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 asukoreu.iso: the same as an ISO country code. The European Union isEU.kind: the kind of document:professional,patient-leafletorregulator-communication.issuer: for aregulator-communication, whose words it is:regulator,companyorgovernment.access: whether we opened the text:opened,could-not-openorno-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,qualificationorregulator-statement.in_warnings: for asexual-persistencepassage, whether it stands in a warnings section of the text.qualifies: for aqualification, 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,officialorours.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
- India
- Report a side effect: PvPI (Indian Pharmacopoeia Commission)
- Address could not be re-checked on
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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.
| Country or region | What the text says | Document | Dates |
|---|---|---|---|
| United KingdomText for professionals · LustralSertraline: the page about it | Sexual side effects that continue after stopping4.4 Special warnings and precautions for use · Sexual dysfunction Sexual side effects, as listed4.8 Undesirable effects · Table 1 · Reproductive system and breast disorders · Very Common (≥1/10) Sexual side effects, as listed4.8 Undesirable effects · Table 1 · Reproductive system and breast disorders · Common (≥1/100 to <1/10) Sexual side effects, as listed4.8 Undesirable effects · Table 1 · Reproductive system and breast disorders · Uncommon (≥1/1,000 to <1/100) Sexual side effects, as listed4.8 Undesirable effects · Table 1 · Reproductive system and breast disorders · Rare (≥1/10,000 to <1/1,000) | 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: emc | Text 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: | 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: emc | Text revisedChecked |
| United KingdomGovernment answer in parliamentSertraline: the page about it | Sexual side effects that continue after stoppingAnswer 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 site | AnsweredChecked |
| United KingdomDocument from the regulatorSertraline: the page about it | Sexual side effects that continue after stoppingNews story 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.UK | PublishedChecked |
| 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 review 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.UK | PublishedChecked |
| 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 dysfunction 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 precautions 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 Agency | PublishedChecked |
| 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 dysfunction 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 precautions 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 Agency | PublishedChecked |
| United StatesText for professionals · ZoloftSertraline: the page about it | Sexual side effects, as listed5 WARNINGS AND PRECAUTIONS · 5.11 Sexual Dysfunction 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: DailyMed | Text revisedChecked |
| United StatesPatient leaflet · ZoloftSertraline: the page about it | Sexual side effects, as listedWhat is the most important information I should know about ZOLOFT? 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: DailyMed | Text 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 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 · Function Sexual side effects, as listed8 ADVERSE REACTIONS · 8.2 Clinical Trial Adverse Reactions · Depression | 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 Database | Text revisedChecked |
| CanadaPatient leaflet · ZoloftSertraline: the page about it | Sexual side effects, as listedSerious side effects and what to do about them · COMMON 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 Database | Text revisedChecked |
| CanadaDocument from the regulatorSertraline: the page about it | Sexual side effects that continue after stoppingConclusions and actions The same text also saysConclusions and actions 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 Portal | PublishedChecked |
| 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) 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 Publications | PublishedChecked |
| 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 eBS | Text 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 eBS | Text 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-antidepressants | Tried |
| New ZealandText for professionals · SetronaSertraline: the page about it | Sexual side effects that continue after stopping4.4. Special warnings and precautions for use · Sexual dysfunction 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: Medsafe | Text revisedChecked |
| New ZealandPatient leaflet · SetronaSertraline: the page about it | Sexual side effects that continue after stoppingBefore you take SETRONA · Before you start to take it 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: Medsafe | Text 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 dysfunction The same text also says3.2.2 Serotonin reuptake inhibitors and persistent sexual dysfunction What the regulator said3.2.2 Serotonin reuptake inhibitors and persistent sexual dysfunction · Recommendation 5 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: Medsafe | AdoptedChecked |
| 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 · Background 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: Medsafe | AdoptedChecked |
| New ZealandDocument from the regulatorSertraline: the page about it | Sexual side effects that continue after stoppingCARM ID: 138298 · Reaction description and data sheet information | Document from the regulator Gathering knowledge from adverse reaction reports: March 2021Read on the regulator's site: Medsafe | PublishedChecked |
| GermanyText for professionals · ZoloftSertraline: the page about it | Sexual side effects that continue after stopping4.4 Besondere Warnhinweise und Vorsichtsmaßnahmen für die Anwendung · Sexuelle Funktionsstörung 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.de | Text 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 Probleme 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-Service | Text 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) 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: BfArM | PublishedChecked |
| 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 sexuelle 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 médicaments | Updated 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 sexuelle 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 médicaments | Updated 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: ANSM | PublishedChecked |
| ItalyText for professionals · ZoloftSertraline: the page about it | Sexual side effects that continue after stopping4.4 Avvertenze speciali e precauzioni di impiego · Disfunzione sessuale 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 Farmaci | Made 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: 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 Farmaci | Made 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 sexual | Text for professionals Ficha técnicaBesitran 50 mg comprimidos recubiertos con película, Viatris Healthcare Limited · Read in the regulator's own database: CIMA | Text 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: | Patient leaflet Prospecto: información para el usuarioBesitran 50 mg comprimidos recubiertos con película, Viatris Healthcare Limited · Read in the regulator's own database: CIMA | Text 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 sexual 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: AEMPS | PublishedChecked |
| BrazilText for professionals · ZoloftSertraline: the page about it | Sexual side effects that continue after stopping5. ADVERTÊNCIAS E PRECAUÇÕES · Disfunção sexual 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? 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.
| Country or region | What the text says | Document | Dates |
|---|---|---|---|
| United KingdomText for professionals · CipramilCitalopram: the page about it | Sexual side effects that continue after stopping4.4 Special warnings and precautions for use · Sexual dysfunction Sexual side effects, as listed4.8 Undesirable effects · Psychiatric disorders · Common Sexual side effects, as listed4.8 Undesirable effects · Psychiatric disorders · Uncommon Sexual side effects, as listed4.8 Undesirable effects · Reproductive system and breast disorders · Common Sexual side effects, as listed4.8 Undesirable effects · Reproductive system and breast disorders · Not known The same text also says4.8 Undesirable effects 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: emc | Text 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: Sexual side effects, as listed4. Possible side effects · Common side effects (may affect up to 1 in 10 people) Sexual side effects, as listed4. Possible side effects · Common side effects (may affect up to 1 in 10 people) Sexual side effects, as listed4. Possible side effects · Common side effects (may affect up to 1 in 10 people) Sexual side effects, as listed4. Possible side effects · Rare (may affect up to 1 in 1000 people) Sexual side effects, as listed4. Possible side effects · Some patient have reported (frequency not known) The same text also says4. Possible side effects | 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: emc | Text revisedChecked |
| United KingdomGovernment answer in parliamentCitalopram: the page about it | Sexual side effects that continue after stoppingAnswer 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 site | AnsweredChecked |
| 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 dysfunction 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 precautions 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 Agency | PublishedChecked |
| 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 dysfunction 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 precautions 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 Agency | PublishedChecked |
| United StatesText for professionals · CelexaCitalopram: the page about it | Sexual side effects, as listed5 WARNINGS AND PRECAUTIONS · 5.10 Sexual Dysfunction The same text also says5 WARNINGS AND PRECAUTIONS · 5.10 Sexual Dysfunction 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: DailyMed | Text revisedChecked |
| United StatesPatient leaflet · CelexaCitalopram: the page about it | Sexual side effects, as listedWhat are the possible side effects of CELEXA? Sexual side effects, as listedWhat are the possible side effects of CELEXA? · Sexual problems (dysfunction) · Symptoms in males may include: Sexual side effects, as listedWhat are the possible side effects of CELEXA? · Sexual problems (dysfunction) · Symptoms in males may include: Sexual side effects, as listedWhat are the possible side effects of CELEXA? · Sexual problems (dysfunction) · Symptoms in males may include: Sexual side effects, as listedWhat are the possible side effects of CELEXA? · Sexual problems (dysfunction) · Symptoms in females may include: Sexual side effects, as listedWhat are the possible side effects of CELEXA? · Sexual problems (dysfunction) · Symptoms in females may include: Sexual side effects, as listedWhat are the possible side effects of CELEXA? 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: DailyMed | Text revisedChecked |
| CanadaText for professionals · CelexaCitalopram: the page about it | Sexual side effects that continue after stopping7. Warnings and Precautions · Reproductive Health · Function Sexual side effects that continue after stopping8. Adverse Reactions · 8.2. Clinical Trial Adverse Reactions · Male and Female Sexual Dysfunction with SSRIs The same text also says8. Adverse Reactions · 8.2. Clinical Trial Adverse Reactions · Male and Female Sexual Dysfunction with SSRIs 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 Database | Text approvedChecked |
| CanadaPatient leaflet · CelexaCitalopram: the page about it | Sexual side effects that continue after stoppingOther warnings you should know about: Sexual side effects, as listedPossible side effects from using CELEXA · Side effects may include: | 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 Database | Text revisedChecked |
| CanadaDocument from the regulatorCitalopram: the page about it | Sexual side effects that continue after stoppingConclusions and actions The same text also saysConclusions and actions 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 Portal | PublishedChecked |
| 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 same text also saysProduct monograph updates · Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) · Key messages for healthcare professionals: 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 Publications | PublishedChecked |
| 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 eBS | Text 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 eBS | Text 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 dysfunction 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: Medsafe | Text revisedChecked |
| New ZealandPatient leaflet · CipramilCitalopram: the page about it | Sexual side effects that continue after stoppingWhile you are taking it · Things you must do Sexual side effects, as listedSide effects · Tell your doctor if you notice any of the following and they worry you: The same text also saysSide effects | 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: Medsafe | Text 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 dysfunction The same text also says3.2.2 Serotonin reuptake inhibitors and persistent sexual dysfunction What the regulator said3.2.2 Serotonin reuptake inhibitors and persistent sexual dysfunction · Recommendation 5 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: Medsafe | AdoptedChecked |
| 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 · Background The same text also says3.2.3 Update on sexual dysfunction (post SSRI sexual dysfunction, PSSD) following discontinuation of serotonin reuptake inhibitors · Discussion 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: Medsafe | AdoptedChecked |
| 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 Vorsichtsmaßnahmen Sexual side effects, as listed4. Welche Nebenwirkungen sind möglich? · Häufig (kann bis zu 1 von 10 Behandelten betreffen) Sexual side effects, as listed4. Welche Nebenwirkungen sind möglich? · Nicht bekannt (Häufigkeit auf Grundlage der verfügbaren Daten nicht abschätzbar) The same text also says4. Welche Nebenwirkungen sind möglich? 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-Service | Text 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 Funktionsstörung Sexual side effects, as listed4.8 Nebenwirkungen · Psychiatrische Erkrankungen · Häufig Sexual side effects, as listed4.8 Nebenwirkungen · Psychiatrische Erkrankungen · Selten Sexual side effects, as listed4.8 Nebenwirkungen · Erkrankungen der Geschlechtsorgane und der Brustdrüse · Häufig Sexual side effects, as listed4.8 Nebenwirkungen · Erkrankungen der Geschlechtsorgane und der Brustdrüse · Nicht bekannt The same text also says4.8 Nebenwirkungen 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 GmbH | Text 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) 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: BfArM | PublishedChecked |
| 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 sexuelle Sexual side effects, as listed4.8. Effets indésirables · Affections psychiatriques · Fréquent Sexual side effects, as listed4.8. Effets indésirables · Affections des organes de reproduction et du sein · Fréquent Sexual side effects, as listed4.8. Effets indésirables · Affections des organes de reproduction et du sein · Fréquence indéterminée The same text also says4.8. Effets indésirables 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 médicaments | Updated 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 précautions Sexual side effects, as listed4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Fréquemment (de 1 à 10 personnes sur 100) : Sexual side effects, as listed4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Fréquemment (de 1 à 10 personnes sur 100) : Sexual side effects, as listed4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Fréquemment (de 1 à 10 personnes sur 100) : Sexual side effects, as listed4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Effets indésirables dont on ne connaît pas la fréquence : Sexual side effects, as listed4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Effets indésirables dont on ne connaît pas la fréquence : The same text also says4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? 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 médicaments | Updated 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 sessuale Sexual side effects, as listed4.8 Effetti indesiderati · Disturbi psichiatrici · Comune Sexual side effects, as listed4.8 Effetti indesiderati · Patologie dell’apparato riproduttivo e della mammella · Comune Sexual side effects, as listed4.8 Effetti indesiderati · Patologie dell’apparato riproduttivo e della mammella · Non nota The same text also says4.8 Effetti indesiderati 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 Farmaci | Made 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 precauzioni Sexual side effects, as listed4. Possibili effetti indesiderati · Comuni (possono interessare fino a 1 su 10 persone): Sexual side effects, as listed4. Possibili effetti indesiderati · Comuni (possono interessare fino a 1 su 10 persone): Sexual side effects, as listed4. Possibili effetti indesiderati · Frequenza non nota (la cui frequenza non può essere definita sulla base dei dati disponibili): The same text also says4. Possibili effetti indesiderati 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 Farmaci | Made 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 sexual Sexual side effects, as listed4.8. Reacciones adversas · Trastornos psiquiátricos · Frecuente Sexual side effects, as listed4.8. Reacciones adversas · Trastornos del aparato reproductor y de la mama · Frecuente Sexual side effects, as listed4.8. Reacciones adversas · Trastornos del aparato reproductor y de la mama · No conocida The same text also says4.8. Reacciones adversas 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: CIMA | Text 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 precauciones Sexual side effects, as listed4. Posibles efectos adversos · Efectos adversos frecuentes (Pueden afectar hasta 1 de cada 10 personas): Sexual side effects, as listed4. Posibles efectos adversos · Efectos adversos frecuentes (Pueden afectar hasta 1 de cada 10 personas): Sexual side effects, as listed4. Posibles efectos adversos · Efectos adversos frecuentes (Pueden afectar hasta 1 de cada 10 personas): Sexual side effects, as listed4. Posibles efectos adversos · Frecuencia no conocida (no puede estimarse a partir de los datos disponibles): The same text also says4. Posibles efectos adversos | Patient leaflet Prospecto: información para el usuarioSeropram 30 mg Comprimidos recubiertos con película, Lundbeck España, SA · Read in the regulator's own database: CIMA | Text 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 sexual 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: AEMPS | PublishedChecked |
| BrazilText for professionals · DenylCitalopram: the page about it | Sexual side effects, as listed9. REAÇÕES ADVERSAS · Distúrbios psiquiátricos · Comum Sexual side effects, as listed9. REAÇÕES ADVERSAS · Distúrbios do sistema reprodutor e mamas · Comum Sexual side effects, as listed9. REAÇÕES ADVERSAS · Distúrbios do sistema reprodutor e mamas · Desconhecido The same text also says9. REAÇÕES ADVERSAS 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: 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: Sexual side effects, as listed8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE CAUSAR? · Alguns pacientes já apresentaram (frequência desconhecida): The same text also says8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE CAUSAR? 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): 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): Sexual side effects, as listed8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Alguns pacientes já apresentaram (frequência desconhecida): The same text also says8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? 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.
| Country or region | What the text says | Document | Dates |
|---|---|---|---|
| United KingdomText for professionals · CipralexEscitalopram: the page about it | Sexual side effects that continue after stopping4.4 Special warnings and precautions for use · Sexual dysfunction Sexual side effects, as listed4.8 Undesirable effects · Psychiatric disorders · Common Sexual side effects, as listed4.8 Undesirable effects · Reproductive system and breast disorders · Common Sexual side effects, as listed4.8 Undesirable effects · Reproductive system and breast disorders · Not known The same text also says4.8 Undesirable effects 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: emc | Text 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 note Sexual side effects, as listed4. POSSIBLE SIDE EFFECTS · Common (may affect up to 1 in 10 people): Sexual side effects, as listed4. POSSIBLE SIDE EFFECTS · Not known (frequency cannot be estimated from the available data): The same text also says4. POSSIBLE SIDE EFFECTS | 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: emc | Text revisedChecked |
| United KingdomGovernment answer in parliamentEscitalopram: the page about it | Sexual side effects that continue after stoppingAnswer 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 site | AnsweredChecked |
| 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 dysfunction 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 precautions 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 Agency | PublishedChecked |
| 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 dysfunction 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 precautions 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 Agency | PublishedChecked |
| United StatesText for professionals · LexaproEscitalopram: the page about it | Sexual side effects, as listed5 WARNINGS AND PRECAUTIONS · 5.11 Sexual Dysfunction The same text also says5 WARNINGS AND PRECAUTIONS · 5.11 Sexual Dysfunction 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: DailyMed | Text revisedChecked |
| United StatesPatient leaflet · LexaproEscitalopram: the page about it | Sexual side effects, as listedWhat are the possible side effects of Lexapro? Sexual side effects, as listedWhat are the possible side effects of Lexapro? · Sexual problems (dysfunction) · Symptoms in males may include: Sexual side effects, as listedWhat are the possible side effects of Lexapro? · Sexual problems (dysfunction) · Symptoms in males may include: Sexual side effects, as listedWhat are the possible side effects of Lexapro? · Sexual problems (dysfunction) · Symptoms in males may include: Sexual side effects, as listedWhat are the possible side effects of Lexapro? · Sexual problems (dysfunction) · Symptoms in females may include: Sexual side effects, as listedWhat are the possible side effects of Lexapro? · Sexual problems (dysfunction) · Symptoms in females may include: Sexual side effects, as listedWhat are the possible side effects of Lexapro? · The most common side effects of Lexapro include: Sexual side effects, as listedWhat are the possible side effects of Lexapro? · The most common side effects of Lexapro include: Sexual side effects, as listedWhat are the possible side effects of Lexapro? · The most common side effects of Lexapro include: 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: DailyMed | Text 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 · Function Sexual side effects that continue after stopping8 ADVERSE REACTIONS · 8.2 Clinical Trial Adverse Reactions · Male and Female Sexual Dysfunction with SSRIs The same text also says8 ADVERSE REACTIONS · 8.2 Clinical Trial Adverse Reactions · Male and Female Sexual Dysfunction with SSRIs 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 Database | Text revisedChecked |
| CanadaPatient leaflet · CipralexEscitalopram: the page about it | Sexual side effects that continue after stoppingOther warnings you should know about: Sexual side effects, as listedWhat are possible side effects from using CIPRALEX? · Side effects may include: Sexual side effects, as listedWhat are possible side effects from using CIPRALEX? · Side effects may include: Sexual side effects, as listedWhat are possible side effects from using CIPRALEX? · Side effects may include: | 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 Database | Text revisedChecked |
| CanadaDocument from the regulatorEscitalopram: the page about it | Sexual side effects that continue after stoppingConclusions and actions The same text also saysConclusions and actions 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 Portal | PublishedChecked |
| 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 same text also saysProduct monograph updates · Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) · Key messages for healthcare professionals: 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 Publications | PublishedChecked |
