FDA’s MedWatch

Report Your Adverse Event to the FDA

Adverse reactions should be reported to the FDA’s MedWatch system.

Report online

Go to the FDA website https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home.

Choose Begin Report As a Consumer/Patient.

Report by phone

Toll free: 1-800-FDA-1088

Report by fax or postal mail:

Download and print Form 3500B


Mail the form to:

Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

Or fax to: