Signal Detection of Depression and Suicidality With the 5-Alpha Reductase Inhibitors: Evidence from the FDA Adverse Event Reporting System Database

The study analyzed the FDA Adverse Event Reporting System (FAERS) database to investigate psychiatric adverse drug reactions (ADRs) associated with 5-alpha reductase inhibitors (5-ARIs), specifically finasteride and dutasteride. A total of 27,578 ADRs were reported for finasteride, with 29.3% being psychiatric, while dutasteride had 9,161 ADRs with 13.3% psychiatric. Finasteride showed a higher disproportional reporting of psychiatric ADRs compared to dutasteride, with common issues including depressive disorders, anxiety, suicidality, and libido disorders. Despite the findings, a causal relationship between these psychiatric issues and 5-ARIs cannot be conclusively determined, highlighting the need for ongoing surveillance and further studies to clarify their neuropsychiatric safety profile.