read in the regulator's own database: TGA eBSText revisedChecked
AustraliaPatient leaflet · PROPECIAFinasteride: the page about it

Sexual side effects that continue after stoppingSection 6 · Less serious side effectsAustralia's consumer medicine information for Propecia lists trouble getting an erection and a lower sex drive as side effects that go on after the medicine is stopped. In the same list it says that in clinical trials these effects went away in men who stopped taking it, and in many who carried on, and that ejaculation problems that go on after stopping are reported, though not often.Summarised, not quoted, because of the TGA's access terms.

The regulator's site asks readers to accept its terms before it shows this text.

Patient leaflet PROPECIA Consumer Medicine InformationPROPECIA, Organon Pharma Pty Ltd · Read in the regulator's own database: TGA eBSText revisedChecked
AustraliaPatient leaflet · PROSCARFinasteride: the page about it

Sexual side effects that continue after stoppingSection 6 · Less serious side effectsAustralia's consumer medicine information for Proscar lists impotence, a lower sex drive and ejaculation problems as side effects that go on after the medicine is stopped. In the same list it says that in some cases these went away while the patient kept taking it, and that if they lasted they usually went away when the tablets were stopped.Summarised, not quoted, because of the TGA's access terms.

The regulator's site asks readers to accept its terms before it shows this text.

Patient leaflet PROSCAR Consumer Medicine InformationPROSCAR, Organon Pharma Pty Ltd · Read in the regulator's own database: TGA eBSText revisedChecked
New ZealandText for professionals · PropeciaFinasteride: the page about it

Sexual side effects, as listed4.8 Undesirable effects · Adverse events identified during clinical trialsIn these studies, the following medicine-related adverse experiences were reported in ≥ 1% of men treated with PROPECIA: • decreased libido (PROPECIA, 1.8% vs. placebo, 1.3%) • erectile dysfunction (1.3%, 0.7%). In addition, decreased volume of ejaculate was reported in 0.8% of men treated with PROPECIA and 0.4% of men treated with placebo.

The same text also says4.8 Undesirable effects · Adverse events identified during clinical trialsResolution of these adverse effects occurred in men who discontinued therapy with PROPECIA and in many who continued therapy. In a separate study, the effect of PROPECIA on ejaculate volume was measured and was not different from that seen with placebo. The incidence of each of the above adverse effects decreased to ≤ 0.3% by the fifth year of treatment with PROPECIA.

Sexual side effects that continue after stopping4.8 Undesirable effects · Adverse events identified during postmarketing experience · Psychiatric disorders:decreased libido that continued after discontinuation of treatment.

Sexual side effects that continue after stopping4.8 Undesirable effects · Adverse events identified during postmarketing experience · Reproductive system and breast disorders:sexual dysfunction (erectile dysfunction and ejaculation disorders) that continued after discontinuation of treatment

The same text also says4.8 Undesirable effects · Adverse events identified during postmarketing experienceBecause these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.

This sentence stands in the list of adverse reactions. The warnings section of this text has no entry on sexual function.

Texts for other products in this country do not all say the same. The ones we read are on the full record.

Text for professionals New Zealand Data Sheet, PROPECIAPropecia 1 mg film coated tablet, Organon (New Zealand) Limited · Read in the regulator's own database: MedsafeText revisedChecked
New ZealandText for professionals · RicitFinasteride: the page about it

Sexual side effects, as listed4.8 Undesirable effectsThe most frequent adverse reactions are impotence and decreased libido. These adverse reactions occur early in the course of therapy and resolve with continued treatment in the majority of patients.

Sexual side effects that continue after stopping4.8 Undesirable effects · Psychiatric disordersCommon: decreased libido Unknown: decreased libido that may continue after discontinuation of therapy, depression

Sexual side effects that continue after stopping4.8 Undesirable effects · Reproductive system and breast disordersCommon: impotence Uncommon: ejaculation disorder, breast tenderness, breast enlargement. Unknown: testicular pain, sexual dysfunction (erectile dysfunction and ejaculation disorder) which may continue after discontinuation of treatment; male infertility and/or poor seminal quality. Normalization or improvement of seminal quality has been reported after discontinuation of finasteride.

The same text also says4.8 Undesirable effectsThe frequency of adverse reactions reported during post-marketing use cannot be determined as they are derived from spontaneous reports.

Sexual side effects, as listed4.8 Undesirable effects · InvestigationsCommon: decreased volume of ejaculate

The originator product is not in the list we read. This is another product from that list.

This sentence stands in the list of adverse reactions. The warnings section of this text has no entry on sexual function.

A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.

Text for professionals New Zealand Datasheet, RicitRicit 5 mg film coated tablets, REX Medical Limited · Read in the regulator's own database: MedsafeText revisedChecked
New ZealandPatient leaflet · PropeciaFinasteride: the page about it

Sexual side effects that continue after stoppingAdverse Effects · Tell your doctor if you notice any of the following and they worry you:less desire for sex that continued after stopping the medication

Sexual side effects, as listedAdverse Effects · Tell your doctor if you notice any of the following and they worry you:decreased amount of semen released during sex (this decrease does not appear to interfere with normal sexual function)

Sexual side effects that continue after stoppingAdverse Effects · Tell your doctor if you notice any of the following and they worry you:problems with ejaculation that continue after stopping medication

Sexual side effects that continue after stoppingAdverse Effects · Tell your doctor if you notice any of the following and they worry you:difficulty in achieving an erection that continued after stopping the medication

The same text also saysAdverse EffectsLess desire for sex, difficulty in achieving an erection and decreased amount of semen released during sex occurred in less than two men in one hundred. It is important to understand that, in clinical trials, these unwanted effects disappeared in men who stopped taking PROPECIA, as well as in many men who continued treatment.

Patient leaflet Consumer Medicine Information (CMI), PROPECIAPropecia 1 mg tablet, Organon New Zealand · Read in the regulator's own database: MedsafeText revisedChecked
New ZealandDocument from the regulatorFinasteride: the page about it

Sexual side effects that continue after stoppingKey MessagesSymptoms (sexual, physical, and mental and neurological) often persist after the patient has stopped taking finasteride.

The same text also saysKey MessagesPost-Finasteride Syndrome can occur in some men who have taken finasteride.

The regulator's page says this article is more than five years old and that some of its content may no longer be current.

Document from the regulator Post-Finasteride SyndromeRead on the regulator's site: MedsafePublishedChecked
GermanyText for professionals · Propecia®Finasteride: the page about it

Sexual side effects, as listed4.8 Nebenwirkungen · Psychiatrische Erkrankungen: · Gelegentlich*verminderte LibidoOriginal text: German. Our translation:decreased libido

Sexual side effects, as listed4.8 Nebenwirkungen · Erkrankungen der Geschlechtsorgane und der Brustdrüse: · Gelegentlich*erektile Dysfunktion, Ejakulationsstörung (einschl. vermindertes Ejakulatvolumen)Original text: German. Our translation:erectile dysfunction, ejaculation disorder (including decreased volume of ejaculate)

Sexual side effects that continue after stopping4.8 NebenwirkungenNach Markteinführung wurde zusätzlich über Folgendes berichtet: Persistenz von sexueller Dysfunktion (verminderte Libido, erektile Dysfunktion und Ejakulationsstörungen) nach dem Absetzen von Finasterid; Brustkrebs beim Mann (siehe Abschnitt 4.4 Besondere Warnhinweise und Vorsichtsmaßnahmen für die Anwendung).Original text: German. Our translation:In addition, the following has been reported after marketing: persistence of sexual dysfunction (decreased libido, erectile dysfunction and ejaculation disorders) after finasteride has been stopped; breast cancer in men (see section 4.4 Special warnings and precautions for use).

The same text also says4.8 NebenwirkungenDie Häufigkeit der nach Markteinführung berichteten unerwünschten Ereignisse kann nicht bestimmt werden, da es sich um Spontanberichte handelt.Original text: German. Our translation:The frequency of the adverse events reported after marketing cannot be determined, as they come from spontaneous reports.

Sexual side effects, as listed4.8 NebenwirkungenMit einer Häufigkeit von 3,8 % bzw. 2,1 % während der ersten 12 Monate waren sexuelle Nebenwirkungen bei den mit Finasterid behandelten Männern häufiger als bei den mit Placebo behandelten Männern. Die Häufigkeit dieser Nebenwirkungen sank bei den mit Finasterid behandelten Männern auf 0,6 % im Laufe der folgenden 4 Jahre. Ca. 1 % der Männer in jeder Behandlungsgruppe beendete die Behandlung aufgrund sexueller Nebenwirkungen während der ersten 12 Monate, danach nahm die Häufigkeit ab.Original text: German. Our translation:With frequencies of 3.8% and 2.1% respectively during the first 12 months, sexual side effects were more common in men treated with finasteride than in men treated with placebo. The frequency of these side effects fell to 0.6% in men treated with finasteride over the following 4 years. About 1% of the men in each treatment group stopped treatment because of sexual side effects during the first 12 months; after that, the frequency decreased.

This is the holder's own copy. The regulator's database asks visitors to accept its terms first, which we did not do.

This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text.

Texts for other products in this country do not all say the same. The ones we read are on the full record.

Text for professionals Fachinformation (Zusammenfassung der Merkmale des Arzneimittels)Propecia® 1 mg Filmtabletten, Organon Healthcare GmbH · Read on the holder's own site: Organon Healthcare GmbHText revisedChecked
GermanyText for professionals · PROSCAR®Finasteride: the page about it

Sexual side effects, as listed4.8 NebenwirkungenDie häufigsten Nebenwirkungen sind Impotenz und verminderte Libido. Bei der Mehrheit der Patienten treten diese Nebenwirkungen zu Beginn der Therapie auf und bilden sich im Verlauf der Therapie zurück.Original text: German. Our translation:The most common side effects are impotence and decreased libido. In most patients these side effects occur at the start of therapy and resolve as therapy continues.

Sexual side effects, as listed4.8 Nebenwirkungen · Psychiatrische Erkrankungen · Häufigverminderte LibidoOriginal text: German. Our translation:decreased libido

Sexual side effects that continue after stopping4.8 Nebenwirkungen · Psychiatrische Erkrankungen · Nicht bekanntDepression; verminderte Libido, die auch nach dem Absetzen der Behandlung andauerte; Angst; SuizidgedankenOriginal text: German. Our translation:Depression; decreased libido that continued even after treatment was stopped; anxiety; suicidal thoughts

Sexual side effects, as listed4.8 Nebenwirkungen · Erkrankungen der Geschlechtsorgane und der Brustdrüse · HäufigImpotenzOriginal text: German. Our translation:Impotence

Sexual side effects, as listed4.8 Nebenwirkungen · Erkrankungen der Geschlechtsorgane und der Brustdrüse · GelegentlichEjakulationsstörungen, Berührungsempfindlichkeit der Brust, Vergrößerung der BrustOriginal text: German. Our translation:Ejaculation disorders, breast tenderness, breast enlargement

Sexual side effects that continue after stopping4.8 Nebenwirkungen · Erkrankungen der Geschlechtsorgane und der Brustdrüse · Nicht bekanntHodenschmerzen; Hämatospermie; sexuelle Funktionsstörungen (erektile Dysfunktion und Ejakulationsstörungen), die auch nach dem Absetzen der Behandlung andauerten; Infertilität bei Männern und/oder schlechte Spermienqualität. Eine Normalisierung oder Verbesserung der Spermienqualität wurde nach dem Absetzen von Finasterid berichtet.Original text: German. Our translation:Testicular pain; haematospermia; sexual dysfunction (erectile dysfunction and ejaculation disorders) that continued even after treatment was stopped; infertility in men and/or poor sperm quality. Normalisation or improvement of sperm quality has been reported after finasteride was stopped.

The same text also says4.8 NebenwirkungenDa die Nebenwirkungen, die nach Markteinführung für PROSCAR und/oder Finasterid in niedrigeren Dosierungen aus Spontanberichten aus einer Population unbestimmter Größe stammen, ist es nicht möglich, ihre Häufigkeit zuverlässig abzuschätzen bzw. einen Kausalzusammenhang mit der Anwendung des Arzneimittels nachzuweisen.Original text: German. Our translation:As the side effects reported after marketing for PROSCAR and/or finasteride at lower doses come from spontaneous reports from a population of uncertain size, it is not possible to estimate their frequency reliably or to establish a causal relationship with the use of the medicine.

Sexual side effects, as listed4.8 Nebenwirkungen · Untersuchungen · Häufigvermindertes EjakulatvolumenOriginal text: German. Our translation:decreased volume of ejaculate

Sexual side effects, as listed4.8 Nebenwirkungen · Kombinationstherapie mit DoxazosinDie folgenden Nebenwirkungen wurden häufiger berichtet, wenn PROSCAR zusammen mit dem alpha-Rezeptorenblocker Doxazosin angewendet wurde: Asthenie 16,8 % (Plazebo 7,1 %), posturale Hypotonie 17,8 % (Plazebo 8,0 %), Schwindel 23,2 % (Plazebo 8,1 %) und Ejakulationsstörungen 14,1 % (Plazebo 2,3 %).Original text: German. Our translation:The following side effects were reported more often when PROSCAR was used together with the alpha-blocker doxazosin: asthenia 16.8% (placebo 7.1%), postural hypotension 17.8% (placebo 8.0%), dizziness 23.2% (placebo 8.1%) and ejaculation disorders 14.1% (placebo 2.3%).

This is the holder's own copy. The regulator's database asks visitors to accept its terms first, which we did not do.

A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.

Text for professionals Fachinformation (Zusammenfassung der Merkmale des Arzneimittels)PROSCAR® 5 mg Filmtabletten, Organon Healthcare GmbH · Read on the holder's own site: Organon Healthcare GmbHText revisedChecked
GermanyPatient leaflet · Propecia®Finasteride: the page about it

Sexual side effects, as listed4. Welche Nebenwirkungen sind möglich? · Gelegentlich: kann bis zu 1 von 100 Behandelten betreffenvermindertes Verlangen nach SexOriginal text: German. Our translation:reduced desire for sex

Sexual side effects, as listed4. Welche Nebenwirkungen sind möglich? · Gelegentlich: kann bis zu 1 von 100 Behandelten betreffenSchwierigkeiten bei der ErektionOriginal text: German. Our translation:difficulty with erection

Sexual side effects, as listed4. Welche Nebenwirkungen sind möglich? · Gelegentlich: kann bis zu 1 von 100 Behandelten betreffenStörungen des Samenergusses einschließlich verminderter SamenergussmengeOriginal text: German. Our translation:ejaculation disorders, including a reduced amount of ejaculate

The same text also says4. Welche Nebenwirkungen sind möglich?Die Nebenwirkungen waren während der Behandlung gewöhnlich vorübergehend oder verschwanden nach Abbruch der Behandlung.Original text: German. Our translation:The side effects were usually temporary during treatment or disappeared when treatment was stopped.

Sexual side effects that continue after stopping4. Welche Nebenwirkungen sind möglich? · Nicht bekannt: Häufigkeit auf Grundlage der verfügbaren Daten nicht abschätzbarnach dem Absetzen der Behandlung andauerndeOriginal text: German. Our translation:lasting after treatment is stopped

Sexual side effects that continue after stopping4. Welche Nebenwirkungen sind möglich? · Nicht bekannt: Häufigkeit auf Grundlage der verfügbaren Daten nicht abschätzbarSchwierigkeiten bei der ErektionOriginal text: German. Our translation:difficulty with erection

Sexual side effects that continue after stopping4. Welche Nebenwirkungen sind möglich? · Nicht bekannt: Häufigkeit auf Grundlage der verfügbaren Daten nicht abschätzbarAbnahme des sexuellen VerlangensOriginal text: German. Our translation:decrease in sexual desire

Sexual side effects that continue after stopping4. Welche Nebenwirkungen sind möglich? · Nicht bekannt: Häufigkeit auf Grundlage der verfügbaren Daten nicht abschätzbarEjakulationsschwierigkeitenOriginal text: German. Our translation:difficulty with ejaculation

This is the holder's own copy. The regulator's database asks visitors to accept its terms first, which we did not do.

This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text.

Patient leaflet Gebrauchsinformation: Information für AnwenderPropecia® 1 mg Filmtabletten, Organon Healthcare GmbH · Read on the holder's own site: Organon Healthcare GmbHText revisedChecked
GermanyPatient leaflet · PROSCAR®Finasteride: the page about it

Sexual side effects, as listed4. Welche Nebenwirkungen sind möglich? · Häufigverminderte Samenflüssigkeitsmenge (vermindertes Ejakulatvolumen), Störungen des sexuellen Reaktionsvermögens (Impotenz), verminderter Sexualtrieb (verminderte Libido).Original text: German. Our translation:reduced amount of seminal fluid (decreased volume of ejaculate), disorders of sexual response (impotence), reduced sex drive (decreased libido).

