MedWatch Learn
FDA MedWatchLearn teaches health professionals, and consumers how to complete the forms necessary to report problems to FDA. Here, you have the opportunity to practice filling out FDA Form 3500 (for health professionals) or FDA Form 3500B (for consumers).
Learn more about MedWatch medical product safety or submit an actual report.
To start, select either “Health Professional” or “Consumer/Patient”.
Health Professional
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, 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) online at https://vaers.hhs.gov/reportevent.html.
- Animal Drug, Device, Vaccine and Food Product Problems: Report animal and livestock product problems https://www.fda.gov/animal-veterinary/report-problem/how-report-animal-drug-side-effects-and-product-problems.
Note that submissions for these products through MedWatch will be accepted and directed to the correct center or office.
