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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
    11. (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
    12. Safety Assessment of Ritlecitinib Based on the FDA Adverse Event Reporting System (FAERS) Database: A Real‐World Pharmacovigilance Study The Journal of Dermatology · 2025
    13. Cutaneous adverse reactions associated with enfortumab vedotin: a pharmacovigilance study based on the FDA adverse event reporting system Frontiers in Medicine · 2026
    14. 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
    15. 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
    16. 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
    17. Ovary and uterus related adverse events associated with statin use: an analysis of the FDA Adverse Event Reporting System Scientific Reports · 2020 · 11 citations
    18. Safety concerns of paternal drug exposure on fertility, pregnancy and offspring: An analysis based on the FDA adverse event reporting system Andrology · 2024
    19. A disproportionality analysis of adverse events caused by pexidartinib from the FDA adverse event reporting system Scientific Reports · 2025 · 2 citations
    20. 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
    21. Safety profile of ipilimumab in elderly patients: a disproportionate analysis based on the FDA Adverse Event Reporting System database Frontiers in Oncology · 2026
    22. Safety Profile of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors: A Disproportionality Analysis of FDA Adverse Event Reporting System Scientific Reports · 2020 · 58 citations
    23. 0557 Possible Contributory and Protective Factors in Medication Associated Obstructive Sleep Apnea (OSA): Results from the US Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS) Sleep · 2020
    24. 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
    25. 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
    26. Post-marketing safety profile of cladribine in multiple sclerosis: a disproportionality analysis based on the FDA adverse event reporting system International Journal of Clinical Pharmacy · 2025 · 1 citations
    27. 0917 Finasteride is Associated with a Higher Odds of Obstructive Sleep Apnea (OSA): Results from the US FDA Adverse Events Reporting System (FAERS) Sleep · 2018 · 1 citations
    28. 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
    29. 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
    30. 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