1. Home
  2. Safety
  3. MedWatch: The FDA Safety Information and Adverse Event Reporting Program
  1. Safety

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 a hospital 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 prefilled drug syringe, auto-injectors, metered-dose inhalers, contact lens coated with a drug and nasal-spray.
  • Cannabinoid hemp products such as products containing CBD.
  • Cosmetics such as moisturizers, shampoos, conditioners, hair dyes and tattoos.

Other products that the FDA regulates include tobacco products, vaccines, and animal drug, device, pet food and livestock feed. These products use 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.
Back to Top