| 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 eBS | Text 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 eBS | Text 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 dysfunction 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: Medsafe | Text revisedChecked |
| New ZealandPatient leaflet · LexaproEscitalopram: the page about it | Sexual side effects that continue after stoppingWhile you are taking it · Things you must do Sexual side effects, as listedSide effects · Tell your doctor if you notice any of the following and they worry you: The same text also saysSide effects | 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: Medsafe | Text 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 dysfunction The same text also says3.2.2 Serotonin reuptake inhibitors and persistent sexual dysfunction What the regulator said3.2.2 Serotonin reuptake inhibitors and persistent sexual dysfunction · Recommendation 5 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: Medsafe | AdoptedChecked |
| 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 · Background The same text also says3.2.3 Update on sexual dysfunction (post SSRI sexual dysfunction, PSSD) following discontinuation of serotonin reuptake inhibitors · Discussion 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: Medsafe | AdoptedChecked |
| 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 Vorsichtsmaßnahmen Sexual side effects, as listed4. Welche Nebenwirkungen sind möglich? · Häufig (kann bis zu 1 von 10 Behandelten betreffen): Sexual side effects, as listed4. Welche Nebenwirkungen sind möglich? · Nicht bekannt (Häufigkeit auf Grundlage der verfügbaren Daten nicht abschätzbar): The same text also says4. Welche Nebenwirkungen sind möglich? 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-Service | Text 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 Funktionsstörung Sexual side effects, as listed4.8 Nebenwirkungen · Psychiatrische Erkrankungen · Häufig Sexual side effects, as listed4.8 Nebenwirkungen · Erkrankungen der Geschlechtsorgane und der Brustdrüse · Häufig Sexual side effects, as listed4.8 Nebenwirkungen · Erkrankungen der Geschlechtsorgane und der Brustdrüse · Nicht bekannt The same text also says4.8 Nebenwirkungen 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 GmbH | Text 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) 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: BfArM | PublishedChecked |
| 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 sexuelle Sexual side effects, as listed4.8. Effets indésirables · Affections psychiatriques · Fréquent Sexual side effects, as listed4.8. Effets indésirables · Affections des organes de reproduction et du sein · Fréquent Sexual side effects, as listed4.8. Effets indésirables · Affections des organes de reproduction et du sein · Fréquence indéterminée The same text also says4.8. Effets indésirables 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 médicaments | Updated 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 précautions Sexual side effects, as listed4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Fréquemment (peut concerner jusqu’à 1 patient sur 10) : Sexual side effects, as listed4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Fréquence indéterminée (fréquence ne pouvant pas être estimée à partir des données disponibles) : The same text also says4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? 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 médicaments | Updated 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 sessuale Sexual side effects, as listed4.8 Effetti indesiderati · Disturbi psichiatrici · Comune Sexual side effects, as listed4.8 Effetti indesiderati · Patologie del sistema riproduttivo e della mammella · Comune Sexual side effects, as listed4.8 Effetti indesiderati · Patologie del sistema riproduttivo e della mammella · Non nota The same text also says4.8 Effetti indesiderati 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 Farmaci | Made 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 precauzioni Sexual side effects, as listed4. Possibili effetti indesiderati · Comune (può interessare fino a 1 persona su 10): Sexual side effects, as listed4. Possibili effetti indesiderati · Non nota (la frequenza non può essere stimata sulla base dei dati disponibili): The same text also says4. Possibili effetti indesiderati 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 Farmaci | Made 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 sexual Sexual side effects, as listed4.8. Reacciones adversas · Trastornos psiquiátricos · Frecuente Sexual side effects, as listed4.8. Reacciones adversas · Trastornos del aparato reproductor y de la mama · Frecuente Sexual side effects, as listed4.8. Reacciones adversas · Trastornos del aparato reproductor y de la mama · Desconocida The same text also says4.8. Reacciones adversas 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: CIMA | Text 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 precauciones Sexual side effects, as listed4. Posibles efectos adversos · Frecuente (puede afectar hasta 1 de cada 10 personas): Sexual side effects, as listed4. Posibles efectos adversos · Desconocido (no se puede determinar la frecuencia a partir de los datos disponibles): The same text also says4. Posibles efectos adversos | Patient leaflet Prospecto: información para el usuarioCipralex 10 mg comprimidos recubiertos con película, Lundbeck España, S.A. · Read in the regulator's own database: CIMA | Text 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 sexual 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: AEMPS | PublishedChecked |
| BrazilText for professionals · EscenaEscitalopram: the page about it | Sexual side effects, as listed9. REAÇÕES ADVERSAS · Distúrbios psiquiátricos · Comum Sexual side effects, as listed9. REAÇÕES ADVERSAS · Distúrbios do sistema reprodutor e mama · Comum Sexual side effects, as listed9. REAÇÕES ADVERSAS · Distúrbios do sistema reprodutor e mama · Desconhecido The same text also says9. REAÇÕES ADVERSAS 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: 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): The same text also says8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? 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: 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): The same text also says8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? 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.
| Country or region | What the text says | Document | Dates |
|---|---|---|---|
| United KingdomText for professionals · FluoxetineFluoxetine: the page about it | Sexual side effects that continue after stopping4.4 Special warnings and precautions for use · Sexual dysfunction Sexual side effects, as listed4.8 Undesirable effects · b) Tabulated list of adverse reactions · Psychiatric disorders · Common Sexual side effects, as listed4.8 Undesirable effects · b) Tabulated list of adverse reactions · Psychiatric disorders · Uncommon Sexual side effects, as listed4.8 Undesirable effects · b) Tabulated list of adverse reactions · Reproductive system and breast disorders · Common Sexual side effects, as listed4.8 Undesirable effects · b) Tabulated list of adverse reactions · Reproductive system and breast disorders · Uncommon Sexual side effects that continue after stopping4.8 Undesirable effects · b) Tabulated list of adverse reactions · footnote 16 Sexual side effects, as listed4.8 Undesirable effects · b) Tabulated list of adverse reactions · Reproductive system and breast disorders · Rare The same text also says4.8 Undesirable effects · a) Summary of the safety profile Sexual side effects, as listed4.8 Undesirable effects · d) Paediatric population 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: emc | Text 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 dysfunction Sexual side effects, as listed4. Possible side effects · Some patients have had: Sexual side effects, as listed4. Possible side effects · Common (may affect up to 1 in 10 people) Sexual side effects that continue after stopping4. Possible side effects · Uncommon (may affect up to 1 in 100 people) The same text also says4. Possible side effects 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: emc | Text revisedChecked |
| United KingdomGovernment answer in parliamentFluoxetine: the page about it | Sexual side effects that continue after stoppingAnswer 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 site | AnsweredChecked |
| 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 dysfunction 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 precautions 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 Agency | PublishedChecked |
| 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 dysfunction 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 precautions 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 Agency | PublishedChecked |
| United StatesText for professionals · ProzacFluoxetine: the page about it | Sexual side effects, as listed5 WARNINGS AND PRECAUTIONS · 5.17 Sexual Dysfunction The same text also says5 WARNINGS AND PRECAUTIONS · 5.17 Sexual Dysfunction Sexual side effects that continue after stopping6 ADVERSE REACTIONS · 6.1 Clinical Trials Experience · Male and female sexual dysfunction with SSRIs The same text also says6 ADVERSE REACTIONS · 6.1 Clinical Trials Experience · Male and female sexual dysfunction with SSRIs 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: DailyMed | Text 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 side effects, as listedWhat is the most important information I should know about PROZAC? · Sexual problems (dysfunction) · Symptoms in males may include: Sexual side effects, as listedWhat is the most important information I should know about PROZAC? · Sexual problems (dysfunction) · Symptoms in males may include: Sexual side effects, as listedWhat is the most important information I should know about PROZAC? · Sexual problems (dysfunction) · Symptoms in males may include: Sexual side effects, as listedWhat is the most important information I should know about PROZAC? · Sexual problems (dysfunction) · Symptoms in females may include: Sexual side effects, as listedWhat is the most important information I should know about PROZAC? · Sexual problems (dysfunction) · Symptoms in females may include: Sexual side effects, as listedWhat are the possible side effects of PROZAC? · Common possible side effects in people who take PROZAC include: 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: DailyMed | Text revisedChecked |
| United StatesDocument from the regulator · ProzacFluoxetine: the page about it | Sexual side effects that continue after stoppingADVERSE REACTIONS · section 6.1, Clinical Trials Experience | 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@FDA | Text 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 · Function Sexual side effects that continue after stopping8 ADVERSE REACTIONS · 8.2 Clinical Trial Adverse Reactions · Male and Female Sexual Dysfunction with SSRIs The same text also says8 ADVERSE REACTIONS · 8.2 Clinical Trial Adverse Reactions · Male and Female Sexual Dysfunction with SSRIs 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 Database | Text revisedChecked |
| CanadaPatient leaflet · APO-FLUOXETINEFluoxetine: the page about it | Sexual side effects that continue after stoppingOther warnings you should know about: Sexual side effects, as listedWhat are possible side effects from using APO-FLUOXETINE? · What are possible side effects from using APO-FLUOXETINE? Sexual side effects, as listedSerious side effects and what to do about them · UNKNOWN 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 Database | Text revisedChecked |
| CanadaDocument from the regulatorFluoxetine: the page about it | Sexual side effects that continue after stoppingConclusions and actions The same text also saysConclusions and actions 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 Portal | PublishedChecked |
| 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 same text also saysProduct monograph updates · Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) · Key messages for healthcare professionals: 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 Publications | PublishedChecked |
| 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 eBS | Text 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 eBS | Text 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 · Common Sexual side effects that continue after stopping4.8 Undesirable effects · b. Adverse reactions from clinical trials · Reproductive system and breast disorders The same text also says4.8 Undesirable effects · b. Adverse reactions from clinical trials 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: Medsafe | Text revisedChecked |
