Risks Associated With 5α-Reductase Inhibitor Use: Analysis of Adverse Drug Reactions Reported to EudraVigilance

The study analyzed 7,777 adverse drug reaction (ADR) reports related to 5α-reductase inhibitors, specifically finasteride and dutasteride, from the EudraVigilance database. Finasteride was linked to 72.19% of reports, with serious ADRs accounting for 72.32% of cases. Common ADRs included erectile dysfunction and decreased libido, with concerns about sexual dysfunctions and neuropsychiatric effects, particularly with finasteride. A significant portion of ADRs were not listed in the Summary of Product Characteristics, highlighting documentation gaps. The study emphasizes the importance of pharmacovigilance and further research to understand the safety profile of these medications, as persistent and serious ADRs could have significant public health impacts.