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  1. MedWatch: The FDA Safety Information and Adverse Event Reporting Program

Medical Product Safety Information

MedWatch - your FDA gateway for clinically important safety information and reporting serious problems with human medical products

Safety Alerts for Human Medical Products (Drugs, Biologics, Medical Devices, Special Nutritional Products and Cosmetics)

MedWatch alerts provide timely new safety information on human drugs, medical devices, vaccines and other biologics, dietary supplements, and cosmetics. The alerts contain actionable information that may impact both treatment and diagnostic choices for healthcare professional and patient.

MedWatch 3500 Forms

Other FDA Safety-Related Information

DailyMed (FDA/National Library of Medicine) 

  • Comprehensive, up-to-date, look-up and download resource of medication content and labeling as found in medication package inserts

Drug Products

Medical Devices 

Biological Products

Main FDA Information Telephone Number: 1-888-INFO-FDA (1-888-463-6332)

Inquiries About Specific Products or Questions Regarding Adverse Event Reporting

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.
  • 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)

Resources For You

MedWatch safety alerts delivered to you

Clinically important and timely information about the drugs and devices you use, prescribe, or dispense every day, delivered to your email from the FDA.