FAERS finasteride reports: what they show

Creator: Morten Skov
Published: 2026-10-28T00:00:00+00:00
Keywords: PFS Support, Patient Support

US FDA reports for finasteride describe sexual problems, depression and suicidal thoughts, some lasting after stopping, as in PFS. What they can't show.

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By Morten SkovPublished 28 October 2026

Poster: FAERS finasteride reports: what they show. Below: some describe lasting sexual problems, but reports can't show how often. Source: FDA; 2015 study of finasteride reports (Ali et al.).

FAERS is the database where the FDA, the US medicines regulator, keeps reports of side effects. It holds thousands of reports about finasteride: sexual problems, depression and suicidal thoughts, sometimes lasting after stopping, as in post-finasteride syndrome (PFS). The reports show a pattern. They can’t show how often these problems happen.

PFS is more than sexual problems. The checklist doctors and researchers proposed in 2022 says it can also bring problems with concentration and memory, depression and suicidal thoughts, with or without the sexual problems. If you’re struggling, the Samaritans are free to call on 116 123, day or night.

FAERS numbers turn up in news stories and in arguments about whether PFS is real. Before you trust or dismiss one, look at who sends reports and what they can prove.

The story in 3 lines

In a 2015 study of FDA reports about young men on the 1 mg hair-loss dose, about 1 in 8 of those reports described lasting sexual problems (Ali and colleagues).
Reports rose sharply around 2012, when the US leaflet added erection problems that continued after stopping (FDA).
The FDA says reports can't be used to estimate how often a side effect happens (FDA). Patients call the lasting condition PFS.

Press: contact@sidefxhub.com

A 2025 study looked at 20 years of reports. More than half of the finasteride ones came from the public.

When the FDA read reports about finasteride lotions that pharmacies mix for the scalp, some patients said they’d been told there was no risk “because the product was topical”, meaning it went on the skin. Some “wished they had been informed”, the FDA wrote.

Gary used one of those scalp lotions. Before he started, he asked: “Are there any side effects?” The answer, he says, was “Not topical.”

An extract from Gary's interview with Moral Medicine, May 2023, in English. It plays from 3:27 to 4:00. The views are his own. He doesn't say whether he reported to the FDA.

What do FAERS reports say about finasteride?

Sexual problems top the list: lower sex drive, and erection and ejaculation problems. The reports also describe depression, anxiety, trouble concentrating and suicidal thoughts, a 2025 study of the database found.

Some reports say the problems lasted. In a 2015 study, researchers looked at reports about men aged 18 to 45 taking the 1 mg dose for hair loss. About 1 in 8 of those reports described lasting sexual problems. Most of the men who reported suicidal thoughts also reported sexual problems.

That study and a 2017 study also compared finasteride with every other medicine in the database. A far bigger share of finasteride’s reports were about sexual problems. Researchers call that a signal: a reason to look harder at the medicine. On its own, it doesn’t prove the medicine caused them.

In 2022 the FDA told the maker of Propecia (finasteride 1 mg) to add the risk of suicidal thoughts and behaviour to the US label, the official information for doctors and patients. Our page on finasteride and suicidal thoughts covers the warnings.

Why did finasteride reports rise after 2011?

They rose sharply around the time the US label changed, a 2018 study and a 2021 study found. In April 2012 the FDA approved a new line for Propecia’s US label, warning of “erectile dysfunction that continued after discontinuation of treatment”. The same year, the Post-Finasteride Syndrome Foundation began raising awareness of PFS.

FDA reports naming finasteride as the main suspect, by year

2009172

2010216

2011399

2012: label change624

2013652

2014978

Reports about any side effect, at any dose. They count reports, not people, and can't show how often anything happens. The chart stops at 2014; in later years the count rose and fell. Source: Zhong and colleagues, 2025, table 1.

Reports of suicidal thoughts followed a similar path. One team found no signal in reports from 2006 to 2011, then signals from 2013 on.

Researchers read the rise in two ways. One team says it could reflect the nocebo effect: expecting a side effect can bring it on. Our page on the nocebo effect has more.

A second team says awareness may have made more people write in. It adds that, by some estimates, most side effects are never reported. So the true number could be higher.

Either way, a rise in reports shows more people wrote in. It can’t show whether more people were harmed.

Can FAERS tell me how common PFS is?

No. The FDA says the reports “cannot be used to estimate the incidence” of side effects: how often they happen. Propecia’s US label says its reports come “from a population of uncertain size”. Nobody knows how many people took the medicine and never wrote in.

Reports from the public cut both ways. People may report symptoms they’d never tell a doctor, but nobody has checked them medically. The FDA says a report doesn’t prove the medicine caused the problem. The condition being treated, or another medicine, could be to blame.

Nobody has measured how often PFS happens. The UK leaflet puts the lasting problems under “Frequency unknown”. Unknown isn’t the same as rare.

Before you quote a FAERS number

Say "reports", never "cases" or "men affected".
Give the years and the study: "reports to the FDA, 2004 to early 2024, in a 2025 study".
Watch the word "persisted". In that study, "persisted beyond one year of treatment" means side effects that began after a year of use.
Never turn a count into a rate, or compare medicines by counts.
Add the FDA's caution: a report "does not establish causation".

