PFS Global Warning Map

Drug-regulatory authorities disclose potential dangers, including decade-long sexual dysfunction and suicide

Second only to “Is there a cure for PFS?” the most common question that comes our way is, “How can this drug still be on the market?” Those asking are typically (a) young men grappling with the reality that a “safe and effective” hair-loss remedy has maimed them—maybe for life—or (b) the loved ones of a PFS patient who recently threatened, attempted, or completed suicide. Our initial response is, “Beats us.” Because we like to think that any astute person who examined the evidence housed here—medical literature, epidemiological data, doctor testimonials, patient pleas, media coverage, and corporate malfeasance—would conclude that marketing authorization for finasteride should immediately be canceled. Then we explain that, since the drug’s 1993 launch, there have been a number of moves by federal drug regulatory authorities to warn the public of its many potential dangers. The Swedish Medical Products Agency got things rolling in 2008 by mandating that Merck add persistent sexual dysfunction and other adverse drug reactions (ADRs) to the finasteride label. Over the next 13 years, agencies running the gamut from the US FDA to the Saudi Arabia FDA followed suit with ADRs ranging from anxiety to completed suicide. It’s our hope that this growing global outcry will someday culminate in finasteride’s removal from the market. Meanwhile, to help you navigate the drug’s increasingly complex pharmacovigilance history, we’ve identified 54 nations that have issued warnings. Below are the sources of those warnings, along with the major PFS symptoms included therein. For a full array of reported PFS symptoms, please refer to our About PFS page.

If you know of additional nations that have issued PFS warnings and/or wish to suggest additional sources to supplement those listed below, please contact Philip Roberts. This page was published June 27, 2022. To read the launch announcement, click here.

Related news: PFS Is ‘Clearly a Problem,’ ‘Warrants Intervention’ and Is ‘Inappropriate to Dismiss,’ Says New USC Research

Nations referencing PFS: 54

Argentina
National Pharmacovigilance System

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • depression
  • suicidal ideation


Cases of depression and, more rarely, suicidal ideation have been observed in men treated with finasteride 1 mg for hair loss. The risk of depression is also associated with finasteride… Patients and healthcare professionals are advised that any change in mood should lead to treatment discontinuation.

International and National News on Drug Safety: October 2017 (English)
Australia
Therapeutic Goods Administration

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • depression
  • suicidal ideation

[T]here is the possibility that finasteride use may result in Post Finasteride Syndrome... [D]own scheduling finasteride to Schedule 3 would set a dangerous precedent for Category X medications, and the potential risks from broader access under Schedule 3 significantly outweigh the benefits.

Interim Decision in Relation to Finasteride: June 2019

[D]epression (feelings of severe sadness and unworthiness) including suicidal thoughts. These are uncommon side effects that have been reported with [finasteride].

Propecia Consumer Medicine Information: January 2021

Austria
Federal Office for Safety in Healthcare

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • anxiety
  • depression
  • suicidal ideation

In patients treated with [finasteride], mood changes such as depressed mood, depression and, less commonly, suicidal thoughts were reported. If you notice any of these symptoms, consult your doctor immediately.

Change in the permits for the marketing of finasteride: December 2017 (English)

Mood changes and depression: In patients treated with Sandoz finasteride, mood changes such as depressed mood, depression and, less commonly reported, suicidal thoughts… Side effects can occur [including] inability to get an erection that persists after stopping treatment, decreased sexual drive that persists after stopping treatment.

Sandoz finasteride 5 mg package leaflet: February 2020 (English)

Azerbaijan
Ministry of Health of Pharmacological and Pharmacopoeial Expert Council

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • depression

The following side effects have been reported with post-marketing use of finasteride: Hypersensitivity reactions, pruritus, edema of the face and lips, pain in the testicles, palpitations, elevated liver enzymes, depression. In some individuals…these symptoms were persistent.

Instructions for the use of finasteride 5 mg: 2020

Belarus
Center for Examinations and Tests in Health Service

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • anxiety
  • depression
  • suicidal ideation

[D]epressed mood, depression and, less commonly, suicidal thoughts have been reported in patients taking finasteride. Patients should be evaluated for psychiatric disorders and, if they occur, the patient should seek medical help… Reproductive system and breast disorders [include] sexual dysfunction that may persist after treatment is stopped.

Instructions for the use MIC finasteride 5 mg: May 2021 (English)
Belgium
Federal Agency for Medicines and Health Products

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • anxiety
  • depression
  • suicidal ideation

New data, analyzed by the European Medicines Agency, has concluded that the risks of mood disorders, suicidal ideation and depression are possible while taking finasteride at 1 mg/day… Treatment with finasteride should be discontinued in the event of any psychiatric symptoms. It is important that patients are informed of these risks, since no leaflet accompanies the custom prescriptions [i.e., those prepared by pharmacists per doctors' specifications] of finasteride at 1mg.

Federal Agency for Medicines and Health Products News: November 2017 (English)

Additional sources
Summary of product characteristics for EG finasteride 5 mg: March 2020 (English)
EG finasteride 5 mg package leaflet: March 2020 (English)

Brazil
National Health Surveillance Agency

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • anxiety
  • depression
  • suicidal ideation


[F]inasteride, when applied topically, has systemic absorption, thus leading to the same side effects when used orally. [The Technical Advisory Committee on Cosmetics] recommends: Prohibit the use of finasteride in cosmetic products.

Technical Opinion No. 4: February 2002 (English)

Patients should also be aware of the risk of sexual dysfunction...during treatment with finasteride. Patients should also be informed that, based on individual patient case reports, sexual dysfunction may also persist for more than 10 years after discontinuation of treatment.