| New ZealandText for professionals · FluoxFluoxetine: the page about it | Sexual side effects, as listed4.8 Undesirable effects · Nervous system disorders · Common: Sexual side effects that continue after stopping4.8 Undesirable effects · Reproductive system and breast disorders The same text also says4.8 Undesirable effects 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: Medsafe | Text revisedChecked |
| New ZealandPatient leaflet · Arrow-FluoxetineFluoxetine: the page about it | Sexual side effects that continue after stoppingSide effects The same text also saysSide effects 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: Medsafe | Text 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: Sexual side effects that continue after stoppingSide effects The same text also saysSide effects | 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: Medsafe | Text 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 Funktionsstörung Sexual side effects, as listed4.8 Nebenwirkungen · Psychiatrische Erkrankungen · Häufig Sexual side effects, as listed4.8 Nebenwirkungen · Psychiatrische Erkrankungen · Gelegentlich Sexual side effects, as listed4.8 Nebenwirkungen · Erkrankungen der Geschlechtsorgane und der Brustdrüse · Häufig Sexual side effects, as listed4.8 Nebenwirkungen · Erkrankungen der Geschlechtsorgane und der Brustdrüse · Gelegentlich Sexual side effects that continue after stopping4.8 Nebenwirkungen · Tabellarische Zusammenfassung der Nebenwirkungen · Fußnote 16 Sexual side effects, as listed4.8 Nebenwirkungen · Erkrankungen der Geschlechtsorgane und der Brustdrüse · Selten The same text also says4.8 Nebenwirkungen · Zusammenfassung des Sicherheitsprofils Sexual side effects, as listed4.8 Nebenwirkungen · Kinder und Jugendliche 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 GmbH | Text 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/aktuell | Tried |
| 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 Funktionsstörung Sexual side effects, as listed4. Welche Nebenwirkungen sind möglich? · Einige Patienten hatten Sexual side effects, as listed4. Welche Nebenwirkungen sind möglich? · Häufig (kann bis zu 1 von 10 Behandelten betreffen) Sexual side effects that continue after stopping4. Welche Nebenwirkungen sind möglich? · Gelegentlich (kann bis zu 1 von 100 Behandelten betreffen) The same text also says4. Welche Nebenwirkungen sind möglich? 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 GmbH | Text 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/aktuell | Tried |
| 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) 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: BfArM | PublishedChecked |
| 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 sexuelle Sexual side effects, as listed4.8. Effets indésirables · Affections psychiatriques · Fréquent Sexual side effects, as listed4.8. Effets indésirables · Affections psychiatriques · Peu fréquent Sexual side effects, as listed4.8. Effets indésirables · Affections des organes de reproduction et du sein · Fréquent Sexual side effects, as listed4.8. Effets indésirables · Affections des organes de reproduction et du sein · Peu fréquent Sexual side effects that continue after stopping4.8. Effets indésirables · b. Tableau récapitulatif des effets indésirables · note 16 Sexual side effects, as listed4.8. Effets indésirables · Affections des organes de reproduction et du sein · Rare The same text also says4.8. Effets indésirables · a. Résumé du profil de sécurité Sexual side effects, as listed4.8. Effets indésirables · d. Population pédiatrique 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 médicaments | Updated 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 sexuelle Sexual side effects, as listed4.8. Effets indésirables · Affections psychiatriques · Fréquent Sexual side effects, as listed4.8. Effets indésirables · Affections psychiatriques · Peu fréquent Sexual side effects, as listed4.8. Effets indésirables · Affections des organes de reproduction et du sein · Fréquent Sexual side effects, as listed4.8. Effets indésirables · Affections des organes de reproduction et du sein · Peu fréquent Sexual side effects that continue after stopping4.8. Effets indésirables · b. Tableau récapitulatif des effets indésirables · note 16 Sexual side effects, as listed4.8. Effets indésirables · Affections des organes de reproduction et du sein · Rare The same text also says4.8. Effets indésirables · a. Résumé du profil de sécurité Sexual side effects, as listed4.8. Effets indésirables · d. Population pédiatrique 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 médicaments | Updated 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 sexuelle Sexual side effects, as listed4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Certains patients ont présenté : Sexual side effects, as listed4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Fréquents (pouvant affecter jusqu’à 1 patient sur 10) Sexual side effects that continue after stopping4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Peu fréquents (pouvant affecter jusqu’à 1 patient sur 100) The same text also says4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? 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 médicaments | Updated 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 sexuelle Sexual side effects, as listed4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Certains patients ont présenté : Sexual side effects, as listed4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Fréquents (pouvant affecter jusqu’à 1 patient sur 10) Sexual side effects that continue after stopping4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Peu fréquents (pouvant affecter jusqu’à 1 patient sur 100) The same text also says4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? 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 médicaments | Updated 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 sessuale Sexual side effects, as listed4.8 Effetti indesiderati · b. Tabella riassuntiva delle reazioni avverse · Disturbi psichiatrici · Comune Sexual side effects, as listed4.8 Effetti indesiderati · b. Tabella riassuntiva delle reazioni avverse · Disturbi psichiatrici · Non comune Sexual side effects, as listed4.8 Effetti indesiderati · b. Tabella riassuntiva delle reazioni avverse · Patologie dell'apparato riproduttivo e della mammella · Comune Sexual side effects, as listed4.8 Effetti indesiderati · b. Tabella riassuntiva delle reazioni avverse · Patologie dell'apparato riproduttivo e della mammella · Non comune Sexual side effects that continue after stopping4.8 Effetti indesiderati · b. Tabella riassuntiva delle reazioni avverse · nota 16 Sexual side effects, as listed4.8 Effetti indesiderati · b. Tabella riassuntiva delle reazioni avverse · Patologie dell'apparato riproduttivo e della mammella · Raro The same text also says4.8 Effetti indesiderati · a. Sommario del profilo di sicurezza Sexual side effects, as listed4.8 Effetti indesiderati · d. Popolazione pediatrica (vedere paragrafi 4.4 e 5.1) 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 Farmaci | Made 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 sessuale Sexual side effects, as listed4.8 Effetti indesiderati · b) Elenco delle reazioni avverse · Disturbi psichiatrici · Comune: Sexual side effects, as listed4.8 Effetti indesiderati · b) Elenco delle reazioni avverse · Disturbi psichiatrici · Non comune: Sexual side effects, as listed4.8 Effetti indesiderati · b) Elenco delle reazioni avverse · Patologie dell’apparato riproduttivo e della mammella · Comune: Sexual side effects, as listed4.8 Effetti indesiderati · b) Elenco delle reazioni avverse · Patologie dell’apparato riproduttivo e della mammella · Non comune: Sexual side effects, as listed4.8 Effetti indesiderati · b) Elenco delle reazioni avverse · Patologie dell’apparato riproduttivo e della mammella · Raro: The same text also says4.8 Effetti indesiderati · a) Sintesi del profilo di sicurezza Sexual side effects, as listed4.8 Effetti indesiderati · d) Popolazione pediatrica (vedere paragrafi 4.4 e 5.1) 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 Farmaci | Made 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 sessuale Sexual side effects, as listed4. Possibili effetti indesiderati · Alcuni pazienti hanno presentato: Sexual side effects, as listed4. Possibili effetti indesiderati · Comuni (che possono interessare fino a 1 paziente su 10) Sexual side effects that continue after stopping4. Possibili effetti indesiderati · Non comuni (che possono interessare fino a 1 paziente su 100) The same text also says4. Possibili effetti indesiderati 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 Farmaci | Made 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 precauzioni Sexual side effects, as listed4. Possibili effetti indesiderati · Effetti indesiderati comuni (possono interessare fino a 1 persona su 10): Sexual side effects, as listed4. Possibili effetti indesiderati · Effetti indesiderati non comuni (possono interessare fino a 1 persona su 100): Sexual side effects, as listed4. Possibili effetti indesiderati · Effetti indesiderati non comuni (possono interessare fino a 1 persona su 100): Sexual side effects, as listed4. Possibili effetti indesiderati · Effetti indesiderati rari (possono interessare fino a 1 persona su 1.000): Sexual side effects, as listed4. Possibili effetti indesiderati · Uso nei bambini e negli adolescenti al di sotto di 18 anni d’età 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 Farmaci | Made 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 sexual Sexual side effects, as listed4.8. Reacciones adversas · Resumen tabulado de reacciones adversas · Trastornos psiquiátricos · Frecuentes Sexual side effects, as listed4.8. Reacciones adversas · Resumen tabulado de reacciones adversas · Trastornos psiquiátricos · Poco frecuentes Sexual side effects, as listed4.8. Reacciones adversas · Resumen tabulado de reacciones adversas · Trastornos del aparato reproductor y de la mama · Frecuentes Sexual side effects, as listed4.8. Reacciones adversas · Resumen tabulado de reacciones adversas · Trastornos del aparato reproductor y de la mama · Poco frecuentes Sexual side effects, as listed4.8. Reacciones adversas · Resumen tabulado de reacciones adversas · Trastornos del aparato reproductor y de la mama · Raras The same text also says4.8. Reacciones adversas · Resumen del perfil de seguridad Sexual side effects, as listed4.8. Reacciones adversas · Población pediátrica (ver secciones 4.4 y 5.1) 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: CIMA | Text 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 sexual Sexual side effects, as listed4. Posibles efectos adversos · Algunos pacientes han padecido: Sexual side effects, as listed4. Posibles efectos adversos · Frecuentes (pueden afectar hasta 1 de cada 10 personas) Sexual side effects that continue after stopping4. Posibles efectos adversos · Poco frecuentes (pueden afectar hasta 1 de cada 100 personas) The same text also says4. Posibles efectos adversos 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: CIMA | Text 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 sexual 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: AEMPS | PublishedChecked |
| BrazilText for professionals · FluoxetinFluoxetine: the page about it | Sexual side effects, as listed9. REAÇÕES ADVERSAS · Reação comum (> 1/100 e < 1/10): Sexual side effects, as listed9. REAÇÕES ADVERSAS · Reação comum (> 1/100 e < 1/10): Sexual side effects, as listed9. REAÇÕES ADVERSAS · Reação comum (> 1/100 e < 1/10): Sexual side effects, as listed9. REAÇÕES ADVERSAS · Reação incomum (> 1/1.000 e <1/100): Sexual side effects, as listed9. REAÇÕES ADVERSAS · Reação incomum (> 1/1.000 e <1/100): Sexual side effects, as listed9. REAÇÕES ADVERSAS · Relatos pós-comercialização: Sexual side effects that continue after stopping9. REAÇÕES ADVERSAS · Relatos pós-comercialização: 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): 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): 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): 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): 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): Sexual side effects, as listed8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Relatos pós-comercialização: Sexual side effects that continue after stopping8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Relatos pós-comercialização: 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.
