Intel · Mass Tort Glossary

FAERS (FDA Adverse Event Reporting System)

The FDA's database of adverse event reports submitted by healthcare providers, manufacturers, and patients following use of drugs and medical devices. FAERS contains over 10 million reports and is a primary source for early causation signal detection. Disproportionality analysis (PRR, ROR) of FAERS data identifies drug-event combinations reported at rates significantly above background.

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