Merck SA Letter to Health Professionals: May 2019 (English)

Bulgaria
Bulgarian Drug Agency

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • anxiety
  • depression
  • suicidal ideation


Mood swings such as depressive mood, depression and, rarely, suicide thoughts, have been reported in patients treated with Accord finasteride 1 mg. If you have any of these symptoms, stop taking Accord finasteride…and contact your doctor as soon as possible… Possible adverse reactions: permanent erectile dysfunction after stopping the treatment; permanent decrease in libido after stopping the treatment; permanent ejaculation problems after stopping the treatment.

Accord finasteride 1 mg package leaflet: June 2019 (English)

Canada
Health Canada

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • depression
  • suicidal ideation
  • self-injury
  • muscle-related disorders






New information regarding the risk of muscle-related disorders has been added to the Post-Market Adverse Drug Reactions and Consumer Information sections of the Canadian product monographs for Proscar and Propecia…Rare cases of muscle-related disorders, such as rhabdomyolysis, myopathy, myalgia, myasthenia, and creatine kinase elevation, have been reported in patients treated with finasteride.

Health Product InfoWatch: Proscar and Propecia: June 2018

Health Canada reviewed the risk of suicidal thoughts and/or behaviours (suicidal ideation) with Proscar and Propecia (finasteride) use. The safety review was triggered because of Canadian and international reported cases of suicidal ideation and self-injury. Health Canada's review concluded that there may be a link between Proscar and Propecia...and the risk of suicidal ideation.

—Assessing the potential risk of suicidal thoughts and/or behaviour: February 2019


Like any medicine, Propecia may cause side effects.

Common side effects:

• less desire to have sex
• difficulty in achieving an erection.
• problems with ejaculation...

In clinical studies, these side effects disappeared in men who stopped taking Propecia and in most men who continued treatment.

In general use, the following have been reported infrequently:

• breast enlargement (swelling) and/or tenderness;
• depression;
• decrease in sex drive that continued after stopping the medication;
• allergic reactions including rash, itching, hives, and swelling of the lips, tongue, throat and face;
• muscle injury, muscle pain, muscle weakness, abnormal test results (CK elevation);
• problems with ejaculation that continued after stopping the medication;
• testicular pain;
• blood in semen
• difficulty in achieving an erection that continued after stopping the medication;
• male infertility and/or poor quality of semen...
• male breast cancer;
• changes in mood, which can include suicidal thoughts.

Organon Canada Propecia Product Monograph: April 2021

China
National Medical Products Administration

PFS symptoms referenced
  • suicidal ideation
  • self-injury

Between 2012 and 2016, the reported rate of finasteride-related suicide/self-harm incidents in Canada increased 2.5-fold. The assessments reported in Canada could neither confirm nor deny a causal association, so an association of finasteride with suicide/self-harm-related events was considered likely… Currently, the US Food and Drug Administration (FDA) has not required changes to the labeling of Proscar or Propecia.

Drug Safety Warning: April 2019 (English)

Colombia
National Institute for Food and Drug Surveillance

PFS symptoms referenced
  • sexual dysfunction
  • depression
  • suicidal ideation


Rare cases…of depression, suicidal thoughts and sexual dysfunction have been identified in the UK in men being treated with finasteride… Patients treated with finasteride should be warned about the possibility of developing depressive disorders, as well as sexual dysfunction, while taking this medicine.

Finasteride Information for Health Professionals: November 2017 (English)

Croatia
Agency for Medicinal Products and Medical Devices

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • genital shrinkage
  • depression
  • anxiety
  • suicidal ideation
  • self-injury


The CMDh considered that the changes recommended for finasteride 1 mg tablets…should additionally be part of the single assessment outcome of this PSUR procedure. Further information…will be published on the [European Medicines Agency] website.

Highlights from the CMDh meeting: April 2017

[T]he product information of medicinal products containing 5 mg finasteride…should be updated to include a warning on depression and suicidal ideation. [The Marketing Authorisation Holders]…should closely monitor events of suicide, suicidality and self-injury…The MAHs should also closely monitor events of penile size reduced and testicular atrophy. In addition, the MAHs should provide a cumulative review of anxiety [and] a cumulative review of reports describing sexual dysfunction-related events reported in conjunction with psychiatric disorder events… Finally, the MAHs…should provide a cumulative review of psychiatric disorders persisting after finasteride discontinuation.

EMA Pharmacovigilance Risk Assessment Committee on Finasteride: April 2017

Cyprus
Republic of Cyprus Ministry of Health

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • anxiety
  • depression
  • suicidal ideation

Mood changes and depression: In patients treated with Accord finasteride, mood changes such as depressed mood, depression and, less commonly reported, suicidal thoughts… Side effects can occur... inability to get an erection that persists after stopping treatment, decreased sexual drive that persists after stopping treatment.

Accord finasteride 5 mg package leaflet: December 2020 (English)

Czechia
State Institute for Drug Control Medicinal Products Database

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • anxiety
  • depression
  • suicidal ideation

Mood swings, including depressed mood, depression and, rarely, suicidal ideation, have been reported in patients treated with finasteride 5 mg. Patients should be monitored for psychiatric symptoms and, if they do occur, patients should be advised to consult a physician… Psychiatric disorders [include] decreased libido, which continues after treatment, anxiety… Reproductive system [disorders include] sexual dysfunction…which continues after treatment.