| Country or region | What the text says | Document | Dates |
|---|---|---|---|
| United KingdomText for professionals · PropeciaFinasteride: the page about it | Sexual side effects, as listed4.8 Undesirable effects · Psychiatric disorders: · Uncommon*: Sexual side effects, as listed4.8 Undesirable effects · Reproductive system and breast disorders: · Uncommon*: Sexual side effects that continue after stopping4.8 Undesirable effects The same text also says4.8 Undesirable effects Sexual side effects, as listed4.8 Undesirable effects Sexual side effects, as listed4.8 Undesirable effects 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: emc | Text revisedChecked |
| United KingdomText for professionals · ProscarFinasteride: the page about it | Sexual side effects, as listed4.8 Undesirable effects Sexual side effects, as listed4.8 Undesirable effects · Psychiatric disorders · Common: Sexual side effects that continue after stopping4.8 Undesirable effects · Psychiatric disorders · Unknown: Sexual side effects, as listed4.8 Undesirable effects · Reproductive system and breast disorders · Common: Sexual side effects, as listed4.8 Undesirable effects · Reproductive system and breast disorders · Uncommon: Sexual side effects that continue after stopping4.8 Undesirable effects · Reproductive system and breast disorders · Unknown: The same text also says4.8 Undesirable effects Sexual side effects, as listed4.8 Undesirable effects · Investigations · Common: Sexual side effects, as listed4.8 Undesirable effects · Medical Therapy of Prostatic Symptoms (MTOPS) 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: emc | Text 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 people Sexual side effects, as listed4. Possible side effects · Uncommon: may affect up to 1 in 100 people Sexual side effects, as listed4. Possible side effects · Uncommon: may affect up to 1 in 100 people The same text also says4. Possible side effects Sexual side effects that continue after stopping4. Possible side effects · Frequency unknown: Sexual side effects that continue after stopping4. Possible side effects · Frequency unknown: Sexual side effects that continue after stopping4. Possible side effects · Frequency unknown: 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: emc | Text revisedChecked |
| United KingdomPatient leaflet · ProscarFinasteride: the page about it | Sexual side effects, as listed4. Possible side effects · Other side effects may include: Sexual side effects, as listed4. Possible side effects · Other side effects may include: Sexual side effects, as listed4. Possible side effects · Other side effects may include: The same text also says4. Possible side effects Sexual side effects that continue after stopping4. Possible side effects · Other side effects reported in some men are: Sexual side effects that continue after stopping4. Possible side effects · Other side effects reported in some men are: Sexual side effects that continue after stopping4. Possible side effects · Other side effects reported in some men are: | 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: emc | Text 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 finasteride Sexual side effects that continue after stopping10. Annexes · Annex 1 · Patient card for finasteride 1mg: Sexual side effects that continue after stopping10. Annexes · Annex 1 · Patient card for finasteride 5mg: | Document from the regulator Safety review of Finasteride. Public Assessment ReportRead on the regulator's site: GOV.UK | PublishedChecked |
| United KingdomDocument from the regulatorFinasteride: the page about it | Sexual side effects that continue after stoppingAdvice for Healthcare Professionals: What the regulator saidAdvice for Healthcare Professionals: What the regulator saidAdvice for Healthcare Professionals: | 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.UK | PublishedChecked |
| United KingdomDocument from the regulatorFinasteride: the page about it | What the regulator saidReview of persistent sexual dysfunction and psychiatric side effects with finasteride Sexual side effects that continue after stoppingAdvice for healthcare professionals: What the regulator saidAdvice for healthcare professionals: Sexual side effects that continue after stoppingAdvice for healthcare professionals to give to patients and caregivers: | 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.UK | PublishedChecked |
| United KingdomDocument from the regulatorFinasteride: the page about it | Sexual side effects, as listedSexual dysfunction 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.UK | PublishedChecked |
| 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 effects | 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.UK | PublishedChecked |
| United KingdomDocument from the regulatorFinasteride: the page about it | What the regulator saidMHRA strengthens safety warnings for finasteride and dutasteride 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.UK | PublishedChecked |
| United KingdomCompany letter to health professionals, on the regulator's siteFinasteride: the page about it | What the regulator saidSummary of the safety concern: 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.UK | PublishedChecked |
| United KingdomGovernment answer in parliamentFinasteride: the page about it | What the regulator saidAnswer 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 site | AnsweredChecked |
| United KingdomGovernment answer in parliamentFinasteride: the page about it | Sexual side effects that continue after stoppingAnswer 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 site | AnsweredChecked |
| United KingdomGovernment answer in parliamentFinasteride: the page about it | What the regulator saidAnswer 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 site | AnsweredChecked |
| 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 Agency | The 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 medicines 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 Agency | PublishedChecked |
| European UnionDocument from the regulatorFinasteride: the page about it | What the regulator saidScientific conclusions · Grounds for PRAC recommendation 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 Agency | The 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 Experience The same text also says6 ADVERSE REACTIONS · 6.2 Postmarketing Experience 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: DailyMed | Text revisedChecked |
| United StatesText for professionals · ProscarFinasteride: the page about it | Sexual side effects that continue after stopping6 ADVERSE REACTIONS · 6.2 Postmarketing Experience The same text also says6 ADVERSE REACTIONS · 6.2 Postmarketing Experience Sexual side effects that continue after stopping6 ADVERSE REACTIONS · 6.2 Postmarketing Experience 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: DailyMed | Text 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: Sexual side effects, as listedWhat are the possible side effects of PROPECIA? · The most common side effects of PROPECIA include: Sexual side effects, as listedWhat are the possible side effects of PROPECIA? · The most common side effects of PROPECIA include: Sexual side effects that continue after stoppingWhat are the possible side effects of PROPECIA? · The following have been reported in general use with PROPECIA: Sexual side effects that continue after stoppingWhat are the possible side effects of PROPECIA? · The following have been reported in general use with PROPECIA: Sexual side effects that continue after stoppingWhat are the possible side effects of PROPECIA? · The following have been reported in general use with PROPECIA: | Patient leaflet Patient Information PROPECIA (Pro-pee-sha) (finasteride) TabletsPropecia tablets 1 mg, Organon LLC · Read in the government's medicines database: DailyMed | Text 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: Sexual side effects, as listedWhat are the possible side effects of PROSCAR? · The most common side effects of PROSCAR include: Sexual side effects, as listedWhat are the possible side effects of PROSCAR? · The most common side effects of PROSCAR include: Sexual side effects, as listedWhat are the possible side effects of PROSCAR? · The most common side effects of PROSCAR include: 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: 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: 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: | Patient leaflet Patient Information about PROSCAR® (Prahs-car)Proscar tablets 5 mg, Organon LLC · Read in the government's medicines database: DailyMed | Text revisedChecked |
| United StatesDocument from the regulator · PropeciaFinasteride: the page about it | Sexual side effects that continue after stoppingSUPPLEMENT APPROVAL | 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@FDA | Text approvedChecked |
| United StatesDocument from the regulator · ProscarFinasteride: the page about it | What the regulator saidSUPPLEMENT APPROVAL 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@FDA | Text approvedChecked |
| United StatesDocument from the regulator · ProscarFinasteride: the page about it | Sexual side effects that continue after stoppingSUPPLEMENT APPROVAL | 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@FDA | Text approvedChecked |
| United StatesDocument from the regulator · PropeciaFinasteride: the page about it | What the regulator saidSUPPLEMENT APPROVAL 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@FDA | Text 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 discussion The same text also saysReview and discussion 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 Administration | Updated 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 Reactions Sexual side effects that continue after stopping8 ADVERSE REACTIONS · 8.5 Post-Market Adverse Reactions The same text also says8 ADVERSE REACTIONS · 8.5 Post-Market Adverse Reactions 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 Database | Text revisedChecked |
| CanadaText for professionals · ProscarFinasteride: the page about it | Sexual side effects that continue after stopping8 ADVERSE REACTIONS · 8.5 Post-Market Adverse Reactions Sexual side effects that continue after stopping8 ADVERSE REACTIONS · 8.5 Post-Market Adverse Reactions The same text also says8 ADVERSE REACTIONS · 8.5 Post-Market Adverse Reactions 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 Database | Text 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: Sexual side effects, as listedWhat are possible side effects from using PROPECIA? · Side effects may include: Sexual side effects, as listedWhat are possible side effects from using PROPECIA? · Side effects may include: Sexual side effects, as listedWhat are possible side effects from using PROPECIA? · Side effects may include: | 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 Database | Text revisedChecked |
| CanadaPatient leaflet · ProscarFinasteride: the page about it | Sexual side effects, as listedOther warnings you should know about Sexual side effects, as listedWhat are possible side effects from using PROSCAR? · Side effects may include: Sexual side effects, as listedWhat are possible side effects from using PROSCAR? · Side effects may include: Sexual side effects that continue after stoppingWhat are possible side effects from using PROSCAR? · Side effects may include: Sexual side effects, as listedWhat are possible side effects from using PROSCAR? · Side effects may include: 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 Database | Text revisedChecked |
