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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 including those administered in hospitals or outpatient infusion centers.
  • Biologics such as blood components, blood/plasma derivatives, blood transfusions, gene therapies, and human cells and tissue transplants.
  • Medical devices such as diabetes glucose-test kit, hearing aids, breast pumps, and many more products.
  • Combination products such as pre-filled drug syringe, auto-injectors, metered-dose inhalers, nasal spray and contact lens coated with a drug.
  • Special nutritional products such as dietary supplements, medical foods and infant formulas.
  • Cosmetics such as moisturizers, makeup, shampoos, conditioners, hair dyes and tattoos.
  • Food such as beverages and ingredients added to foods.

Other products that the FDA regulates such as tobacco products, vaccines and animal/livestock medicine and feed utilize different reporting pathways. It is recommended that reports concerning these products be submitted directly to the appropriate portals below.

Note that submissions for these products through MedWatch will be accepted and directed to the correct center or office.



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.