FDA AEMS Adverse Events

The FDA AEMS Adverse Events Dataset unifies 20M+ U.S. FDA adverse event reports for both drugs and medical devices into a single, analysis-ready schema — with built-in pharmacovigilance signal detection so safety teams move straight from raw reports to actionable signals. Sourced from the FDA's openFDA FAERS (drug) and MAUDE (device) systems and normalized into one consistent set of tables, it removes the work of parsing openFDA JSON and stitching two separate reporting systems together.

It ships with precomputed Proportional Reporting Ratio (PRR), 95% confidence intervals, and an IS_SIGNAL flag for fast disproportionality triage; MedDRA-coded reactions; openFDA drug enrichment (NDC, RxNorm, UNII, pharmacologic class, brand & generic); full-text device MDR narratives for NLP; and pre-built manufacturer rollups and surveillance dashboards.

Every event traces back to its source report, and new data lands the day openFDA publishes it. AEMS is the successor to our standalone FDA FAERS and FDA MAUDE products.