| CanadaDocument from the regulatorFinasteride: the page about it | What the regulator saidKey Messages The same text also saysOverview 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 Portal | The text prints no dateChecked |
| CanadaDocument from the regulatorFinasteride: the page about it | What the regulator saidMONTHLY RECAP OF HEALTH PRODUCT SAFETY INFORMATION · Finasteride and dutasteride The same text also saysMONTHLY RECAP OF HEALTH PRODUCT SAFETY INFORMATION 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 Publications | PublishedChecked |
| 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 eBS | Text 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 eBS | Text 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 eBS | Text 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 eBS | Text revisedChecked |
| New ZealandText for professionals · PropeciaFinasteride: the page about it | Sexual side effects, as listed4.8 Undesirable effects · Adverse events identified during clinical trials The same text also says4.8 Undesirable effects · Adverse events identified during clinical trials Sexual side effects that continue after stopping4.8 Undesirable effects · Adverse events identified during postmarketing experience · Psychiatric disorders: Sexual side effects that continue after stopping4.8 Undesirable effects · Adverse events identified during postmarketing experience · Reproductive system and breast disorders: The same text also says4.8 Undesirable effects · Adverse events identified during postmarketing experience 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: Medsafe | Text revisedChecked |
| New ZealandText for professionals · RicitFinasteride: the page about it | Sexual side effects, as listed4.8 Undesirable effects Sexual side effects that continue after stopping4.8 Undesirable effects · Psychiatric disorders Sexual side effects that continue after stopping4.8 Undesirable effects · Reproductive system and breast disorders The same text also says4.8 Undesirable effects Sexual side effects, as listed4.8 Undesirable effects · Investigations 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: Medsafe | Text 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: Sexual side effects, as listedAdverse Effects · Tell your doctor if you notice any of the following and they worry you: Sexual side effects that continue after stoppingAdverse Effects · Tell your doctor if you notice any of the following and they worry you: Sexual side effects that continue after stoppingAdverse Effects · Tell your doctor if you notice any of the following and they worry you: The same text also saysAdverse Effects | Patient leaflet Consumer Medicine Information (CMI), PROPECIAPropecia 1 mg tablet, Organon New Zealand · Read in the regulator's own database: Medsafe | Text revisedChecked |
| New ZealandDocument from the regulatorFinasteride: the page about it | Sexual side effects that continue after stoppingKey Messages The same text also saysKey Messages 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: Medsafe | PublishedChecked |
| GermanyText for professionals · Propecia®Finasteride: the page about it | Sexual side effects, as listed4.8 Nebenwirkungen · Psychiatrische Erkrankungen: · Gelegentlich* Sexual side effects, as listed4.8 Nebenwirkungen · Erkrankungen der Geschlechtsorgane und der Brustdrüse: · Gelegentlich* Sexual side effects that continue after stopping4.8 Nebenwirkungen The same text also says4.8 Nebenwirkungen Sexual side effects, as listed4.8 Nebenwirkungen 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 GmbH | Text revisedChecked |
| GermanyText for professionals · PROSCAR®Finasteride: the page about it | Sexual side effects, as listed4.8 Nebenwirkungen Sexual side effects, as listed4.8 Nebenwirkungen · Psychiatrische Erkrankungen · Häufig Sexual side effects that continue after stopping4.8 Nebenwirkungen · Psychiatrische Erkrankungen · Nicht bekannt Sexual side effects, as listed4.8 Nebenwirkungen · Erkrankungen der Geschlechtsorgane und der Brustdrüse · Häufig Sexual side effects, as listed4.8 Nebenwirkungen · Erkrankungen der Geschlechtsorgane und der Brustdrüse · Gelegentlich Sexual side effects that continue after stopping4.8 Nebenwirkungen · Erkrankungen der Geschlechtsorgane und der Brustdrüse · Nicht bekannt The same text also says4.8 Nebenwirkungen Sexual side effects, as listed4.8 Nebenwirkungen · Untersuchungen · Häufig Sexual side effects, as listed4.8 Nebenwirkungen · Kombinationstherapie mit Doxazosin 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 GmbH | Text 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 betreffen Sexual side effects, as listed4. Welche Nebenwirkungen sind möglich? · Gelegentlich: kann bis zu 1 von 100 Behandelten betreffen Sexual side effects, as listed4. Welche Nebenwirkungen sind möglich? · Gelegentlich: kann bis zu 1 von 100 Behandelten betreffen The same text also says4. Welche Nebenwirkungen sind möglich? Sexual side effects that continue after stopping4. Welche Nebenwirkungen sind möglich? · Nicht bekannt: Häufigkeit auf Grundlage der verfügbaren Daten nicht abschätzbar Sexual side effects that continue after stopping4. Welche Nebenwirkungen sind möglich? · Nicht bekannt: Häufigkeit auf Grundlage der verfügbaren Daten nicht abschätzbar Sexual side effects that continue after stopping4. Welche Nebenwirkungen sind möglich? · Nicht bekannt: Häufigkeit auf Grundlage der verfügbaren Daten nicht abschätzbar Sexual side effects that continue after stopping4. Welche Nebenwirkungen sind möglich? · Nicht bekannt: Häufigkeit auf Grundlage der verfügbaren Daten nicht abschätzbar 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 GmbH | Text revisedChecked |
| GermanyPatient leaflet · PROSCAR®Finasteride: the page about it | Sexual side effects, as listed4. Welche Nebenwirkungen sind möglich? · Häufig Sexual side effects, as listed4. Welche Nebenwirkungen sind möglich? · Gelegentlich Sexual side effects that continue after stopping4. Welche Nebenwirkungen sind möglich? · Nicht bekannt Sexual side effects, as listed4. Welche Nebenwirkungen sind möglich? · Kombinationsbehandlung mit Doxazosin 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 GmbH | Text 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: BfArM | PublishedChecked |
| GermanyCompany letter to health professionals, on the regulator's siteFinasteride: the page about it | Sexual side effects that continue after stoppingZusammenfassung 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: BfArM | PublishedChecked |
| GermanyDocument from the regulatorFinasteride: the page about it | Sexual side effects that continue after stoppingAKTUELLE ANGABEN IN DEN PRODUKTINFORMATIONEN | 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: BfArM | PublishedChecked |
| 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: BfArM | PublishedChecked |
| FranceText for professionals · FINASTERIDE ARROW LABFinasteride: the page about it | Sexual side effects, as listed4.8. Effets indésirables · Affections psychiatriques · Peu fréquent* Sexual side effects, as listed4.8. Effets indésirables · Affections des organes de reproduction et du sein · Peu fréquent* Sexual side effects that continue after stopping4.8. Effets indésirables The same text also says4.8. Effets indésirables Sexual side effects, as listed4.8. Effets indésirables 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 médicaments | Updated by the regulatorChecked |
| FranceText for professionals · CHIBRO-PROSCARFinasteride: the page about it | Sexual side effects that continue after stopping4.8. Effets indésirables · Affections psychiatriques Sexual side effects that continue after stopping4.8. Effets indésirables · Affections des organes de reproduction et du sein The same text also says4.8. Effets indésirables 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 médicaments | Updated 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) : Sexual side effects, as listed4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Peu fréquents (pouvant affecter jusqu’à 1 personne sur 100) : Sexual side effects, as listed4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Peu fréquents (pouvant affecter jusqu’à 1 personne sur 100) : The same text also says4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? 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) : 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) : 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) : 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 médicaments | Updated 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 : Sexual side effects, as listed4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Les effets secondaires fréquemment rapportés : Sexual side effects, as listed4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Les effets secondaires fréquemment rapportés : Sexual side effects that continue after stopping4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Moins fréquemment, ont été rapportés : Sexual side effects that continue after stopping4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Moins fréquemment, ont été rapportés : Sexual side effects that continue after stopping4. QUELS SONT LES EFFETS INDESIRABLES EVENTUELS ? · Moins fréquemment, ont été rapportés : 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 médicaments | Updated 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: ANSM | PublishedChecked |
| 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 secondaires 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 secondaires | 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: ANSM | PublishedChecked |
| FranceDocument from the regulatorFinasteride: the page about it | Sexual side effects that continue after stoppingRappel sur les troubles sexuels | 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: ANSM | PublishedChecked |
| FranceDocument from the regulatorFinasteride: the page about it | Sexual side effects that continue after stoppingTroubles sexuels | Document from the regulator Finastéride : rappel sur les risques de troubles psychiatriques et de la fonction sexuelleRead on the regulator's site: ANSM | PublishedChecked |
| FranceCompany letter to health professionals, on the regulator's siteFinasteride: the page about it | Sexual side effects that continue after stoppingRésumé · TROUBLES SEXUELS 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: ANSM | PublishedChecked |
| 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 SEXUALITE | Document from the regulator FINASTERIDE 1 mg (Propecia® et génériques) Pour la chute des cheveux : information pour les patientsRead on the regulator's site: ANSM | PublishedChecked |
| FranceDocument from the regulatorFinasteride: the page about it | What the regulator saidActualisation du 24/05/2023 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: ANSM | PublishedChecked |
| 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 dutastéride | Document from the regulator Réévaluation européenne de la balance bénéfice/risque des médicaments contenant du finastéride ou du dutastérideRead on the regulator's site: ANSM | PublishedChecked |
| FranceDocument from the regulatorFinasteride: the page about it | Sexual side effects that continue after stoppingPosition ANSM | Document from the regulator Retour d’information sur le PRAC de mai 2025 (5 – 8 mai)Read on the regulator's site: ANSM | PublishedChecked |
| FranceDocument from the regulatorFinasteride: the page about it | Sexual side effects that continue after stoppingFinastéride et risque d’idées suicidaires : nouvelles mesures | Document from the regulator Finastéride et risque d’idées suicidaires : nouvelles mesuresRead on the regulator's site: ANSM | PublishedChecked |
