MedWatch - your FDA gateway for clinically important safety information and reporting serious problems with human medical products
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.
Drug Safety Labeling Changes
From January 2016 forward, the Drug Safety Labeling Changes (SLC) database provides approved safety labeling changes.
The following are 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.
Archival MedWatch Information
- MedWatch Archive 1996 - 2008
This zip file is an html archive of MedWatch safety alerts and drug safety labeling change information from 1996 - 2008. 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 "MedWatch-1996-2008". Open that folder and launch the file called "safety_archive.htm" to browse the archive using your default web browser.
Other FDA Safety-Related Information
- Comprehensive, up-to-date, look-up and download resource of medication content and labeling as found in medication package inserts
- 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
- Unapproved Drugs: Enforcement Actions
Enforcement efforts on classes of unapproved drugs or firms marketing unapproved drugs.
- FDA Drug Info Rounds
Training videos for practicing clinical and community pharmacists.
- Medical Device Safety page
- List of Tips and Articles on Medical Device Safety
Safety Tips for Laboratorians
Inquiries About Specific Products or Questions Regarding Adverse Event Reporting
|Product Type||E-mail Inquiries||Telephone Inquiries|
Division of Drug Information
|Special Nutritional Products|
(dietary supplements, infant formulas, medical foods), Cosmetics and Foods/Beverages
Center for Devices and Radiological Health, Division of Industry and Consumer Education
|Vaccines, blood products, other biologics|
|1-877-CTP-1373 or 301-796-9200|
|Veterinary Products including animal feed, pet food and drug products|
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)