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 “ Figshare
    Zihao Zhao, Changjing Wu, Yang Xiong, Wei Wang, Feng Qin, Jihai Yuan
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    TLDR These medications for BPH have known risks and may have new side effects.
    The study evaluates the safety profiles of α-1 blockers, 5α-reductase inhibitors (5ARIs), and phosphodiesterase type 5 inhibitors (PDE5I) used for benign prostatic hyperplasia (BPH) by analyzing adverse events reported in the FDA Adverse Event Reporting System (FAERS). The analysis includes drugs such as Tamsulosin, Silodosin, Doxazosin, Alfuzosin, Terazosin, Finasteride, Dutasteride, and Tadalafil. The study aims to identify any disproportionality in adverse events associated with these medications, providing insights into their safety in real-world settings. However, specific conclusions or findings from the analysis are not detailed in the provided text.
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