What can I do if my symptoms have lasted?

Finasteride helps many people with hair loss. If you have side effects, what to do is a decision for you and your prescriber. If your mood drops, the UK leaflet says to stop taking it and contact your doctor as soon as possible.

If your symptoms have lasted after stopping, you can report them. In the US, use MedWatch, the FDA’s scheme: our step-by-step guide shows each box. In the UK, use the Yellow Card scheme. Our PFS page explains what’s known.

The FDA’s 80-second film shows what to put in a report.

The FDA's film for consumers, January 2022, 80 seconds, in English. It covers every medicine, not finasteride in particular.

Report it: it helps everyone

A doctor’s note helps you. A report to the medicines regulator helps everyone else: it is how patterns get noticed.

No proof needed. A suspicion is enough, even years after stopping.
Where: the Yellow Card scheme in the UK, MedWatch in the US.
Use the right words. If symptoms continued after stopping, write Post 5-alpha-reductase inhibitor syndrome (MedDRA 10082430).

Our reporting guide walks you through it

What else do people ask?

Are UK reports in FAERS? Some are. In that 2025 study, the UK was the second-largest source of finasteride reports, after the US. If you’re in the UK, your own report goes to the MHRA, the UK medicines regulator, through the Yellow Card scheme.

Is FAERS the same as AEMS? Yes. The FDA’s public dashboard, where anyone can search them, is now called AEMS (Adverse Event Monitoring System). The page adds: “Formerly FDA Adverse Event Reporting System (FAERS)”. Older studies say FAERS.

Are there FAERS reports for topical finasteride? Yes. The FDA’s 2025 alert says most of its reports about pharmacy-mixed scalp lotions described problems that “continued to persist” after stopping. A 2026 study found signals for topical too, though fewer than for tablets. Our page on topical finasteride has more.

Gary asked about side effects and was told “Not topical”. If your symptoms have lasted, report them in your own words, and name the condition.

