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    Glossary FDA Adverse Event Reporting System

    database tracking drug and biologic safety issues post-marketing

    The FDA Adverse Event Reporting System (FAERS) is a database managed by the U.S. Food and Drug Administration that collects information on adverse events and medication errors reported by healthcare professionals, consumers, and manufacturers. This system helps the FDA monitor the safety of drugs and biologics after they are marketed, ensuring that any potential risks are identified and managed appropriately.

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    1. (719) Signal Detection of Depression and Suicidality With the 5-Alpha Reductase Inhibitors: Evidence from the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) Database The Journal of Sexual Medicine · 2026
    2. Adverse event reporting of four anti-Calcitonin gene-related peptide monoclonal antibodies for migraine prevention: a real-world study based on the FDA adverse event reporting system Frontiers in Pharmacology · 2024 · 30 citations
    3. Drug-induced erectile dysfunction: a real-world pharmacovigilance study using the FDA adverse event reporting system database Expert Opinion on Drug Safety · 2024 · 1 citations
    4. Drug-associated insomnia: A pharmacovigilance study based on FDA adverse event reporting system Medicine · 2026
    5. Impact of Reporter Type on Signal Detection of Cancer Therapy-Induced Alopecia: A Hypothesis-Generating Study Using the FDA Adverse Event Reporting System Pharmaceuticals · 2026
    6. Impact of Reporter Type on Signal Detection of Cancer Therapy–Induced Alopecia: A Hypothesis-Generating Study Using the FDA Adverse Event Reporting System Preprints.org · 2026
    7. Oral finasteride use and sexual adverse events: signal detection from disproportionality analyses of data from the United States Food and Drug Administration Adverse Event Reporting System Journal of Dermatological Treatment · 2026
    8. Drug related lipid metabolism abnormalities: a real-world pharmacovigilance exploratory analysis based on U.S. FDA adverse event reporting system (FAERS) Nutrición Hospitalaria · 2026
    9. Real-world safety of ixekizumab: a disproportionality analysis using the FDA adverse event reporting system and the VigiAccess databases Frontiers in Medicine · 2025
    10. Risk assessment of the top 60 drugs for drug-related sexual dysfunction: a disproportion analysis from the Food and Drug Administration adverse event reporting system The Journal of Sexual Medicine · 2025
    11. 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 PLoS ONE · 2025
    12. Cyclosporine-induced alopecia:a case report, FDA adverse event reporting system analysis and literature assessment Frontiers in Pharmacology · 2024
    13. 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
    14. Correction to: An evaluation of the federal adverse events reporting system data on adverse effects of 5‑alpha reductase inhibitors World journal of urology · 2021
    15. A cross‐sectional analysis of medications used by patients reporting alopecia areata on the FDA adverse events reporting system International Journal of Dermatology · 2024 · 6 citations
    16. Association of alopecia areata with COVID-19 vaccination: A vaccine adverse events reporting system analysis Dermatology Online Journal · 2026
    17. Cutaneous adverse reactions associated with enfortumab vedotin: a pharmacovigilance study based on the FDA adverse event reporting system Frontiers in Medicine · 2026
    18. Safety Assessment of Ritlecitinib Based on the FDA Adverse Event Reporting System (FAERS) Database: A Real‐World Pharmacovigilance Study The Journal of Dermatology · 2025
    19. Is the Safety of Finasteride Correlated With Its Route of Administration: Topical Versus Oral? A Pharmacovigilance Study With Data From the United States Food and Drug Administration Adverse Event Reporting System International Journal of Dermatology · 2025
    20. Ovary and uterus related adverse events associated with statin use: an analysis of the FDA Adverse Event Reporting System Scientific Reports · 2020 · 11 citations
    21. Signal Detection for Adverse Events of Finasteride Using Korea Adverse Event Reporting System (KAERS) Database Korean Journal of Clinical Pharmacy · 2021 · 2 citations
    22. Evaluating the safety profile of α-1 blockers, 5α-reductase inhibitors, and PDE5I for BPH: a disproportionality analysis of real-world adverse events based on FDA adverse event reporting system (FAERS) Figshare · 2026
    23. Safety concerns of paternal drug exposure on fertility, pregnancy and offspring: An analysis based on the FDA adverse event reporting system Andrology · 2024
    24. Low‐Dose Oral Minoxidil and Associated Adverse Events: Analyses of the FDA Adverse Event Reporting System (FAERS) With a Focus on Pericardial Effusions Journal of Cosmetic Dermatology · 2024
    25. A pharmacovigilance study of drug‐reduced male semen quality based on the Food and Drug Administration adverse event reporting system database Andrology · 2024
    26. Drug-Induced Hair Loss: Analysis of the Food and Drug Administration’s Adverse Events Reporting System Database Skin Appendage Disorders · 2024
    27. Safety profile of human papilloma virus vaccines: an analysis of the US Vaccine Adverse Event Reporting System from 2007 to 2017 British Journal of Clinical Pharmacology · 2018 · 22 citations
    28. A disproportionality analysis of adverse events caused by pexidartinib from the FDA adverse event reporting system Scientific Reports · 2025 · 2 citations
    29. Evaluating the safety profile of α-1 blockers, 5α-reductase inhibitors, and PDE5I for BPH: a disproportionality analysis of real-world adverse events based on FDA adverse event reporting system (FAERS) The Aging Male · 2026
    30. Response to “The Role of Patient‐ and Drug‐Related Factors in Oral Minoxidil and Pericardial Effusion: Analyses of Data From the United States Food and Drug Administration Adverse Event Reporting System” Journal of Cosmetic Dermatology · 2025