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
4 hours ago
- #FAERS
- #Pharmacovigilance
- #BPH
- Study evaluates safety profiles of α1-blockers, 5ARIs, and PDE5Is for BPH using FAERS data.
- Retrospective analysis of FAERS data from 2004 to 2025, focusing on male BPH patients.
- Most adverse events (AEs) occurred within 30 days of treatment initiation, with hospitalization as a common serious outcome.
- Identified 16 significant AEs, including pollakiuria, gynecomastia, and breast pain, with distinct patterns across drug classes.
- Findings confirm known risks and suggest potential novel adverse-event signals requiring further investigation.