Finasteride warnings: what the pack now says

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.

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.

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.

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.

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.

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.

Sexual side effects, as listed4.8 Nebenwirkungen · Psychiatrische Erkrankungen: · Gelegentlich*verminderte LibidoOriginal text: German. Our translation:decreased libido

Sexual side effects, as listed4.8 Nebenwirkungen · Erkrankungen der Geschlechtsorgane und der Brustdrüse: · Gelegentlich*erektile Dysfunktion, Ejakulationsstörung (einschl. vermindertes Ejakulatvolumen)Original text: German. Our translation:erectile dysfunction, ejaculation disorder (including decreased volume of ejaculate)

Sexual side effects that continue after stopping4.8 NebenwirkungenNach Markteinführung wurde zusätzlich über Folgendes berichtet: Persistenz von sexueller Dysfunktion (verminderte Libido, erektile Dysfunktion und Ejakulationsstörungen) nach dem Absetzen von Finasterid; Brustkrebs beim Mann (siehe Abschnitt 4.4 Besondere Warnhinweise und Vorsichtsmaßnahmen für die Anwendung).Original text: German. Our translation:In addition, the following has been reported after marketing: persistence of sexual dysfunction (decreased libido, erectile dysfunction and ejaculation disorders) after finasteride has been stopped; breast cancer in men (see section 4.4 Special warnings and precautions for use).

The same text also says4.8 NebenwirkungenDie Häufigkeit der nach Markteinführung berichteten unerwünschten Ereignisse kann nicht bestimmt werden, da es sich um Spontanberichte handelt.Original text: German. Our translation:The frequency of the adverse events reported after marketing cannot be determined, as they come from spontaneous reports.

Sexual side effects, as listed4.8 NebenwirkungenMit einer Häufigkeit von 3,8 % bzw. 2,1 % während der ersten 12 Monate waren sexuelle Nebenwirkungen bei den mit Finasterid behandelten Männern häufiger als bei den mit Placebo behandelten Männern. Die Häufigkeit dieser Nebenwirkungen sank bei den mit Finasterid behandelten Männern auf 0,6 % im Laufe der folgenden 4 Jahre. Ca. 1 % der Männer in jeder Behandlungsgruppe beendete die Behandlung aufgrund sexueller Nebenwirkungen während der ersten 12 Monate, danach nahm die Häufigkeit ab.Original text: German. Our translation:With frequencies of 3.8% and 2.1% respectively during the first 12 months, sexual side effects were more common in men treated with finasteride than in men treated with placebo. The frequency of these side effects fell to 0.6% in men treated with finasteride over the following 4 years. About 1% of the men in each treatment group stopped treatment because of sexual side effects during the first 12 months; after that, the frequency decreased.

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

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

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

Sexual side effects, as listed4.8. Effets indésirables · Affections psychiatriques · Peu fréquent*baisse de la libidoOriginal text: French. Our translation:decreased libido

Sexual side effects, as listed4.8. Effets indésirables · Affections des organes de reproduction et du sein · Peu fréquent*troubles de l'érection, troubles de l'éjaculation (y compris diminution du volume de l'éjaculat)Original text: French. Our translation:erection disorders, ejaculation disorders (including decreased volume of ejaculate)

Sexual side effects that continue after stopping4.8. Effets indésirablesDe plus, depuis la mise sur le marché, les effets indésirables suivants ont été rapportés : persistance des troubles de la fonction sexuelle (baisse de la libido, troubles de l'érection et de l'éjaculation) après l'arrêt du traitement par finastéride ; cancer du sein chez l'homme (voir rubrique 4.4 « Mises en garde spéciales et précautions d'emploi »).Original text: French. Our translation:In addition, since marketing, the following adverse effects have been reported: persistence of sexual function disorders (decreased libido, erection and ejaculation disorders) after treatment with finasteride has been stopped; breast cancer in men (see section 4.4 “Special warnings and precautions for use”).

The same text also says4.8. Effets indésirablesLa fréquence des effets indésirables rapportés depuis la commercialisation ne peut être déterminée dans la mesure où elle découle de cas de pharmacovigilance spontanés.Original text: French. Our translation:The frequency of the adverse effects reported since marketing cannot be determined, as it derives from spontaneous pharmacovigilance cases.

Sexual side effects, as listed4.8. Effets indésirablesLes effets indésirables sexuels ont été plus fréquents chez les hommes traités par le finastéride que chez les hommes recevant le placebo, avec des fréquences respectives de 3,8 % vs 2,1 % pendant les 12 premiers mois. L'incidence de ces effets a diminué à 0,6 % chez les hommes traités par le finastéride au cours des quatre années suivantes. Environ 1 % des hommes (dans chaque groupe) ont arrêté le traitement au cours des 12 premiers mois en raison d'effets indésirables sexuels liés au traitement. Cette incidence a diminué par la suite.Original text: French. Our translation:Sexual adverse effects were more frequent in men treated with finasteride than in men receiving placebo, with frequencies of 3.8% and 2.1% respectively during the first 12 months. The incidence of these effects fell to 0.6% in men treated with finasteride over the following four years. About 1% of men (in each group) stopped treatment during the first 12 months because of treatment-related sexual adverse effects. This incidence decreased thereafter.