Sources

Ali AK, Heran BS, Etminan M. Persistent sexual dysfunction and suicidal ideation in young men treated with low-dose finasteride: a pharmacovigilance study. Pharmacotherapy 2015;35(7):687-95. Read as an abstract only. FAERS reports for low-dose finasteride in men aged 18 to 45, 1998 to 2013: of 4,910 reports, 577 of persistent sexual dysfunction (11.8%) and 39 of suicidal ideation; 34 of the 39 also had sexual dysfunction. “The majority of these events were serious.” Sexual dysfunction was reported “more than expected” compared with all other drugs in the database; suicidal ideation “did not reach signal threshold”. The abstract does not say whether “persistent” means after stopping.
Gupta AK, Carviel J, MacLeod MA, Shear N. Assessing finasteride-associated sexual dysfunction using the FAERS database. J Eur Acad Dermatol Venereol 2017;31(6):1069-1075. Read as an abstract only. “A significant disproportionality in reporting of sexual dysfunction with the use of finasteride was observed”, for hair loss, prostate enlargement or any indication, compared with all other drugs in FAERS. A measure of reporting, not of how often it happens.
Zhong X, Yang Y, Wei S, Liu Y. Multidimensional assessment of adverse events of finasteride: a real-world pharmacovigilance analysis based on FDA Adverse Event Reporting System (FAERS) from 2004 to April 2024. PLoS One 2025;20(3):e0309849. Reports with finasteride as the primary suspected drug, first quarter of 2004 to first quarter of 2024. Table 1: reports by year (2009: 172; 2010: 216; 2011: 399; 2012: 624; 2013: 652; 2014: 978); reporters: consumers 53.67%, physicians 20.73%; United States 46.68% of reports, United Kingdom 16.19% (second); no country for 27.44%. Common reactions across ages include erectile dysfunction, decreased libido, depression, suicidal ideation and “disturbance in attention”. Its line that events “persisted beyond one year of treatment” is about when they began, not about lasting after stopping.
Baas WR, Butcher MJ, Lwin A and colleagues. A review of the FAERS data on 5-alpha reductase inhibitors: implications for postfinasteride syndrome. Urology 2018;120:143-149. Abstract: reports from April 2011 to October 2014; “Possibly related to labeling changes, from 2011 to 2014, there was a significant increase” in reports involving the 1 mg dose.
Harrell MB, Ho K, Te AE and colleagues. An evaluation of the federal adverse events reporting system data on adverse effects of 5-alpha reductase inhibitors. World J Urol 2021;39(4):1233-1239. Abstract: “Case report submissions rose dramatically following FDA-mandated finasteride label change”; “The causality and the rate of AEs are not certain based on the FAERS data.”
US Food and Drug Administration, supplement approval letter, NDA 020788/S-020, S-021, S-023, Propecia, signed 11 April 2012. S-021 adds “erectile dysfunction that continued after discontinuation of treatment” to the postmarketing section and the patient labelling.
Gupta AK, Bamimore MA, Williams G, Talukder M. Finasteride use: evaluation of depression and suicide risk. J Cosmet Dermatol 2025;24(3):e70102. No signal for five suicide-related terms in 2006 to 2011; signals for some in 2013 to 2018 and 2019 to 2023 (2012 left out). “This increase may be linked to heightened awareness of AEs following the recognition of so-called PFS in 2012.” Awareness of PFS “formally” began in 2012 with the Post Finasteride Syndrome Foundation, the paper says.
Gupta AK, Talukder M, Williams G, Bamimore MA. Oral finasteride use and sexual adverse events: signal detection from disproportionality analyses of data from the United States Food and Drug Administration Adverse Event Reporting System. J Dermatolog Treat 2026;37(1):2611703. Read as an abstract only: more reporting from 2012, which “could be attributed to the nocebo effect”.
Thaibah HA, Banji OJF, Banji D, Almansour HA, Alshammari TM. Suicidality risks associated with finasteride, a 5-alpha reductase inhibitor: an evaluation of real-world data from the FDA adverse event reports. Pharmaceuticals 2025;18(7):957. Awareness “may have stimulated reporting”; “Underreporting is a limitation of the spontaneous reporting systems, with studies estimating that as few as 1-10% of actual adverse drug events are reported. This implies that the true incidence … could be higher than documented.” FAERS “receives adverse event reports from around the world”.
US Food and Drug Administration, supplement approval letter, NDA 020788/S-030, Propecia, signed 1 August 2022. Refers to the FDA’s letter of 31 May 2022 on “new safety information” for the label: “the risk of suicidal ideation and behavior, additional risk of sexual dysfunction and psychoneurocognitive adverse events”.
Propecia (finasteride 1 mg), US prescribing information and Patient Information, Organon, DailyMed, opened 28 October 2026. Section 6.2: reactions “reported voluntarily from a population of uncertain size”. So it is “not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure”. It lists “depression, suicidal ideation and behavior” and “sexual dysfunction that continued after discontinuation of treatment”.
US Food and Drug Administration, FDA Adverse Event Monitoring System (AEMS) Public Dashboard, “Formerly FDA Adverse Event Reporting System (FAERS)”, content current as of 11 March 2026. “Information in reports has not been verified”. “Existence of a report does not establish causation.” The event “may have been related to the underlying disease being treated, or caused by some other drug”. “The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.”
US Food and Drug Administration, FDA alerts health care providers, compounders and consumers of potential risks associated with compounded topical finasteride products, content current as of 22 April 2025. 32 cases reported to FAERS, 2019 to 2024. “Most of the reports FDA has received state the adverse events continued to persist after product discontinuation.” Some patients “were told by the prescribers that there was no risk of any adverse event because the product was topical”. Also: “consumers said they wished they had been informed about the possible side effects.”
Gupta AK, Talukder M, Keene SA, Bamimore MA. Is the safety of finasteride correlated with its route of administration: topical versus oral? Int J Dermatol 2026;65(1):108-118. “Signals for PFS-like AEs were detected with topical finasteride, but were less frequent than with oral finasteride.”
Healy D, Bahrick A, Bak M and colleagues. Diagnostic criteria for enduring sexual dysfunction after treatment with antidepressants, finasteride and isotretinoin. Int J Risk Saf Med 2022;33(1):65-76. Proposed criteria from expert agreement. Section 5: “cognitive impairment”, “depression” and “suicidality” “can occur independently of any sexual difficulties but may also accompany sexual problems”.
Organon Pharma (UK). Propecia 1 mg patient information leaflet, electronic Medicines Compendium, revised May 2026, opened 28 October 2026. Section 2: “stop taking Propecia and contact your doctor for further medical advice as soon as possible”. Also: “Impaired sexual function that may contribute to mood alterations, including suicidal thoughts, has been reported in some patients.” Section 4, “Frequency unknown”: persistent erection, sex drive and ejaculation problems “after discontinuation of treatment”.
Moral Medicine, Post Finasteride Syndrome - Gary’s Experience with Topical Finasteride, 17 May 2023 (the title is the channel’s). Extract 3:27 to 4:00; “Are there any side effects?” and “Not topical” (3:34 to 3:47), from the YouTube captions as checked for our FDA reporting guide.
US Food and Drug Administration, MedWatch Minute for Consumers, 20 January 2022, 80 seconds.

Sources checked on 28 October 2026. AI-assisted writing and review, not clinical review.

This information does not replace medical advice. Talk to your doctor before you make any decision about your treatment.

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Finasteride: what the official texts say, country by country

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.

This is a record of what each text says and of the date it prints. A text is quoted in its own words, or summarised where the row says so. It is not a comparison of countries. All medicines and countries

Finasteride: the official texts, country by country (85 texts read)

