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.
- Tobacco or E-cigarettes: Report problems or adverse health events and tobacco product problems that include e-cigarettes (also known as "vapes"), e-liquids, heated tobacco products, cigarettes, roll-your-own cigarettes, cigars, little cigars, pipes, waterpipes (also known as hookah), chewing tobacco, snuff, or snus. Report issues to the Safety Reporting Portal.
- Vaccines: Report vaccine events to the Vaccine Adverse Event Reporting System (VAERS) online.
- Animal Drug, Device, Vaccine and Food Product Problems: Visit CVM (Center for Veterinary Medicine) website for more information.
Note that submissions for these products through MedWatch will be accepted and directed to the correct center or office.