Evaluating the safety profile of α-1 blockers, 5α-reductase inhibitors, and PDE5I for BPH: a disproportionality analysis of real-world adverse events based on FDA adverse event reporting system (FAERS)

This large-scale pharmacovigilance analysis identified distinct post-marketing safety signals among guideline-recommended pharmacotherapies for BPH, confirming known risks and suggesting potential novel adverse-event signals warranting further investigation.