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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-induced erectile dysfunction: a real-world pharmacovigilance study using the FDA adverse event reporting system database Expert Opinion on Drug Safety · 2024 · 1 citations
    2. Drug-associated insomnia: A pharmacovigilance study based on FDA adverse event reporting system Medicine · 2026
    3. 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
    4. 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
    5. Drug related lipid metabolism abnormalities: a real-world pharmacovigilance exploratory analysis based on U.S. FDA adverse event reporting system (FAERS) Nutrición Hospitalaria · 2026
    6. Real-world safety of ixekizumab: a disproportionality analysis using the FDA adverse event reporting system and the VigiAccess databases Frontiers in Medicine · 2025
    7. 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
    8. Cyclosporine-induced alopecia:a case report, FDA adverse event reporting system analysis and literature assessment Frontiers in Pharmacology · 2024
    9. 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
    10. 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
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    1. Low Level Laser Therapy Red-light devices, such as caps, combs and helmets, used on the scalp
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