Safety

Medical Product Safety Information

MedWatch logo MedWatch - The FDA Safety Information and Adverse Event Reporting Program

 

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.

2014 Safety Alerts

2013201220112010 | 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.

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

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.
     
  • MedWatch "What's New" Archive, May 29 - Dec 31, 2009

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

 

Product Type E-mail Inquiries Telephone Inquiries
Drugs

Drug Information Questions and Comments

 

druginfo@fda.hhs.gov

Division of Drug Information
888-463-6332
(888-INFO-FDA)
 
Special Nutritional Products
(dietary supplements, infant formulas, and medical foods) and Cosmetics
Food, Nutrition, and Cosmetics Questions & Answers888-723-3366
Medical DevicesCenter for Devices and Radiological Health, Division of Small Manufacturers, International and Consumer Assistance800-638-2041
Vaccines, blood products, other biologicsCenter for Biologics Evaluation and Research Questions800-835-4709
Tobacco ProductsCenter for Tobacco Products General Inquiries
1-877-CTP-1373
1-877-287-1373
(9am EST-4pm EST)

 

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: 10/16/2014
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