FDA MedWatch

Also known as: FDA MedWatch consumer reporting

US FDA adverse-event and product-problem reporting program with public safety communications and reporting channels.

Real-World Data Snapshot

Verified

Verification

Verified

Coverage

1 country

Access Model

Open access

Last Verified

Apr 7, 2026

Methodology

Safety reports are submitted by consumers and professionals, reviewed by FDA, and used for pharmacovigilance workflows.

Safety monitoring registriesWeeklySafety surveillance data

Primary Dataset

Source Evidence

2 sources

MedWatch Program

https://www.fda.gov/medwatch-fda-safety-information-and-adverse-event-reporting-program

Reporting Serious Problems to FDA (MedWatch)

https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda