# FDA Adverse Event Reporting System (FAERS)

> A computerized database designed to support the FDA's post-market safety surveillance program for approved drugs and therapeutic biologic products.

**Category:** Regulatory
**Canonical URL:** https://drugsmonitor.com/glossary/faers
**Last updated:** 2026-06-11

FAERS contains millions of adverse event reports submitted since 1969. The database supports the FDA's ability to identify safety signals that may warrant regulatory action such as label changes, safety communications, or market withdrawal.

FAERS data is publicly searchable through the FDA's dashboard and the OpenFDA API. However, the data has important limitations: reports are not verified for accuracy, there is no control group, and reporting rates do not necessarily reflect actual incidence.

Despite its limitations, FAERS analysis plays a significant role in pharmaceutical litigation. An increase in reports of a specific injury following a drug launch can serve as evidence that the manufacturer had notice of a potential safety issue.

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*Glossary entry from DrugsMonitor.com.*