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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. Drug related lipid metabolism abnormalities: a real-world pharmacovigilance exploratory analysis based on U.S. FDA adverse event reporting system (FAERS) Nutrición Hospitalaria · 2026
    2. Suicidal behaviors (suicidal ideation, suicide attempt and completed suicide) in patients treated with finasteride for hair loss: Results from the U.S. FDA Adverse Event Reporting System (FAERS) database Journal of The American Academy of Dermatology · 2018
    3. 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
    4. Drug-associated insomnia: A pharmacovigilance study based on FDA adverse event reporting system Medicine · 2026
    5. Drug-Induced Hair Loss: Analysis of the Food and Drug Administration’s Adverse Events Reporting System Database Skin Appendage Disorders · 2024
    6. A Real‐World Disproportionality Analysis of Avacopan in Anti‐Neutrophil Cytoplasmic Antibodies Associated Vasculitis: Insights From FDA Adverse Event Reporting System Pharmacology Research & Perspectives · 2025 · 2 citations
    7. 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
    8. A disproportionality analysis of adverse events caused by pexidartinib from the FDA adverse event reporting system Scientific Reports · 2025 · 2 citations
    9. Real-world study of adverse events associated with gepant use in migraine treatment based on the VigiAccess and U.S. Food and Drug Administration’s adverse event reporting system databases Frontiers in Pharmacology · 2024 · 25 citations
    10. A pharmacovigilance study of drug‐reduced male semen quality based on the Food and Drug Administration adverse event reporting system database Andrology · 2024
    11. 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
    12. Sun protection policies and behaviors among U.S. child care centers Journal of The American Academy of Dermatology · 2018
    13. How routine pharmacovigilance failed to identify finasteride’s persistent sexual side effects International Journal of Andrology · 2021
    14. Supplementary Material for: Finasteride and Suicide: A Postmarketing Case Series Figshare · 2020
    15. Machine Learning--Enhanced Pharmacovigilance Assessment of Cardiac Adverse Events Associated With Minoxidil 2026
    16. Adverse events associated with vismodegib: insights from a real-world pharmacovigilance study using the FAERS database Frontiers in Pharmacology · 2025 · 3 citations
    17. Sunscreen: Cosmetic or medical therapy? Journal of The American Academy of Dermatology · 2018
    18. Real-world safety of Tepotinib: Insights from the Food and Drug Administration Adverse Event Reporting System PLoS ONE · 2025 · 1 citations
    19. Sun behaviors and quality of life after first cutaneous melanoma diagnosis Journal of The American Academy of Dermatology · 2018
    20. (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
    21. 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
    22. Cutaneous adverse reactions associated with enfortumab vedotin: a pharmacovigilance study based on the FDA adverse event reporting system Frontiers in Medicine · 2026
    23. Safety profile of ipilimumab in elderly patients: a disproportionate analysis based on the FDA Adverse Event Reporting System database Frontiers in Oncology · 2026
    24. Safety Profile of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors: A Disproportionality Analysis of FDA Adverse Event Reporting System Scientific Reports · 2020 · 58 citations
    25. Cyclosporine-induced alopecia:a case report, FDA adverse event reporting system analysis and literature assessment Frontiers in Pharmacology · 2024
    26. 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
    27. Real-world safety of ixekizumab: a disproportionality analysis using the FDA adverse event reporting system and the VigiAccess databases Frontiers in Medicine · 2025
    28. 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
    29. 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
    30. 054 Post Finasteride Syndrome: Guess Who-Demographics from FDA Database The Journal of Sexual Medicine · 2016