# How to file an FDA MedWatch adverse event report

> Step-by-step guide for patients to report drug side effects or device injuries to the FDA.

**Canonical URL:** https://drugsmonitor.com/guides/how-to-file-fda-medwatch-report
**Last updated:** 2026-06-11

MedWatch is the FDA's Safety Information and Adverse Event Reporting Program. Patients, caregivers, and healthcare professionals can submit reports online, by phone, or by mail about any medication or medical device.

To file a report, you will need the product name, manufacturer, date of use, description of the adverse event or problem, and your contact information. You can file anonymously if you prefer.

Patient reports help the FDA identify new safety signals and take regulatory action. Our FAERS guide white paper has more detail on how these reports are used in drug safety monitoring.

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*Educational guide from DrugsMonitor.com. Not legal advice.*