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  3. MedWatch: The FDA Safety Information and Adverse Event Reporting Program
  4. Reporting Serious Problems to FDA
  1. MedWatch: The FDA Safety Information and Adverse Event Reporting Program

Reporting Serious Problems to FDA

 

MedWatch Form 3500B English

Español

MedWatch is the Food and Drug Administration's (FDA) program for reporting serious reactions, product quality problems, therapeutic inequivalence/failure, and product use errors with human medical products, including drugs, biologic products, medical devices, dietary supplements, infant formula, and cosmetics.

If you think you or someone in your family has experienced a serious reaction to a medical product, you are encouraged to take the reporting form to your doctor. Your health care provider can provide clinical information based on your medical record that can help FDA evaluate your report.

However, we understand that for a variety of reasons, you may not wish to have the form filled out by your health care provider, or your health care provider may choose not to complete the form. Your health care provider is NOT required to report to the FDA. In these situations, you may complete the Online Reporting Form yourself.

Voluntary Reporting by Consumers, Patients and Health Professionals

In order to keep effective medical products available on the market, the FDA relies on the voluntary reporting of these events. FDA uses these data to maintain our safety surveillance of these products. Your report may be the critical action that prompts a modification in use or design of the product, improves its safety profile and leads to increased patient safety.

If the link to the PDF voluntary reporting form (below) does not automatically open the form in your browser, try installing the latest version of the free Adobe Acrobat Reader.

For Use By Form

Health Professionals, Patients, and Consumers
Easy online, voluntary reporting for health professionals, patients, and consumers.

Online Reporting Form

Health Professionals
For use by health professionals, consumers, and patients. Instructions for Completing Form FDA 3500

Form FDA 3500 - Voluntary Reporting (pdf)

Patients and Consumers
A consumer-friendly version of the 3500 reporting form.

Form FDA 3500B for Consumer Reporting (pdf)

Industry (Mandatory)
Reporting by IND reporters, manufacturers, distributors, importers, user facilities personnel. 

These particular reports must be submitted in an electronic format that FDA can process, review, and archive.  See the guidance for industry “Providing Submissions in Electronic Format —Postmarketing Safety Reports”.

Pacientes y consumidores
Para uso de pacientes y consumidores.

Form FDA 3500b - Denuncia Voluntaria del Consumidor FORMULARIO FDA 3500B (pdf)

Regulated Medical Product  Website

Tobacco, Cigars, E-cigarettes/Vaping and Chewing Tobacco
For use by health professionals, consumers, and patients.

Safety Reporting Portal

Vaccines
For use by health professionals, consumers, and patients.  		Vaccine Online Reporting

Animal Food, Drugs and Devices
For use by industry, veterinarians and animal owners.

Report a problem with an animal or veterinary product

Related Information for Consumers

  • If you need information or if you have questions or comments about a medical product, please call the FDA's toll-free information line, 1-888-INFO-FDA (1-888-463-6332) Press 2 to report into MedWatch or for instructions.

Guides to Reporting Problems to FDA

Videos

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.

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