Finasteride: what each text says about sexual side effects, and about side effects that continue after stopping.
Country or region	What the text says	Document	Dates
United Kingdom	Sexual side effects, as listed4.8 Undesirable effects · Psychiatric disorders: · Uncommon:Decreased libido. Sexual side effects, as listed4.8 Undesirable effects · Reproductive system and breast disorders: · Uncommon:Erectile dysfunction, ejaculation disorder (including decreased volume of ejaculate). Sexual side effects that continue after stopping4.8 Undesirable effectsIn addition, the following have been reported in post-marketing use: persistence of sexual dysfunction (decreased libido, erectile dysfunction and ejaculation disorder) after discontinuation of treatment with 'Propecia'; male breast cancer (see 4.4 Special warnings and precautions for use). The same text also says4.8 Undesirable effectsThe frequency of adverse reactions reported during post-marketing use cannot be determined as they are derived from spontaneous reports. Sexual side effects, as listed4.8 Undesirable effectsIn these studies, the following drug-related adverse experiences were reported in ≥1% of men treated with 'Propecia': decreased libido ('Propecia', 1.8% vs. placebo, 1.3%) and erectile dysfunction (1.3%, 0.7%). In addition, decreased volume of ejaculate was reported in 0.8% of men treated with 'Propecia' and 0.4% of men treated with placebo. Resolution of these side effects occurred in men who discontinued therapy with 'Propecia' and in many who continued therapy. The effect of 'Propecia' on ejaculate volume was measured in a separate study and was not different from that seen with placebo. Sexual side effects, as listed4.8 Undesirable effectsDrug-related sexual undesirable effects were more common in the finasteride 1 mg-treated men than the placebo-treated men, with frequencies during the first 12 months of 3.8% vs 2.1%, respectively. The incidence of these effects decreased to 0.6% in finasteride 1 mg-treated men over the following four years. Approximately 1% of men in each treatment group discontinued due to drug-related sexual adverse experiences in the first 12 months, and the incidence declined thereafter. This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text. Texts for other products in this country do not all say the same. The ones we read are on the full record.	Text for professionals Summary of Product Characteristics (SmPC): Propecia 1 mg Film-Coated TabletsPropecia 1 mg film-coated tablets, Organon Pharma (UK) Limited · Read in a compendium of product information: emcAlso on record: 1 more text for professionals, with such a sentence; 2 patients' leaflets, with such a sentence; 5 related documents, with such a sentence; 5 related documents, with no such sentence	Text revised29 Jun 2026Checked14 Oct 2026
European Union	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 AgencyAlso on record: 2 more related documents, with no such sentence	The text prints no dateChecked14 Oct 2026
United States	Sexual side effects that continue after stopping6 ADVERSE REACTIONS · 6.2 Postmarketing ExperienceReproductive System: sexual dysfunction that continued after discontinuation of treatment, including erectile dysfunction, libido disorders, ejaculation disorders, and orgasm disorders; male infertility and/or poor seminal quality (normalization or improvement of seminal quality has been reported after discontinuation of finasteride); testicular pain; hematospermia. The same text also says6 ADVERSE REACTIONS · 6.2 Postmarketing ExperienceThe following adverse reactions have been identified during post approval use of PROPECIA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: This sentence stands in the list of adverse reactions. The warnings section of this text has no entry on sexual function. Texts for other products in this country do not all say the same. The ones we read are on the full record. This text names sexual side effects in several places that this row does not show. Together those passages are too long to reproduce here. The document link in this row opens the text. That they are not shown says nothing about how common these side effects are. On 14 October 2026 we searched the labels in openFDA, the FDA's open database. A sentence that sexual dysfunction continued after treatment was stopped stood on 151 of the 181 labels in that database that name finasteride, and on each of them among the adverse reactions, in no warnings section. Of the 30 without it, 10 are hair products with labels in the Drug Facts style, 5 are listings of compounded solutions for the skin, 2 have no text on adverse reactions, and 13 are older labels of 5 mg tablets with an earlier list of adverse reactions. A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.	Text for professionals PROPECIA® (finasteride) tablets for oral use: Full Prescribing InformationPropecia tablets 1 mg, Organon LLC · Read in the government's medicines database: DailyMedAlso on record: 1 more text for professionals, with such a sentence; 2 patients' leaflets, with such a sentence; 2 related documents, with such a sentence; 3 related documents, with no such sentence	Text revisedAug 2022Checked14 Oct 2026
Canada	Sexual side effects that continue after stopping8 ADVERSE REACTIONS · 8.5 Post-Market Adverse ReactionsPsychiatric disorders: mood alterations and depression, decreased libido that continued after discontinuation of treatment. Sexual side effects that continue after stopping8 ADVERSE REACTIONS · 8.5 Post-Market Adverse ReactionsReproductive system and breast disorders: sexual dysfunction (erectile dysfunction and ejaculation disorders) that continued after discontinuation of treatment, breast tenderness and enlargement, male breast cancer, testicular pain, hematospermia, male infertility and/or poor seminal quality. The same text also says8 ADVERSE REACTIONS · 8.5 Post-Market Adverse ReactionsBecause these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure. This sentence stands in the list of adverse reactions. The warnings section of this text has no entry on sexual function. Texts for other products in this country do not all say the same. The ones we read are on the full record. This text names sexual side effects in several places that this row does not show. Together those passages are too long to reproduce here. The document link in this row opens the text. That they are not shown says nothing about how common these side effects are. A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.	Text for professionals PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION: PrPROPECIA® finasteride tablets, Film-coated Tablets 1 mg, USPPropecia film-coated tablets 1 mg, Organon Canada Inc. · Read in the regulator's own database: Drug Product DatabaseAlso on record: 1 more text for professionals, with such a sentence; 2 patients' leaflets, with such a sentence; 2 related documents, with no such sentence	Text revised24 Nov 2023Checked14 Oct 2026