| 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 dispensation 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: ANSM | PublishedChecked |
| 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 mg 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: ANSM | PublishedChecked |
| FranceDocument from the regulatorFinasteride: the page about it | Sexual side effects that continue after stoppingTroubles sexuels | 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: ANSM | PublishedChecked |
| ItalyText for professionals · PropeciaFinasteride: the page about it | Sexual side effects, as listed4.8 Effetti indesiderati · Disturbi psichiatrici: · Non comune* Sexual side effects, as listed4.8 Effetti indesiderati · Patologie dell’apparato riproduttivo e della mammella: · Non comune* The same text also says4.8 Effetti indesiderati Sexual side effects that continue after stopping4.8 Effetti indesiderati Sexual side effects, as listed4.8 Effetti indesiderati 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 Farmaci | Made available by the regulatorChecked |
| ItalyText for professionals · ProscarFinasteride: the page about it | Sexual side effects, as listed4.8 Effetti indesiderati Sexual side effects, as listed4.8 Effetti indesiderati · Disturbi psichiatrici · Comune Sexual side effects, as listed4.8 Effetti indesiderati · Disturbi psichiatrici · Non nota Sexual side effects that continue after stopping4.8 Effetti indesiderati · nota (*) Sexual side effects, as listed4.8 Effetti indesiderati · Patologie dell’apparato riproduttivo e della mammella · Comune Sexual side effects, as listed4.8 Effetti indesiderati · Patologie dell’apparato riproduttivo e della mammella · Non comune Sexual side effects that continue after stopping4.8 Effetti indesiderati · Patologie dell’apparato riproduttivo e della mammella · Non nota The same text also says4.8 Effetti indesiderati Sexual side effects, as listed4.8 Effetti indesiderati · Esami diagnostici · Comune Sexual side effects, as listed4.8 Effetti indesiderati · Medical Therapy Of Prostatic Symptoms (MTOPS) 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 Farmaci | Made 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): Sexual side effects, as listed4. Possibili effetti indesiderati · Non comune: (può interessare fino a 1 persona su 100): Sexual side effects, as listed4. Possibili effetti indesiderati · Non comune: (può interessare fino a 1 persona su 100): The same text also says4. Possibili effetti indesiderati Sexual side effects that continue after stopping4. Possibili effetti indesiderati · Non nota: la frequenza non può essere definita sulla base dei dati disponibili Sexual side effects that continue after stopping4. Possibili effetti indesiderati · Non nota: la frequenza non può essere definita sulla base dei dati disponibili Sexual side effects that continue after stopping4. Possibili effetti indesiderati · Non nota: la frequenza non può essere definita sulla base dei dati disponibili 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 Farmaci | Made available by the regulatorChecked |
| ItalyPatient leaflet · ProscarFinasteride: the page about it | Sexual side effects, as listed4. Possibili effetti indesiderati Sexual side effects, as listed4. Possibili effetti indesiderati · Effetti indesiderati comuni (possono interessare fino a 1 persona su 10) Sexual side effects, as listed4. Possibili effetti indesiderati · Effetti indesiderati comuni (possono interessare fino a 1 persona su 10) Sexual side effects, as listed4. Possibili effetti indesiderati · Effetti indesiderati comuni (possono interessare fino a 1 persona su 10) Sexual side effects, as listed4. Possibili effetti indesiderati · Effetti indesiderati non comuni (possono interessare fino a 1 persona su 100) 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) 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) 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) 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 Farmaci | Made available by the regulatorChecked |
| ItalyCompany letter to health professionals, on the regulator's siteFinasteride: the page about it | Sexual side effects that continue after stoppingRiassunto 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: AIFA | PublishedChecked |
| ItalyDocument from the regulatorFinasteride: the page about it | Sexual side effects that continue after stoppingSintesi Sexual side effects that continue after stoppingSintesi The same text also saysSintesi | Document from the regulator Comunicazione di sicurezza: FINASTERIDE 1 mg e possibili disturbi sessuali e psichiatriciRead on the regulator's site: AIFA | PublishedChecked |
| 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 dutasteride 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: AIFA | PublishedChecked |
| 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) 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: AIFA | PublishedChecked |
| SpainText for professionals · PropeciaFinasteride: the page about it | Sexual side effects, as listed4.8. Reacciones adversas · Trastornos psiquiátricos: · Poco frecuentes* Sexual side effects, as listed4.8. Reacciones adversas · Trastornos del aparato reproductor y de la mama: · Poco frecuentes* The same text also says4.8 Reacciones adversas Sexual side effects that continue after stopping4.8. Reacciones adversas Sexual side effects, as listed4.8. Reacciones adversas 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: CIMA | Text revisedChecked |
| SpainText for professionals · ProscarFinasteride: the page about it | Sexual side effects, as listed4.8. Reacciones adversas Sexual side effects, as listed4.8. Reacciones adversas · Trastornos psiquiátricos · Frecuente Sexual side effects that continue after stopping4.8. Reacciones adversas · Trastornos psiquiátricos · Frecuencia no conocida Sexual side effects, as listed4.8. Reacciones adversas · Trastornos del aparato reproductor y de la mama · Frecuente Sexual side effects, as listed4.8. Reacciones adversas · Trastornos del aparato reproductor y de la mama · Poco frecuente Sexual side effects that continue after stopping4.8. Reacciones adversas · Trastornos del aparato reproductor y de la mama · Frecuencia no conocida The same text also says4.8. Reacciones adversas Sexual side effects, as listed4.8. Reacciones adversas · Exploraciones complementarias · Frecuente Sexual side effects, as listed4.8. Reacciones adversas · Tratamiento médico de los síntomas prostáticos (MTOPS) 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: CIMA | Text revisedChecked |
| SpainPatient leaflet · PropeciaFinasteride: the page about it | Sexual side effects, as listed4. Posibles efectos adversos · Poco frecuentes: pueden afectar hasta 1 de 100 personas Sexual side effects, as listed4. Posibles efectos adversos · Poco frecuentes: pueden afectar hasta 1 de 100 personas Sexual side effects, as listed4. Posibles efectos adversos · Poco frecuentes: pueden afectar hasta 1 de 100 personas The same text also says4. Posibles efectos adversos Sexual side effects that continue after stopping4. Posibles efectos adversos · Frecuencia no conocida: la frecuencia no puede estimarse a partir de los datos disponibles Sexual side effects that continue after stopping4. Posibles efectos adversos · Frecuencia no conocida: la frecuencia no puede estimarse a partir de los datos disponibles Sexual side effects that continue after stopping4. Posibles efectos adversos · Frecuencia no conocida: la frecuencia no puede estimarse a partir de los datos disponibles 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: CIMA | Text 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) Sexual side effects that continue after stopping4. Posibles efectos adversos · Frecuencia no conocida (no puede estimarse a partir de los datos disponibles) Sexual side effects, as listed4. Posibles efectos adversos · Frecuentes (pueden afectar hasta 1 de cada 10 pacientes) Sexual side effects, as listed4. Posibles efectos adversos · Poco frecuentes (pueden afectar hasta 1 de cada 100 pacientes) Sexual side effects that continue after stopping4. Posibles efectos adversos · Frecuencia no conocida (no puede estimarse a partir de los datos disponibles) Sexual side effects, as listed4. Posibles efectos adversos · Frecuentes (pueden afectar hasta 1 de cada 10 pacientes) The same text also says4. Posibles efectos adversos 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: CIMA | Text 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: CIMA | PublishedChecked |
| 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 finasterida 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: AEMPS | PublishedChecked |
| 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): 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): The same text also says8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? 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: 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: 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: 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 EMS | Text 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): 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): The same text also says8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? 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: 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: 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: 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/A | Text 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: Sexual side effects, as listed8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Outros efeitos colaterais podem incluir: Sexual side effects, as listed8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Outros efeitos colaterais podem incluir: The same text also says8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? Sexual side effects that continue after stopping8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Outros efeitos colaterais relatados em alguns homens são: Sexual side effects that continue after stopping8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Outros efeitos colaterais relatados em alguns homens são: Sexual side effects that continue after stopping8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Outros efeitos colaterais relatados em alguns homens são: 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 EMS | Text 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: Sexual side effects, as listed8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Outros efeitos colaterais podem incluir: Sexual side effects, as listed8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Outros efeitos colaterais podem incluir: The same text also says8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? Sexual side effects that continue after stopping8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Outros efeitos colaterais relatados em alguns homens são: Sexual side effects that continue after stopping8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Outros efeitos colaterais relatados em alguns homens são: Sexual side effects that continue after stopping8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Outros efeitos colaterais relatados em alguns homens são: 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/A | Text 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: The same text also saysUndesirable Effects · Postmarketing Experience 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 Experience The same text also saysUndesirable Effects · Postmarketing Experience Sexual side effects that continue after stoppingUndesirable Effects · Postmarketing Experience 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).
