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
    Studysummary This study analyzed adverse event reports from the FDA Adverse Event Reporting System and identified new side effects of topical minoxidil, such as application site acne and cysts, which are not well-documented on product labels, suggesting a need for updated safety information.
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    Research cited in this study 13

    1. Clinical Efficacy and Safety of Low-Dose Oral Minoxidil Versus Topical Solution in the Improvement of Androgenetic Alopecia: A Randomized Controlled Trial Journal of Cosmetic Dermatology · 2023
    2. Androgenetic Alopecia: Therapy Update Drugs · 2023
    3. Topical Minoxidil-Induced Paresthesia Dermatologic therapy · 2022
    4. Minoxidil: A Comprehensive Review Journal of Dermatological Treatment · 2021
    5. Androgenetic Alopecia in Women and Men: Italian Guidelines Adapted from European Dermatology Forum/European Academy of Dermatology and Venereology Guidelines Giornale italiano di dermatologia e venereologia · 2020
    6. Minoxidil and Its Use in Hair Disorders: A Review DOAJ (DOAJ: Directory of Open Access Journals) · 2019
    7. Tretinoin Enhances Minoxidil Response in Androgenetic Alopecia Patients by Upregulating Follicular Sulfotransferase Enzymes Dermatologic Therapy · 2019
    8. A Randomized, Double-Blind Controlled Study of the Efficacy and Safety of Topical Solution of 0.25% Finasteride Admixed with 3% Minoxidil vs. 3% Minoxidil Solution in the Treatment of Male Androgenetic Alopecia Journal of The European Academy of Dermatology and Venereology · 2018
    9. Facial Eruptive Vellus Hair Cysts After 3% Minoxidil Application Annals of Dermatology · 2018
    10. Differences in Reproductive Toxicology Between Alopecia Drugs: An Analysis on Adverse Events Among Female and Male Cases Oncotarget · 2016
    11. Pseudofolliculitis Barbae Induced by Oral Minoxidil Clinical and experimental dermatology · 2012
    12. A Randomized Clinical Trial of 5% Topical Minoxidil Versus 2% Topical Minoxidil and Placebo in the Treatment of Androgenetic Alopecia in Men Journal of The American Academy of Dermatology · 2002
    13. Scalp Comedones After Topical Minoxidil Journal of The American Academy of Dermatology · 1985

    Related research 1

    1. Multidimensional Assessment of Adverse Events of Finasteride: A Real-World Pharmacovigilance Analysis Based on FDA Adverse Event Reporting System (FAERS) from 2004 to April 2024 medRxiv (Cold Spring Harbor Laboratory) · 2024