Australia	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 eBSAlso on record: 1 more text for professionals, with such a sentence; 2 patients' leaflets, with such a sentence	Text revised2 Sept 2026Checked14 Oct 2026
New Zealand	Sexual side effects, as listed4.8 Undesirable effects · Adverse events identified during clinical trialsIn these studies, the following medicine-related adverse experiences were reported in ≥ 1% of men treated with PROPECIA: • decreased libido (PROPECIA, 1.8% vs. placebo, 1.3%) • erectile dysfunction (1.3%, 0.7%). In addition, decreased volume of ejaculate was reported in 0.8% of men treated with PROPECIA and 0.4% of men treated with placebo. The same text also says4.8 Undesirable effects · Adverse events identified during clinical trialsResolution of these adverse effects occurred in men who discontinued therapy with PROPECIA and in many who continued therapy. In a separate study, the effect of PROPECIA on ejaculate volume was measured and was not different from that seen with placebo. The incidence of each of the above adverse effects decreased to ≤ 0.3% by the fifth year of treatment with PROPECIA. Sexual side effects that continue after stopping4.8 Undesirable effects · Adverse events identified during postmarketing experience · Psychiatric disorders:decreased libido that continued after discontinuation of treatment. Sexual side effects that continue after stopping4.8 Undesirable effects · Adverse events identified during postmarketing experience · Reproductive system and breast disorders:sexual dysfunction (erectile dysfunction and ejaculation disorders) that continued after discontinuation of treatment The same text also says4.8 Undesirable effects · Adverse events identified during postmarketing experienceBecause these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure. This sentence stands in the list of adverse reactions. The warnings section of this text has no entry on sexual function. Texts for other products in this country do not all say the same. The ones we read are on the full record.	Text for professionals New Zealand Data Sheet, PROPECIAPropecia 1 mg film coated tablet, Organon (New Zealand) Limited · Read in the regulator's own database: MedsafeAlso on record: 1 more text for professionals, with such a sentence; patients' leaflet, with such a sentence; related document, with such a sentence	Text revised11 Dec 2023Checked14 Oct 2026
Germany	Sexual side effects, as listed4.8 Nebenwirkungen · Psychiatrische Erkrankungen: · Gelegentlichverminderte LibidoOriginal text: German. Our translation:decreased libido Sexual side effects, as listed4.8 Nebenwirkungen · Erkrankungen der Geschlechtsorgane und der Brustdrüse: · Gelegentlicherektile Dysfunktion, Ejakulationsstörung (einschl. vermindertes Ejakulatvolumen)Original text: German. Our translation:erectile dysfunction, ejaculation disorder (including decreased volume of ejaculate) Sexual side effects that continue after stopping4.8 NebenwirkungenNach Markteinführung wurde zusätzlich über Folgendes berichtet: Persistenz von sexueller Dysfunktion (verminderte Libido, erektile Dysfunktion und Ejakulationsstörungen) nach dem Absetzen von Finasterid; Brustkrebs beim Mann (siehe Abschnitt 4.4 Besondere Warnhinweise und Vorsichtsmaßnahmen für die Anwendung).Original text: German. Our translation:In addition, the following has been reported after marketing: persistence of sexual dysfunction (decreased libido, erectile dysfunction and ejaculation disorders) after finasteride has been stopped; breast cancer in men (see section 4.4 Special warnings and precautions for use). The same text also says4.8 NebenwirkungenDie Häufigkeit der nach Markteinführung berichteten unerwünschten Ereignisse kann nicht bestimmt werden, da es sich um Spontanberichte handelt.Original text: German. Our translation:The frequency of the adverse events reported after marketing cannot be determined, as they come from spontaneous reports. Sexual side effects, as listed4.8 NebenwirkungenMit einer Häufigkeit von 3,8 % bzw. 2,1 % während der ersten 12 Monate waren sexuelle Nebenwirkungen bei den mit Finasterid behandelten Männern häufiger als bei den mit Placebo behandelten Männern. Die Häufigkeit dieser Nebenwirkungen sank bei den mit Finasterid behandelten Männern auf 0,6 % im Laufe der folgenden 4 Jahre. Ca. 1 % der Männer in jeder Behandlungsgruppe beendete die Behandlung aufgrund sexueller Nebenwirkungen während der ersten 12 Monate, danach nahm die Häufigkeit ab.Original text: German. Our translation:With frequencies of 3.8% and 2.1% respectively during the first 12 months, sexual side effects were more common in men treated with finasteride than in men treated with placebo. The frequency of these side effects fell to 0.6% in men treated with finasteride over the following 4 years. About 1% of the men in each treatment group stopped treatment because of sexual side effects during the first 12 months; after that, the frequency decreased. This is the holder's own copy. The regulator's database asks visitors to accept its terms first, which we did not do. This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text. Texts for other products in this country do not all say the same. The ones we read are on the full record.	Text for professionals Fachinformation (Zusammenfassung der Merkmale des Arzneimittels)Propecia® 1 mg Filmtabletten, Organon Healthcare GmbH · Read on the holder's own site: Organon Healthcare GmbHAlso on record: 1 more text for professionals, with such a sentence; 2 patients' leaflets, with such a sentence; patients' leaflet, with no such sentence; 2 related documents, with such a sentence; related document, with no such sentence	Text revisedSept 2025Checked14 Oct 2026
France	Sexual side effects, as listed4.8. Effets indésirables · Affections psychiatriques · Peu fréquentbaisse de la libidoOriginal text: French. Our translation:decreased libido Sexual side effects, as listed4.8. Effets indésirables · Affections des organes de reproduction et du sein · Peu fréquenttroubles de l'érection, troubles de l'éjaculation (y compris diminution du volume de l'éjaculat)Original text: French. Our translation:erection disorders, ejaculation disorders (including decreased volume of ejaculate) Sexual side effects that continue after stopping4.8. Effets indésirablesDe plus, depuis la mise sur le marché, les effets indésirables suivants ont été rapportés : persistance des troubles de la fonction sexuelle (baisse de la libido, troubles de l'érection et de l'éjaculation) après l'arrêt du traitement par finastéride ; cancer du sein chez l'homme (voir rubrique 4.4 « Mises en garde spéciales et précautions d'emploi »).Original text: French. Our translation:In addition, since marketing, the following adverse effects have been reported: persistence of sexual function disorders (decreased libido, erection and ejaculation disorders) after treatment with finasteride has been stopped; breast cancer in men (see section 4.4 “Special warnings and precautions for use”). The same text also says4.8. Effets indésirablesLa