Oral Finasteride Use and Sexual Adverse Events: Signal Detection from Disproportionality Analyses of Data from the United States Food and Drug Administration Adverse Event Reporting System

The study analyzed data from the FDA Adverse Event Reporting System to assess the association between oral finasteride and sexual adverse events, finding a disproportionately higher number of reports for finasteride compared to dutasteride, potentially due to the nocebo effect and negative publicity. Despite dutasteride being a more potent inhibitor, finasteride had more adverse event reports, complicating the establishment of a causal link due to potential reporting bias. The study emphasizes the need for monitoring patients on finasteride, as some sexual adverse events may persist post-discontinuation, possibly influenced by confounding factors like psychiatric conditions. While the benefits of finasteride and dutasteride are considered to outweigh the risks, further research is necessary to understand the impact of underlying factors on these adverse events.