Sexual side effects, as listed4. Welche Nebenwirkungen sind möglich? · GelegentlichStörungen des Samenergusses (Ejakulationsstörungen); Vergrößerung der Brust, Berührungsempfindlichkeit in der Brust, Hautausschlag.Original text: German. Our translation:disorders of ejaculation (ejaculation disorders); breast enlargement, breast tenderness, skin rash.

Sexual side effects that continue after stopping4. Welche Nebenwirkungen sind möglich? · Nicht bekanntJuckreiz, erhöhte Leberwerte, Herzklopfen, Hodenschmerzen; Blut im Sperma, sexuelle Funktionsstörungen (Schwierigkeiten bei der Erektion und Störungen des Samenergusses), die auch nach dem Absetzen des Arzneimittels anhielten. Unfruchtbarkeit bei Männern und/oder eine schlechte Samenqualität. Nach dem Absetzen des Arzneimittels wurde über eine Verbesserung der Samenqualität berichtet. Depression; verminderter Sexualtrieb (verminderte Libido), der auch nach dem Absetzen der Behandlung andauerte; Angst; Selbstmordgedanken.Original text: German. Our translation:Itching, raised liver values, palpitations, testicular pain; blood in the sperm, sexual dysfunction (difficulty with erection and disorders of ejaculation) that persisted even after the medicine was stopped. Infertility in men and/or poor semen quality. An improvement in semen quality has been reported after the medicine was stopped. Depression; reduced sex drive (decreased libido) that continued even after treatment was stopped; anxiety; suicidal thoughts.

Sexual side effects, as listed4. Welche Nebenwirkungen sind möglich? · Kombinationsbehandlung mit DoxazosinDie folgenden Nebenwirkungen wurden häufiger berichtet, wenn PROSCAR zusammen mit dem alpha-Rezeptorenblocker Doxazosin angewendet wurde: Abgeschlagenheit 16,8 % (Scheinmedikament 7,1 %), Blutdruckabfall im Stehen 17,8 % (Scheinmedikament 8,0 %), Schwindel 23,2 % (Scheinmedikament 8,1 %) und Störungen des Samenergusses (Ejakulationsstörungen) 14,1 % (Scheinmedikament 2,3 %).Original text: German. Our translation:The following side effects were reported more often when PROSCAR was used together with the alpha-blocker doxazosin: tiredness 16.8% (dummy medicine 7.1%), drop in blood pressure on standing 17.8% (dummy medicine 8.0%), dizziness 23.2% (dummy medicine 8.1%) and disorders of ejaculation (ejaculation disorders) 14.1% (dummy medicine 2.3%).

This is the holder's own copy. The regulator's database asks visitors to accept its terms first, which we did not do.

A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.

Patient leaflet Gebrauchsinformation: Information für AnwenderPROSCAR® 5 mg Filmtabletten, Organon Healthcare GmbH · Read on the holder's own site: Organon Healthcare GmbHText revisedChecked
GermanyPatient leafletFinasteride: the page about it

This text has no sentence about sexual side effects continuing after the medicine is stopped.

This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text.

Patient leaflet Patientenkarte zur sicheren AnwendungRead on the regulator's site: BfArMPublishedChecked
GermanyCompany letter to health professionals, on the regulator's siteFinasteride: the page about it

Sexual side effects that continue after stoppingZusammenfassungPatienten sollten ebenfalls darüber informiert werden, dass sexuelle Dysfunktionen - basierend auf einzelnen Fallberichten über Patienten - auch nach Absetzen der Therapie länger als 10 Jahre fortbestehen können.Original text: German. Our translation:Patients should also be informed that, on the basis of individual case reports on patients, sexual dysfunction may persist for more than 10 years even after therapy has been stopped.

The letter opens by saying it was written in agreement with the regulator. The words are the company's, and it is not the product's own text.

Company letter to health professionals, on the regulator's site Rote-Hand-Brief zu Finasterid: Risiko sexueller Dysfunktionen und psychischer StörungenRead on the regulator's site: BfArMPublishedChecked
GermanyDocument from the regulatorFinasteride: the page about it

Sexual side effects that continue after stoppingAKTUELLE ANGABEN IN DEN PRODUKTINFORMATIONENEs wird darauf hingewiesen, dass sexuelle Dysfunktionen (verminderte Libido, erektile Dysfunktion und Ejakulationsstörungen) nach Absetzen der Therapie persistieren können.Original text: German. Our translation:It is pointed out that sexual dysfunction (decreased libido, erectile dysfunction and ejaculation disorders) may persist after therapy is stopped.

Document from the regulator Bulletin zur Arzneimittelsicherheit, Ausgabe 3, September 2018: „Depressionen und sexuelle Funktionsstörungen unter Anwendung von Finasterid zur Behandlung der androgenetischen Alopezie“Read on the regulator's site: BfArMPublishedChecked
GermanyCompany letter to health professionals, on the regulator's siteFinasteride: the page about it

This text has no sentence about sexual side effects continuing after the medicine is stopped.

The letter opens by saying it was written in agreement with the regulator. The words are the company's, and it is not the product's own text.

Company letter to health professionals, on the regulator's site Rote-Hand-Brief zu Finasterid und Dutasterid: Neue Maßnahmen zur Minimierung des Risikos für SuizidgedankenRead on the regulator's site: BfArMPublishedChecked
FranceText for professionals · FINASTERIDE ARROW LABFinasteride: the page about it

Sexual side effects, as listed4.8. Effets indésirables · Affections psychiatriques · Peu fréquent*baisse de la libidoOriginal text: French. Our translation:decreased libido

Sexual side effects, as listed4.8. Effets indésirables · Affections des organes de reproduction et du sein · Peu fréquent*troubles de l'érection, troubles de l'éjaculation (y compris diminution du volume de l'éjaculat)Original text: French. Our translation:erection disorders, ejaculation disorders (including decreased volume of ejaculate)

Sexual side effects that continue after stopping4.8. Effets indésirablesDe plus, depuis la mise sur le marché, les effets indésirables suivants ont été rapportés : persistance des troubles de la fonction sexuelle (baisse de la libido, troubles de l'érection et de l'éjaculation) après l'arrêt du traitement par finastéride ; cancer du sein chez l'homme (voir rubrique 4.4 « Mises en garde spéciales et précautions d'emploi »).Original text: French. Our translation:In addition, since marketing, the following adverse effects have been reported: persistence of sexual function disorders (decreased libido, erection and ejaculation disorders) after treatment with finasteride has been stopped; breast cancer in men (see section 4.4 “Special warnings and precautions for use”).

The same text also says4.8. Effets indésirablesLa fréquence des effets indésirables rapportés depuis la commercialisation ne peut être déterminée dans la mesure où elle découle de cas de pharmacovigilance spontanés.Original text: French. Our translation:The frequency of the adverse effects reported since marketing cannot be determined, as it derives from spontaneous pharmacovigilance cases.

Sexual side effects, as listed4.8. Effets indésirablesLes effets indésirables sexuels ont été plus fréquents chez les hommes traités par le finastéride que chez les hommes recevant le placebo, avec des fréquences respectives de 3,8 % vs 2,1 % pendant les 12 premiers mois. L'incidence de ces effets a diminué à 0,6 % chez les hommes traités par le finastéride au cours des quatre années suivantes. Environ 1 % des hommes (dans chaque groupe) ont arrêté le traitement au cours des 12 premiers mois en raison d'effets indésirables sexuels liés au traitement. Cette incidence a diminué par la suite.Original text: French. Our translation:Sexual adverse effects were more frequent in men treated with finasteride than in men receiving placebo, with frequencies of 3.8% and 2.1% respectively during the first 12 months. The incidence of these effects fell to 0.6% in men treated with finasteride over the following four years. About 1% of men (in each group) stopped treatment during the first 12 months because of treatment-related sexual adverse effects. This incidence decreased thereafter.

The text itself prints no date of revision.

An official list of medicines we read shows the originator product as cancelled, revoked or archived. This is the text of another product, the one named in this row.

This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text.

Texts for other products in this country do not all say the same. The ones we read are on the full record.

Text for professionals Résumé des Caractéristiques du ProduitFINASTERIDE ARROW LAB 1 mg, comprimé pelliculé, ARROW GENERIQUES · Read in the government's medicines database: Base de données publique des médicamentsUpdated by the regulatorChecked
FranceText for professionals · CHIBRO-PROSCARFinasteride: the page about it

Sexual side effects that continue after stopping4.8. Effets indésirables · Affections psychiatriquesdiminution de la libido persistant à l'arrêt du traitementOriginal text: French. Our translation:decreased libido persisting when treatment is stopped

Sexual side effects that continue after stopping4.8. Effets indésirables · Affections des organes de reproduction et du seinanomalies de la fonction sexuelle (troubles de l'érection et de l’éjaculation) persistant à l'arrêt du traitementOriginal text: French. Our translation:anomalies of sexual function (erection and ejaculation disorders) persisting when treatment is stopped

The same text also says4.8. Effets indésirablesLa fréquence des effets indésirables rapportés depuis la mise sur le marché n'a pu être établie, car elle repose sur des signalements spontanés.Original text: French. Our translation:The frequency of the adverse effects reported since marketing could not be established, as it rests on spontaneous reports.

The text itself prints no date of revision.

This text names sexual side effects in several places that this row does not show. Together those passages are too long to reproduce here. The document link in this row opens the text. That they are not shown says nothing about how common these side effects are.

Text for professionals Résumé des Caractéristiques du ProduitCHIBRO-PROSCAR 5 mg, comprimé pelliculé, ORGANON France · Read in the government's medicines database: Base de données publique des médicamentsUpdated by the regulatorChecked
FrancePatient leaflet · FINASTERIDE ARROW LABFinasteride: the page about it

Sexual side effects, as listed4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Peu fréquents (pouvant affecter jusqu’à 1 personne sur 100) :diminution de la libido ;Original text: French. Our translation:decreased libido;

Sexual side effects, as listed4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Peu fréquents (pouvant affecter jusqu’à 1 personne sur 100) :troubles de l'érection ;Original text: French. Our translation:erection problems;

Sexual side effects, as listed4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Peu fréquents (pouvant affecter jusqu’à 1 personne sur 100) :problèmes d'éjaculation, tels qu'une diminution du volume de l'éjaculat ;Original text: French. Our translation:ejaculation problems, such as a decrease in the volume of ejaculate;

The same text also says4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ?Les effets indésirables ont généralement été transitoires pendant le traitement ou ont disparu à l'arrêt du traitement.Original text: French. Our translation:The adverse effects were generally temporary during treatment or disappeared when treatment was stopped.

Sexual side effects that continue after stopping4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Fréquence indéterminée (la fréquence ne peut être estimée sur la base des données disponibles) :persistance de difficultés à avoir des érections après l’arrêt du traitement ;Original text: French. Our translation:persistent difficulty in having erections after treatment is stopped;

Sexual side effects that continue after stopping4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Fréquence indéterminée (la fréquence ne peut être estimée sur la base des données disponibles) :diminution de la libido persistant après l’arrêt du traitement ;Original text: French. Our translation:decreased libido persisting after treatment is stopped;

Sexual side effects that continue after stopping4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Fréquence indéterminée (la fréquence ne peut être estimée sur la base des données disponibles) :persistance de troubles de l’éjaculation après l’arrêt du traitement ;Original text: French. Our translation:persistent ejaculation problems after treatment is stopped;

The text itself prints no date of revision.

An official list of medicines we read shows the originator product as cancelled, revoked or archived. This is the text of another product, the one named in this row.

This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text.

Patient leaflet Notice patientFINASTERIDE ARROW LAB 1 mg, comprimé pelliculé, ARROW GENERIQUES · Read in the government's medicines database: Base de données publique des médicamentsUpdated by the regulatorChecked
FrancePatient leaflet · CHIBRO-PROSCARFinasteride: the page about it

Sexual side effects, as listed4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Les effets secondaires fréquemment rapportés :impuissance,Original text: French. Our translation:impotence,

Sexual side effects, as listed4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Les effets secondaires fréquemment rapportés :diminution de la libido,Original text: French. Our translation:decreased libido,

Sexual side effects, as listed4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Les effets secondaires fréquemment rapportés :diminution du volume de l'éjaculat.Original text: French. Our translation:decreased volume of ejaculate.

Sexual side effects that continue after stopping4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Moins fréquemment, ont été rapportés :troubles de l'éjaculation persistant à l’arrêt du traitement,Original text: French. Our translation:ejaculation problems persisting when treatment is stopped,

Sexual side effects that continue after stopping4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Moins fréquemment, ont été rapportés :incapacité à avoir une érection persistante à l'arrêt du traitement,Original text: French. Our translation:inability to have an erection, persisting when treatment is stopped,

Sexual side effects that continue after stopping4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Moins fréquemment, ont été rapportés :diminution de la libido persistant à l'arrêt du traitement,Original text: French. Our translation:decreased libido persisting when treatment is stopped,

The text itself prints no date of revision.

Patient leaflet Notice patientCHIBRO-PROSCAR 5 mg, comprimé pelliculé, ORGANON France · Read in the government's medicines database: Base de données publique des médicamentsUpdated by the regulatorChecked
FrancePatient leafletFinasteride: the page about it

This text has no sentence about sexual side effects continuing after the medicine is stopped.

This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text.

Patient leaflet CARTE PATIENT, FINASTERIDE 1 mg, Comprimé pelliculéRead on the regulator's site: ANSMPublishedChecked
FranceDocument from the regulatorFinasteride: the page about it

Sexual side effects that continue after stoppingPoint d’Information du 13 mars 2012 : Finastéride (Propecia et génériques) dans le traitement de la calvitie chez l’homme jeune (alopécie androgénétique) : surveillance des effets secondairesDepuis lors, des cas de troubles de l’érection persistant après l’arrêt du traitement et de cancer du sein chez l’homme ont été rapportés.Original text: French. Our translation:Since then, cases of erection problems persisting after treatment was stopped, and of breast cancer in men, have been reported.

The same text also saysPoint d’Information du 13 mars 2012 : Finastéride (Propecia et génériques) dans le traitement de la calvitie chez l’homme jeune (alopécie androgénétique) : surveillance des effets secondairesA ce jour le lien de causalité entre la prise de finastéride et la persistance des troubles de l’érection, après l’arrêt du traitement, n’est pas établi.Original text: French. Our translation:To date, a causal link between taking finasteride and the persistence of erection problems after treatment is stopped has not been established.

Document from the regulator Point d’Information du 13 mars 2012 : Finastéride (Propecia et génériques) dans le traitement de la calvitie chez l’homme jeune (alopécie androgénétique) : surveillance des effets secondairesRead on the regulator's site: ANSMPublishedChecked
FranceDocument from the regulatorFinasteride: the page about it

Sexual side effects that continue after stoppingRappel sur les troubles sexuelsL’ANSM rappelle qu’il est possible d’observer une persistance de troubles sexuels après l’arrêt d’un traitement par finastéride.Original text: French. Our translation:The ANSM points out that sexual problems may persist after treatment with finasteride has been stopped.

Document from the regulator Point d’Information du 26 octobre 2017 : Finastéride : surveiller le risque de dépression et d’idées suicidairesRead on the regulator's site: ANSMPublishedChecked
FranceDocument from the regulatorFinasteride: the page about it

Sexual side effects that continue after stoppingTroubles sexuelsL’ANSM rappelle qu’il est possible d’observer une persistance de ces troubles sexuels après l’arrêt d’un traitement par finastéride.Original text: French. Our translation:The ANSM points out that these sexual problems may persist after treatment with finasteride has been stopped.

Document from the regulator Finastéride : rappel sur les risques de troubles psychiatriques et de la fonction sexuelleRead on the regulator's site: ANSMPublishedChecked
FranceCompany letter to health professionals, on the regulator's siteFinasteride: the page about it

Sexual side effects that continue after stoppingRésumé · TROUBLES SEXUELSLes troubles de la fonction sexuelle, dans certains cas, peuvent persister après l'arrêt du traitement.Original text: French. Our translation:Sexual function disorders may, in some cases, persist after treatment is stopped.

The letter opens by saying it was written in agreement with the regulator. The words are the company's, and it is not the product's own text.