fréquence des effets indésirables rapportés depuis la commercialisation ne peut être déterminée dans la mesure où elle découle de cas de pharmacovigilance spontanés.Original text: French. Our translation:The frequency of the adverse effects reported since marketing cannot be determined, as it derives from spontaneous pharmacovigilance cases. Sexual side effects, as listed4.8. Effets indésirablesLes effets indésirables sexuels ont été plus fréquents chez les hommes traités par le finastéride que chez les hommes recevant le placebo, avec des fréquences respectives de 3,8 % vs 2,1 % pendant les 12 premiers mois. L'incidence de ces effets a diminué à 0,6 % chez les hommes traités par le finastéride au cours des quatre années suivantes. Environ 1 % des hommes (dans chaque groupe) ont arrêté le traitement au cours des 12 premiers mois en raison d'effets indésirables sexuels liés au traitement. Cette incidence a diminué par la suite.Original text: French. Our translation:Sexual adverse effects were more frequent in men treated with finasteride than in men receiving placebo, with frequencies of 3.8% and 2.1% respectively during the first 12 months. The incidence of these effects fell to 0.6% in men treated with finasteride over the following four years. About 1% of men (in each group) stopped treatment during the first 12 months because of treatment-related sexual adverse effects. This incidence decreased thereafter. The text itself prints no date of revision. An official list of medicines we read shows the originator product as cancelled, revoked or archived. This is the text of another product, the one named in this row. This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text. Texts for other products in this country do not all say the same. The ones we read are on the full record.	Text for professionals Résumé des Caractéristiques du ProduitFINASTERIDE ARROW LAB 1 mg, comprimé pelliculé, ARROW GENERIQUES · Read in the government's medicines database: Base de données publique des médicamentsAlso on record: 1 more text for professionals, with such a sentence; 2 patients' leaflets, with such a sentence; patients' leaflet, with no such sentence; 9 related documents, with such a sentence; 3 related documents, with no such sentence	Updated by the regulator5 Jan 2026Checked14 Oct 2026
Italy	Sexual side effects, as listed4.8 Effetti indesiderati · Disturbi psichiatrici: · Non comuneDiminuzione della libidoOriginal text: Italian. Our translation:Decreased libido Sexual side effects, as listed4.8 Effetti indesiderati · Patologie dell’apparato riproduttivo e della mammella: · Non comuneDisfunzione erettile, disordini dell’eiaculazione (incluso diminuzione del volume dell’eiaculato)Original text: Italian. Our translation:Erectile dysfunction, ejaculation disorders (including decreased volume of ejaculate) The same text also says4.8 Effetti indesideratiIncidenze presentate quali differenze dal placebo negli studi clinici al 12° mese.Original text: Italian. Our translation:Incidences given as differences from placebo in clinical studies at month 12. Sexual side effects that continue after stopping4.8 Effetti indesideratiInoltre, durante l’uso post-marketing sono stati riportati: disfunzione sessuale persistente (riduzione della libido, disfunzione erettile e disturbi dell’eiaculazione) dopo l’interruzione del trattamento con finasterideOriginal text: Italian. Our translation:In addition, during post-marketing use the following has been reported: persistent sexual dysfunction (reduced libido, erectile dysfunction and ejaculation disorders) after treatment with finasteride was stopped Sexual side effects, as listed4.8 Effetti indesideratiEffetti indesiderati correlati al medicinale inerenti la sfera sessuale sono stati più comuni fra gli uomini trattati con finasteride che fra quelli trattati con placebo con frequenze durante i primi 12 mesi di 3,8 % vs 2,1 %, rispettivamente. L’incidenza di tali effetti è diminuita allo 0,6 % negli uomini trattati con finasteride nel corso dei successivi quattro anni. Circa l’1 % degli uomini in ciascun gruppo di trattamento ha interrotto la terapia a seguito di esperienze avverse della sfera sessuale correlate con il medicinale verificatesi nei primi 12 mesi e l’incidenza è in seguito diminuita.Original text: Italian. Our translation:Drug-related adverse effects affecting the sexual sphere were more common among men treated with finasteride than among those treated with placebo, with frequencies during the first 12 months of 3.8% vs 2.1% respectively. The incidence of these effects fell to 0.6% in men treated with finasteride over the following four years. About 1% of men in each treatment group stopped therapy because of drug-related sexual adverse experiences in the first 12 months, and the incidence decreased thereafter. The text itself prints no date of revision. This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text. Texts for other products in this country do not all say the same. The ones we read are on the full record.	Text for professionals Riassunto delle caratteristiche del prodottoPropecia 1 mg compresse rivestite con film, Organon Italia S.r.l. · Read in the regulator's own database: Banca Dati FarmaciAlso on record: 1 more text for professionals, with such a sentence; 2 patients' leaflets, with such a sentence; 2 related documents, with such a sentence; 2 related documents, with no such sentence	Made available by the regulator25 Feb 2026Checked14 Oct 2026
Spain	Sexual side effects, as listed4.8. Reacciones adversas · Trastornos psiquiátricos: · Poco frecuentesDisminución de la libidoOriginal text: Spanish. Our translation:Decreased libido Sexual side effects, as listed4.8. Reacciones adversas · Trastornos del aparato reproductor y de la mama: · Poco frecuentesDisfunción eréctil, trastorno de la eyaculación (incluida disminución del volumen de eyaculación)Original text: Spanish. Our translation:Erectile dysfunction, ejaculation disorder (including decreased volume of ejaculate) The same text also says4.8 Reacciones adversasLas incidencias se presentan en forma de diferencia respecto al placebo en estudios clínicos a los 12 meses.Original text: Spanish. Our translation:Incidences are given as the difference from placebo in clinical studies at 12 months. Sexual side effects that continue after stopping4.8. Reacciones adversasAdemás, durante su uso después de la comercialización se ha notificado: persistencia de la disfunción sexual (disminución de la libido, disfunción eréctil y trastornos de la eyaculación) después de la interrupción del tratamiento con finasteridaOriginal text: Spanish. Our translation:In addition, during use after marketing the following has been reported: persistence of sexual dysfunction (decreased libido, erectile dysfunction and ejaculation disorders) after treatment with finasteride was stopped Sexual side effects, as listed4.8. Reacciones adversasLas reacciones adversas sexuales relacionadas con el medicamento fueron más frecuentes en los varones tratados con finasterida