US FDA Medwatch Program

The U.S. Food and Drug Administration (FDA) has the responsibility for assuring the safety and efficacy of all regulated marketed medical products in the United States.

MedWatch, The FDA Safety Information and Adverse Event Reporting Program, serves both healthcare professionals and the medical product-using public.

MedWatch – Home Page

Medwatch  – Safety Information

MedWatch – Consumers – How To Report

MedWatch – form 3500 for reporting to the FDA (pdf file)

  • MedWatch provides important and timely clinical information about safety issues involving medical products, including prescription and over-the-counter drugs, biologics, medical and radiation-emitting devices, and special nutritional products (e.g., medical foods, dietary supplements and infant formulas).
  • MedWatch provides medical product safety alerts, recalls, withdrawals, and important labeling changes that may affect the health of all Americans via the web site and the MedWatch E-list. Select “Safety Information” on the MedWatch website to see reports, safety notifications, and labeling changes posted to the website since 1996.
  • MedWatch allows healthcare professionals and consumers to report serious problems that they suspect are associated with the drugs and medical devices they prescribe, dispense, or use.
  • Reporting can be done on line, by phone, or by submitting the MedWatch 3500 form (PDF file) by mail or fax.
    Select “How to Report” on the MedWatch website for more details.

Report adverse experiences with:

  • Medications (drugs or biologics)
  • Medical devices (including in-vitro diagnostics)
  • Special nutritional products (dietary supplements, medical foods, infant formulas)
  • Cosmetics
  • Medication errors

Report product problems – quality, performance or safety concerns such as:

  • Suspected counterfeit product
  • Suspected contamination
  • Questionable stability
  • Defective components
  • Poor packaging or labeling
  • Therapeutic failures

Report SERIOUS adverse events. An event is serious when the patient outcome is:

  • Death Life-threatening (real risk of dying)
  • Hospitalization (initial or prolonged)
  • Disability (significant, persistent or permanent)
  • Congenital anomaly
  • Required intervention to prevent permanent impairment or damage

Report even if:

  • You’re not certain the product caused the event
  • You don’t have all the details