Assessing the Safety of Topical Minoxidil Through Disproportionality Analysis of FAERS Reports

    February 2025 in “ Expert Opinion on Drug Safety ”
    Yanbo Li, Bo Liu, Wei Wu, Jian Li
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    TLDR Topical minoxidil may cause more side effects than currently listed, needing updated safety information.
    This study analyzed 45,130 adverse event reports from the FDA Adverse Event Reporting System (FAERS) to assess the safety of topical minoxidil, a treatment for androgenetic alopecia. The analysis revealed a significant increase in adverse events since 2015, with newly identified issues such as application site acne and cysts, which are not well-documented on current product labels. The findings highlight the need for updated patient information and regulatory reassessment to improve safety and inform clinical practices. The authors reported no conflicts of interest, and the study was not funded.
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