Adverse drug reaction reports worldwide: 18,393
The World Health Organization Programme for International Drug Monitoring's database of adverse drug reactions (ADRs) currently contains 18,393 finasteride ADRs, including 3,389 reports of erectile dysfunction and 1,947 reports of sexual dysfunction. Additionally, the database contains 4,485 reports of psychiatric disorders, including 1,809 cases of depression and 1,417 cases of anxiety.
If you, or a loved one, have experienced any adverse reactions to finasteride and have not yet reported those reactions to your federal drug-regulatory agency(s), please access our Report Your Side Effects page and do so as soon as possible.
Known suicides worldwide: 89
The World Health Organization Programme for International Drug Monitoring’s database of adverse drug reactions currently contains 89 cases of completed suicide, 42 cases of suicide attempt and 401 cases of suicidal ideation. Additionally, the database contains 571 cases of "death" as a subset of "General disorders and administration site conditions."
If you know of any PFS patients who have taken their own lives, please email email@example.com. Please be prepared to furnish us with pertinent medical records, or with contact information for a family member who has such records, so that we may independently verify each case.
Nations warning of PFS: 49
In April 2012, the US Food and Drug Administration (FDA) mandated that the following ADRs be added to the Postmarketing Experience section of the finasteride label: depression, sexual dysfunction that continued after discontinuation of treatment (including erectile dysfunction, libido disorders, ejaculation on disorders, and orgasm disorders), male infertility and/or poor seminal quality, testicular pain, male breast cancer, breast tenderness and enlargement, hypersensitivity reactions (including rash, pruritus, urticaria, and swelling of the lips and face). In August 2017, the European Medicines Agency (EMA) recommended in a Periodic Safety Update that finasteride packaging be revised to include warnings of depression and suicidal ideation. To date, 49 nations are known to have complied with those directives and/or issued independent warnings:
Argentina: National Pharmacovigilance System
Australia: Therapeutic Goods Administration (December 2013) (January 2021)
Austria: Austrian Federal Office for Safety in Healthcare (February 2020) (December 2017)
Azerbaijan: Ministry of Health of Pharmacological and Pharmacopoeial Expert Council
Belarus: Center for Examinations and Tests in Health Service (English)
Belgium: Federal Agency for Medicines and Health Products (February 2019) (November 2017)
Brazil: National Health Surveillance Agency (English)
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada (September 2019) (February 2019) (June 2018)
China: National Medical Products Administration (English)
Colombia: National Pharmacovigilance Program
Croatia: Agency for Medicinal Products and Medical Devices of Croatia
Cyprus: Republic of Cyprus Ministry of Health
Czechia: State Institute for Drug Control Medicinal Products Database
Denmark: Danish Medicines Agency (November 2019) (May 2017)
Estonia: State Medicines Agency
Finland: Finnish Medicines Agency
France: National Agency for the Safety of Medicine and Health Products (December 2019) (February 2019) (November 2017)
Germany: Federal Institute for Drugs and Medical Devices (May 2018) Paul Ehrlich Institute (June 2020) (September 2018)
Greece: National Organization for Medicines
Hungary: National Institute of Pharmacy and Nutrition
Iceland: Icelandic Medicines Agency
Ireland: Health Products Regulatory Authority (August 2019) (November 2018)
Israel: Pharmaceutical and Drug Information Department (September 2013)
Italy: Italian Drug Agency (April 2019) (November 2017)
Jordan: Food and Drug Administration
Latvia: State Agency of Medicines
Lithuania: State Medicines Control Agency
Malta: Medicines Authority
Malaysia: National Pharmaceutical Regulatory Agency
Montenegro: Agency for Medicines and Medical Devices
Netherlands: Dutch Medicines Evaluation Board (April 2019) (April 2017)
New Zealand: Medicines and Medical Devices Safety Authority (September 2018) (March 2016)
Norway: Norwegian Medicines Agency
Peru: Directorate General of Drug Supplies and Drugs (March 2018)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (August 2018) (April 2017)
Portugal: National Authority of Medicines and Health Products (November 2016)
Romania: National Authority of Medicines and Medical Devices (October 2021)
Saudi Arabia: Saudi Food & Drug Authority (October 2018) (August 2021)
Serbia: Medicines and Medical Devices Agency of Serbia
Slovakia: State Institute for Drug Control
Slovenia: Agency for Medicinal Products and Medical Devices
Spain: Spanish Agency for Medicines and Health Products
South Korea: Korean Ministry of Food and Drug Safety (English translation of data)
Sweden: Medical Products Agency
Ukraine: Department of Pharmacovigilance (English)
United Arab Emirates: Ministry of Health and Prevention
United Kingdom: Medicines and Healthcare Products Regulatory Agency (November 2017) (May 2017)
United States: Food and Drug Administration (April 2012)
If you know of any additional nations that have issued finasteride warnings, please email pertinent links to firstname.lastname@example.org.
PFS research studies published: 56
Over the past 10 years, researchers at leading institutions—from Harvard Medical School to Northwestern University Feinberg School of Medicine to Baylor College of Medicine to The George Washington University School of Medicine and Health Sciences—have published clinical studies and statistical analyses on PFS in leading journals, including JAAD, JAMA Dermatology, The Journal of Clinical Endocrinology & Metabolism, PeerJ, Pharmacotherapy and American Journal of Men's Health. To date, the PFS Foundation has aggregated 56 such papers on our Medical Literature page. Going forward, we will continue to review such literature and house it here for the edification of clinicians, researchers, patients and their family members, regulatory officials, and members of the media.
If you know of any additional PFS-related medical literature that you would like us to consider housing on our website, please email pertinent links to email@example.com.
Doctors and researchers speaking out worldwide: 94
A growing number of doctors, researchers and therapists have in recent years been voicing their concerns about finasteride’s potential to cause persistent physical and mental side effects, known as post-finasteride syndrome (PFS), in a subset of patients. To date, the PFS Foundation has identified 94 such professionals who have published scientific findings and/or voiced opinions on causative links between finasteride and PFS. Those findings and opinions can be reviewed on our Doctors & Researchers Speaking Out page. Some of these same doctors and researchers are also members of our Medical Professionals team, counseling PFS patients and their loved ones worldwide.
If you know of any additional doctors, researchers and/or therapists who have published warnings of persistent side effects stemming from finasteride use, and/or if you would like to suggest adding a medical professional to our Medical Professionals list, please email pertinent links/names to firstname.lastname@example.org.
National media reports worldwide: 281
The PFS Foundation tracks global media coverage of post-finasteride syndrome on an ongoing basis. We then house significant media reports about the condition on our PFS Media Awareness page. To date, we have aggregated 281 national media reports and 54 local and/or trade media reports.
If you know of any PFS media reports, in any language, that are not currently housed on our PFS Media Awareness page, please email pertinent links to media@PFSFoundation.org.
Years finasteride on the market: 29
Proscar (finasteride 5-mg), a prescription medication used to treat enlarged prostate in men, was approved by the US Food and Drug Administration on April 5, 1993.
Propecia (finasteride 1-mg), a prescription medication used to treat male pattern hair loss, was approved by the US Food and Drug Administration on December 19, 1997.