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 “ The Aging Male ”
    Zihao Zhao, Changjing Wu, Yang Xiong … Jiuhong Yuan
    Studysummary 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.
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    Research cited in this study 4

    1. Risk of Depression Associated with Finasteride Treatment Journal of Clinical Psychopharmacology · 2021
    2. Dutasteride‐mediated morphological changes in the genitourinary tract associated with altered expression patterns of the androgen and estrogen receptors in male rats Andrology · 2016
    3. Dihydrotestosterone And The Prostate: The Scientific Rationale For 5α-Reductase Inhibitors In The Treatment Of Benign Prostatic Hyperplasia ˜The œJournal of urology/˜The œjournal of urology · 2004
    4. The Long-Term Effect of Doxazosin, Finasteride, and Combination Therapy on the Clinical Progression of Benign Prostatic Hyperplasia The New England Journal of Medicine · 2003