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)
Abstract
OBJECTIVE
To compare the real-world safety profiles of α1-adrenoceptor antagonists (α1-blockers), 5α-reductase inhibitors (5ARIs), and phosphodiesterase type 5 inhibitor (PDE5I) used in the treatment of benign prostatic hyperplasia (BPH).
METHODS
This retrospective pharmacovigilance study analyzed FDA Adverse Event Reporting System (FAERS) from Q1 of 2004 to Q2 of 2025. Reports of adverse events (AEs) in male BPH patients receiving AUA guideline-recommended drugs including α-1 blockers (tamsulosin, silodosin, doxazosin, and alfuzosin), 5ARIs (finasteride and dutasteride), and tadalafil were extracted. Disproportionality analysis was performed to detect significant safety signals. AEs were classified using MedDRA terms.
RESULTS
Among 9,540 unique reports and 25,796 AEs entries, patients aged 65-80 years accounted for the majority of the reports. Most AEs occurred within 30 days of treatment initiation. Hospitalization was the most common serious outcome. Sixteen significant AEs were detected, including pollakiuria, gynecomastia, breast pain and so on, with distinct reporting patterns across drug classes.
CONCLUSIONS
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.
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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