Aurovitas finasteride 5 mg package leaflet: September 2019 (English)

Denmark
Danish Medicines Agency

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • anxiety
  • depression
  • suicidal ideation

The [Danish Medicines Agency], has been contacted by several citizens who have experienced psychiatric adverse reactions in connection with a longer course of treatment with finasteride (1 mg) for hair loss… The issue was discussed at the last meeting in the European Pharmacovigilance Risk Assessment Committee, PRAC, which resolved to place a warning in the product information. The warning will describe that there have been reports of depression, mood changes and suicidal thoughts in treatment with finasteride for hair loss.

Danish Pharmacovigilance Update: May 2017

Additional source
Finasteride 1 mg package leaflet: November 2019 (English)

Estonia
State Medicines Agency

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • anxiety
  • depression
  • suicidal ideation

Mood swings such as depressive mood, depression and, rarely, suicide thoughts, have been reported in patients treated with Accord finasteride... If you have any of these symptoms, stop taking Accord finasteride…and contact your doctor as soon as possible… Possible adverse reactions: permanent erectile dysfunction after stopping treatment; permanent decrease in libido after stopping treatment; permanent ejaculation problems after stopping treatment.

Accord finasteride 5 mg package leaflet: December 2021 (English)

Finland
Finnish Medicines Agency

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • anxiety
  • depression
  • suicidal ideation

Mood swings such as depressive mood, depression and, rarely, suicide thoughts, have been reported in patients treated with Orion finasteride... If you have any of these symptoms, stop taking Orion finasteride…and contact your doctor as soon as possible… Possible adverse reactions: permanent erectile dysfunction after stopping treatment; permanent decrease in libido after stopping treatment; permanent ejaculation problems after stopping treatment.

Orion finasteride 5 mg package leaflet: July 2019 (English)

France
• National Agency for the Safety of Medicine and Health Products
• Network of Regional Pharmacovigilance Centers

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • penile atrophy
  • pudendal neuralgia
  • Peyronie’s disease
  • memory loss
  • language impairment
  • migraine headaches
  • liver damage
  • heart rhythm disorders
  • muscle or bone disorders
  • tinnitus
  • dry eyes
  • anxiety
  • panic attacks
  • insomnia
  • sleep apnea
  • depression
  • anhedonia
  • suicidal ideation
  • suicide attempt
  • completed suicide

Patients have reported sexual disorders when using finasteride 1 mg. These may include erection disorders, ejaculation disorders…testicular pain, a decrease in libido, as well as male infertility problems and/or poor semen quality... Patients have also reported mental disorders, including anxiety, depression [and] suicidal thoughts that could lead to suicide. Symptoms of depression may include constant sadness, depression, loss of interest and pleasure, difficulty concentrating and remembering, reduced energy or fatigue (abnormal or even intense) and sleep disorders. All of these disorders can have an impact on social and professional life. Sexual and psychological disorders may persist after stopping treatment for an indefinite period.

ANSM News: Risks of Taking Finasteride 1 mg: July 2022 (English)

Remember that finasteride 1 mg has a hormonal action and can cause mental disorders and sexual disorders… Given the nature of the adverse effects, in particular those of a psychological nature, it is advisable to schedule a follow-up consultation within three months after initiation of treatment, to assess its tolerance, then regularly (for example, every 6 months) during the treatment.

ANSM News: Information for Healthcare Professionals about Finasteride 1 mg: July 2022 (English)

In our ongoing efforts to promote proper and safe use of finasteride 1 mg, we are making available…new tools designed in collaboration with the Association for Aid to the Victims of Finasteride [including] a “step-by-step” video, from the Network of Regional Pharmacovigilance Centers, to facilitate the reporting of adverse reactions associated with this drug.

ANSM News: Finasteride 1 mg for the Treatment of Early-stage Hair Loss: July 2022 (English)

Additional sources
Centres Régionaux de Pharmacovigilance: Reporting ADRs (video, French only): July 2022
ANSM News: Finasteride 1 mg and Hair Loss: July 2022 (English)
Letter to health professionals regarding finasteride's potential risks: November 2019 (English)
Reminder regarding the risks of psychiatric disorders: February 2019 (English)

Germany
• Federal Institute for Drugs and Medical Devices
• Paul Ehrlich Institute

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • anxiety
  • depression
  • suicidal ideation

Patients should be aware of the risk of sexual dysfunction (including erectile dysfunction, ejaculation disorder, and decreased libido) when starting finasteride therapy. Patients should also be informed that, based on individual patient case reports, sexual dysfunction may persist for more than 10 years after discontinuation of the therapy. Patients should also be advised that mood changes (including depressive mood, depression and suicidal thoughts) have been reported… On the recommendation of the European Medicines Agency, 'anxiety' is included as a new side effect.

Red Hand Letter on finasteride: July 2018 (English)

[The US Food and Drug Administration]'s side effects database…showed that use of 1 mg finasteride in the indication of androgenetic alopecia could be associated with the risk of persistent sexual dysfunction due to disproportionate reporting rates. [S]tudies also indicated that sexual dysfunction could persist after discontinuation of finasteride [ranging] from months to years. The [Federal Institute for Drugs and Medical Devices] is aware of a case from Germany in which the reported sexual dysfunction persisted for more than 10 years… A total of 38 case reports on sexual dysfunction when taking finasteride are available in Germany, for which the outcome is given as “not recovered/not resolved.”

Safety Bulletin on depression and sexual dysfunction: September 2018 (English)

Greece
National Organization for Medicines

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • anxiety
  • depression
  • suicidal ideation


Mood swings such as depressive mood, depression and, rarely, suicide thoughts, have been reported in patients treated with Avelid finasteride... If you have any of these symptoms, stop taking Avelid finasteride…and contact your doctor as soon as possible… Possible adverse reactions: permanent erectile dysfunction after stopping treatment; permanent decrease in libido after stopping treatment; permanent ejaculation problems after stopping treatment.