que en los que recibían un placebo, con frecuencias durante los 12 primeros meses del 3,8 y el 2,1% respectivamente. La incidencia de estos efectos disminuyó al 0,6% en varones tratados con finasterida durante los cuatro años siguientes. Aproximadamente el 1% de los varones en cada grupo de tratamiento interrumpió el tratamiento debido a reacciones adversas sexuales relacionadas con el medicamento en los primeros 12 meses, y después la incidencia disminuyó.Original text: Spanish. Our translation:Drug-related sexual adverse reactions were more frequent in men treated with finasteride than in those receiving placebo, with frequencies during the first 12 months of 3.8% and 2.1% respectively. The incidence of these effects fell to 0.6% in men treated with finasteride over the following four years. About 1% of the men in each treatment group stopped treatment because of drug-related sexual adverse reactions in the first 12 months, and the incidence decreased afterwards. This text also has a warning about changes in mood that names sexual dysfunction as something that may contribute to them. That warning says nothing about sexual side effects continuing after stopping. It is not reproduced here, because this record shows the sexual side effects a text lists and whether it says they continue after stopping. The document link in this row opens the text. Texts for other products in this country do not all say the same. The ones we read are on the full record.	Text for professionals Ficha técnicaPropecia 1 mg comprimidos recubiertos con película, Organon Salud, S.L. · Read in the regulator's own database: CIMAAlso on record: 1 more text for professionals, with such a sentence; 2 patients' leaflets, with such a sentence; patients' leaflet, with no such sentence; related document, with no such sentence	Text revisedNov 2025Checked14 Oct 2026
Brazil	Sexual side effects, as listed8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Reação comum (ocorre entre 1% e 10% dos pacientes que utilizam este medicamento):pode sentir menos desejo de manter relações sexuais e/ou dificuldade na obtenção de uma ereção.Original text: Portuguese. Our translation:you may feel less desire to have sexual relations and/or have difficulty getting an erection. Sexual side effects, as listed8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Reação incomum (ocorre entre 0,1% e 1% dos pacientes que utilizam este medicamento):pode ter uma redução na quantidade de sêmen liberada durante a relação sexual (isto não parece interferir na função sexual normal).Original text: Portuguese. Our translation:you may have a reduction in the amount of semen released during sexual intercourse (this does not appear to interfere with normal sexual function). The same text also says8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR?Nos estudos clínicos, estes efeitos adversos desapareceram em homens que pararam de tomar finasterida e em muitos homens que continuaram o tratamento.Original text: Portuguese. Our translation:In clinical studies, these adverse effects disappeared in men who stopped taking finasteride and in many men who continued treatment. Sexual side effects that continue after stopping8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Frequência desconhecida: durante a comercialização do medicamento, as seguintes reações foram relatadas voluntariamente, não sendo possível estimar o tamanho da população exposta:problemas de ejaculação que continuou após a descontinuação do tratamentoOriginal text: Portuguese. Our translation:problems with ejaculation that continued after treatment was discontinued Sexual side effects that continue after stopping8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Frequência desconhecida: durante a comercialização do medicamento, as seguintes reações foram relatadas voluntariamente, não sendo possível estimar o tamanho da população exposta:diminuição do desejo sexual que continuou após a descontinuação do tratamentoOriginal text: Portuguese. Our translation:decreased sexual desire that continued after treatment was discontinued Sexual side effects that continue after stopping8. QUAIS OS MALES QUE ESTE MEDICAMENTO PODE ME CAUSAR? · Frequência desconhecida: durante a comercialização do medicamento, as seguintes reações foram relatadas voluntariamente, não sendo possível estimar o tamanho da população exposta:dificuldade de ter ereção que continuou após a descontinuação do tratamentoOriginal text: Portuguese. Our translation:difficulty having an erection that continued after treatment was discontinued This is the holder's own copy. The regulator's database refused our requests (it blocks by country; we asked from Denmark). An official list of medicines we read shows the originator product as cancelled, revoked or archived. This is the text of another product, the one named in this row. Texts for other products in this country do not all say the same. The ones we read are on the full record.	Patient leaflet finasterida, EMS S/A, comprimido revestido 1 mg: bula para o pacienteFinasterida 1 mg comprimido revestido, EMS S/A · Read on the holder's own site: Sara – Plataforma Oficial de Bulas Digitais de Medicamentos do Grupo EMSAlso on record: 2 texts for professionals, could not be opened; 3 more patients' leaflets, with such a sentence; 2 more patients' leaflets, could not be opened	Text approved13 Feb 2025Checked14 Oct 2026
India	Sexual side effects that continue after stoppingUndesirable Effects · Postmarketing Experience · Reproductive System:Sexual dysfunction that continued after discontinuation of treatment, including erectile dysfunction, libido disorders, ejaculation disorders, and orgasm disorders; male infertility and/or poor seminal quality (normalization or improvement of seminal quality has been reported after discontinuation of finasteride); testicular pain. The same text also saysUndesirable Effects · Postmarketing ExperienceThe following adverse reactions have been identified during post-approval use of finasteride. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: This is the holder's own copy. This regulator publishes no database of such texts. This sentence stands in the list of adverse reactions. The warnings section of this text has no entry on sexual function. Texts for other products in this country do not all say the same. The ones we read are on the full record. This text names sexual side effects in several places that this row does not show. Together those passages are too long to reproduce here. The document link in this row opens the text. That they are not shown says nothing about how common these side effects are. A table cell or list line is shown whole, as the text prints it. Some of them also name side effects that are not sexual.	Text for professionals FINPECIA TabletsFinpecia tablets (finasteride IP 1 mg, film-coated), Cipla Ltd. · Read on the holder's own site: Cipla (ciplamed.com)Also on record: 1 more text for professionals, with such a sentence	Text revisedOct 2018Checked14 Oct 2026

