The Data Developers
Regulatory

FDA Adverse Event Signal Intelligence (FAERS)

All seven linked adverse event tables — case demographics, suspect drugs, reactions, outcomes, indications, therapy details, report sources — fully normalized with PRR signal scores pre-computed.

25M+ reports Quarterly Updated 2026-07-01

Overview

All seven linked adverse event tables — case demographics, suspect drugs, reactions, outcomes, indications, therapy details, report sources — fully normalized with PRR signal scores pre-computed.

Query normalized adverse event case, drug, reaction, outcome, indication, and reporter dimensions immediately.

Rank drug-event pairs by PRR score, seriousness outcome, label coverage, and unlabeled signal tier.

Connect safety signals to FDA label history, REMS programs, indications, and lifecycle events.

Audit source lineage by FAERS quarter, case version, and deduplication status.

Source authority

U.S. Food and Drug Administration — FAERS

Freshness

Last refreshed 2026-07-01

Quarterly

Coverage

25M+ reports

2 delivery tables