Avelid finasteride 1 mg package leaflet: November 2019 (English)

Hungary
National Institute of Pharmacy and Nutrition

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • anxiety
  • depression
  • suicidal ideation

Possible adverse reactions[:] permanent erectile dysfunction after stopping treatment, permanent decrease in libido after stopping treatment, permanent ejaculation problems after stopping treatment.

Sandoz finasteride 1 mg package leaflet: February 2020 (English)

Psychiatric disorders: Depression, decreased libido that persists after stopping treatment, anxiety. Reproductive system and breast disorders: Testicular pain, erectile dysfunction that persists after stopping treatment; male infertility and/or poor sperm quality.

Sandoz finasteride 5 mg summary of product characteristics: February 2020 (English)

Iceland
Icelandic Medicines Agency

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • anxiety
  • depression
  • suicidal ideation

Mood swings such as depressive mood, depression and, rarely, suicide thoughts, have been reported in patients treated with STADA finasteride 1 mg... If you have any of these symptoms, stop taking STADA finasteride…and contact your doctor as soon as possible… Possible adverse reactions: permanent erectile dysfunction after stopping treatment; permanent decrease in libido after stopping treatment; permanent ejaculation problems after stopping treatment.

STADA finasteride package leaflet: December 2021 (English)

Ireland
Health Products Regulatory Authority

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • depression
  • suicidal ideation

Reproductive system and breast disorders: Unknown: sexual dysfunction (erectile dysfunction and ejaculation disorders) that continued after discontinuation of treatment... Psychiatric disorders: Common: decreased libido. Unknown: depression, decreased libido that continued after discontinuation of treatment.

Finasteride 5 mg Summary of Product Characteristics: February 2014

Mood alterations such as depressed mood, depression and, less frequently, suicidal thoughts have been reported in patients treated with finasteride 5 mg... If you experience any of these symptoms, contact your doctor for further medical advice as soon as possible.

Accord finasteride 5 mg package leaflet: November 2018

Israel
Pharmaceutical and Drug Information Department

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • anxiety
  • depression
  • suicidal ideation

Mood alterations such as depressed mood, depression and, less frequently, suicidal thoughts, have been reported in patients treated with this medicine. If you experience any of these symptoms, stop taking ProAvenir and contact your doctor as soon as possible. Side effects of unknown frequency[:] persistent difficulty having an erection after discontinuation of treatment; persistent decrease in sex drive after discontinuation of treatment; persistent problems with ejaculation after discontinuation of treatment; male infertility and/or poor quality of semen; anxiety.

ProAvenir finasteride 1 mg Patient Information: March 2021 (Hebrew)

Italy
Italian Drug Agency

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • anxiety
  • depression
  • suicidal ideation

There have been reports of depression and/or suicidal ideation with use of medicines containing finasteride 1 mg, indicated for the treatment of early states of androgenetic alopecia in men ages 18 to 41… [T]he Committee of Pharmacovigilance Risk Assessment…recommended the inclusion of a warning in the product information to inform that cases of mood alterations have been reported, namely depression and suicidal ideation, with the use of finasteride 1 mg.

Finasteride warning letter: November 2017 (English)

Additional source
Propecia 1 mg package leaflet: April 2019 (English)

Jordan
Food & Drug Administration

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • anxiety
  • depression
  • suicidal ideation

[S]ide effects reported in some men [include] an inability to have an erection which may continue after stopping the medication, male infertility and/or poor quality of semen…depression, decrease in sex drive that may continue after stopping the medication, problems with ejaculation that may continue after stopping the medication, anxiety… Mood alterations such as depressed mood, depression and, less frequently, suicidal thoughts have been reported in patients treated with Proscar.

Proscar 5 mg package leaflet: May 2018

Kazakhstan
National Center for Expertise of Medicines and Medical Devices

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction

The [US Food and Drug Administration] has received information that after discontinuation of finasteride therapy, some patients have sexual side effects such as decreased libido, impaired ejaculation, decreased ejaculate, and impotence (in very rare cases)… According to a ruling by the FDA, the manufacturer included information on the decrease in libido and the possible development of male infertility while taking the drug.

Changes have been made to the finasteride patient instructions: March 2012 (English)

Latvia
State Agency of Medicines

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • anxiety
  • depression
  • suicidal ideation

[D]epression (feelings of severe sadness and unworthiness) including suicidal thoughts. These are uncommon side effects that have been reported with [finasteride]... If you have any of these symptoms, stop taking Accord finasteride 1 mg film-coated tablets and contact your doctor as soon as possible.

Accord finasteride 1 mg package leaflet: November 2021 (English)

Lithuania
State Medicines Control Agency

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • anxiety
  • depression
  • suicidal ideation


Possible adverse reactions[:] permanent erectile dysfunction after stopping treatment, permanent decrease in libido after stopping treatment, permanent ejaculation problems after stopping treatment.

Accord finasteride 5 mg package leaflet: February 2022 (English)

Psychiatric disorders: Depression, decreased libido which persists after stopping treatment, anxiety. Reproductive system and breast disorders: Testicular pain, erectile dysfunction that persists after stopping treatment; male infertility and/or poor sperm quality.

