MedWatch – FDA Safety Information & Adverse Event Reporting Program

MedWatch is the U.S. Food and Drug Administration’s (FDA) program to collect data regarding adverse events in healthcare. What’s an adverse event? It’s an undesirable experience associated with the use of a medical product, such as over-the-counter (OTC) medicines or dietary supplements.

The MedWatch system collects reports of adverse events from consumers, healthcare professionals, and patients to help detect potential safety hazards. If a safety hazard is detected, the FDA can issue medical product safety alerts or order product recalls, withdrawals, or labeling changes to protect public health.

To learn more about MedWatch or report an adverse event, please visit the MedWatch website.