Company letter to health professionals, on the regulator's site Lettre aux professionnels de santé, Février 2019 : Finastéride (Propecia, Chibro-Proscar, génériques) : rappel sur les risques de troubles de la fonction sexuelle et de troubles psychiatriquesRead on the regulator's site: ANSMPublishedChecked
FranceDocument from the regulatorFinasteride: the page about it

Sexual side effects that continue after stoppingQUELS SONT LES EFFETS INDÉSIRABLES DU FINASTÉRIDE · LES TROUBLES DE LA SEXUALITEDes patients ont rapporté des troubles sexuels. Il peut s’agir de troubles de l’érection, de l’éjaculation, de douleurs testiculaires, d’une diminution de la libido. Il est possible que ces effets persistent après l’arrêt du traitement et ce, pour une durée indéterminée.Original text: French. Our translation:Patients have reported sexual problems. These may be problems with erection or ejaculation, testicular pain or decreased libido. These effects may persist after treatment is stopped, and for an undetermined length of time.

Document from the regulator FINASTERIDE 1 mg (Propecia® et génériques) Pour la chute des cheveux : information pour les patientsRead on the regulator's site: ANSMPublishedChecked
FranceDocument from the regulatorFinasteride: the page about it

What the regulator saidActualisation du 24/05/2023Depuis le 28 avril 2023, sont progressivement mises sur le marché des boîtes de finastéride 1 mg comportant sur leur face principale (face avant) un encadré rouge indiquant que des effets indésirables de type sexuel et/ou psychiatrique peuvent survenir pendant et après le traitement, accompagné d’un QR code qui renvoie à notre dossier thématique « Finastéride 1 mg et chute de cheveux ».Original text: French. Our translation:Since 28 April 2023, packs of finasteride 1 mg have gradually been coming onto the market with a red box on their main (front) face stating that sexual and/or psychiatric adverse effects may occur during and after treatment, together with a QR code linking to our topic file “Finasteride 1 mg and hair loss”.

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Document from the regulator Finastéride 1 mg (Propecia et génériques) : ajout de mentions d’alerte sur les boîtes pour renforcer l’information sur les effets indésirablesRead on the regulator's site: ANSMPublishedChecked
FranceDocument from the regulatorFinasteride: the page about it

Sexual side effects that continue after stoppingRéévaluation européenne de la balance bénéfice/risque des médicaments contenant du finastéride ou du dutastérideMalgré ces actions, des cas graves de troubles psychiatriques et de troubles sexuels (pouvant parfois perdurer longtemps après l’arrêt du traitement) continuent de nous être rapportés.Original text: French. Our translation:Despite these actions, serious cases of psychiatric disorders and sexual disorders (which can sometimes last long after treatment is stopped) continue to be reported to us.

Document from the regulator Réévaluation européenne de la balance bénéfice/risque des médicaments contenant du finastéride ou du dutastérideRead on the regulator's site: ANSMPublishedChecked
FranceDocument from the regulatorFinasteride: the page about it

Sexual side effects that continue after stoppingPosition ANSMPar ailleurs, les troubles de la fonction sexuelle peuvent persister à l’arrêt du traitement et potentiellement conduire à des altérations de l’humeur, dont des idées suicidaires.Original text: French. Our translation:In addition, sexual function disorders may persist when treatment is stopped and may lead to changes in mood, including suicidal thoughts.

Document from the regulator Retour d’information sur le PRAC de mai 2025 (5 – 8 mai)Read on the regulator's site: ANSMPublishedChecked
FranceDocument from the regulatorFinasteride: the page about it

Sexual side effects that continue after stoppingFinastéride et risque d’idées suicidaires : nouvelles mesuresCes médicaments exposent à des risques de troubles psychiatriques, ainsi qu’à des troubles de la fonction sexuelle qui peuvent persister après l’arrêt du traitement.Original text: French. Our translation:These medicines carry risks of psychiatric disorders, and of sexual function disorders that may persist after treatment is stopped.

Document from the regulator Finastéride et risque d’idées suicidaires : nouvelles mesuresRead on the regulator's site: ANSMPublishedChecked
FranceDocument from the regulatorFinasteride: the page about it

A general sentence about side effects that may continue. It does not name sexual function.Finastéride 1 mg : une attestation d’information partagée bientôt nécessaire pour toute dispensationLa persistance possible de certains effets après l’arrêt du traitement ;Original text: French. Our translation:The possible persistence of certain effects after treatment is stopped;

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Document from the regulator Finastéride 1 mg : une attestation d’information partagée bientôt nécessaire pour toute dispensationRead on the regulator's site: ANSMPublishedChecked
FranceDocument from the regulatorFinasteride: the page about it

A general sentence about side effects that may continue. It does not name sexual function.Attestation d’information partagée : attestation destinée aux patients traités par les spécialités à base de finastéride 1 mgCertains effets peuvent persister de quelques années à une durée indéterminée après l’arrêt du traitement.Original text: French. Our translation:Certain effects may persist from a few years to an undetermined length of time after treatment is stopped.

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Document from the regulator Attestation d’information partagée : attestation destinée aux patients traités par les spécialités à base de finastéride 1 mgRead on the regulator's site: ANSMPublishedChecked
FranceDocument from the regulatorFinasteride: the page about it

Sexual side effects that continue after stoppingTroubles sexuelsDes patients ont rapporté des troubles sexuels lors de l’utilisation de finastéride 1 mg. Dans certains cas, ceux-ci peuvent persister après l’arrêt du traitement.Original text: French. Our translation:Patients have reported sexual problems while using finasteride 1 mg. In some cases, these may persist after treatment is stopped.

Document from the regulator Dossier thématique « Finastéride 1 mg et chute de cheveux », page « Risques liés à la prise de finastéride 1 mg »Read on the regulator's site: ANSMPublishedChecked
ItalyText for professionals · PropeciaFinasteride: the page about it

Sexual side effects, as listed4.8 Effetti indesiderati · Disturbi psichiatrici: · Non comune*Diminuzione della libidoOriginal text: Italian. Our translation:Decreased libido

Sexual side effects, as listed4.8 Effetti indesiderati · Patologie dell’apparato riproduttivo e della mammella: · Non comune*Disfunzione erettile, disordini dell’eiaculazione (incluso diminuzione del volume dell’eiaculato)Original text: Italian. Our translation:Erectile dysfunction, ejaculation disorders (including decreased volume of ejaculate)

The same text also says4.8 Effetti indesideratiIncidenze presentate quali differenze dal placebo negli studi clinici al 12° mese.Original text: Italian. Our translation:Incidences given as differences from placebo in clinical studies at month 12.

Sexual side effects that continue after stopping4.8 Effetti indesideratiInoltre, durante l’uso post-marketing sono stati riportati: disfunzione sessuale persistente (riduzione della libido, disfunzione erettile e disturbi dell’eiaculazione) dopo l’interruzione del trattamento con finasterideOriginal text: Italian. Our translation:In addition, during post-marketing use the following has been reported: persistent sexual dysfunction (reduced libido, erectile dysfunction and ejaculation disorders) after treatment with finasteride was stopped

Sexual side effects, as listed4.8 Effetti indesideratiEffetti indesiderati correlati al medicinale inerenti la sfera sessuale sono stati più comuni fra gli uomini trattati con finasteride che fra quelli trattati con placebo con frequenze durante i primi 12 mesi di 3,8 % vs 2,1 %, rispettivamente. L’incidenza di tali effetti è diminuita allo 0,6 % negli uomini trattati con finasteride nel corso dei successivi quattro anni. Circa l’1 % degli uomini in ciascun gruppo di trattamento ha interrotto la terapia a seguito di esperienze avverse della sfera sessuale correlate con il medicinale verificatesi nei primi 12 mesi e l’incidenza è in seguito diminuita.Original text: Italian. Our translation:Drug-related adverse effects affecting the sexual sphere were more common among men treated with finasteride than among those treated with placebo, with frequencies during the first 12 months of 3.8% vs 2.1% respectively. The incidence of these effects fell to 0.6% in men treated with finasteride over the following four years. About 1% of men in each treatment group stopped therapy because of drug-related sexual adverse experiences in the first 12 months, and the incidence decreased thereafter.

The text itself prints no date of revision.

This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text.

Texts for other products in this country do not all say the same. The ones we read are on the full record.

Text for professionals Riassunto delle caratteristiche del prodottoPropecia 1 mg compresse rivestite con film, Organon Italia S.r.l. · Read in the regulator's own database: Banca Dati FarmaciMade available by the regulatorChecked
ItalyText for professionals · ProscarFinasteride: the page about it

Sexual side effects, as listed4.8 Effetti indesideratiImpotenza e diminuzione della libido sono le reazioni avverse più frequenti. Queste reazioni avverse si manifestano nella fase iniziale della terapia e nella maggior parte dei pazienti si risolvono nel corso della terapia.Original text: Italian. Our translation:Impotence and decreased libido are the most frequent adverse reactions. These adverse reactions appear in the early phase of therapy and, in most patients, resolve during therapy.

Sexual side effects, as listed4.8 Effetti indesiderati · Disturbi psichiatrici · Comunediminuzione della libido.Original text: Italian. Our translation:decreased libido.

Sexual side effects, as listed4.8 Effetti indesiderati · Disturbi psichiatrici · Non notadepressione, disfunzione sessuale persistente*, ansia, ideazione suicidaria.Original text: Italian. Our translation:depression, persistent sexual dysfunction*, anxiety, suicidal ideation.

Sexual side effects that continue after stopping4.8 Effetti indesiderati · nota (*)(*) Durante l’uso post-marketing è stata riportata: disfunzione sessuale persistente (riduzione della libido, disfunzione erettile e disturbi dell’eiaculazione) dopo l’interruzione del trattamento con PROSCAR.Original text: Italian. Our translation:(*) During post-marketing use the following has been reported: persistent sexual dysfunction (reduced libido, erectile dysfunction and ejaculation disorders) after treatment with PROSCAR was stopped.

Sexual side effects, as listed4.8 Effetti indesiderati · Patologie dell’apparato riproduttivo e della mammella · Comuneimpotenza.Original text: Italian. Our translation:impotence.

Sexual side effects, as listed4.8 Effetti indesiderati · Patologie dell’apparato riproduttivo e della mammella · Non comunedisturbi dell’eiaculazione, tensione mammaria, aumento di volume della mammella.Original text: Italian. Our translation:ejaculation disorders, breast tenderness, breast enlargement.

Sexual side effects that continue after stopping4.8 Effetti indesiderati · Patologie dell’apparato riproduttivo e della mammella · Non notadolore testicolare, disfunzione erettile che è proseguita dopo l’interruzione del trattamento, ematospermia, infertilità maschile e/o scarsa qualità del liquido seminale. Normalizzazione o miglioramento della qualità del liquido seminale è stata riportata dopo l’interruzione della finasteride. Cancro della mammella nell’uomo (vedere 4.4 Avvertenze speciali e precauzioni d’impiego).Original text: Italian. Our translation:testicular pain, erectile dysfunction that continued after treatment was stopped, haematospermia, male infertility and/or poor seminal quality. Normalisation or improvement of seminal quality has been reported after finasteride was stopped. Breast cancer in men (see 4.4 Special warnings and precautions for use).

The same text also says4.8 Effetti indesideratiLa frequenza o la relazione causale delle reazioni avverse, riportate durante l’uso post-marketing con finasteride a dosi più basse, non può essere determinata poiché derivano da segnalazioni spontanee.Original text: Italian. Our translation:The frequency or causal relationship of the adverse reactions reported during post-marketing use with finasteride at lower doses cannot be determined, as they come from spontaneous reports.

Sexual side effects, as listed4.8 Effetti indesiderati · Esami diagnostici · Comunediminuzione del volume dell’eiaculato.Original text: Italian. Our translation:decreased volume of ejaculate.

Sexual side effects, as listed4.8 Effetti indesiderati · Medical Therapy Of Prostatic Symptoms (MTOPS)L’incidenza di disturbi dell’eiaculazione nei pazienti trattati con l’associazione è risultata paragonabile alla somma delle incidenze di tale esperienza avversa per le due monoterapie.Original text: Italian. Our translation:The incidence of ejaculation disorders in patients treated with the combination was comparable to the sum of the incidences of this adverse experience for the two monotherapies.

The text itself prints no date of revision.

A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.

Text for professionals Riassunto delle caratteristiche del prodottoProscar 5 mg compresse rivestite con film, Organon Italia S.r.l. · Read in the regulator's own database: Banca Dati FarmaciMade available by the regulatorChecked
ItalyPatient leaflet · PropeciaFinasteride: the page about it

Sexual side effects, as listed4. Possibili effetti indesiderati · Non comune: (può interessare fino a 1 persona su 100):diminuzione del desiderio sessualeOriginal text: Italian. Our translation:decreased sexual desire

Sexual side effects, as listed4. Possibili effetti indesiderati · Non comune: (può interessare fino a 1 persona su 100):difficoltà nel raggiungimento dell’erezioneOriginal text: Italian. Our translation:difficulty in achieving an erection

Sexual side effects, as listed4. Possibili effetti indesiderati · Non comune: (può interessare fino a 1 persona su 100):problemi con l’eiaculazione quali riduzione della quantità di sperma emessoOriginal text: Italian. Our translation:problems with ejaculation, such as a reduced amount of semen released

The same text also says4. Possibili effetti indesideratiGli effetti indesiderati sono stati generalmente temporanei con un trattamento continuativo o sono regrediti con la interruzione del trattamento.Original text: Italian. Our translation:The side effects were generally temporary with continued treatment or went away when treatment was stopped.

Sexual side effects that continue after stopping4. Possibili effetti indesiderati · Non nota: la frequenza non può essere definita sulla base dei dati disponibilidifficoltà persistente ad avere una erezione dopo l’interruzione del trattamentoOriginal text: Italian. Our translation:persistent difficulty in having an erection after treatment is stopped

Sexual side effects that continue after stopping4. Possibili effetti indesiderati · Non nota: la frequenza non può essere definita sulla base dei dati disponibilipersistente riduzione dell’impulso sessuale dopo l’interruzione del trattamentoOriginal text: Italian. Our translation:persistent reduction in sexual drive after treatment is stopped

Sexual side effects that continue after stopping4. Possibili effetti indesiderati · Non nota: la frequenza non può essere definita sulla base dei dati disponibilipersistenti problemi di eiaculazione dopo l’interruzione del trattamentoOriginal text: Italian. Our translation:persistent problems with ejaculation after treatment is stopped

The text itself prints no date of revision.

This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text.

Patient leaflet Foglio illustrativo: informazioni per l’utilizzatorePropecia 1 mg compresse rivestite con film, Organon Italia S.r.l. · Read in the regulator's own database: Banca Dati FarmaciMade available by the regulatorChecked
ItalyPatient leaflet · ProscarFinasteride: the page about it

Sexual side effects, as listed4. Possibili effetti indesideratiImpotenza e diminuzione del desiderio sessuale sono le reazioni avverse più frequenti. Queste reazioni avverse si manifestano nella fase iniziale della terapia e nella maggior parte dei pazienti si risolvono nel corso della terapia.Original text: Italian. Our translation:Impotence and decreased sexual desire are the most frequent adverse reactions. These adverse reactions appear in the early phase of therapy and, in most patients, resolve during therapy.

Sexual side effects, as listed4. Possibili effetti indesiderati · Effetti indesiderati comuni (possono interessare fino a 1 persona su 10)diminuzione del volume di spermaOriginal text: Italian. Our translation:decreased volume of semen

Sexual side effects, as listed4. Possibili effetti indesiderati · Effetti indesiderati comuni (possono interessare fino a 1 persona su 10)impotenzaOriginal text: Italian. Our translation:impotence

Sexual side effects, as listed4. Possibili effetti indesiderati · Effetti indesiderati comuni (possono interessare fino a 1 persona su 10)diminuzione del desiderio sessualeOriginal text: Italian. Our translation:decreased sexual desire

Sexual side effects, as listed4. Possibili effetti indesiderati · Effetti indesiderati non comuni (possono interessare fino a 1 persona su 100)disturbi dell’eiaculazioneOriginal text: Italian. Our translation:ejaculation disorders

Sexual side effects that continue after stopping4. Possibili effetti indesiderati · Effetti indesiderati con frequenza non nota (la frequenza non può essere definita sulla base dei dati disponibili)disfunzione erettile, che può proseguire dopo l’interruzione della finasterideOriginal text: Italian. Our translation:erectile dysfunction, which may continue after finasteride is stopped

Sexual side effects that continue after stopping4. Possibili effetti indesiderati · Effetti indesiderati con frequenza non nota (la frequenza non può essere definita sulla base dei dati disponibili)persistente riduzione dell’impulso sessuale dopo l’interruzione del trattamentoOriginal text: Italian. Our translation:persistent reduction in sexual drive after treatment is stopped

Sexual side effects that continue after stopping4. Possibili effetti indesiderati · Effetti indesiderati con frequenza non nota (la frequenza non può essere definita sulla base dei dati disponibili)persistenti problemi di eiaculazione dopo l’interruzione del trattamentoOriginal text: Italian. Our translation:persistent problems with ejaculation after treatment is stopped

The text itself prints no date of revision.

Patient leaflet Foglio illustrativo: informazioni per il pazienteProscar 5 mg compresse rivestite con film, Organon Italia S.r.l. · Read in the regulator's own database: Banca Dati FarmaciMade available by the regulatorChecked
ItalyCompany letter to health professionals, on the regulator's siteFinasteride: the page about it

Sexual side effects that continue after stoppingRiassuntoInoltre, i pazienti devono essere informati del fatto che sono stati segnalati eventi avversi di disfunzione sessuale che persistevano anche dopo l’interruzione della terapiaOriginal text: Italian. Our translation:In addition, patients must be informed that adverse events of sexual dysfunction have been reported that persisted even after therapy was stopped

The letter opens by saying it was written in agreement with the regulator. The words are the company's, and it is not the product's own text.

Company letter to health professionals, on the regulator's site Nota Informativa Importante concordata con l’Agenzia Italiana del Farmaco (AIFA)Read on the regulator's site: AIFAPublishedChecked
ItalyDocument from the regulatorFinasteride: the page about it

Sexual side effects that continue after stoppingSintesiSono stati segnalati casi in cui i pazienti hanno riportato: - disturbi sessuali tra cui disfunzione erettile, disfunzione eiaculatoria, dolore ai testicoli e diminuzione della libido; - disturbi psichiatrici, come ansia, depressione o persino pensieri suicidi. Tutti questi disturbi possono avere un importante impatto sulla vita sociale e personale. Il tempo di comparsa dei sintomi sopra riportati può variare, da pochi giorni ad alcuni anni dopo l’inizio del trattamento. Anche la durata degli effetti avversi può variare ampiamente da paziente a paziente. Gli effetti avversi possono persistere dopo l’interruzione del trattamento e, in alcuni casi, per un periodo indefinito.Original text: Italian. Our translation:Cases have been reported in which patients reported: - sexual disorders, including erectile dysfunction, ejaculatory dysfunction, pain in the testicles and decreased libido; - psychiatric disorders, such as anxiety, depression or even suicidal thoughts. All these disorders can have a major impact on social and personal life. The time at which the above symptoms appear can vary, from a few days to several years after the start of treatment. The duration of the adverse effects can also vary widely from patient to patient. The adverse effects can persist after treatment is stopped and, in some cases, for an indefinite period.

Sexual side effects that continue after stoppingSintesidiscutere con i pazienti dei benefici che ci si potrebbe aspettare dal trattamento con finasteride 1 mg e dei potenziali rischi, con particolare riferimento alla possibilità che si verifichino disturbi sessuali e/o disordini psichiatrici e che tali eventi, in alcuni casi, possano persistere anche dopo l’interruzione della terapia.Original text: Italian. Our translation:discuss with patients the benefits that could be expected from treatment with finasteride 1 mg and the potential risks, with particular reference to the possibility that sexual disorders and/or psychiatric disorders may occur and that such events may, in some cases, persist even after therapy is stopped.

The same text also saysSintesiQueste raccomandazioni si applicano al dosaggio da 1 mg e all'indicazione per il trattamento dell'alopecia androgeneticaOriginal text: Italian. Our translation:These recommendations apply to the 1 mg dose and to the indication for the treatment of androgenetic alopecia

Document from the regulator Comunicazione di sicurezza: FINASTERIDE 1 mg e possibili disturbi sessuali e psichiatriciRead on the regulator's site: AIFAPublishedChecked
ItalyDocument from the regulatorFinasteride: the page about it

What the regulator saidMisure per minimizzare il rischio di pensieri suicidari con i medicinali contenenti finasteride e dutasterideLe informazioni sul prodotto per finasteride 1 mg compresse avviseranno adesso i pazienti anche sulla necessità di consultare il medico in caso di problemi di disfunzione sessuale (come diminuzione del desiderio sessuale o disfunzione erettile), che sono effetti indesiderati noti del medicinale e possono contribuire ai cambiamenti di umore.Original text: Italian. Our translation:The product information for finasteride 1 mg tablets will now also advise patients of the need to consult their doctor in case of problems of sexual dysfunction (such as decreased sexual desire or erectile dysfunction), which are known side effects of the medicine and may contribute to mood changes.

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Document from the regulator Misure per minimizzare il rischio di pensieri suicidari con i medicinali contenenti finasteride e dutasterideRead on the regulator's site: AIFAPublishedChecked
ItalyCompany letter to health professionals, on the regulator's siteFinasteride: the page about it

What the regulator saidInformazioni generali sul problema di sicurezza · Finasteride 1 mg (alopecia androgenetica)Le avvertenze e le precauzioni d’impiego saranno aggiornate per raccomandare ai pazienti di contattare il proprio medico qualora insorgano disfunzione sessuale e di prendere in considerazione l’interruzione del trattamento.Original text: Italian. Our translation:The warnings and precautions for use will be updated to recommend that patients contact their doctor if sexual dysfunction occurs, and consider stopping treatment.

This text has no sentence about sexual side effects continuing after the medicine is stopped.

The letter opens by saying it was written in agreement with the regulator. The words are the company's, and it is not the product's own text.

This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text.

Company letter to health professionals, on the regulator's site Nota Informativa Importante di Sicurezza concordata con le Autorita’ Regolatorie Europee e l’Agenzia Italiana del Farmaco (AIFA)Read on the regulator's site: AIFAPublishedChecked
SpainText for professionals · PropeciaFinasteride: the page about it

Sexual side effects, as listed4.8. Reacciones adversas · Trastornos psiquiátricos: · Poco frecuentes*Disminución de la libidoOriginal text: Spanish. Our translation:Decreased libido

Sexual side effects, as listed4.8. Reacciones adversas · Trastornos del aparato reproductor y de la mama: · Poco frecuentes*Disfunción eréctil, trastorno de la eyaculación (incluida disminución del volumen de eyaculación)Original text: Spanish. Our translation:Erectile dysfunction, ejaculation disorder (including decreased volume of ejaculate)

The same text also says4.8 Reacciones adversasLas incidencias se presentan en forma de diferencia respecto al placebo en estudios clínicos a los 12 meses.Original text: Spanish. Our translation:Incidences are given as the difference from placebo in clinical studies at 12 months.

Sexual side effects that continue after stopping4.8. Reacciones adversasAdemás, durante su uso después de la comercialización se ha notificado: persistencia de la disfunción sexual (disminución de la libido, disfunción eréctil y trastornos de la eyaculación) después de la interrupción del tratamiento con finasteridaOriginal text: Spanish. Our translation:In addition, during use after marketing the following has been reported: persistence of sexual dysfunction (decreased libido, erectile dysfunction and ejaculation disorders) after treatment with finasteride was stopped

Sexual side effects, as listed4.8. Reacciones adversasLas reacciones adversas sexuales relacionadas con el medicamento fueron más frecuentes en los varones tratados con finasterida que en los que recibían un placebo, con frecuencias durante los 12 primeros meses del 3,8 y el 2,1% respectivamente. La incidencia de estos efectos disminuyó al 0,6% en varones tratados con finasterida durante los cuatro años siguientes. Aproximadamente el 1% de los varones en cada grupo de tratamiento interrumpió el tratamiento debido a reacciones adversas sexuales relacionadas con el medicamento en los primeros 12 meses, y después la incidencia disminuyó.Original text: Spanish. Our translation:Drug-related sexual adverse reactions were more frequent in men treated with finasteride than in those receiving placebo, with frequencies during the first 12 months of 3.8% and 2.1% respectively. The incidence of these effects fell to 0.6% in men treated with finasteride over the following four years. About 1% of the men in each treatment group stopped treatment because of drug-related sexual adverse reactions in the first 12 months, and the incidence decreased afterwards.

This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text.

Texts for other products in this country do not all say the same. The ones we read are on the full record.

Text for professionals Ficha técnicaPropecia 1 mg comprimidos recubiertos con película, Organon Salud, S.L. · Read in the regulator's own database: CIMAText revisedChecked
SpainText for professionals · ProscarFinasteride: the page about it

Sexual side effects, as listed4.8. Reacciones adversasLas reacciones adversas más frecuentes son impotencia y disminución de la libido. Estas reacciones adversas se producen en las primeras fases del tratamiento y en la mayoría de los pacientes se resuelven al continuar con el tratamiento.Original text: Spanish. Our translation:The most frequent adverse reactions are impotence and decreased libido. These adverse reactions occur in the early phases of treatment and, in most patients, resolve with continued treatment.

Sexual side effects, as listed4.8. Reacciones adversas · Trastornos psiquiátricos · Frecuentedisminución de la libidoOriginal text: Spanish. Our translation:decreased libido

Sexual side effects that continue after stopping4.8. Reacciones adversas · Trastornos psiquiátricos · Frecuencia no conocidadepresión, disminución de la libido que continuó después de la discontinuación del tratamiento, ansiedad, ideación suicidaOriginal text: Spanish. Our translation:depression, decreased libido that continued after treatment was discontinued, anxiety, suicidal ideation

Sexual side effects, as listed4.8. Reacciones adversas · Trastornos del aparato reproductor y de la mama · FrecuenteimpotenciaOriginal text: Spanish. Our translation:impotence

Sexual side effects, as listed4.8. Reacciones adversas · Trastornos del aparato reproductor y de la mama · Poco frecuentetrastornos de la eyaculación, hipersensibilidad mamaria, crecimiento mamarioOriginal text: Spanish. Our translation:ejaculation disorders, breast tenderness, breast enlargement

Sexual side effects that continue after stopping4.8. Reacciones adversas · Trastornos del aparato reproductor y de la mama · Frecuencia no conocidadisfunción sexual (disfunción eréctil y trastornos de la eyaculación) que continuó después de la discontinuación del tratamiento, dolor testicular, hematospermia, infertilidad masculina o calidad seminal pobre. Se ha notificado normalización o mejora de la calidad seminal después de la discontinuación de finasterida.Original text: Spanish. Our translation:sexual dysfunction (erectile dysfunction and ejaculation disorders) that continued after treatment was discontinued, testicular pain, haematospermia, male infertility or poor seminal quality. Normalisation or improvement of seminal quality has been reported after finasteride was discontinued.

The same text also says4.8. Reacciones adversasNo se puede determinar la frecuencia de reacciones adversas notificadas durante el uso posterior a la comercialización, ya que proceden de notificaciones espontáneas.Original text: Spanish. Our translation:The frequency of adverse reactions reported during use after marketing cannot be determined, as they come from spontaneous reports.

Sexual side effects, as listed4.8. Reacciones adversas · Exploraciones complementarias · Frecuentedisminución del volumen de eyaculaciónOriginal text: Spanish. Our translation:decreased volume of ejaculate

Sexual side effects, as listed4.8. Reacciones adversas · Tratamiento médico de los síntomas prostáticos (MTOPS)La incidencia del trastorno de eyaculación en pacientes recibiendo tratamiento combinado fue comparable a la suma de las incidencias de esta experiencia adversa para las dos monoterapias.Original text: Spanish. Our translation:The incidence of ejaculation disorder in patients receiving combined treatment was comparable to the sum of the incidences of this adverse experience for the two monotherapies.

A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.

Text for professionals Ficha técnicaProscar 5 mg comprimidos recubiertos con película, Organon Salud, S.L. · Read in the regulator's own database: CIMAText revisedChecked
SpainPatient leaflet · PropeciaFinasteride: the page about it

Sexual side effects, as listed4. Posibles efectos adversos · Poco frecuentes: pueden afectar hasta 1 de 100 personasmenos deseo sexualOriginal text: Spanish. Our translation:less sexual desire

Sexual side effects, as listed4. Posibles efectos adversos · Poco frecuentes: pueden afectar hasta 1 de 100 personasdificultades para lograr la erecciónOriginal text: Spanish. Our translation:difficulty achieving an erection

Sexual side effects, as listed4. Posibles efectos adversos · Poco frecuentes: pueden afectar hasta 1 de 100 personasproblemas con la eyaculación, incluyendo una disminución de la cantidad de semen eyaculadoOriginal text: Spanish. Our translation:problems with ejaculation, including a decrease in the amount of semen ejaculated

The same text also says4. Posibles efectos adversosLos efectos adversos han sido, normalmente, pasajeros con el tratamiento continuado o han desaparecido cuando el tratamiento se interrumpe.Original text: Spanish. Our translation:The side effects have usually been temporary with continued treatment, or have disappeared when treatment is stopped.

Sexual side effects that continue after stopping4. Posibles efectos adversos · Frecuencia no conocida: la frecuencia no puede estimarse a partir de los datos disponiblesdificultad persistente para tener erección después de interrumpir el tratamientoOriginal text: Spanish. Our translation:persistent difficulty in having an erection after stopping treatment

Sexual side effects that continue after stopping4. Posibles efectos adversos · Frecuencia no conocida: la frecuencia no puede estimarse a partir de los datos disponiblesdisminución persistente en el deseo sexual después de interrumpir el tratamientoOriginal text: Spanish. Our translation:persistent decrease in sexual desire after stopping treatment

Sexual side effects that continue after stopping4. Posibles efectos adversos · Frecuencia no conocida: la frecuencia no puede estimarse a partir de los datos disponiblesproblemas persistentes de eyaculación después de interrumpir el tratamientoOriginal text: Spanish. Our translation:persistent problems with ejaculation after stopping treatment

This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text.

Patient leaflet Prospecto: información para el usuarioPropecia 1 mg comprimidos recubiertos con película, Organon Salud, S.L. · Read in the regulator's own database: CIMAText revisedChecked
SpainPatient leaflet · ProscarFinasteride: the page about it

Sexual side effects, as listed4. Posibles efectos adversos · Frecuentes (pueden afectar hasta 1 de cada 10 pacientes)reducción del deseo sexual.Original text: Spanish. Our translation:reduced sexual desire.

Sexual side effects that continue after stopping4. Posibles efectos adversos · Frecuencia no conocida (no puede estimarse a partir de los datos disponibles)depresión, disminución del deseo sexual que continuó después de suspender la medicación, ansiedad, pensamientos suicidas.Original text: Spanish. Our translation:depression, decreased sexual desire that continued after the medicine was stopped, anxiety, suicidal thoughts.

Sexual side effects, as listed4. Posibles efectos adversos · Frecuentes (pueden afectar hasta 1 de cada 10 pacientes)impotencia (imposibilidad de tener una erección).Original text: Spanish. Our translation:impotence (inability to have an erection).

Sexual side effects, as listed4. Posibles efectos adversos · Poco frecuentes (pueden afectar hasta 1 de cada 100 pacientes)hinchazón y aumento de la sensibilidad en el pecho y problemas con la eyaculación.Original text: Spanish. Our translation:swelling and increased tenderness in the breast, and problems with ejaculation.

Sexual side effects that continue after stopping4. Posibles efectos adversos · Frecuencia no conocida (no puede estimarse a partir de los datos disponibles)dolor en los testículos, sangre en el semen, imposibilidad de tener una erección que continuó después de suspender la medicación; problemas con la eyaculación que continuaron después de suspender la medicación, infertilidad masculina o calidad seminal pobre. Se ha notificado la mejora de la calidad seminal después de suspender la medicación.Original text: Spanish. Our translation:pain in the testicles, blood in the semen, inability to have an erection that continued after the medicine was stopped; problems with ejaculation that continued after the medicine was stopped, male infertility or poor seminal quality. Improvement in seminal quality has been reported after the medicine was stopped.

Sexual side effects, as listed4. Posibles efectos adversos · Frecuentes (pueden afectar hasta 1 de cada 10 pacientes)disminución de la cantidad de semen expulsado en el acto sexual. Esta disminución en la cantidad de semen no parece alterar el funcionamiento sexual normal.Original text: Spanish. Our translation:a decrease in the amount of semen released during sex. This decrease in the amount of semen does not appear to affect normal sexual function.

The same text also says4. Posibles efectos adversosEn algunos casos, estos efectos secundarios desaparecieron a pesar de que el paciente continuó tomando Proscar. Cuando los síntomas persistieron, estos generalmente desaparecieron al dejar de tomar Proscar.Original text: Spanish. Our translation:In some cases, these side effects disappeared even though the patient continued taking Proscar. When the symptoms persisted, they generally disappeared on stopping Proscar.

A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.

