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 MedWatch logoThe FDA Safety Information and Adverse Event Reporting Program

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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:

Product Type E-mail Inquiries Telephone Inquiries
Drugs Drug Information Questions and Comments Division of Drug Information,
Special Nutritional Products
(dietary supplements, infant formulas, and medical foods) and Cosmetics
Food, Nutrition, and Cosmetics Questions & Answers 1-888-723-3366
Medical Devices Center for Devices and Radiological Health Comments and Feedback Page


Vaccines, blood products, other biologics Center for Biologics Evaluation and Research Contact Page 1-800-835-4709


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 System (VAERS)
    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).

  • Manufacturer 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)
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