| Country or region | What the text says | Document | Dates |
|---|---|---|---|
| United KingdomText for professionals · RoaccutaneIsotretinoin: the page about it | Sexual side effects that continue after stopping4.4 Special warnings and precautions for use · Sexual disorders A general sentence about side effects that may continue. It does not name sexual function.4.8 Undesirable effects · Summary of safety profile 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* 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: emc | Text 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 patients Sexual side effects that continue after stopping2. What you need to know before you take Roaccutane · Warnings and precautions · Advice for all patients A general sentence about side effects that may continue. It does not name sexual function.4. Possible side effects 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: emc | Text revisedChecked |
| United KingdomDocument from the regulatorIsotretinoin: the page about it | Sexual side effects that continue after stoppingRecommendations from the review The same text also saysRecommendations from the review 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.UK | PublishedChecked |
| United KingdomDocument from the regulatorIsotretinoin: the page about it | What the regulator saidIsotretinoin treatment and new safety measures 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.UK | PublishedChecked |
| United KingdomDocument from the regulatorIsotretinoin: the page about it | Sexual side effects that continue after stopping8.2.1. Changes to product information | Document from the regulator REPORT OF THE COMMISSION ON HUMAN MEDICINES ISOTRETINOIN EXPERT WORKING GROUPRead on the regulator's site: GOV.UK | PublishedChecked |
| United KingdomDocument from the regulatorIsotretinoin: the page about it | Sexual side effects, as listedSexual dysfunction 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.UK | PublishedChecked |
| 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 4.8 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) 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 Agency | AdoptedChecked |
| 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 Agency | PublishedChecked |
| 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 Agency | AdoptedChecked |
| United StatesText for professionals · Absorica and Absorica LDIsotretinoin: the page about it | Sexual side effects that continue after stopping6 ADVERSE REACTIONS · Reproductive System The same text also says6 ADVERSE REACTIONS 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: DailyMed | Text revisedChecked |
| United StatesText for professionals · ClaravisIsotretinoin: the page about it | Sexual side effects that continue after stopping6 ADVERSE REACTIONS · Reproductive System The same text also says6 ADVERSE REACTIONS 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: DailyMed | Text revisedChecked |
| United StatesText for professionals · AmnesteemIsotretinoin: the page about it | Sexual side effects that continue after stopping6 ADVERSE REACTIONS · Reproductive System The same text also says6 ADVERSE REACTIONS 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: DailyMed | Text revisedChecked |
| United StatesText for professionals · ZenataneIsotretinoin: the page about it | Sexual side effects that continue after stopping6 ADVERSE REACTIONS · Reproductive System The same text also says6 ADVERSE REACTIONS 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: DailyMed | Text 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: DailyMed | Text 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: DailyMed | Text 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: DailyMed | Text 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: DailyMed | Text 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: DailyMed | Text 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: DailyMed | Text 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 System | 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 APPROVAL 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@FDA | Text 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-4088-0040 | Tried |
| United StatesDocument from the regulatorIsotretinoin: the page about it | What the regulator saidFDA Requests Labeling Updates for Generic Isotretinoin Products 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 bulletins | PublishedChecked |
| 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 Effects Sexual side effects that continue after stopping7 WARNINGS AND PRECAUTIONS · Reproductive Health: Female and Male Potential · Function · Risk of Sexual Side Effects Sexual side effects, as listed8 ADVERSE REACTIONS · 8.2 Clinical Trial Adverse Reactions Sexual side effects, as listed8 ADVERSE REACTIONS · 8.5 Post-Market Adverse Reactions | 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 Database | Text 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 Effects | 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 Database | Text 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 Effects | 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 Database | Text 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 · Function | 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 Database | Text revisedChecked |
| CanadaPatient leaflet · AccutaneIsotretinoin: the page about it | Sexual side effects, as listedOther warnings you should know about · Sexual Dysfunction Sexual side effects that continue after stoppingOther warnings you should know about · Sexual Dysfunction | 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 Database | Text revisedChecked |
| CanadaPatient leaflet · EpurisIsotretinoin: the page about it | Sexual side effects that continue after stoppingOther warnings you should know about · Sexual Dysfunction: Sexual side effects that continue after stoppingPossible side effects from using EPURIS®: | 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 Database | Text approvedChecked |
| CanadaPatient leaflet · ClarusIsotretinoin: the page about it | Sexual side effects that continue after stoppingOther warnings you should know about · Sexual Dysfunction | 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 Database | Text revisedChecked |
| CanadaPatient leaflet · Absorica LDIsotretinoin: the page about it | Sexual side effects that continue after stoppingOther warnings you should know about · Sexual Dysfunction: Sexual side effects that continue after stoppingWhat are possible side effects from using Absorica LD? | 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 Database | Text revisedChecked |
| CanadaDocument from the regulatorIsotretinoin: the page about it | Sexual side effects that continue after stoppingSafety Review Findings The same text also saysSafety Review Findings What the regulator saidConclusions and Actions | 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 Portal | The text prints no dateChecked |
| CanadaDocument from the regulatorIsotretinoin: the page about it | What the regulator saidConclusions and actions 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 Portal | PublishedChecked |
| CanadaDocument from the regulatorIsotretinoin: the page about it | Sexual side effects that continue after stoppingMONTHLY RECAP OF HEALTH PRODUCT SAFETY INFORMATION · Isotretinoin | Document from the regulator Health Product InfoWatch, July 2024Read on the regulator's site: Government of Canada Publications | PublishedChecked |
| 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 eBS | Text 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 eBS | Text 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-roaccutane | Tried |
| New ZealandText for professionals · OrataneIsotretinoin: the page about it | Sexual side effects that continue after stopping4.4. Special warnings and precautions for use · Sexual disorders The same text also says4.4. Special warnings and precautions for use · Sexual disorders Sexual side effects, as listed4.8. Undesirable effects · Reproductive system and breast 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: Medsafe | Text 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: The same text also saysSide effects 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: Medsafe | Text 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, 4.4 | Document from the regulator Recent data sheet updates: Important new safety informationRead on the regulator's site: Medsafe | PublishedChecked |
| 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: Medsafe | AdoptedChecked |
| 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 Sicherheitsprofils 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 bekannt 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 GmbH | Text 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? Sexual side effects, as listed4. Welche Nebenwirkungen sind möglich? · Andere Nebenwirkungen · Nicht bekannt (Häufigkeit auf Grundlage der verfügbaren Daten nicht abschätzbar) 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 GmbH | Text revisedChecked |
| GermanyDocument from the regulatorIsotretinoin: the page about it | Sexual side effects, as listedAnlage 3 · ANHANG II · ZUSAMMENFASSUNG DER MERKMALE DES ARZNEIMITTELS • Abschnitt 4.8 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: BfArM | PublishedChecked |
| 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 tolérance Sexual side effects, as listed4.8. Effets indésirables · Liste tabulée des effets indésirables · Affections des organes de reproduction et du sein · Indéterminée 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 médicaments | Updated 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 indéterminée 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 médicaments | Updated 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 orale 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: ANSM | Text 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 sicurezza 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 nota 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 Farmaci | Text 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 indesiderati Sexual side effects, as listed4. Possibili effetti indesiderati · Altri effetti indesiderati: · Non noti (non possono essere definiti sulla base dei dati disponibili). 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 Farmaci | Text 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 seguridad 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 conocida 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: CIMA | Text 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) 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: CIMA | Text 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 · Isotretinoína 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: AEMPS | PublishedChecked |
| 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? Sexual side effects, as listed8. QUAIS MALES ESTE MEDICAMENTO PODE ME CAUSAR? · Reações sem frequência estabelecida: The same text also says8. QUAIS MALES ESTE MEDICAMENTO PODE ME CAUSAR? 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/A | Text 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 Relationship Sexual side effects, as listedCLINICAL PARTICULARS · Undesirable Effects · Clinical Trials and Postmarketing Surveillance The same text also saysCLINICAL PARTICULARS · Undesirable Effects · Clinical Trials and Postmarketing Surveillance 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: CDSCO | PublishedChecked |
| 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 profile 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* 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 effects Sexual side effects, as listed4. Possible side effects · Unknown frequency: (frequency cannot be estimated from the available data) 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 stoppingSummary Sexual side effects, as listedFurther information on the safety concerns and recommendations · Sexual disorders Sexual side effects that continue after stoppingFurther information on the safety concerns and recommendations · Sexual disorders 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 dysfunction Sexual side effects that continue after stoppingBackground of the Safety Issue · Sexual dysfunction The same text also saysBackground of the Safety Issue Sexual side effects that continue after stoppingAdvice for Health Care Providers 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 Profile 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 Search | Text revisedChecked |
| MalaysiaPatient leaflet · ROACCUTANEIsotretinoin: the page about it | A general sentence about side effects that may continue. It does not name sexual function.Side effects 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 Search | Text 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 |