Patient leaflet Prospecto: información para el usuarioProscar 5 mg comprimidos recubiertos con película, Organon Salud, S.L. · Read in the regulator's own database: CIMAText revisedChecked
SpainPatient leafletFinasteride: the page about it

This text has no sentence about sexual side effects continuing after the medicine is stopped.

This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text.

Patient leaflet Tarjeta de información para el paciente · Finasterida 1mgRead in the regulator's own database: CIMAPublishedChecked
SpainDocument from the regulatorFinasteride: the page about it

What the regulator saidLa AEMPS informa de las nuevas recomendaciones para minimizar el riesgo de ideación suicida en pacientes tratados con finasteridaComo medida adicional, se incluirá una tarjeta de información para el paciente en todos los envases de finasterida 1 mg para informar sobre los riesgos de alteraciones del estado de ánimo y la disfunción sexual, indicando cómo actuar en cada caso.Original text: Spanish. Our translation:As an additional measure, a patient information card will be included in all packs of finasteride 1 mg to inform about the risks of mood changes and sexual dysfunction, saying how to act in each case.

This text has no sentence about sexual side effects continuing after the medicine is stopped.

This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text.

Document from the regulator Nota de seguridad MUH (FV), 02/2025: «La AEMPS informa de las nuevas recomendaciones para minimizar el riesgo de ideación suicida en pacientes tratados con finasterida»Read on the regulator's site: AEMPSPublishedChecked
BrazilPatient leaflet · FinasteridaFinasteride: the page about it

Sexual side effects, as listed8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Reação comum (ocorre entre 1% e 10% dos pacientes que utilizam este medicamento):pode sentir menos desejo de manter relações sexuais e/ou dificuldade na obtenção de uma ereção.Original text: Portuguese. Our translation:you may feel less desire to have sexual relations and/or have difficulty getting an erection.

Sexual side effects, as listed8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Reação incomum (ocorre entre 0,1% e 1% dos pacientes que utilizam este medicamento):pode ter uma redução na quantidade de sêmen liberada durante a relação sexual (isto não parece interferir na função sexual normal).Original text: Portuguese. Our translation:you may have a reduction in the amount of semen released during sexual intercourse (this does not appear to interfere with normal sexual function).

The same text also says8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?Nos estudos clínicos, estes efeitos adversos desapareceram em homens que pararam de tomar finasterida e em muitos homens que continuaram o tratamento.Original text: Portuguese. Our translation:In clinical studies, these adverse effects disappeared in men who stopped taking finasteride and in many men who continued treatment.

Sexual side effects that continue after stopping8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Frequência desconhecida: durante a comercialização do medicamento, as seguintes reações foram relatadas voluntariamente, não sendo possível estimar o tamanho da população exposta:problemas de ejaculação que continuou após a descontinuação do tratamentoOriginal text: Portuguese. Our translation:problems with ejaculation that continued after treatment was discontinued

Sexual side effects that continue after stopping8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Frequência desconhecida: durante a comercialização do medicamento, as seguintes reações foram relatadas voluntariamente, não sendo possível estimar o tamanho da população exposta:diminuição do desejo sexual que continuou após a descontinuação do tratamentoOriginal text: Portuguese. Our translation:decreased sexual desire that continued after treatment was discontinued

Sexual side effects that continue after stopping8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Frequência desconhecida: durante a comercialização do medicamento, as seguintes reações foram relatadas voluntariamente, não sendo possível estimar o tamanho da população exposta:dificuldade de ter ereção que continuou após a descontinuação do tratamentoOriginal text: Portuguese. Our translation:difficulty having an erection that continued after treatment was discontinued

This is the holder's own copy. The regulator's database refused our requests (it blocks by country; we asked from Denmark).

An official list of medicines we read shows the originator product as cancelled, revoked or archived. This is the text of another product, the one named in this row.

Texts for other products in this country do not all say the same. The ones we read are on the full record.

Patient leaflet finasterida, EMS S/A, comprimido revestido 1 mg: bula para o pacienteFinasterida 1 mg comprimido revestido, EMS S/A · Read on the holder's own site: Sara – Plataforma Oficial de Bulas Digitais de Medicamentos do Grupo EMSText approvedChecked
BrazilText for professionals · FinalopFinasteride: the page about it

We could not open this text on 14 October 2026: the site refused our requests (it blocks by country; we asked from Denmark); the site asked us to prove we are not a robot, which we did not do. This says nothing about what the text contains.

Text for professionalsFinalop 1 mg, Libbs Farmacêutica Ltda.We tried: consultas.anvisa.gov.br/#/bulario/Tried
BrazilText for professionals · FinasteridaFinasteride: the page about it

We could not open this text on 14 October 2026: the site refused our requests (it blocks by country; we asked from Denmark); the site asked us to prove we are not a robot, which we did not do. This says nothing about what the text contains.

Text for professionalsFinasterida 5 mg, Eurofarma Laboratórios S.A.We tried: consultas.anvisa.gov.br/#/bulario/Tried
BrazilPatient leaflet · FinasteridaFinasteride: the page about it

Sexual side effects, as listed8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Reação comum (ocorre entre 1% e 10% dos pacientes que utilizam este medicamento):pode sentir menos desejo de manter relações sexuais e/ou dificuldade na obtenção de uma ereção.Original text: Portuguese. Our translation:you may feel less desire to have sexual relations and/or have difficulty getting an erection.

Sexual side effects, as listed8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Reação incomum (ocorre entre 0,1% e 1% dos pacientes que utilizam este medicamento):pode ter uma redução na quantidade de sêmen liberada durante a relação sexual (isto não parece interferir na função sexual normal).Original text: Portuguese. Our translation:you may have a reduction in the amount of semen released during sexual intercourse (this does not appear to interfere with normal sexual function).

The same text also says8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?Nos estudos clínicos, estes efeitos adversos desapareceram em homens que pararam de tomar finasterida e em muitos homens que continuaram o tratamento.Original text: Portuguese. Our translation:In clinical studies, these adverse effects disappeared in men who stopped taking finasteride and in many men who continued treatment.

Sexual side effects that continue after stopping8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Frequência desconhecida: durante a comercialização do medicamento, as seguintes reações foram relatadas voluntariamente, não sendo possível estimar o tamanho da população exposta:problemas de ejaculação que continuou após a descontinuação do tratamentoOriginal text: Portuguese. Our translation:problems with ejaculation that continued after treatment was discontinued

Sexual side effects that continue after stopping8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Frequência desconhecida: durante a comercialização do medicamento, as seguintes reações foram relatadas voluntariamente, não sendo possível estimar o tamanho da população exposta:diminuição do desejo sexual que continuou após a descontinuação do tratamentoOriginal text: Portuguese. Our translation:decreased sexual desire that continued after treatment was discontinued

Sexual side effects that continue after stopping8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Frequência desconhecida: durante a comercialização do medicamento, as seguintes reações foram relatadas voluntariamente, não sendo possível estimar o tamanho da população exposta:dificuldade de ter ereção que continuou após a descontinuação do tratamentoOriginal text: Portuguese. Our translation:difficulty having an erection that continued after treatment was discontinued

This is the holder's own copy. The regulator's database refused our requests (it blocks by country; we asked from Denmark).

This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text.

Patient leaflet finasterida, Laboratório Teuto Brasileiro S/A, comprimido revestido 1 mg: bula para o pacienteFinasterida 1 mg comprimido revestido, Laboratório Teuto Brasileiro S/A · Read on the holder's own site: Laboratório Teuto Brasileiro S/AText approvedChecked
BrazilPatient leaflet · FinastilFinasteride: the page about it

Sexual side effects, as listed8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Outros efeitos colaterais podem incluir:não conseguir ter uma ereção (impotência);Original text: Portuguese. Our translation:not being able to have an erection (impotence);

Sexual side effects, as listed8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Outros efeitos colaterais podem incluir:ter menos vontade de fazer sexo;Original text: Portuguese. Our translation:having less desire to have sex;

Sexual side effects, as listed8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Outros efeitos colaterais podem incluir:ter problemas com a ejaculação, por exemplo, uma diminuição na quantidade de esperma liberada durante o ato sexual. Essa diminuição na quantidade de sêmen não parece afetar a função sexual normal.Original text: Portuguese. Our translation:having problems with ejaculation, for example a decrease in the amount of sperm released during the sexual act. This decrease in the amount of semen does not appear to affect normal sexual function.

The same text also says8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?Estes efeitos secundários acima podem desaparecer depois de algum tempo se continuar a tomar finasterida 5 mg. Se não, eles geralmente regridem depois de parar de usar este medicamento.Original text: Portuguese. Our translation:These side effects above may disappear after a while if you continue taking finasteride 5 mg. If not, they usually go away after you stop using this medicine.

Sexual side effects that continue after stopping8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Outros efeitos colaterais relatados em alguns homens são:incapacidade de ter uma ereção que pode continuar depois de parar a medicaçãoOriginal text: Portuguese. Our translation:inability to have an erection, which may continue after stopping the medication

Sexual side effects that continue after stopping8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Outros efeitos colaterais relatados em alguns homens são:diminuição do desejo sexual que pode continuar depois de parar a medicaçãoOriginal text: Portuguese. Our translation:decreased sexual desire, which may continue after stopping the medication

Sexual side effects that continue after stopping8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Outros efeitos colaterais relatados em alguns homens são:problemas com a ejaculação que podem continuar depois de parar a medicaçãoOriginal text: Portuguese. Our translation:problems with ejaculation, which may continue after stopping the medication

This is the holder's own copy. The regulator's database refused our requests (it blocks by country; we asked from Denmark).

This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text.

Patient leaflet FINASTIL® finasterida, EMS Sigma Pharma Ltda, comprimido revestido 5 mg: bula para o pacienteFinastil 5 mg comprimido revestido, EMS Sigma Pharma Ltda. · Read on the holder's own site: Sara – Plataforma Oficial de Bulas Digitais de Medicamentos do Grupo EMSText approvedChecked
BrazilPatient leaflet · FinaridFinasteride: the page about it

Sexual side effects, as listed8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Outros efeitos colaterais podem incluir:Não conseguir ter uma ereção (impotência);Original text: Portuguese. Our translation:Not being able to have an erection (impotence);

Sexual side effects, as listed8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Outros efeitos colaterais podem incluir:Ter menos vontade de fazer sexo;Original text: Portuguese. Our translation:Having less desire to have sex;

Sexual side effects, as listed8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Outros efeitos colaterais podem incluir:Ter problemas com a ejaculação, por exemplo, uma diminuição na quantidade de esperma liberada durante o ato sexual. Essa diminuição na quantidade de sêmen não parece afetar a função sexual normal.Original text: Portuguese. Our translation:Having problems with ejaculation, for example a decrease in the amount of sperm released during the sexual act. This decrease in the amount of semen does not appear to affect normal sexual function.

The same text also says8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?Estes efeitos secundários acima podem desaparecer depois de algum tempo se continuar a tomar finasterida. Se não, eles geralmente regridem depois de parar de usar finasterida.Original text: Portuguese. Our translation:These side effects above may disappear after a while if you continue taking finasteride. If not, they usually go away after you stop using finasteride.

Sexual side effects that continue after stopping8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Outros efeitos colaterais relatados em alguns homens são:Incapacidade de ter uma ereção que pode continuar depois de parar a medicaçãoOriginal text: Portuguese. Our translation:Inability to have an erection, which may continue after stopping the medication

Sexual side effects that continue after stopping8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Outros efeitos colaterais relatados em alguns homens são:Diminuição do desejo sexual que pode continuar depois de parar a medicaçãoOriginal text: Portuguese. Our translation:Decreased sexual desire, which may continue after stopping the medication

Sexual side effects that continue after stopping8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Outros efeitos colaterais relatados em alguns homens são:Problemas com a ejaculação que podem continuar depois de parar a medicaçãoOriginal text: Portuguese. Our translation:Problems with ejaculation, which may continue after stopping the medication

This is the holder's own copy. The regulator's database refused our requests (it blocks by country; we asked from Denmark).

Patient leaflet Finarid® finasterida, Laboratório Teuto Brasileiro S/A, comprimido revestido 5 mg: bula para o pacienteFinarid 5 mg comprimido revestido, Laboratório Teuto Brasileiro S/A · Read on the holder's own site: Laboratório Teuto Brasileiro S/AText approvedChecked
BrazilPatient leaflet · FinalopFinasteride: the page about it

We could not open this text on 14 October 2026: the site refused our requests (it blocks by country; we asked from Denmark); the site asked us to prove we are not a robot, which we did not do. This says nothing about what the text contains.

Patient leafletFinalop 1 mg, Libbs Farmacêutica Ltda.We tried: consultas.anvisa.gov.br/#/bulario/Tried
BrazilPatient leaflet · FinasteridaFinasteride: the page about it

We could not open this text on 14 October 2026: the site refused our requests (it blocks by country; we asked from Denmark); the site asked us to prove we are not a robot, which we did not do. This says nothing about what the text contains.

Patient leafletFinasterida 5 mg, Eurofarma Laboratórios S.A.We tried: consultas.anvisa.gov.br/#/bulario/Tried
IndiaText for professionals · FinpeciaFinasteride: the page about it

Sexual side effects that continue after stoppingUndesirable Effects · Postmarketing Experience · Reproductive System:Sexual dysfunction that continued after discontinuation of treatment, including erectile dysfunction, libido disorders, ejaculation disorders, and orgasm disorders; male infertility and/or poor seminal quality (normalization or improvement of seminal quality has been reported after discontinuation of finasteride); testicular pain.

The same text also saysUndesirable Effects · Postmarketing ExperienceThe following adverse reactions have been identified during post-approval use of finasteride. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:

This is the holder's own copy. This regulator publishes no database of such texts.

This sentence stands in the list of adverse reactions. The warnings section of this text has no entry on sexual function.

Texts for other products in this country do not all say the same. The ones we read are on the full record.

This text names sexual side effects in several places that this row does not show. Together those passages are too long to reproduce here. The document link in this row opens the text. That they are not shown says nothing about how common these side effects are.

A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.

Text for professionals FINPECIA TabletsFinpecia tablets (finasteride IP 1 mg, film-coated), Cipla Ltd. · Read on the holder's own site: Cipla (ciplamed.com)Text revisedChecked
IndiaText for professionals · FincarFinasteride: the page about it

Sexual side effects that continue after stoppingUndesirable Effects · Postmarketing Experiencesexual dysfunction that continued after discontinuation of treatment including erectile dysfunction, decreased libido and ejaculation disorders (e.g. reduced ejaculate volume).

The same text also saysUndesirable Effects · Postmarketing ExperienceThese events were reported rarely in men taking finasteride for the treatment of BPH. Most men were older and were taking concomitant medications and/or had co-morbid conditions. The independent role of finasteride in these events is unknown.

Sexual side effects that continue after stoppingUndesirable Effects · Postmarketing ExperienceThe following additional adverse event related to sexual dysfunction that continued after discontinuation of treatment has been reported in postmarketing experience with finasteride at lower doses used to treat male pattern baldness. Because the event is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate its frequency or establish a causal relationship to drug exposure: - orgasm disorders

This is the holder's own copy. This regulator publishes no database of such texts.

This text names sexual side effects in several places that this row does not show. Together those passages are too long to reproduce here. The document link in this row opens the text. That they are not shown says nothing about how common these side effects are.

Text for professionals FINCAR TabletsFincar tablets (finasteride 5 mg, film-coated), Cipla Ltd. · Read on the holder's own site: Cipla (ciplamed.com)Text revisedChecked

Isotretinoin

For the acne medicine isotretinoin (Roaccutane, Accutane), the texts for professionals we read in the United Kingdom, in the United States (some products), in Canada, in Australia and in New Zealand say that sexual side effects have been reported to continue, or may continue, after the medicine is stopped; several of those texts add that a causal link has not been established, and one that an effect cannot be ruled out. Some other texts we read, among them the wording EU regulators agreed in 2017, list sexual side effects and have no sentence about them continuing after the medicine is stopped. Patients call lasting effects after isotretinoin post-Accutane syndrome (PAS).

Isotretinoin: what each text says about sexual side effects, and about side effects that continue after stopping.
Country or regionWhat the text saysDocumentDates
United KingdomText for professionals · RoaccutaneIsotretinoin: the page about it

Sexual side effects that continue after stopping4.4 Special warnings and precautions for use · Sexual disordersThere have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of isotretinoin.On record since 2023, according to MHRA, 31 October 2023; MHRA, 26 April 2023.

A general sentence about side effects that may continue. It does not name sexual function.4.8 Undesirable effects · Summary of safety profileThe side effects are generally reversible after altering the dose or discontinuation of treatment, however some may persist after treatment has stopped.

