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        MedWatch: The FDA Safety Information and Adverse Event Reporting Program

Reporting Serious Problems to FDA

                        
                What is a Serious Adverse Event?
          Product Problems
          Reporte  problemas serios a la FDA
          ¿Qué es una reacción adversa grave?
          Problemas con los productos Home
          Safety
          MedWatch: The FDA Safety Information and Adverse Event Reporting Program
          Reporting Serious Problems to FDAMedWatch: The FDA Safety Information and Adverse Event Reporting Program Reporting Serious Problems to FDA
  	
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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

MedWatch*Learn* - Teaching students, health professionals, and consumers how to report problems to FDA
	FDA 101: How to Use the Consumer Complaint System and MedWatchVideos

MedWatch Minute for Consumers
	Minuto de MedWatch para los consumidores
	MedWatch Minute for Health Care ProfessionalsResources For You

Where to Send Completed Form FDA 3500A MANDATORY Reporting Form
	Drug/Biologic/Human Cell, Tissues and Cellular and Tissue-Based Product Manufacturers, Distributors, and Packers
	Human Cell & Tissue Products (HCT/P) Adverse Reaction Reporting
	HIPAA Compliance for Reporters to FDA MedWatch

                                                                                  Content current as of:
      05/18/2023Reporting Serious Problems to FDA                
                          

                        What is a Serious Adverse Event?
          Product Problems
          Reporte  problemas serios a la FDA
          ¿Qué es una reacción adversa grave?
          Problemas con los productos
 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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