Brand names

These are the brand names of finasteride we saw in the official lists, compendia and regulators' pages we opened on or after 14 October 2026. A country may have more.

Propecia: United Kingdom, United States, Canada, New Zealand, Germany, Italy, Spain
Proscar: United Kingdom, United States, Canada, Germany, Italy, Spain
Chibro-Proscar: France
Ricit: New Zealand
Prostide: Italy
Genaprost: Italy
Finastid: Italy
Asterid: Italy
Ridestin: Italy
Finestar: Italy
Fendazel: Italy
Stecur: Italy
Sitas: Italy
Finacapil: Italy
Ormicton: Italy
Carefinast: Italy
Finedor: Italy
Terip: Italy
Alocare: Spain
Litace: Spain
Maxpil: Spain
Excalv: Brazil
Finalop: Brazil
Finarid: Brazil
Finastil: Brazil
Prohair: Brazil

What is not known

How often PFS happens is unknown. The UK text for professionals says the frequency of the side effects reported after marketing, among them sexual dysfunction that persisted after treatment was stopped, “cannot be determined”, because they come from spontaneous reports. (source)

Code and reporting

In a report to a medicines regulator, the term is Post 5-alpha-reductase inhibitor syndrome (MedDRA code 10082430). Where to report, country by country

Every row in this table was checked on or after 14 October 2026. To quote this record, name SIDEfxHUB and give this page's address. All medicines and countries · The whole record as a file: JSON · CSV · How these texts are checked

You may reuse this record under CC BY 4.0 if you credit SIDEfxHUB and give this page's address. The licence covers our compilation, not the texts quoted in it, in the original or in our translation, and not the article above.

FAERS finasteride reports: what they show

What do FAERS reports say about finasteride?

Why did finasteride reports rise after 2011?

Can FAERS tell me how common PFS is?

What can I do if my symptoms have lasted?

Report it: it helps everyone

What else do people ask?

Sources

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Read next

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Finasteride: what the official texts say, country by country

Brand names

What is not known

Code and reporting