U.S. flag An official website of the United States government
  1. Home
  2. Safety
  3. MedWatch: The FDA Safety Information and Adverse Event Reporting Program
  4. Medical Product Safety Information
  5. MedWatch Forms for FDA Safety Reporting
  1. Medical Product Safety Information

MedWatch Forms for FDA Safety Reporting

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 3500 - Voluntary Reporting (pdf) and Instructions for Completing Form FDA 3500 
For use by healthcare professionals, consumers, and patients.

Form FDA 3500B - Voluntary Reporting for Consumers
A consumer-friendly version of the 3500 reporting form.

 FDA Form 3500A pdf

Form FDA 3500A - Mandatory Reporting and Instructions for Completing Form FDA 3500A
Mandatory reporting For use by IND reporters, manufacturers, distributors, importers, user facilities personnel.

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

MedWatch Safety Information

Clinically important medical product safety alerts and timely information about the products you use, prescribe, or dispense every day.