What is FAERS? The FDA Adverse Event Reporting System (FAERS) contains millions of voluntary adverse event reports from healthcare professionals, patients, and manufacturers. It is the world's largest pharmacovigilance database — but it has important limitations: reports ≠ causality, underreporting is substantial, and early drugs accumulate more reports (Weber effect). Use alongside clinical judgment, not instead of it.
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See real-world adverse event reports from the FDA FAERS database — top reactions, serious outcome rates, and demographic breakdown. Educational pharmacovigilance training.