MedWatch Voluntary Reporting Form


What to Report to FDA MedWatch:

Use the MedWatch form to report adverse events that you observe or suspect for human medical products, including serious drug side effects, product use/medication error, product quality problems, and therapeutic failures for:

  • Prescription or over-the-counter medicines, as well as medicines administered to hospital patients or at outpatient infusion centers
  • Biologics (including blood components, blood and plasma derivatives, allergenic, blood transfusions, gene therapies, and human cells and tissue transplants. For example, tendons, bone, and corneas)
  • Medical devices (including diabetes glucose-test kit, hearing aids, breast pumps, and many more products)
  • Combination products
  • Special nutritional products (dietary supplements, medical foods, infant formulas)
  • Cosmetics (such as moisturizers, makeup, shampoos and conditioners, face and body washes, deodorants, nail care products, hair dyes and relaxers, and tattoos)
  • Food (including beverages and ingredients added to foods)
  • Images (if attached) The image formats accepted by FDA are JPG, JPEG, GIF and PNG with a maximum total size of 8MB (usually 1-2 pictures from a phone camera)

What Not to Report to FDA MedWatch:

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