Sexual side effects, as listed4.8 Undesirable effects · Table 1 Tabulated list of adverse reactions in patients treated with isotretinoin · Reproductive system and breast disorders · Not known*Sexual dysfunction including erectile dysfunction and decreased libido, gynaecomastia, Vulvovaginal dryness, orgasm abnormal, genital hypoaesthesia

One of these documents announced the sentence and the other reports the update as done. Neither prints the day the text changed.

Text for professionals Summary of Product Characteristics (SmPC): Roaccutane 10 mg soft capsulesRoaccutane 10 mg soft capsules, Neon Healthcare Limited · Read in a compendium of product information: emcText revisedChecked
United KingdomPatient leaflet · RoaccutaneIsotretinoin: the page about it

Sexual side effects, as listed2. What you need to know before you take Roaccutane · Warnings and precautions · Advice for all patientsIsotretinoin has been associated with sexual problems. These include problems getting or maintaining an erection, lower libido, vaginal dryness, orgasm difficulties and reduced sensation in the genitals.

Sexual side effects that continue after stopping2. What you need to know before you take Roaccutane · Warnings and precautions · Advice for all patientsThere have been reports of long-lasting sexual problems where the symptoms have continued despite stopping treatment with isotretinoin.On record since 2023, according to MHRA, 31 October 2023; MHRA, 26 April 2023.

A general sentence about side effects that may continue. It does not name sexual function.4. Possible side effectsThe side effects are generally reversible after changing the dose or stopping treatment, however some may continue after treatment has stopped.

One of these documents announced the sentence and the other reports the update as done. Neither prints the day the text changed.

Patient leaflet Package leaflet: Information for the user. Roaccutane 10 mg and 20 mg soft capsules. isotretinoinRoaccutane 10 mg and 20 mg soft capsules, Neon Healthcare Limited · Read in a compendium of product information: emcText revisedChecked
United KingdomDocument from the regulatorIsotretinoin: the page about it

Sexual side effects that continue after stoppingRecommendations from the reviewThe product information for isotretinoin medicines is being updated with these new requirements and to add new information and warnings regarding psychiatric and sexual disorders. This will include a warning that there have been reports of long-lasting sexual dysfunction where the symptoms have continued despite discontinuation of isotretinoin.

The same text also saysRecommendations from the reviewThe IEWG considered all the available evidence, including information from patients and their families and concluded that gaps in the available evidence meant that it was not possible to say that isotretinoin definitively caused many of the short-term or longer-term psychiatric and sexual side effects.

The regulator has marked this document as superseded.

Document from the regulator Isotretinoin (Roaccutane▼): new safety measures to be introduced in the coming months, including additional oversight on initiation of treatment for patients under 18 yearsRead on the regulator's site: GOV.UKPublishedChecked
United KingdomDocument from the regulatorIsotretinoin: the page about it

What the regulator saidIsotretinoin treatment and new safety measuresThe product information for isotretinoin medicines has been updated following the review’s recommendations.

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Document from the regulator Isotretinoin (Roaccutane▼): introduction of new safety measures, including additional oversight of the initiation of treatment for patients under 18 years of ageRead on the regulator's site: GOV.UKPublishedChecked
United KingdomDocument from the regulatorIsotretinoin: the page about it

Sexual side effects that continue after stopping8.2.1. Changes to product informationWarnings about the potential for the sexual side effects (erectile dysfunction, vulvovaginal dryness, reduced libido, orgasm difficulties and genital hypoaesthesia) to continue long-term after treatment with isotretinoin has been stopped should be added to the SmPC and PIL.

Document from the regulator REPORT OF THE COMMISSION ON HUMAN MEDICINES ISOTRETINOIN EXPERT WORKING GROUPRead on the regulator's site: GOV.UKPublishedChecked
United KingdomDocument from the regulatorIsotretinoin: the page about it

Sexual side effects, as listedSexual dysfunctionThe review recommended that sexual dysfunction including erectile dysfunction and decreased libido should be added to the list of side effects in the product information. The package leaflet for patients will include “Problems getting or maintaining an erection and lower libido” as possible side effects.

This text has no sentence about sexual side effects continuing after the medicine is stopped.

The regulator has marked this document as superseded.

Document from the regulator Isotretinoin (Roaccutane): rare reports of erectile dysfunction and decreased libidoRead on the regulator's site: GOV.UKPublishedChecked
European UnionDocument from the regulatorIsotretinoin: the page about it

Sexual side effects, as listedAnnex II · Amendments to the product information of the nationally authorised medicinal product(s) · Summary of Product Characteristics · Section 4.8Sexual dysfunction including erectile dysfunction and decreased libido

Sexual side effects, as listedAnnex II · Amendments to the product information of the nationally authorised medicinal product(s) · Package Leaflet · 4. Possible side effects · Unknown frequency: (frequency cannot be estimated from the available data)• Problems getting or maintaining an erection • Lower libido

This text has no sentence about sexual side effects continuing after the medicine is stopped.

This is wording for national product texts. There is no single EU product text for this medicine.

Document from the regulator Isotretinoin (oral formulations): CMDh scientific conclusions and grounds for variation, amendments to the Product Information and timetable for the implementation - PSUSA/00010488/201611Read on the regulator's site: European Medicines AgencyAdoptedChecked
European UnionDocument from the regulatorIsotretinoin: the page about it

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Document from the regulator Updated measures for pregnancy prevention during retinoid use. Warning on possible risk of neuropsychiatric disorders also to be included for oral retinoidsRead on the regulator's site: European Medicines AgencyPublishedChecked
European UnionDocument from the regulatorIsotretinoin: the page about it

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Document from the regulator Isotretinoin (oral formulations) : Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s) - PSUSA/00010488/202505Read on the regulator's site: European Medicines AgencyAdoptedChecked
United StatesText for professionals · Absorica and Absorica LDIsotretinoin: the page about it

Sexual side effects that continue after stopping6 ADVERSE REACTIONS · Reproductive SystemAbnormal menses and sexual dysfunction that may continue after discontinuation of treatment (including erectile dysfunction, decreased libido, decreased vaginal lubrication, and vaginal dryness).In this product's text since 2026, according to FDA, 11 August 2026.

The same text also says6 ADVERSE REACTIONSThe following adverse reactions associated with the use of isotretinoin capsules were identified in clinical trials or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

This sentence stands in the list of adverse reactions. The warnings section of this text has no entry on sexual function.

The date given is for this product. Texts for other products carry other dates.

Texts for other products in this country do not all say the same. The ones we read are on the full record.

On 13 October 2026 this sentence was in 10 of the 31 isotretinoin listings on DailyMed. No Medication Guide, the text for patients, had it.

Text for professionals ABSORICA (isotretinoin) capsules, for oral use; ABSORICA LD (isotretinoin) capsules, for oral use: Full Prescribing InformationAbsorica and Absorica LD capsules, Sun Pharmaceutical Industries, Inc. · Read in the government's medicines database: DailyMedText revisedChecked
United StatesText for professionals · ClaravisIsotretinoin: the page about it

Sexual side effects that continue after stopping6 ADVERSE REACTIONS · Reproductive SystemAbnormal menses, sexual dysfunction that may continue after discontinuation of treatment (including erectile dysfunction, decreased libido, decreased vaginal lubrication, and vaginal dryness).

The same text also says6 ADVERSE REACTIONSThe following adverse reactions, presented alphabetically by body system, associated with the use of Claravis were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

This sentence stands in the list of adverse reactions. The warnings section of this text has no entry on sexual function.

Text for professionals CLARAVIS (isotretinoin capsules), for oral use: Full Prescribing InformationClaravis capsules 10 mg, 20 mg, 30 mg, and 40 mg, Teva Pharmaceuticals USA, Inc. · Read in the government's medicines database: DailyMedText revisedChecked
United StatesText for professionals · AmnesteemIsotretinoin: the page about it

Sexual side effects that continue after stopping6 ADVERSE REACTIONS · Reproductive SystemAbnormal menses, sexual dysfunction that may continue after discontinuation of treatment (including erectile dysfunction, decreased libido, decreased vaginal lubrication, and vaginal dryness).

The same text also says6 ADVERSE REACTIONSThe following adverse reactions, presented alphabetically by body system, associated with the use of Amnesteem were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

This sentence stands in the list of adverse reactions. The warnings section of this text has no entry on sexual function.

Text for professionals AMNESTEEM (isotretinoin capsules), for oral use: Full Prescribing InformationAmnesteem capsules 10 mg, 20 mg, 30 mg and 40 mg, Mylan Pharmaceuticals Inc. · Read in the government's medicines database: DailyMedText revisedChecked
United StatesText for professionals · ZenataneIsotretinoin: the page about it

Sexual side effects that continue after stopping6 ADVERSE REACTIONS · Reproductive SystemAbnormal menses, sexual dysfunction that may continue after discontinuation of treatment (including erectile dysfunction, decreased libido, decreased vaginal lubrication, and vaginal dryness).

The same text also says6 ADVERSE REACTIONSThe following adverse reactions, presented alphabetically by body system, associated with the use of Zenatane were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

This sentence stands in the list of adverse reactions. The warnings section of this text has no entry on sexual function.

Text for professionals ZENATANE (isotretinoin capsules), for oral use: Full Prescribing InformationZenatane capsules 10 mg, 20 mg, 30 mg and 40 mg, Dr. Reddy's Laboratories Limited · Read in the government's medicines database: DailyMedText revisedChecked
United StatesText for professionals · AccutaneIsotretinoin: the page about it

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Text for professionals Accutane (isotretinoin capsules USP)Accutane capsules 10 mg, 20 mg, 30 mg, 40 mg, JG Pharma Inc. · Read in the government's medicines database: DailyMedText revisedChecked
United StatesText for professionals · MyorisanIsotretinoin: the page about it

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Text for professionals Myorisan (isotretinoin capsules, USP)Myorisan capsules 10 mg, 20 mg, 30 mg, 40 mg, Akorn · Read in the government's medicines database: DailyMedText revisedChecked
United StatesPatient leaflet · Absorica and Absorica LDIsotretinoin: the page about it

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Patient leaflet MEDICATION GUIDE: ABSORICA (isotretinoin) capsules and ABSORICA LD (isotretinoin) capsulesAbsorica and Absorica LD capsules, Sun Pharmaceutical Industries, Inc. · Read in the government's medicines database: DailyMedText revisedChecked
United StatesPatient leaflet · ClaravisIsotretinoin: the page about it

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Patient leaflet MEDICATION GUIDE: CLARAVIS (isotretinoin capsules), for oral useClaravis capsules 10 mg, 20 mg, 30 mg, and 40 mg, Teva Pharmaceuticals USA, Inc. · Read in the government's medicines database: DailyMedText revisedChecked
United StatesPatient leaflet · AmnesteemIsotretinoin: the page about it

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Patient leaflet MEDICATION GUIDE: AMNESTEEM (isotretinoin capsules), for oral useAmnesteem capsules 10 mg, 20 mg, 30 mg and 40 mg, Mylan Pharmaceuticals Inc. · Read in the government's medicines database: DailyMedText revisedChecked
United StatesPatient leaflet · ZenataneIsotretinoin: the page about it

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Patient leaflet MEDICATION GUIDE: ZENATANE (isotretinoin capsules), for oral useZenatane capsules 10 mg, 20 mg, 30 mg and 40 mg, Dr. Reddy's Laboratories Limited · Read in the government's medicines database: DailyMedText revisedChecked
United StatesDocument from the regulator · AbsoricaIsotretinoin: the page about it

Sexual side effects that continue after stopping08/11/2026 (SUPPL-31) · 6 Adverse Reactions · Reproductive SystemAbnormal menses and sexual dysfunction that may continue after discontinuation of treatment (including erectile dysfunction, decreased libido, decreased vaginal lubrication, and vaginal dryness).

Document from the regulator Drug Safety-related Labeling Changes (SrLC): ABSORICA (NDA-021951) (ISOTRETINOIN)Absorica capsules, Sun Pharmaceutical Industries, Inc. · Read in the regulator's own database: Drug Safety-related Labeling Changes (SrLC)PublishedChecked
United StatesDocument from the regulator · AbsoricaIsotretinoin: the page about it

What the regulator saidSUPPLEMENT APPROVALWe also refer to our letter dated June 16, 2026, notifying you, under Section 505(o)(4) of the FD&C Act, of new safety information that we have determined should be included in the labeling for Absorica and Absorica LD. This information pertains to the risk of reproductive system adverse events.

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Document from the regulator SUPPLEMENT APPROVAL, NDA 021951/S-031 and NDA 211913/S-023Absorica capsules, Sun Pharmaceutical Industries, Inc. · Read in the regulator's own database: Drugs@FDAText approvedChecked
United StatesDocument from the regulatorIsotretinoin: the page about it

We could not open this text on 13 October 2026: the site refused our request. This says nothing about what the text contains.

Document from the regulatorWe tried: www.regulations.gov/document/FDA-2018-P-4088-0040Tried
United StatesDocument from the regulatorIsotretinoin: the page about it

What the regulator saidFDA Requests Labeling Updates for Generic Isotretinoin ProductsYesterday, the U.S. Food and Drug Administration requested labeling updates for all generic drugs referencing Accutane (isotretinoin) capsules as their reference listed drug (RLD).

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Document from the regulator FDA Requests Labeling Updates for Generic Isotretinoin ProductsRead on the regulator's site: FDA email bulletinsPublishedChecked
CanadaText for professionals · AccutaneIsotretinoin: the page about it

Sexual side effects, as listed7 WARNINGS AND PRECAUTIONS · Reproductive Health: Female and Male Potential · Function · Risk of Sexual Side EffectsCases of sexual dysfunction including erectile dysfunction, decreased/loss of libido, vulvovaginal dryness, orgasm difficulties, and genital hypoaesthesia have been reported in patients with the use of isotretinoin.

Sexual side effects that continue after stopping7 WARNINGS AND PRECAUTIONS · Reproductive Health: Female and Male Potential · Function · Risk of Sexual Side EffectsThere have been reports of persistence of these events following drug discontinuation. While causality to isotretinoin could not be definitively established, an effect cannot be ruled out.

Sexual side effects, as listed8 ADVERSE REACTIONS · 8.2 Clinical Trial Adverse ReactionsReproductive system: abnormal menses, erectile dysfunction.

Sexual side effects, as listed8 ADVERSE REACTIONS · 8.5 Post-Market Adverse ReactionsReproductive system: Sexual dysfunction.

Text for professionals PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION: ACCUTANE, Isotretinoin CapsulesAccutane capsules USP 10 mg and 40 mg, CHEPLAPHARM Schweiz GmbH · Read in the regulator's own database: Drug Product DatabaseText revisedChecked
CanadaText for professionals · EpurisIsotretinoin: the page about it

Sexual side effects that continue after stopping7. Warnings and Precautions · Reproductive Health: Female and Male Potential · Function · Risk of Sexual Side EffectsThere have been reports of persistence of these events following drug discontinuation. While causality to isotretinoin could not be definitively established, an effect cannot be ruled out.

Text for professionals PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION: EPURIS, Isotretinoin CapsulesEpuris capsules 10, 20, 30, 40 mg, Cipher Pharmaceuticals Inc. · Read in the regulator's own database: Drug Product DatabaseText approvedChecked
CanadaText for professionals · ClarusIsotretinoin: the page about it

Sexual side effects that continue after stopping7 WARNINGS AND PRECAUTIONS · Reproductive Health: Female and Male Potential · Function · Risk of Sexual Side EffectsThere have been reports of persistence of these events following drug discontinuation. While causality to isotretinoin could not be definitively established, an effect cannot be ruled out.

Text for professionals PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION: CLARUS, Isotretinoin Capsules, USPClarus capsules USP 10 mg and 40 mg, Mylan Pharmaceuticals ULC · Read in the regulator's own database: Drug Product DatabaseText revisedChecked
CanadaText for professionals · Absorica LDIsotretinoin: the page about it

Sexual side effects that continue after stopping7 WARNINGS AND PRECAUTIONS · Reproductive Health: Female and Male Potential · FunctionThere have been reports of persistence of these events following drug discontinuation. While causality to isotretinoin could not be definitively established, an effect cannot be ruled out.

Text for professionals PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION: Absorica LD, Isotretinoin Capsules, Micronized formulationAbsorica LD capsules, micronized formulation, 8 mg, 16 mg, 24 mg, and 32 mg, Sun Pharmaceutical Industries Limited · Read in the regulator's own database: Drug Product DatabaseText revisedChecked
CanadaPatient leaflet · AccutaneIsotretinoin: the page about it

Sexual side effects, as listedOther warnings you should know about · Sexual DysfunctionWhile taking ACCUTANE, you may have the inability to get or maintain an erection, dryness in the vagina or vulva, reduced interest in sex, orgasm difficulties and loss of sensation or tingling in the genital area.

Sexual side effects that continue after stoppingOther warnings you should know about · Sexual DysfunctionThis may continue after treatment.

Patient leaflet PATIENT MEDICATION INFORMATION: ACCUTANE, Isotretinoin CapsulesAccutane capsules USP 10 mg and 40 mg, CHEPLAPHARM Schweiz GmbH · Read in the regulator's own database: Drug Product DatabaseText revisedChecked
CanadaPatient leaflet · EpurisIsotretinoin: the page about it

Sexual side effects that continue after stoppingOther warnings you should know about · Sexual Dysfunction:This may continue after treatment.

Sexual side effects that continue after stoppingPossible side effects from using EPURIS®:You may experience following side effects while EPURIS® and even after you stop taking it: inability to have or maintain an erection during sex, dryness in the vagina or vulva, reduced sexual drive interest, orgasm difficulties and loss of sensation or tingling in the genital area.

Patient leaflet PATIENT MEDICATION INFORMATION: EPURIS, Isotretinoin CapsulesEpuris capsules 10, 20, 30, 40 mg, Cipher Pharmaceuticals Inc. · Read in the regulator's own database: Drug Product DatabaseText approvedChecked
CanadaPatient leaflet · ClarusIsotretinoin: the page about it

Sexual side effects that continue after stoppingOther warnings you should know about · Sexual DysfunctionThis may continue after treatment.

Patient leaflet PATIENT MEDICATION INFORMATION: CLARUS, Isotretinoin Capsules, USPClarus capsules USP 10 mg and 40 mg, Mylan Pharmaceuticals ULC · Read in the regulator's own database: Drug Product DatabaseText revisedChecked
CanadaPatient leaflet · Absorica LDIsotretinoin: the page about it

Sexual side effects that continue after stoppingOther warnings you should know about · Sexual Dysfunction:This may continue after treatment.

Sexual side effects that continue after stoppingWhat are possible side effects from using Absorica LD?You may experience following side effects while you are taking Absorica LD and even after you stop taking it: inability to have or maintain an erection during sex, dryness in the vagina or vulva, reduced sexual drive interest, orgasm difficulties and loss of sensation or tingling in the genital area.

Patient leaflet PATIENT MEDICATION INFORMATION: Absorica LD, Isotretinoin Capsules, Micronized formulationAbsorica LD capsules, micronized formulation, 8 mg, 16 mg, 24 mg, and 32 mg, Sun Pharmaceutical Industries Limited · Read in the regulator's own database: Drug Product DatabaseText revisedChecked
CanadaDocument from the regulatorIsotretinoin: the page about it

Sexual side effects that continue after stoppingSafety Review FindingsIn just over half of the events, the sexual dysfunction was reported as persisting for months to years following drug discontinuation.

The same text also saysSafety Review FindingsThese cases overall did not include sufficient clinical information, including details on mental health at the time of sexual dysfunction, to definitively determine a link between isotretinoin use and sexual dysfunction. However, given the timing of the events, a link could not be ruled out.

What the regulator saidConclusions and ActionsHealth Canada’s review of the available information concluded that a link between isotretinoin and the risk of sexual dysfunction, including persistent sexual dysfunction after drug discontinuation, could not be ruled out.

Document from the regulator Summary Safety Review - Isotretinoin - Assessing the Potential Risk of Sexual Dysfunction, Including Persistent Sexual Dysfunction After Drug DiscontinuationRead on the regulator's site: Drug and Health Product PortalThe text prints no dateChecked
CanadaDocument from the regulatorIsotretinoin: the page about it

What the regulator saidConclusions and actionsHealth Canada's review of the available information concluded that there may be a link between the use of oral isotretinoin products and the risk of impotence, but could not draw the same conclusion for the other drugs in the class.

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Document from the regulator Summary Safety Review - Oral Retinoid Products - Assessing the Potential Risk of Impotence (erectile dysfunction)Read on the regulator's site: Drug and Health Product PortalPublishedChecked
CanadaDocument from the regulatorIsotretinoin: the page about it

Sexual side effects that continue after stoppingMONTHLY RECAP OF HEALTH PRODUCT SAFETY INFORMATION · IsotretinoinThis safety review evaluated the risk of sexual dysfunction, including persistent sexual dysfunction after drug discontinuation, with the use of isotretinoin-containing products. Health Canada’s review of the available information concluded that a link could not be ruled out.

Document from the regulator Health Product InfoWatch, July 2024Read on the regulator's site: Government of Canada PublicationsPublishedChecked
AustraliaText for professionals · RoaccutaneIsotretinoin: the page about it

Sexual side effects that continue after stoppingSection 4.4 · Sexual DisordersSection 4.4 of Australia's product information for Roaccutane has a warning headed sexual disorders. It says erection problems, lower sex drive, dryness of the vulva and vagina, loss of pleasure and breast growth in men have been reported, and tells prescribers to ask about sexual problems before treatment and to check for new ones during it. It says no mechanism for these effects has been established, and that stopping the medicine may not relieve the symptoms, so a specialist may need to assess them.Summarised, not quoted, because of the TGA's access terms.

Sexual side effects, as listedSection 4.8 · Reproductive system and breast disordersSection 4.8 lists sexual dysfunction, including erection problems, lower sex drive, dryness of the vulva and vagina, loss of pleasure and breast growth in men.Summarised, not quoted, because of the TGA's access terms.

The same text also saysSection 4.8 · Reproductive system and breast disordersDirectly after that list, section 4.8 says it has not been established that the medicine causes these effects.Summarised, not quoted, because of the TGA's access terms.

The regulator's site asks readers to accept its terms before it shows this text.

Text for professionals AUSTRALIAN PRODUCT INFORMATION Roaccutane (isotretinoin)Roaccutane, Pharmaco · Read in the regulator's own database: TGA eBSText revisedChecked
AustraliaPatient leaflet · RoaccutaneIsotretinoin: the page about it

Sexual side effects, as listedSide effects: sexual and reproductive healthAustralia's consumer medicine information for Roaccutane has a list of symptoms to do with sexual and reproductive health. It names trouble getting or keeping an erection, a lower sex drive or feeling less pleasure, dryness of the vagina and breast swelling in men.Summarised, not quoted, because of the TGA's access terms.

This text has no sentence about sexual side effects continuing after the medicine is stopped.

The regulator's site asks readers to accept its terms before it shows this text.

Patient leaflet Consumer Medicine InformationRoaccutane, Pharmaco · Read in the regulator's own database: TGA eBSText revisedChecked
AustraliaDocument from the regulatorIsotretinoin: the page about it

We could not open this text on 13 October 2026: the site did not answer. This says nothing about what the text contains.

Document from the regulatorWe tried: www.tga.gov.au/news/safety-updates/new-safety-warnings-isotretinoin-roaccutaneTried
New ZealandText for professionals · OrataneIsotretinoin: the page about it

Sexual side effects that continue after stopping4.4. Special warnings and precautions for use · Sexual disordersErectile dysfunction, decreased libido, vulvovaginal dryness, anhedonia and gynaecomastia have been reported in patients treated with isotretinoin (refer to section 4.8, Reproductive system and breast disorders). In some cases, symptoms have persisted after discontinuation of isotretinoin.

The same text also says4.4. Special warnings and precautions for use · Sexual disordersA causal relationship or mechanism of action for these events has not been established. However, vulvovaginal dryness may be related to the known mucocutaneous effects of isotretinoin (refer to section 4.8, Hypervitaminosis A)

Sexual side effects, as listed4.8. Undesirable effects · Reproductive system and breast disordersErectile dysfunction, decreased libido, vulvovaginal dryness, anhedonia and gynaecomastia (unknown frequency) (refer to section 4.4, Sexual disorders).

The originator product is not in the list we read. This is another product from that list.

Text for professionals New Zealand Data Sheet, ORATANEOratane 5 mg, 10 mg, 20 mg, 30 mg and 40 mg soft gelatin capsules, Douglas Pharmaceuticals Ltd · Read in the regulator's own database: MedsafeText revisedChecked
New ZealandPatient leaflet · OrataneIsotretinoin: the page about it

Sexual side effects, as listedSide effects · Tell your doctor if you notice any of the following and they worry you:• Problems getting or maintaining an erection • Lower libido or ability to feel pleasure.

The same text also saysSide effectsThese side effects are usually mild and dose related. After the dose of ORATANE capsules is reduced or stopped most of these side effects should disappear within a few days or weeks.

This text has no sentence about sexual side effects continuing after the medicine is stopped.

The originator product is not in the list we read. This is another product from that list.

Patient leaflet Consumer Medicine Information, ORATANEOratane 5 mg, 10 mg, 20 mg, 30 mg and 40 mg capsules, Douglas Pharmaceuticals Ltd · Read in the regulator's own database: MedsafeText revisedChecked
New ZealandDocument from the regulatorIsotretinoin: the page about it

Sexual side effects that continue after stoppingTable 1: Recently updated data sheets (by active ingredient): important new safety information · Isotretinoin, Oratane, 4.4Sexual disorders have been reported in patients treated with isotretinoin. In some cases, symptoms have persisted after discontinuation.

Document from the regulator Recent data sheet updates: Important new safety informationRead on the regulator's site: MedsafePublishedChecked
New ZealandDocument from the regulatorIsotretinoin: the page about it

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Document from the regulator Minutes of the 195th Medicines Adverse Reactions Committee Meeting, 14 September 2023Read on the regulator's site: MedsafeAdoptedChecked
GermanyText for professionals · Isotretinoin-ratiopharmIsotretinoin: the page about it

A general sentence about side effects that may continue. It does not name sexual function.4.8 Nebenwirkungen · Zusammenfassung des SicherheitsprofilsDie Nebenwirkungen klingen im Allgemeinen nach Dosisänderung oder Abbruch der Behandlung ab, manche können jedoch auch nach dem Ende der Behandlung bestehen bleiben.Original text: German. Our translation:The side effects generally subside after a change of dose or after treatment is stopped, but some may remain even after the end of treatment.

Sexual side effects, as listed4.8 Nebenwirkungen · Tabelle 1 „Tabellarische Liste der Nebenwirkungen bei mit Isotretinoin behandelten Patienten“ · Erkrankungen der Geschlechtsorgane und der Brustdrüse · Nicht bekanntSexuelle Dysfunktion einschließlich erektiler Dysfunktion und verminderter Libido, Gynäkomastie, ulvovaginale TrockenheitOriginal text: German. Our translation:Sexual dysfunction including erectile dysfunction and decreased libido, gynaecomastia, vulvovaginal dryness

This text has no sentence about sexual side effects continuing after the medicine is stopped.

This is the holder's own copy. The regulator's database asks visitors to accept its terms first, which we did not do.

Spelling and punctuation are the document's own.

Text for professionals FachinformationIsotretinoin-ratiopharm 10 mg Weichkapseln, ratiopharm GmbH · Read on the holder's own site: ratiopharm GmbHText revisedChecked
GermanyPatient leaflet · Isotretinoin-ratiopharmIsotretinoin: the page about it

A general sentence about side effects that may continue. It does not name sexual function.4. Welche Nebenwirkungen sind möglich?Die Nebenwirkungen klingen im Allgemeinen nach Dosisänderung oder nach Beendigung der Behandlung ab, manche können jedoch auch nach dem Ende der Behandlung bestehen bleiben.Original text: German. Our translation:The side effects generally subside after a change of dose or after treatment has ended, but some may remain even after the end of treatment.

Sexual side effects, as listed4. Welche Nebenwirkungen sind möglich? · Andere Nebenwirkungen · Nicht bekannt (Häufigkeit auf Grundlage der verfügbaren Daten nicht abschätzbar)Schwierigkeiten eine Erektion zu bekommen oder aufrechtzuerhalten schwächere Libido Brustschwellung bei Männern mit oder ohne Druckempfindlichkeit ScheidentrockenheitOriginal text: German. Our translation:Difficulty getting or keeping an erection lower libido breast swelling in men, with or without tenderness vaginal dryness

This text has no sentence about sexual side effects continuing after the medicine is stopped.

This is the holder's own copy. The regulator's database asks visitors to accept its terms first, which we did not do.

Patient leaflet Gebrauchsinformation: Information für AnwenderIsotretinoin-ratiopharm 10 mg Weichkapseln, ratiopharm GmbH · Read on the holder's own site: ratiopharm GmbHText revisedChecked
GermanyDocument from the regulatorIsotretinoin: the page about it

Sexual side effects, as listedAnlage 3 · ANHANG II · ZUSAMMENFASSUNG DER MERKMALE DES ARZNEIMITTELS • Abschnitt 4.8Sexuelle Dysfunktion einschließlich erektiler Dysfunktion und verminderter LibidoOriginal text: German. Our translation:Sexual dysfunction including erectile dysfunction and decreased libido

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Document from the regulator Bescheid vom 19.02.2019: Umsetzung der zwei einstimmigen Beschlüsse der Koordinierungsgruppe EMA/CMDh/439088/2017 vom 19.07.2017 und EMA/CMDh/848760/2018 vom 12.12.2018 betreffend die Zulassungen für Humanarzneimittel mit dem Wirkstoff „Isotretinoin (orale Darreichungsformen)“Read on the regulator's site: BfArMPublishedChecked
FranceText for professionals · CONTRACNEIsotretinoin: the page about it

A general sentence about side effects that may continue. It does not name sexual function.4.8. Effets indésirables · Résumé du profil de toléranceD'une manière générale, la plupart des effets indésirables sont réversibles après diminution de la posologie ou interruption du traitement ; certains cependant persistent après l'arrêt du traitement.Original text: French. Our translation:In general, most side effects are reversible after the dose is reduced or treatment is interrupted; some, however, persist after treatment is stopped.

Sexual side effects, as listed4.8. Effets indésirables · Liste tabulée des effets indésirables · Affections des organes de reproduction et du sein · IndéterminéeDysfonctionnement sexuel, y compris dysfonctionnement érectile et baisse de la libido. Gynécomastie. Sécheresse vulvo-vaginale.Original text: French. Our translation:Sexual dysfunction, including erectile dysfunction and decreased libido. Gynaecomastia. Vulvovaginal dryness.

This text has no sentence about sexual side effects continuing after the medicine is stopped.

The originator product is not in the list we read. This is another product from that list.

The text itself prints no date of revision.

Text for professionals Résumé des Caractéristiques du ProduitCONTRACNE 10 mg, capsule molle, LABORATOIRES BAILLEUL S.A. · Read in the government's medicines database: Base de données publique des médicamentsUpdated by the regulatorChecked
FrancePatient leaflet · CONTRACNEIsotretinoin: the page about it

Sexual side effects, as listed4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Effets au niveau des organes de reproduction et du sein : fréquence indéterminéeProblèmes d’obtention ou de maintien d’une érection, Baisse de la libido, Gonflement des seins chez les hommes, avec ou sans sensibilité, Sécheresse vaginale.Original text: French. Our translation:Problems getting or keeping an erection, Lower libido, Breast swelling in men, with or without tenderness, Vaginal dryness.

This text has no sentence about sexual side effects continuing after the medicine is stopped.

The originator product is not in the list we read. This is another product from that list.

The text itself prints no date of revision.

Another product's leaflet reads differently. This row shows the product named, and no other.

Patient leaflet Notice patientCONTRACNE 10 mg, capsule molle, LABORATOIRES BAILLEUL S.A. · Read in the government's medicines database: Base de données publique des médicamentsUpdated by the regulatorChecked
FranceDocument from the regulatorIsotretinoin: the page about it

A general sentence about side effects that may continue. It does not name sexual function.Risques liés à la prise d’isotrétinoïne par voie oraleLa plupart de ces effets sont réversibles après une diminution de la posologie ou l’arrêt du traitement, cependant certains effets peuvent persister après la fin du traitement.Original text: French. Our translation:Most of these effects are reversible after the dose is reduced or treatment is stopped; however, some effects may persist after the end of treatment.

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Document from the regulator Risques liés à la prise d’isotrétinoïne par voie oraleRead on the regulator's site: ANSMText revisedChecked
ItalyText for professionals · Isotretinoina Difa CooperIsotretinoin: the page about it

A general sentence about side effects that may continue. It does not name sexual function.4.8 Effetti indesiderati · Riassunto del profilo di sicurezzaGli effetti indesiderati sono in genere reversibili dopo la modifica della dose o la sospensione del trattamento, alcuni comunque, possono persistere dopo l’interruzione della terapia.Original text: Italian. Our translation:The side effects are generally reversible after the dose is changed or treatment is stopped; some, however, may persist after therapy is stopped.

