Safety

Medical Product Safety Information

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Safety Alerts for Human Medical Products (Drugs, Biologics, Medical Devices, Special Nutritionals, 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.

2016 Safety Alerts

2015 | 2014 | 20132012 | 20112010 | 2009 | 2008

2007 |2006 | 2005 | 2004 | 2003 | 2002 | 2001 | 2000 

Drug Safety Labeling Changes

Monthly summaries of drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections.

2016: Jan|Feb|Mar|Apr|May|Jun|Jul

2015: Jan|Feb|Mar|Apr|May|Jun|Jul|Aug|Sep|Oct|Nov|Dec

2014: Jan|Feb|Mar|Apr|May|Jun|Jul|Aug|Sep|Oct|Nov|Dec

2013: Jan|Feb|Mar|Apr|May|Jun|Jul|Aug|Sep|Oct|Nov|Dec

2012: Jan|Feb|Mar|Apr|May|Jun|Jul|Aug|Sep|Oct|Nov|Dec

2011: Jan|Feb|Mar|Apr|May|Jun|Jul|Aug|Sep|Oct|Nov|Dec

2010: Jan|Feb|Mar|Apr|May|Jun|Jul|Aug|Sep|Oct|Nov|Dec

2009: Jan|Feb|Mar|Apr|May|Jun|Jul|Aug|Sep|Oct|Nov|Dec

2008: Jan|Feb|Mar|Apr|May|Jun|Jul|Aug|Sep|Oct|Nov|Dec

Archival MedWatch Information

  • MedWatch Archive 1996 - 2007
    This zip file is an html archive of MedWatch safety alerts from 1996 - 1999 and drug safety labeling change information from 1996 - 2007. Please keep in mind this is an archive of older MedWatch web pages. Certain hyperlinks, such as links to drug labels, no longer work. Please refer to Drugs@FDA for historical drug labeling.

    Download the file to your computer, and extract (or unzip) the archive using the "Use folder names" option. This will create a folder on your computer named "MW-archive_1996-2007". Open that folder and launch the file called "safety_archive.htm" to browse the archive.
     

Other FDA Safety-Related Information

 

FDA Patient Safety News

  • Video News Show for Health Professionals

DailyMed (FDA/National Library of Medicine) 

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

Drug Products

Medical Devices 


Biological Products


Dietary Supplements


Inquiries About Specific Products or Questions Regarding Adverse Event Reporting

Product TypeE-mail InquiriesTelephone Inquiries
Drugs

Drug Information Questions and Comments 

Email: Druginfo@fda.hhs.gov

Division of Drug Information

855-543-3784
301-796-3400

Special Nutritional Products
(dietary supplements, infant formulas, medical foods), Cosmetics and Foods/Beverages

Food, Nutrition, and Cosmetics Questions & Answers

Email: Consumer@fda.gov

888-723-3366 
Medical Devices 

Center for Devices and Radiological Health, Division of Industry and Consumer Education

Email: DICE@fda.hhs.gov 

800-638-2041 
Vaccines, blood products, other biologics 

Center for Biologics Evaluation and Research, Division of Communication and Consumer Affairs, Consumer Affairs Branch, Questions and Answers 

Email: ocod@fda.hhs.gov

800-835-4709 
Tobacco products 

Center for Tobacco Products General Inquiries

Email: AskCTP@fda.hhs.gov 

1-877-CTP-1373 or 301-796-9200 
Veterinary Products including animal feed, pet food and drug products
 

Center for Veterinary Medicine Inquiries

Email: AskCVM@fda.hhs.gov

1-888-INFO-FDA
(1-888-463-6332)

240-276-9300

Main FDA Information Telephone Number: 1-888-INFO-FDA (1-888-463-6332)

Access to FDA Safety Data

  • Adverse Event Reporting System (AERS)
    AERS collects information about adverse events, medication errors and product problems that occur after the administration of approved drug and therapeutic biologic products. Quarterly (noncumulative) data files since January 2004 are available for downloading on the AERS website.
  • 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)

 

Page Last Updated: 08/15/2016
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