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    Did you mean FDA Adverse Event Reporting System?
    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
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