Accord finasteride 5 mg summary of product characteristics: February 2022 (English)

Malaysia
National Pharmaceutical Regulatory Agency

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • depression

Some men have also reported the following: allergic reactions such as rash; itching, hives and swelling of the lips, tongue, throat and face; testicular pain; an inability to have an erection that continued after stopping the medication; problems with ejaculation that continued after stopping the medication; male infertility and/or poor quality of semen. Improvement in the quality of semen has been reported after stopping the medication; depression; decrease in sex drive that continued after stopping the medication.

Proscar Consumer Medication Information Leaflet: January 2016 (English)

In general use, the following have been reported infrequently: breast tenderness and enlargement; depression; decrease in sex drive that continued after stopping the medication; allergic reactions including rash, itching, hives, and swelling of the lips and face; problems with ejaculation that continued after stopping the medication; testicular pain; difficulty in achieving an erection that continued after stopping the medication; male infertility and/or poor quality of semen. Improvement in the quality of semen has been reported after stopping the medication.

Propecia Consumer Medication Information Leaflet: January 2016 (English)

Additional source
Malaysian Adverse Drug Reaction Newsletter: August 2011

Malta
Medicines Authority

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • anxiety
  • depression
  • suicidal ideation

[D]epressed mood, depression and, less commonly, suicidal thoughts have been reported in patients taking finasteride. Patients should be evaluated for psychiatric disorders and, if they occur, the patient should seek medical help… Reproductive system and breast disorders [include] sexual dysfunction that may persist after treatment is stopped.

Accord finasteride 1 mg package leaflet: April 2020

Additional source
Accord finasteride 1 mg summary of product characteristics: February 2019

Montenegro
Agency for Medicines and Medical Devices

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • anxiety
  • depression
  • suicidal ideation

Possible adverse reactions [include] permanent erectile dysfunction after stopping treatment, permanent decrease in libido after stopping treatment, permanent ejaculation problems after stopping treatment.

Proscar 5 mg patient instructions: August 2014 (English)

Psychiatric disorders: Depression, decreased libido which persists after stopping treatment, anxiety. Reproductive system and breast disorders: Testicular pain, erectile dysfunction that persists after stopping treatment; male infertility and/or poor sperm quality.

Proscar 5 mg Summary of Product Characteristics: August 2014 (English)

Netherlands
Medicines Evaluation Board

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • anxiety
  • depression
  • suicidal ideation

Psychiatric disorders: Depression, decreased libido which persists after stopping treatment, anxiety. Reproductive system and breast disorders: Testicular pain, erectile dysfunction that persists after stopping treatment; male infertility and/or poor sperm quality.

Accord finasteride 1 mg Summary of Product Characteristics: February 2019 (English)

Mood swings such as depressive mood, depression and, rarely, suicide thoughts, have been reported in patients treated with Accord finasteride... If you have any of these symptoms, stop taking Accord finasteride…and contact your doctor as soon as possible… Possible adverse reactions: permanent erectile dysfunction after stopping treatment; permanent decrease in libido after stopping treatment; permanent ejaculation problems after stopping treatment.

Accord finasteride 1 mg package leaflet: December 2021 (English)

New Zealand
Medicines and Medical Devices Safety Authority

PFS symptoms referenced
  • loss of libido
  • erectile dysfunction
  • loss of morning erections
  • sexual anhedonia
  • decreased semen volume
  • penile shrinkage
  • Peyronie’s disease
  • scrotal shrinkage
  • gynecomastia
  • chronic fatigue
  • muscle atrophy
  • decreased oil production
  • thinning of skin
  • melasma
  • tinnitus
  • increased fat deposition
  • lowered body temperature
  • reduced HDL cholesterol
  • suicidal ideation
  • attempted suicide
  • completed suicide
  • memory impairment
  • slowed thought processes
  • cognitive dysfunction
  • depression
  • anxiety
  • emotional flatness
  • insomnia

Post-Finasteride Syndrome (PFS) was recently added to the US National Institutes of Health (NIH) list of genetic and rare diseases… PFS includes sexual, physical, and mental and neurological symptoms in patients who have taken finasteride. Symptoms often persist after the patient has stopped taking finasteride…Importantly, some patients can experience suicidal ideation and depression after stopping finasteride treatment. Patients and their families should be advised about these symptoms and to seek medical advice as soon as possible if they occur.

Medsafe Prescriber Update: April 2016

Additional source
Propecia 1 mg package leaflet: August 2021
Norway
Norwegian Medicines Agency

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • anxiety
  • depression
  • suicidal ideation

Psychiatric disorders: Depression, decreased libido which persists after stopping treatment, anxiety. Reproductive system and breast disorders: Testicular pain, erectile dysfunction that persists after stopping treatment; male infertility and/or poor sperm quality.

Actavis finasteride 5 mg Summary of Product Characteristics: September 2021 (English)

Mood swings such as depressive mood, depression and, rarely, suicide thoughts, have been reported in patients treated with finasteride 1 mg film-coated tablets. If you have any of these symptoms, stop taking Accord finasteride…and contact your doctor as soon as possible… Possible adverse reactions: permanent erectile dysfunction after stopping treatment; permanent decrease in libido after stopping treatment; permanent ejaculation problems after stopping treatment.

Actavis finasteride 5 mg package leaflet: July 2020 (English)

Panama
National Directorate of Pharmacy and Drugs

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • depression
  • suicidal ideation
  • self-injury
  • muscle-related disorders

Health Canada analyzed the risk of possible serious muscle-related side effects with the use of finasteride… At the time of the review, Health Canada had received 11 reports of serious muscle-related side effects suspected to be related to the use of finasteride… Health Canada’s review of the available information concluded that the risk of serious muscle-related side effects with the use of finasteride could not be ruled out.

