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        MedWatch: The FDA Safety Information and Adverse Event Reporting Program

Medical Product Safety Information

                        
                


                Drug Safety-related Labeling Changes
          MedWatch Forms for FDA Safety Reporting Home
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          MedWatch: The FDA Safety Information and Adverse Event Reporting Program
          Medical Product Safety InformationMedWatch: The FDA Safety Information and Adverse Event Reporting Program Medical Product Safety Information
  	
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Safety Alerts for Human Medical Products (Drugs, Biologics, Medical Devices, Special Nutritional Products and Cosmetics)

MedWatch alerts provide timely new safety information on human drugs, medical devices, vaccines and other biologics, dietary supplements, and cosmetics. The alerts contain actionable information that may impact both treatment and diagnostic choices for healthcare professional and patient.

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.

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 healthcare professionals, consumers, and patients.
			Form FDA 3500 - Voluntary Reporting (pdf)

			Instructions for Completing Form FDA 3500**Patients and Consumers**
			A consumer-friendly version of the 3500 reporting form.
			Form FDA 3500B - Voluntary Reporting for Consumers (pdf)**Industry**
			Mandatory reporting for use by IND reporters, manufacturers, distributors, importers, user facilities personnel.
			Form FDA 3500A - Mandatory Reporting (pdf)

			Instructions for Completing Form FDA 3500A (pdf)**Denuncia Voluntaria del Consumer Formulario**
			Siga las instrucciones en el formulario para mandarlo por fax o enviarlo por correo.
			Formulario FDA 3500B (En Español)    
Other FDA Safety-Related Information
	**DailyMed (FDA/National Library of Medicine)**

Comprehensive, up-to-date, look-up and downloadresource of medication content and labeling as found in medication package inserts

**Drug Products**

Index to Drug-Specific Information
	Medication Guides: FDA-approved patient information for selected prescription drugs that pose a serious and significant public health concern
	Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS): Drugs for which FDA has identified a potential safety issue, but not a causal relationship between the drug and the listed risk.
	Medication Errors
	Drug Shortages
	FDA Drug Info Rounds: Training videos for practicing clinical and community pharmacists.**Medical Devices**

Medical Device Safety
	Medical Device Safety Communications**Biological Products**

Safety Information
	Recalls and Withdrawals**Main FDA Information Telephone Number**

1-888-INFO-FDA (1-888-463-6332)    
Inquiries About Specific Products or Questions Regarding Adverse Event Reporting
	**Drugs**

Contact Drug Information, call 855-543-3784 or 301-796-3400 or email: Druginfo@fda.hhs.gov

**Medical Devices**

Contact Division of Industry and Consumer Education, call 800-638-2041 or email: DICE@fda.hhs.gov

**Special Nutritional Products, Cosmetics and Foods/Beverages**

Contact Food, Nutrition, and Cosmetics Questions, call 888-723-3366 or email: Consumer@fda.gov

**Vaccines, Blood products, other Biologics**

Contact Center for Biologics Evaluation and Research, call 800-835-4709 or email: ocod@fda.hhs.gov

**Animal Food, Drugs and Devices**

Contact Center for Veterinary Medicine, call 1-888-463-6332 or 240-276-9300 or email: AskCVM@fda.hhs.gov

**Tobacco**

Contact Center for Tobacco Products, call 1-877-CTP-1373 or 301-796-9200 or email: AskCTP@fda.hhs.gov    
Access to FDA Safety Data
	**FDA Adverse Event Reporting System (FAERS)**
	FAERS collects information about adverse events, medication errors and product problems that occur after the administration of approved drug and therapeutic biologic products. The FAERS website provides two methods to access the public extract of the FAERS data. 
	Quarterly (noncumulative) data files since January 2004 are available for downloading
		FAERS Public Dashboard is a highly interactive web-based tool that allows for querying of cumulative FAERS data in a user friendly fashion
	**Vaccine Adverse Event Reporting System (VAERS)**
	VAERS is a cooperative program for vaccine safety of the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS collects information about adverse events that occur after the administration of U.S. licensed vaccines.
	**Manufacturer and User Facility Device Experience Database (MAUDE)**
	Search database information of all voluntary reports since June, 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August, 1996. (MDR Data files, 1992-1996)

                                                                                  Content current as of:
      11/09/2022Medical Product Safety Information                
                          

                        


                        Drug Safety-related Labeling Changes
          MedWatch Forms for FDA Safety Reporting
 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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