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This retrospective pharmacovigilance study reviewed adverse event reports from 2004 to 2025 for drugs treating benign prostatic hyperplasia, identifying distinct safety signals for α1-blockers, 5ARIs, and PDE5I, including some potential new adverse events that require further investigation.

This study found that in men with benign prostatic hyperplasia, 5-alpha reductase inhibitors significantly increased the risk of gynecomastia and breast tenderness compared to placebo or alpha-blockers.

This study found that 5-α reductase inhibitors do not significantly increase the risk of erectile dysfunction in men with benign prostatic hyperplasia or alopecia, although duration of benign prostatic hyperplasia may elevate risk.

This study found that combining 5-alpha reductase inhibitors with alpha-blockers provided the best symptomatic relief and reduced the risk of clinical progression for BPH, while PDE5 inhibitors could offset sexual side effects.

This review discusses recent developments in α1-adrenoceptor antagonists and 5α-reductase inhibitors for treating benign prostatic hyperplasia, reporting no new clinical results while identifying potential areas for future drug development.