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

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.