Why Report Serious or Unexpected ADEs to MedWatch
MedWatch is 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 tobacco products, vaccines, and animal drugs, devices and food, including pet food. These products utilize different reporting pathways and it is recommended that reports concerning these products be submitted directly to the appropriate portals.
Learn more about the FDA safety programs on the FDA website .
Reporting serious or common adverse events involving any of the above should be made to the MedWatch program as recommended in the Indian Health Manual. We request that you include “IHS” in the reporter section (section G).