Finasteride and the Potential Risk of Serious Muscle-Related Side Effects: August 2017 (English)

Health Canada conducted a safety review for finasteride, due to reported cases of suicidal ideation and self-harm received in Canada and internationally. The cases led to the investigation of a possible relationship between finasteride use and suicidal ideation… Between 2012 and 2016, the reporting rate in Canada for finasteride-related adverse reactions and suicide/self-harm increased 2.5-fold.

Potential Risk of Suicidal Thoughts and/or Behaviors with Finasteride Use: May 2019 (English)

Additional sources
Depression and Suicidal Ideation with Finasteride: November 2017 (English)
Adverse reactions associated with inappropriate use of finasteride: July 2014 (English)

Peru
Directorate General of Drug Supplies and Drugs

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • depression
  • suicidal ideation



[T]he European Medicines Agency published the scientific conclusions referring to the evaluation of the Periodic Safety Reports for finasteride. The evaluation was carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), which observed that during the reference period two serious cases were obtained for finasteride 5 mg, one in which suicidal behavior was reported and in the other case suicidal ideation. Cumulatively, 51 cases of suicidal ideation have been obtained according to the information in the summary table of adverse drug reactions during post-marketing use.

Director’s Resolution: March 2018 (English)

After initiation of finasteride, observe patients for psychiatric problems. Advise patients to discontinue finasteride treatment if they develop mood disturbances, depression, and suicidal ideation… Instruct patients to inform their physician if they experience mood swings, depression and/or suicidal ideation while taking finasteride.

Risk of Mood Alterations, Depression and Suicidal Ideation: March 2018 (English)

Poland
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

PFS symptoms referenced
  • anxiety

Based on the reported cases of anxiety related to treatment with finasteride…and also taking into account that a high prevalence of anxiety in patients with MPHL has been confirmed, the PRAC considered that the adverse drug reaction anxiety should be included in…the Summary of Product Characteristics of all finasteride-containing products, with a frequency not known. The package leaflet is updated accordingly.

EMA Pharmacovigilance Risk Assessment Committee: February 2017 (English)

Portugal
National Authority of Medicines and Health Products

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • anxiety
  • depression
  • gynecomastia
  • suicidal ideation

Interactions to keep in mind! Potentiation of depression, suicidal ideation with: finasteride, dutasteride.

INFARMED Pharmacovigilence Newsletter: September 2011

Gynecomastia is not rare in adult men… [It] also appears as a side effect of medicines. The authors of this study undertook a systematic literature review encompassing articles from over one hundred publications. The result was the following list of medicines that are potentially associated with the occurrence of gynecomastia… finasteride.

INFARMED Pharmacovigilence Newsletter: November 2015

Mood swings such as depressive mood, depression and, rarely, suicide thoughts, have been reported in patients treated with Accord finasteride... If you have any of these symptoms, stop taking Accord finasteride…and contact your doctor as soon as possible for additional medical help… Possible adverse reactions: permanent erectile dysfunction after stopping treatment; permanent decrease in libido after stopping treatment; permanent ejaculation problems after stopping treatment.

Accord finasteride 1 mg package leaflet: November 2016 (English)

Romania
National Agency of Medicines and Medical Devices

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • anxiety
  • depression
  • suicidal ideation

In patients treated with finasteride, mood changes such as depressed mood, depression and, less commonly reported, suicidal thoughts. If you notice any of these symptoms, consult your doctor immediately… Side effects can occur [including] inability to get an erection that persists after stopping treatment [and] decreased sexual drive that persists after stopping treatment.

Organon Proscar 5 mg package leaflet: October 2021 (English)

Additional source
Organon Propecia 1 mg package leaflet: October 2021 (English)

Russia
Federal Service for Surveillance in Healthcare

PFS symptoms referenced
  • depression
  • suicidal ideation

[T]he Ministry of Health of the Russian Federation informs you that it is necessary to make changes to the instructions for use of…finasteride…according to updated information on experience based on their clinical application… The following information must be included… 'It is indicated that mood changes, including depression and suicidal ideation, were observed in patients taking finasteride at a dose of 5 mg. It is necessary to monitor the appearance of psychopathological symptoms and, when they take place, patients should be referred for consultation with a specialist.'

Finasteride label-change mandate: October 2017 (English)

Saudi Arabia
Food and Drug Authority

PFS symptoms referenced
  • diabetes mellitus
  • loss of libido
  • sexual dysfunction
  • anxiety
  • depression
  • suicidal ideation

[T]he Saudi Food & Drug Authority inform[s] you about the below safety aspects[:] Patients should be aware of the risk of experiencing the adverse event (AE) of sexual dysfunction (including erectile dysfunction, ejaculation disorder, and decreased libido) during finasteride therapy. Patients should also be informed that case reports have been received of sexual dysfunction AEs that persisted after discontinuation of therapy...Healthcare Professionals should carefully monitor patients during treatment with finasteride for psychiatric symptoms (including anxiety, depression and suicidal ideation).

Confidential Merck DHPC finasteride warning letter: October 2018

The weighted cumulative evidence identified from the reported cases, literature and data mining are sufficient to support a causal association between Finasteride and the risk of Diabetes Mellitus. Health regulators and health care professionals must be aware of this potential risk and it is advisable to monitor any signs or symptoms in treated patients.

Safety Signal of Finasteride and the Risk of Diabetes Mellitus: August 2021

Serbia
Medicines and Medical Devices Agency of Serbia

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • anxiety
  • depression
  • suicidal ideation

In patients treated with finasteride [symptoms included] mood changes such as depressed mood, depression and, less commonly reported, suicidal thoughts. If you notice any of these symptoms, consult your doctor immediately… Side effects can occur [including] inability to get an erection that persists after stopping treatment [and] decreased sexual drive that persists after stopping treatment.

