Evaluating the Safety Profile of Alpha-1 Blockers, 5-Alpha-Reductase Inhibitors, and PDE5 Inhibitors for BPH: A Disproportionality Analysis of Real-World Adverse Events Based on FDA Adverse Event Reporting System
March 2026
in “
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TLDR These medications for BPH have known risks and may have new side effects.
This study analyzed the safety profiles of α1-blockers, 5α-reductase inhibitors, and PDE5I used for treating benign prostatic hyperplasia (BPH) by examining 9,540 reports and 25,796 adverse event entries from the FDA Adverse Event Reporting System between 2004 and 2025. The majority of reports involved patients aged 65–80, with most adverse events occurring within 30 days of starting treatment. Hospitalization was the most common serious outcome. Sixteen significant adverse events, such as pollakiuria and gynecomastia, were identified, showing distinct patterns across drug classes. The analysis confirmed known risks and suggested potential new adverse-event signals that require further investigation.
