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MedWatch: The FDA Safety Information and Adverse Event Reporting Program

MedWatch, the FDA’s medical product safety reporting program for health professionals, patients and consumers.

MedWatch receives reports from the public and when appropriate, publishes safety alerts for FDA-regulated products such as:

  • Prescription and over-the-counter medicines
  • Biologics such as blood components, blood/plasma derivatives and gene therapies.
  • Medical devices such as hearing aids breast pumps, and pacemakers.
  • Combination products such as pre-filled drug syringe, metered-dose inhalers and nasal spray.
  • Special nutritional products such as dietary supplements, medical foods and infant formulas.
  • Cosmetics such as moisturizers, makeup, shampoos, hair dyes and tattoos.
  • Food such as beverages and ingredients added to foods.

Other products that the FDA regulates include , , and animal drug, device, pet food and livestock feed. These products utilize different reporting pathways and it is recommended that reports concerning these products be submitted directly to the appropriate portals.



Date Safety Alert Product Type

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Your FDA gateway for clinically important safety information and reporting serious problems with human medical products.

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