# Adverse Event Report (AER)

> A report submitted to the FDA describing a negative medical occurrence associated with the use of a drug or medical device.

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

Adverse event reports are submitted to the FDA's Adverse Event Reporting System (FAERS) by manufacturers, healthcare providers, and consumers. Manufacturers are legally required to report adverse events they receive within specific timeframes.

FAERS data is publicly available through the OpenFDA platform. While useful for identifying safety signals, AERs alone do not prove causation because they include unverified reports without established causal relationships.

Plaintiffs' attorneys often analyze FAERS data to identify patterns of adverse events that may indicate a safety issue. An increase in reports of a particular injury following a drug's approval can support a failure-to-warn claim.

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*Glossary entry from DrugsMonitor.com.*