Medical Product Safety Information
MedWatch Safety Information
Other FDA Safety-Related Information
Inquiries About Specific Products
FDA Index - Use the FDA Web Site Index to look up a specific product, or:
Access to FDA Safety Data
- Adverse Event Reporting System (AERS)
AERS collects information about adverse events, medication errors and product problems that occur after the administration of approved drug and therapeutic biologic products. Quarterly (noncumulative) data files since January 2004 are available for downloading on the AERS website.
- Vaccine Adverse Event Reporting
VAERS is a cooperative program for vaccine
safety of the Centers for Disease Control and Prevention (CDC)
and the Food and Drug Administration (FDA). VAERS collects
information about adverse events that occur after the administration
of U.S. licensed vaccines.
- The Special
Nutritionals Adverse Event Monitoring System
Adverse event (illness or injury) reports
associated with use of dietary supplements, infant formulas,
and medical foods. (1993-1998 data).
and User Facility Device Experience Database (MAUDE)
Search database information of all voluntary
reports since June, 1993, user facility reports since 1991,
distributor reports since 1993, and manufacturer reports since
August, 1996. (MDR Data files, 1992-1996)