Voluntary Reporting For use by Health Professionals, Consumers, and Patients
Reporting can be done through our online reporting portal or by downloading, completing and then submitting FDA Form 3500 (health professional) or 3500B (consumer/patient) to MedWatch:The FDA Safety Information and Adverse Event Reporting Program,
Form FDA 3500B - Voluntary Reporting for Consumers
A consumer-friendly version of the 3500 reporting form.
Online Voluntary Reporting
Easy online reporting with a by Health Professionals and Consumers and Patients.
Form FDA 3500b - Denuncia Voluntaria del Consumidor FORMULARIO FDA 3500B (En Español).
Siga las instrucciones en el formulario para mandarlo por fax o enviarlo por correo.
Where to Report Other FDA Regulated Product Safety Information
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, E-cigarettes or Vaping: Report problems or adverse health events and tobacco product problems to include problems with 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).
- Animal Drug, Device, Vaccine and Food Product Problems: For information on who to report animal and livestock product problems please visit the FDA.GOV website.
Note that submissions for these products through MedWatch will be accepted and directed to the correct.
Resources For You
- Join MedWatch Alerts E-list
- Reporting Unlawful Sales of Medical Products on the Internet
CME America Announces a Follow-Up on the Voluntary Recall of BodyGuard® Infusion System Administration Sets
Granules Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity