Propeciafinasteride
According to the FDA label: PROPECIA ® is indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY . Efficacy in bitemporal recession has not been established. PROPECIA is not indicated for use in women. PROPECIA is a 5α-reductase inhibitor indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY ( 1 ). PROPECIA is not indicated for use in women ( 1 , 4 , 5.1 ).
51,511 adverse event reports submitted to the FDA (2003–2026)
Top Reported Adverse Events
The most frequently reported events in association with Propecia in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Erectile Dysfunction 3,945 reports
Difficulty getting or keeping an erection.
Full definition in the glossary → See all drugs reporting this event →Fatigue 3,554 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Depression 3,467 reports
A persistent low mood, loss of interest, or feelings of sadness. If you are struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary → See all drugs reporting this event →Anxiety 2,854 reports
A feeling of worry, nervousness, or unease.
Full definition in the glossary → See all drugs reporting this event →Adverse Drug Reaction 2,736 reports
A general report of a harmful or unintended response to a medication, used when no more specific reaction is named.
Full definition in the glossary →- Sexual Dysfunction 2,319 reports
Drug Ineffective 2,216 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Dizziness 2,077 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Diarrhoea 1,936 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Death 1,900 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →Insomnia 1,870 reports
Difficulty falling asleep or staying asleep.
Full definition in the glossary → See all drugs reporting this event →Asthenia 1,812 reports
Physical weakness or lack of strength.
Full definition in the glossary →Dyspnoea 1,803 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Off Label Use 1,744 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →- Loss Of Libido 1,595 reports
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Male | 45,455 |
| Female | 1,309 |
| Unknown | 59 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 149 |
| 18-34 | 3,069 |
| 35-49 | 2,177 |
| 50-64 | 3,903 |
| 65-74 | 7,544 |
| 75+ | 12,718 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Propecia. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 21,281 |
| Non-Serious | 18,757 |
| Hospitalization | 13,052 |
| Death | 4,175 |
| Disability | 3,898 |
| Life-Threatening | 2,135 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Propecia. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2003 | 1 |
| 2004 | 249 |
| 2005 | 281 |
| 2006 | 295 |
| 2007 | 311 |
| 2008 | 350 |
| 2009 | 427 |
| 2010 | 638 |
| 2011 | 958 |
| 2012 | 1,493 |
| 2013 | 1,860 |
| 2014 | 1,882 |
| 2015 | 2,657 |
| 2016 | 2,905 |
| 2017 | 2,889 |
| 2018 | 3,536 |
| 2019 | 3,387 |
| 2020 | 3,833 |
| 2021 | 3,283 |
| 2022 | 3,037 |
| 2023 | 2,909 |
| 2024 | 4,908 |
| 2025 | 7,164 |
| 2026 (partial) | 2,258 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Propecia
In FDA adverse event reports that mention Propecia, these medications appeared most often in the same report.
- Aspirin (7,782 reports)
- Omeprazole (5,731 reports)
- Furosemide (5,542 reports)
- Ergocalciferol (5,008 reports)
- Lisinopril (4,341 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026