MedWatch Online 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, medication errors/product use errors, 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, human cells, tissues, and cellular and tissue-based products (HCT/Ps))
  • Medical devices (including in vitro diagnostic products)
  • Combination products
  • Special nutritional products (infant formulas, and medical foods)
  • Cosmetics
  • Foods/beverages (including reports of serious allergic reactions)

What Not to Report to FDA MedWatch: