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MedWatch Online Voluntary Reporting Form
Welcome
What to Report to FDA MedWatch:
Use the MedWatch form to report adverse events that you observe or suspect for human medical products, including serious drug side effects, product use errors, product quality problems, and therapeutic failures for:
- Prescription or over-the-counter medicines, as well as medicines administered to hospital patients or at outpatient infusion centers
- Biologics (including blood components, blood and plasma derivatives, allergenic, human cells, tissues, and cellular and tissue-based products (HCT/Ps))
- Medical devices (including in vitro diagnostic products)
- Combination products
- Special nutritional products (dietary supplements, infant formulas, and medical foods)
- Cosmetics
- Foods/beverages (including reports of serious allergic reactions)
What Not to Report to MedWatch:
- Vaccines: Report vaccine events to the Vaccine Adverse Event Reporting System (VAERS) online at https://vaers.hhs.gov/esub/step1
- Investigational (study) drugs: Report investigational (study) drug adverse events as required in the study protocol and send to the address and contact person listed in the study protocol.
- Mandatory reporting by regulated industry:
- Reporting on Dietary Supplements
- Reporting on Veterinary Medicine Products
- Reports FDA Does Not Handle (e.g. CPSC, FTC, State Health Departments) and Where to Send Them
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