# MedWatch

> The FDA's safety information and adverse event reporting program for healthcare professionals, patients, and consumers.

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

MedWatch is the primary portal for reporting serious adverse events, product quality problems, and medication errors to the FDA. Reports can be submitted online, by phone, or through the mail, and may be filed anonymously.

Reports submitted through MedWatch become part of the FAERS database and contribute to the FDA's ability to identify safety signals requiring regulatory action. Patient reports have led to important safety label changes and market withdrawals.

The MedWatch program also distributes FDA safety alerts and provides educational materials about recognizing and reporting adverse events. Patients are encouraged to report any serious side effect regardless of whether a causal link has been established.

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*Glossary entry from DrugsMonitor.com.*