The text itself prints no date of revision.

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

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

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

Sexual side effects, as listed4.8 Effetti indesiderati · Disturbi psichiatrici: · Non comune*Diminuzione della libidoOriginal text: Italian. Our translation:Decreased libido

Sexual side effects, as listed4.8 Effetti indesiderati · Patologie dell’apparato riproduttivo e della mammella: · Non comune*Disfunzione erettile, disordini dell’eiaculazione (incluso diminuzione del volume dell’eiaculato)Original text: Italian. Our translation:Erectile dysfunction, ejaculation disorders (including decreased volume of ejaculate)

The same text also says4.8 Effetti indesideratiIncidenze presentate quali differenze dal placebo negli studi clinici al 12° mese.Original text: Italian. Our translation:Incidences given as differences from placebo in clinical studies at month 12.

Sexual side effects that continue after stopping4.8 Effetti indesideratiInoltre, durante l’uso post-marketing sono stati riportati: disfunzione sessuale persistente (riduzione della libido, disfunzione erettile e disturbi dell’eiaculazione) dopo l’interruzione del trattamento con finasterideOriginal text: Italian. Our translation:In addition, during post-marketing use the following has been reported: persistent sexual dysfunction (reduced libido, erectile dysfunction and ejaculation disorders) after treatment with finasteride was stopped

Sexual side effects, as listed4.8 Effetti indesideratiEffetti indesiderati correlati al medicinale inerenti la sfera sessuale sono stati più comuni fra gli uomini trattati con finasteride che fra quelli trattati con placebo con frequenze durante i primi 12 mesi di 3,8 % vs 2,1 %, rispettivamente. L’incidenza di tali effetti è diminuita allo 0,6 % negli uomini trattati con finasteride nel corso dei successivi quattro anni. Circa l’1 % degli uomini in ciascun gruppo di trattamento ha interrotto la terapia a seguito di esperienze avverse della sfera sessuale correlate con il medicinale verificatesi nei primi 12 mesi e l’incidenza è in seguito diminuita.Original text: Italian. Our translation:Drug-related adverse effects affecting the sexual sphere were more common among men treated with finasteride than among those treated with placebo, with frequencies during the first 12 months of 3.8% vs 2.1% respectively. The incidence of these effects fell to 0.6% in men treated with finasteride over the following four years. About 1% of men in each treatment group stopped therapy because of drug-related sexual adverse experiences in the first 12 months, and the incidence decreased thereafter.

The text itself prints no date of revision.

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

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

Sexual side effects, as listed4.8. Reacciones adversas · Trastornos psiquiátricos: · Poco frecuentes*Disminución de la libidoOriginal text: Spanish. Our translation:Decreased libido

Sexual side effects, as listed4.8. Reacciones adversas · Trastornos del aparato reproductor y de la mama: · Poco frecuentes*Disfunción eréctil, trastorno de la eyaculación (incluida disminución del volumen de eyaculación)Original text: Spanish. Our translation:Erectile dysfunction, ejaculation disorder (including decreased volume of ejaculate)

The same text also says4.8 Reacciones adversasLas incidencias se presentan en forma de diferencia respecto al placebo en estudios clínicos a los 12 meses.Original text: Spanish. Our translation:Incidences are given as the difference from placebo in clinical studies at 12 months.

Sexual side effects that continue after stopping4.8. Reacciones adversasAdemás, durante su uso después de la comercialización se ha notificado: persistencia de la disfunción sexual (disminución de la libido, disfunción eréctil y trastornos de la eyaculación) después de la interrupción del tratamiento con finasteridaOriginal text: Spanish. Our translation:In addition, during use after marketing the following has been reported: persistence of sexual dysfunction (decreased libido, erectile dysfunction and ejaculation disorders) after treatment with finasteride was stopped

Sexual side effects, as listed4.8. Reacciones adversasLas reacciones adversas sexuales relacionadas con el medicamento fueron más frecuentes en los varones tratados con finasterida que en los que recibían un placebo, con frecuencias durante los 12 primeros meses del 3,8 y el 2,1% respectivamente. La incidencia de estos efectos disminuyó al 0,6% en varones tratados con finasterida durante los cuatro años siguientes. Aproximadamente el 1% de los varones en cada grupo de tratamiento interrumpió el tratamiento debido a reacciones adversas sexuales relacionadas con el medicamento en los primeros 12 meses, y después la incidencia disminuyó.Original text: Spanish. Our translation:Drug-related sexual adverse reactions were more frequent in men treated with finasteride than in those receiving placebo, with frequencies during the first 12 months of 3.8% and 2.1% respectively. The incidence of these effects fell to 0.6% in men treated with finasteride over the following four years. About 1% of the men in each treatment group stopped treatment because of drug-related sexual adverse reactions in the first 12 months, and the incidence decreased afterwards.

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

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

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.

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.