PharmaS finasteride 5 mg package leaflet: October 2021 (English)
Slovakia
State Institute for Drug Control

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • anxiety
  • depression
  • suicidal ideation

Reproductive system and breast disorders: sexual dysfunction (erectile dysfunction and ejaculation
disorders) that continued after discontinuation of treatment... Psychiatric disorders: Common: decreased libido. Unknown: depression, decreased libido that continued after discontinuation of treatment.

Accord finasteride 5 mg Summary of Product Characteristics: January 2019 (English)

Additional source
Accord finasteride 5 mg package leaflet: January 2019 (English)

Slovenia
Agency for Medicinal Products and Medical Devices

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • depression
  • suicidal ideation

Stop using [finasteride] and immediately contact a doctor if you experience any of the following symptoms[:] persistent difficulty having an erection after discontinuation of treatment, persistent decrease in sex drive after discontinuation of treatment, persistent problems with ejaculation after discontinuation of treatment.

Swedish Medical Products Agency: Finasteride PSUR: November 2013

[T]he following have been reported in post-marketing use: persistence of sexual dysfunction (decreased libido, erectile dysfunction and ejaculation disorders) after discontinuation of treatment with finasteride.

Finasteride 1 mg Core Safety Profile: 2017

Additional source
Finpros finasteride 5 mg package leaflet: July 2019 (English)

South Africa
Health Products Regulatory Authority

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • depression



The following additional adverse experiences have been reported in post-marketing use[:] Depression, decreased libido that continued after discontinuation of treatment… Breast tenderness and enlargement, testicular pain, haematospermia, sexual dysfunction (erectile dysfunction and ejaculation disorders) that continued after discontinuation of treatment, male infertility and/or poor seminal quality.

Proscar 5 mg package leaflet: October 2018

South Korea
Ministry of Food and Drug Safety

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • depression
  • suicidal ideation

Warning: Mood swings including depressed mood, depression and suicidal thoughts were reported by patients treated with 1 mg of finasteride. Please make sure to observe patients for psychological symptoms. If any of the above symptoms are found in a patient, stop the treatment with finasteride and consult a medical provider.

Finasteride label-change mandate: July 2017 (English)

Warning labels will be added to finasteride…noting that [it] may cause side effects including depression and suicidal thoughts, among other things. [T]he Ministry of Food and Drug Safety announced the warning…based on a safety report submitted by Merck Sharp & Dohme Korea, which originally developed the drug…Propecia was released in the Korean market in 2000. When its patent expired in 2008, several generic drugs were also released...There are presently more than 60 generic hair-loss drugs and 70 generic prostate-enlargement drugs on the market that have the same ingredients as Propecia.

Warning Against Depression and Suicidal Thoughts (Yonhap News): July 2017 (English)

Additional sources
Korea FDA Drug Safety Information June 2012 (English)
Korea Institute of Drug Safety: Finasteride ADRs 2013-2016 (English)

Spain
Spanish Agency for Medicines and Health Products

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • anxiety
  • depression
  • suicidal ideation


Cases of mood disturbances, including depressed mood, depression and, less frequently, suicidal ideation have been reported in patients treated with finasteride 5 mg. This information will be included in the warning section of the drug’s data sheet together with the recommendation to monitor patients for the appearance of psychiatric symptoms and, if these occur, instruct them to seek medical advice.

Monthly Bulletin on Human Medicines: May 2017 (English)

Psychiatric disorders: Depression, decreased libido which persists after stopping treatment, anxiety. Reproductive system and breast disorders: Testicular pain, erectile dysfunction that persists after stopping treatment; male infertility and/or poor sperm quality.

Normon finasteride 1 mg Summary of Product Characteristics: February 2018 (English)

Additional sources
Organon Propecia 1 mg package leaflet: September 2020 (English)
Cinfa finasteride 5 mg: June 2021 (English)

Sweden
Medical Products Agency

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • anxiety
  • depression
  • suicidal ideation

In the SmPC [Summary of Product Characteristics] for Propecia, it is stated that adverse reactions usually have resolved themselves while on treatment or after cessation of therapy... This was supported by clinical data presented before the approval. After the approval, reported spontaneous reports received from [healthcare personnel] have regularly been presented... The most frequently reported adverse reactions...were erectile dysfunction, gynaecomastia and testicular pain. Within the cumulative submitted documentation, no new data has been presented indicating an increasing problem with male reproductive system symptoms...not being reversible after cessation of therapy.

Medical Products Agency (MPA) letter to Merck Sharp & Dohme (MSD): November 2006

With regards to the MPA request to update section 4.4 of the SPC with information on the persistence of erectile dysfunction after cessation of treatment, MSD wishes to confirm our position that the pre-clinical, clinical and post-marketing data do not support inclusion of precautionary text in the SPC.

Merck response to MPA: June 2007

The second report…concerned a 19-year-old male, who was placed on finasteride 1 mg... Subsequently the patient experienced erectile dysfunction, gynaecomastia, fatigue and feeling ‘mentally unclear.’ Finasteride was discontinued. The patient’s experiences persisted for almost two years [and] laboratory test results were normal.

MPA response to Merck: November 2007

Comments on [labeling]: Section 4.8 should be revised according to the Guideline on Summary Product characteristics. The first sentence ‘Undesirable effects have usually been transient during treatment or resolved upon discontinuation’ should be deleted.

