Suicidality Risks Associated with Finasteride, a 5-Alpha Reductase Inhibitor: An Evaluation of Real-World Data from the FDA Adverse Event Reports

June 2025 in “ Pharmaceuticals ”

Hilal A. Thaibah, Otilia J.F. Banji, David Banji, Hadi A. Almansour, Thamir M. Alshammari

finasteride 5-alpha reductase inhibitor FDA Adverse Event Reporting System suicidality hair loss pharmacovigilance Propecia

Studysummary This study analyzed reports from the FDA Adverse Event Reporting System and observed an upward trend in suicidality-related safety signals among young male finasteride users since 2019, peaking in 2022, highlighting emerging psychiatric safety concerns and the need for vigilant monitoring of this population.

Our plain-language summary. Not medical advice or a treatment recommendation. Consult a qualified healthcare professional before changing treatment. Full disclaimer

The study analyzed 1,566 finasteride-related suicidality adverse event reports from the FDA Adverse Event Reporting System between 2015 and 2024, focusing on young male users primarily using finasteride for hair loss. It found an upward trend in suicidality-related reports, peaking in 2024 with 363 reports. Serious outcomes included disability (18.7%), life-threatening events (12.9%), and death (7.5%). The findings suggest a potential risk of suicidality associated with finasteride use, emphasizing the need for pharmacovigilance and collaborative efforts among healthcare professionals, regulatory authorities, and pharmaceutical companies to mitigate psychiatric risks. The study also acknowledges limitations such as reporting biases and the influence of external factors like the COVID-19 pandemic on mental health.

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