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FDA FAERS — Adverse-Event Drug Involvement (DRUG file)

The drug side of the FDA's adverse-event reports: for each reported event, which drugs were involved and whether each was the primary suspect, a secondary suspect, or taken alongside. A drug-safety surveillance signal.

What Vlada adds: Preserves the publisher data, normalizes schema eras and identifiers, and connects the product to compatible healthcare entities with measured join coverage.

rows
2.0M
rows
datasets
1
datasets
cadence
Varies by publisher release
cadence
coverage
2025
coverage

Publishers: U.S. Food and Drug Administration

What's inside

Primary dataset
FDA FAERS (Adverse Event Reporting System) DRUG file — per adverse-event report × drug: the drug's role (PS primary-suspect / SS secondary / C concomitant / I interacting), drug name, active ingredient, NDA number, route/dose, dechallenge/ rechallenge.
2.0M rows