Sexual side effects, as listed4.8 Effetti indesiderati · Tabella 1 Elenco delle reazioni avverse in pazienti trattati con isotretinoina · Patologie dell'apparato riproduttivo e della mammella · Non notaDisfunzione sessuale, tra cui disfunzione erettile e calo della libido, ginecomastia, secchezza vulvovaginaleOriginal text: Italian. Our translation:Sexual dysfunction, including erectile dysfunction and decreased libido, gynaecomastia, vulvovaginal dryness

This text has no sentence about sexual side effects continuing after the medicine is stopped.

The originator product is not in the list we read. This is another product from that list.

Spelling and punctuation are the document's own.

Text for professionals Riassunto delle Caratteristiche del ProdottoIsotretinoina Difa Cooper 10 mg capsule molli, Difa Cooper S.p.A. · Read in the regulator's own database: Banca Dati FarmaciText revisedChecked
ItalyPatient leaflet · Isotretinoina Difa CooperIsotretinoin: the page about it

A general sentence about side effects that may continue. It does not name sexual function.4. Possibili effetti indesideratiGli effetti indesiderati sono in genere reversibili dopo la modifica della dose o l’interruzione del trattamento, alcuni comunque, possono continuare dopo la sospensione della terapia.Original text: Italian. Our translation:The side effects are generally reversible after the dose is changed or treatment is stopped; some, however, may continue after therapy is stopped.

Sexual side effects, as listed4. Possibili effetti indesiderati · Altri effetti indesiderati: · Non noti (non possono essere definiti sulla base dei dati disponibili).- Problemi a raggiungere o mantenere l’erezione - Calo della libido - Ingrossamento delle mammelle con o senza dolorabilità negli uomini - Secchezza vaginaleOriginal text: Italian. Our translation:- Problems getting or keeping an erection - Decreased libido - Breast enlargement with or without tenderness in men - Vaginal dryness

This text has no sentence about sexual side effects continuing after the medicine is stopped.

The originator product is not in the list we read. This is another product from that list.

Patient leaflet Foglio illustrativo: informazioni per l’utilizzatoreIsotretinoina Difa Cooper 10 mg capsule molli, Difa Cooper S.p.A. · Read in the regulator's own database: Banca Dati FarmaciText revisedChecked
SpainText for professionals · IsdibenIsotretinoin: the page about it

A general sentence about side effects that may continue. It does not name sexual function.4.8. Reacciones adversas · Resumen del perfil de seguridadEn general, los efectos secundarios revierten después de modificar la dosis o interrumpir el tratamiento pero algunos persisten una vez finalizado éste.Original text: Spanish. Our translation:In general, the side effects reverse after the dose is changed or treatment is stopped, but some persist once it has ended.

Sexual side effects, as listed4.8. Reacciones adversas · Tabla 1 – Listado tabulado de reacciones adversas en pacientes tratados con isotretinoína. · Trastornos del aparato reproductor y de la mama · Frecuencia no conocidaDisfunción sexual que incluye disfunción eréctil y disminución de la libido, ginecomastia, sequedad vulvovaginalOriginal text: Spanish. Our translation:Sexual dysfunction including erectile dysfunction and decreased libido, gynaecomastia, vulvovaginal dryness

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Text for professionals Ficha técnicaIsdiben 20 mg cápsulas blandas EFG, Isdin, S.A. · Read in the regulator's own database: CIMAText revisedChecked
SpainPatient leaflet · IsdibenIsotretinoin: the page about it

Sexual side effects, as listed4. Posibles efectos adversos · Frecuencia no conocida: (la frecuencia no puede estimarse a partir de los datos disponibles)Problemas para obtener o mantener una erección. Disminución de la libido. Inflamación de los senos con o sin sensibilidad en los hombres. Sequedad vaginalOriginal text: Spanish. Our translation:Problems getting or keeping an erection. Decreased libido. Swelling of the breasts with or without tenderness in men. Vaginal dryness

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Patient leaflet Prospecto: INFORMACIÓN PARA EL PACIENTEIsdiben 20 mg Cápsulas blandas EFG, Isdin, S.A. · Read in the regulator's own database: CIMAText revisedChecked
SpainDocument from the regulatorIsotretinoin: the page about it

Sexual side effects, as listedInformación sobre seguridad · Nueva información de seguridad procedente de la evaluación periódica de los datos de farmacovigilancia · IsotretinoínaLos datos presentados en la última revisión sugieren que hay evidencia de que la isotretinoína pueda estar asociada con disfunción sexual incluyendo disfunción eréctil y disminución de la libido; el mecanismo responsable puede estar mediado por una reducción de la testosterona en plasma. Por este motivo se incluirán, en la información del producto de medicamentos con isotretinoína, como reacciones adversas los trastornos del aparato reproductor y de la mama de frecuencia desconocida: disfunción sexual incluyendo disfunción eréctil y disminución de la libido.Original text: Spanish. Our translation:The data presented in the latest review suggest there is evidence that isotretinoin may be associated with sexual dysfunction, including erectile dysfunction and decreased libido; the mechanism responsible may be mediated by a reduction in plasma testosterone. For this reason, the product information of medicines with isotretinoin will include, as adverse reactions, reproductive system and breast disorders of unknown frequency: sexual dysfunction including erectile dysfunction and decreased libido.

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Document from the regulator Boletín mensual de la AEMPS sobre medicamentos de uso humano. Septiembre de 2017Read on the regulator's site: AEMPSPublishedChecked
BrazilPatient leaflet · RoacutanIsotretinoin: the page about it

A general sentence about side effects that may continue. It does not name sexual function.8. QUAIS MALES ESTE MEDICAMENTO PODE ME CAUSAR?Os efeitos adversos são geralmente reversíveis, com a alteração da dose ou interrupção do tratamento, e alguns podem persistir após a suspensão da medicação.Original text: Portuguese. Our translation:The adverse effects are generally reversible with a change of dose or discontinuation of treatment, and some may persist after the medicine is stopped.

Sexual side effects, as listed8. QUAIS MALES ESTE MEDICAMENTO PODE ME CAUSAR? · Reações sem frequência estabelecida:Sistema reprodutivo: disfunção sexual, inclusive disfunção erétil (incapacidade de alcançar ou manter ereção satisfatória para a relação sexual) e diminuição da libido (redução no impulso sexual).Original text: Portuguese. Our translation:Reproductive system: sexual dysfunction, including erectile dysfunction (inability to reach or keep an erection satisfactory for sexual intercourse) and decreased libido (reduced sex drive).

The same text also says8. QUAIS MALES ESTE MEDICAMENTO PODE ME CAUSAR?Os eventos adversos listados a seguir refletem a experiência de estudos de investigação e de pós-comercialização. A relação de alguns desses eventos com a terapia com Roacutan® é desconhecida.Original text: Portuguese. Our translation:The adverse events listed below reflect experience from investigational studies and from post-marketing use. The relationship of some of these events to therapy with Roacutan® is unknown.

This text has no sentence about sexual side effects continuing after the medicine is stopped.

This is the holder's own copy. The regulator's database refused our requests (it blocks by country; we asked from Denmark).

Patient leaflet Roacutan® Isotretinoína: BULA PACIENTERoacutan cápsulas gelatinosas 20 mg, Farmoquímica S/A · Read on the holder's own site: Farmoquímica S/AText approvedChecked
BrazilText for professionals · RoacutanIsotretinoin: the page about it

We could not open this text on 13 October 2026: the site refused our requests (it blocks by country; we asked from Denmark). This says nothing about what the text contains.

Text for professionalsRoacutan cápsulas gelatinosas moles 20 mg, Farmoquímica S/AWe tried: consultas.anvisa.gov.br/#/bulario/Tried
IndiaText for professionals · IsotroinIsotretinoin: the page about it

A general sentence about side effects that may continue. It does not name sexual function.CLINICAL PARTICULARS · Undesirable Effects · Dose RelationshipMost adverse reactions reported in clinical trials with isotretinoin were reversible when therapy was discontinued; however, some persisted after cessation of therapy.

Sexual side effects, as listedCLINICAL PARTICULARS · Undesirable Effects · Clinical Trials and Postmarketing SurveillanceReproductive System: Abnormal menses, sexual dysfunction including erectile dysfunction and decreased libido.

The same text also saysCLINICAL PARTICULARS · Undesirable Effects · Clinical Trials and Postmarketing SurveillanceThe adverse reactions listed below reflect experience from investigational studies of isotretinoin, and the postmarketing experience. The relationship of some of these events to isotretinoin therapy is unknown.

This text has no sentence about sexual side effects continuing after the medicine is stopped.

This is the holder's own copy. This regulator publishes no database of such texts.

Text for professionals ISOTROIN Capsules (Isotretinoin Capsules)Isotroin capsules, Cipla Ltd. · Read on the holder's own site: Cipla (ciplamed.com)Text revisedChecked
IndiaPatient leaflet · IsotroinIsotretinoin: the page about it

This text has no sentence about sexual side effects continuing after the medicine is stopped.

This is the holder's own copy. This regulator publishes no database of such texts.

Patient leaflet PATIENT INFORMATION LEAFLET: PATIENT COUNSELLING INFORMATION (ISOTROIN)Isotroin, Cipla Ltd. · Read on the holder's own site: Cipla (ciplamed.com)The text prints no dateChecked
IndiaDocument from the regulatorIsotretinoin: the page about it

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Document from the regulator Safety guidelines for Isotretinoin - RegardingRead on the regulator's site: CDSCOPublishedChecked
IrelandText for professionals · RoaccutaneIsotretinoin: the page about it

A general sentence about side effects that may continue. It does not name sexual function.4.8 Undesirable effects · Summary of safety profileThe side effects are generally reversible after altering the dose or discontinuation of treatment, however some may persist after treatment has stopped.

Sexual side effects, as listed4.8 Undesirable effects · Table 1 Tabulated list of adverse reactions in patients treated with isotretinoin · Reproductive system and breast disorders · Not known*Sexual dysfunction including erectile dysfunction and decreased libido, gynaecomastia, vulvovaginal dryness

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Text for professionals Summary of Product CharacteristicsRoaccutane 20 mg soft capsules, Cheplapharm Registration GmbH · Read in the regulator's own database: Health Products Regulatory Authority (HPRA)Text revisedChecked
IrelandPatient leaflet · RoaccutaneIsotretinoin: the page about it

A general sentence about side effects that may continue. It does not name sexual function.4. Possible side effectsThe side effects are generally reversible after changing the dose or stopping treatment, however some may continue after treatment has stopped.

Sexual side effects, as listed4. Possible side effects · Unknown frequency: (frequency cannot be estimated from the available data)Problems getting or maintaining an erection Lower libido Breast swelling with or without tenderness in males Vaginal dryness

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Patient leaflet Package leaflet: Information for the userRoaccutane 10 mg and 20 mg soft capsules, CHEPLAPHARM Registration GmbH · Read in the regulator's own database: Health Products Regulatory Authority (HPRA)The text prints no dateChecked
Saudi ArabiaCompany letter to health professionals, on the regulator's site · RoaccutaneIsotretinoin: the page about it

Sexual side effects that continue after stoppingSummaryDiscontinuation of isotretinoin may not always resolve psychiatric or sexual disorders.

Sexual side effects, as listedFurther information on the safety concerns and recommendations · Sexual disordersPost-marketing reports describe sexual dysfunction including erectile dysfunction and decreased libido, gynecomastia and vulvovaginal dryness in patients treated with isotretinoin.

Sexual side effects that continue after stoppingFurther information on the safety concerns and recommendations · Sexual disordersThese events may persist after discontinuation, and in such cases, further specialist evaluation is recommended.

The letter opens by saying it was written in agreement with the regulator. The words are the company's, and it is not the product's own text.

Company letter to health professionals, on the regulator's site Direct Healthcare Professional Communication: Isotretinoin (Roaccutane®) – Important Safety Information on Psychiatric and Sexual DisordersRoaccutane capsules, CHEPLAPHARM Schweiz GmbH · Read on the regulator's site: Saudi Food and Drug Authority (SFDA)DatedChecked
Saudi ArabiaText for professionals · ROACCUTANEIsotretinoin: the page about it

We could not open this text on 13 October 2026: the site did not answer. This says nothing about what the text contains.

Text for professionalsROACCUTANE 20MG CAPS, CHEPLAPHARM Arzneimittel GmbHWe tried: sdi.sfda.gov.sa/Tried
Saudi ArabiaPatient leaflet · ROACCUTANEIsotretinoin: the page about it

We could not open this text on 13 October 2026: the site did not answer. This says nothing about what the text contains.

Patient leafletROACCUTANE 20MG CAPS, CHEPLAPHARM Arzneimittel GmbHWe tried: sdi.sfda.gov.sa/Tried
Saudi ArabiaCompany letter to health professionals, on the regulator's site · RuatineIsotretinoin: the page about it

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Company letter to health professionals, on the regulator's site Direct Healthcare Professional Communication (DHPC)Ruatine capsules, MS Pharma · Read on the regulator's site: Saudi Food and Drug Authority (SFDA)PublishedChecked
MalaysiaDocument from the regulatorIsotretinoin: the page about it

Sexual side effects, as listedBackground of the Safety Issue · Sexual dysfunctionSexual dysfunction including erectile dysfunction, decreased libido, vulvovaginal dryness, difficulties achieving orgasm, and reduced sensation in the genital area have also been reported following isotretinoin use.

Sexual side effects that continue after stoppingBackground of the Safety Issue · Sexual dysfunctionSome cases have also reported persistent sexual dysfunction even after discontinuing isotretinoin.

The same text also saysBackground of the Safety IssueThe in-depth safety review by the IEWG of the CHM concluded that the currently available data is unable to definitively confirm that isotretinoin caused the psychiatric and sexual side effects.

Sexual side effects that continue after stoppingAdvice for Health Care ProvidersBe vigilant as there are reported cases of persistent sexual dysfunction even after the discontinuation of isotretinoin.

This is a safety alert for health professionals. It does not order a change to product texts about sexual function.

The sentence about the UK review (“unable to definitively confirm”) reports the conclusion of a UK expert group (the Isotretinoin Expert Working Group of the Commission on Human Medicines). It is not the Malaysian regulator's own conclusion.

The package insert and patient leaflet we read for one product in this country list no sexual side effect.

Document from the regulator Isotretinoin: Risk of Psychiatric Disorders and Sexual DysfunctionRead on the regulator's site: National Pharmaceutical Regulatory Agency (NPRA)PublishedChecked
MalaysiaText for professionals · ROACCUTANEIsotretinoin: the page about it

A general sentence about side effects that may continue. It does not name sexual function.2.6 Undesirable Effects · 2.6.1 Clinical Trials · Summary of Safety ProfileThe side effects are generally reversible after altering the dose or discontinuation of treatment, however, some may persist after treatment has stopped.

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Text for professionals Roaccutane® IsotretinoinROACCUTANE CAPSULE 20MG, ZUELLIG PHARMA SDN. BHD. · Read in the regulator's own database: QUEST 3+ Product SearchText revisedChecked
MalaysiaPatient leaflet · ROACCUTANEIsotretinoin: the page about it

A general sentence about side effects that may continue. It does not name sexual function.Side effectsThe side effects are generally reversible after altering the dose or discontinuation of treatment, however, some may persist after treatment has stopped.

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Patient leaflet Consumer Medication Information Leaflet (RiMUP): ROACCUTANE CAPSULE® Isotretinoin (10mg, 20mg)ROACCUTANE CAPSULE 20MG, ZUELLIG PHARMA SDN. BHD. · Read in the regulator's own database: QUEST 3+ Product SearchText revisedChecked
MalaysiaDocument from the regulatorIsotretinoin: the page about it

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Document from the regulator Arahan Pengarah Kanan Perkhidmatan Farmasi Bilangan 6 Tahun 2019: Direktif untuk semua produk yang mengandungi retinoid (oral): Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan neuropsychiatric disordersRead on the regulator's site: National Pharmaceutical Regulatory Agency (NPRA)PublishedChecked
MalaysiaDocument from the regulatorIsotretinoin: the page about it

This text has no sentence about sexual side effects continuing after the medicine is stopped.

Document from the regulator Arahan Pengarah Perkhidmatan Farmasi Bilangan 7 Tahun 2025: Direktif untuk semua produk yang mengandungi isotretinoin : Pengemaskinian sisip bungkusan dan Risalah Maklumat Ubat untuk Pengguna (RiMUP) dengan maklumat keselamatan berkaitan risiko sacroiliitis dan urethritisRead on the regulator's site: National Pharmaceutical Regulatory Agency (NPRA)PublishedChecked