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

Reporting Serious Problems to FDA

Thank you for visiting the MedWatch Web site to voluntarily report a serious adverse event, product quality problem, product use/medication error, or therapeutic inequivalence/failure that you suspect is associated with the use of an FDA-regulated drug, biologic, medical device, dietary supplement or cosmetic. You can also report suspected counterfeit medical products to FDA through MedWatch. The instructions on this webpage apply to both consumers and healthcare professionals who are submitting reports on a voluntary basis, and to certain entities with mandatory reporting obligations under FDA regulations.

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 - Voluntary Reporting for Consumers (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 and Veterinary Products
For use by industry, health professionals and consumers.

Find safety information on animal & veterinary products.

 

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.