—
Public FDA reports indexed
Research prototype
Statistical screening for real-world adverse event signals
Ten tools for disproportionality screening, drug comparison, and case-level review — built directly on FDA's public AEMS/FAERS adverse-event index.
—
Dataset last updated
ROR
Reporting odds ratio
PRR
Proportional reporting ratio
Responsible interpretation
FDA states that adverse-event reports are not extensively validated and do not by themselves establish causality. A single report may list several drugs and reactions without linking a specific drug to a specific outcome. This tool therefore labels every result a statistical screening signal, never a confirmed safety finding — and every ROR/PRR calculation ships with its 95% confidence interval so the uncertainty is visible, not hidden in a single number.
02 · Drug analysis
Reaction profile by drug
Pulls every reaction term reported against a medicinal product, ranked by report volume, plus a live sex breakdown of the patients who experienced them.
03 · Reaction search
Drugs implicated by reaction / MedDRA PT
Search by symptom or MedDRA preferred term instead of by drug — pulls every medicinal product reported against that reaction, ranked by report volume. Plain-language terms (e.g. "heart attack", "throwing up") are matched to their MedDRA PT automatically.
04 · Compare drugs
Side-by-side comparison
Compares total report volume and top reaction terms for two drugs, so relative risk profiles are visible at a glance.
05 · Signal detection
Disproportionality screen
Builds the 2×2 contingency table for a drug–reaction pair across the full FAERS index and computes ROR and PRR with 95% confidence intervals.
06 · Outcome severity
Serious outcome breakdown
Shows what share of reports naming this drug were coded as death, hospitalization, disability, life-threatening, or another serious outcome.
07 · Trend
Report volume over time
Report counts by receive date — useful for spotting reporting spikes after label changes, media coverage, or REMS updates.
08 · Report viewer
Individual case safety report
Look up one public FAERS report by its safety report ID and see exactly what was submitted.
09 · Leaderboard
Top terms by openFDA aggregation
The highest-count raw text strings returned by openFDA's own frequency aggregation across the entire public FAERS index — not an independently-verified ranking.
10 · Recent reports
Latest public submissions
The 20 most recently received reports in the openFDA index.