MPA Prel Renewal Assessment Report: April 2008

Additional sources
Does Propecia Impair Sexual Function: December 2006 (English)
EMA Pharmacovigilance Risk Assessment Committee meeting: May 2019
Accord finasteride 1 mg package leaflet: October 2019 (English)

Switzerland
Swissmedic

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • anxiety
  • depression
  • suicidal ideation

Reproductive system and breast disorders: sexual dysfunction (erectile dysfunction and ejaculation disorders) that persists after discontinuation of treatment... Psychiatric disorders: Common: decreased libido. Unknown: depression, decreased libido that continued after discontinuation of treatment.

Sandoz finasteride 5 mg Summary of Product Characteristics: December 2019 (English)

Additional source
Sandoz finasteride 5 mg package leaflet: December 2019 (English)

Ukraine
Department of Pharmacovigilance

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • depression


Reproductive system and breast disorders: sexual dysfunction (erectile dysfunction and ejaculation
disorders) that continued after discontinuation of treatment... Psychiatric disorders: Common: decreased libido. Unknown: depression, decreased libido that continued after discontinuation of treatment.

Proscar 5 mg Summary of Product Characteristics: February 2019 (English)

Additional source
Instruction for Medical Use of Proscar: February 2019 (English)

United Arab Emirates
Ministry of Health & Prevention

PFS symptoms referenced
  • muscle-related disorders


Health Canada recently recommended adding a warning to products containing [finasteride]... While being administered the above-mentioned drug, patients may develop muscle weakness and stiffness, which in turn may cause pain to the patient, damage to muscle tissue and an increase in kinase enzymes. Accordingly, Health Canada and the UAE Ministry of Health recommend that companies that produce products containing [finasteride] add the above-mentioned warning to the internal leaflet of their products.

Adding a warning to pharmaceutical preparations containing finasteride: July 2017 (English)

United Kingdom
Medicines and Healthcare products Regulatory Agency

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • anxiety
  • depression
  • suicidal ideation

Some men have reported episodes of depressive illness in association with the use of Propecia... Some men also reported having suicidal thoughts. Depression and suicidal thoughts have been reported in men with and without a previous history of depression... A recent review of the evidence has suggested more significant depression can occur and so the advice is being updated to reflect this.

Finasteride: Rare Reports of Depression and Suicidal Thoughts: May 2017.

Additional sources
MHRA Finasteride Public Assessment Report: July 2009
Propecia 1 mg package leaflet: November 2017
Dr. Reddy's finasteride 5 mg Summary of Product Characteristics: September 2018
Drug Alerts: January 2020
Promotion of finasteride by Careforsons Limited t/a Sons: December 2021

United States
Food and Drug Administration

PFS symptoms referenced
  • loss of libido
  • sexual dysfunction
  • depression
  • suicidal ideation and behavior

What are the possible side effects of Propecia?

Like all prescription products, Propecia may cause side effects. In clinical studies, side effects from Propecia were uncommon and did not affect most men. A small number of men experienced certain sexual side effects. These men reported one or more of the following:

• less desire for sex;
• difficulty in achieving an erection; and
• a decrease in the amount of semen.

Each of these side effects occurred in less than 2% of men. These side effects went away in men who stopped taking Propecia. They also disappeared in most men who continued taking Propecia.

Merck Propecia 1 mg Patient Information: August 2001

What are the possible side effects of Propecia?

The most common side effects of Propecia include:

• decrease in sex drive
• trouble getting or keeping an erection
• a decrease in the amount of semen

The following have been reported in general use with Propecia:

• breast tenderness and enlargement...
• depression;
• decrease in sex drive that continued after stopping the medication;
• allergic reactions including rash, itching, hives and swelling of the lips and face;
• problems with ejaculation that continued after stopping medication;
• testicular pain;
• difficulty in achieving an erection that continued after stopping the medication;
• male infertility and/or poor quality of semen;
• in rare cases, male breast cancer.

Merck Propecia 1 mg Patient Information: April 2012

What are the possible side effects of Propecia?

• decrease in your blood Prostate Specific Antigen (PSA) levels...
• There may be an increased risk of a more serious form of prostate cancer in men taking finasteride at 5 times the dose of Propecia.

The most common side effects of Propecia include:

• decrease in sex drive
• trouble getting or keeping an erection
• a decrease in the amount of semen

The following have been reported in general use with Propecia:

• breast tenderness and enlargement...
• depression;
• decrease in sex drive that continued after stopping the medication;
• allergic reactions including rash, itching, hives and swelling of the lips, tongue, throat, and face;
• problems with ejaculation that continued after stopping medication;
• testicular pain;
• blood in semen;
• difficulty in achieving an erection that continued after stopping the medication;
• male infertility and/or poor quality of semen.
• in rare cases, male breast cancer.

Organon Propecia 1 mg Patient Information: June 2021

Postmarketing Experience

The 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:

• Hypersensitivity Reaction: hypersensitivity reactions such as rash, pruritus, urticaria, and angioedema (including swelling of the lips, tongue, throat, and face);
• 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; hematospermia.
• Neoplasms: male breast cancer;
• Breast disorders: breast tenderness and enlargement;
• Nervous System/Psychiatric: depression, suicidal ideation and behavior.

Organon Propecia 1 mg Prescribing Information: August 2022


FDA is concerned that use of finasteride by pediatric patients may pose long-term safety risks regarding growth, development and sexual function. Any proposed use in the pediatric population would, of course, need to account for these safety concerns. Accordingly, your petition is denied.

FDA response to Merck’s Citizen Petition to approve finasteride for pediatric use: May 2000

Additional source
Merck application for addition of depression to finasteride label: March 2011