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
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM349464.pdf
Mail the form to:
MedWatch
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Or fax to:
1-800-332-0178