MedWatch: The FDA Safety Information and Adverse Event Reporting Program
Your FDA gateway for clinically important safety information and reporting serious problems with human medical products.
What's New
ZIKV Detect IgM Capture ELISA by InBios International, Inc: FDA Safety Communication - Wait for Confirmatory Test Results Before Making Patient Management Decisions IgM tests remain useful in ruling out Zika exposure, but require confirmatory testing. Posted 12/23/2016 Standard Offset Cup Impactor with POM-C Handle by Greatbatch Medical: Class I Recall - Inadequate Sterilization Non-sterile surgical devices can lead to infections, and other serious adverse health consequences, including death. Posted 12/20/2016 Chantix (varenicline) and Zyban (bupropion): Drug Safety Communication - Mental Health Side Effects Revised FDA determined the risk of serious side effects on mood, behavior, or thinking is lower than previously suspected. Posted 12/16/2016 General Anesthetic and Sedation Drugs: Drug Safety Communication - New Warnings for Young Children and Pregnant Women Published studies in pregnant animals and young animals have shown the use of general anesthetic and sedation drugs for more than 3 hours caused widespread loss of nerve cells in the brain. Posted 12/14/2016 Pioglitazone-containing Medicines: Drug Safety Communication - Updated FDA Review, Increased Risk of Bladder Cancer FDA approved label updates to describe additional studies reviewed. Posted 12/12/2016
FDA Approved Safety Information
DailyMed (National Library of Medicine)
Current Drug Prescribing Information. (NOTE: Drugs marked "unapproved" on this site have not been reviewed by FDA for safety and efficacy, and their labeling has not been approved.)Medication Guides
Paper handouts that come with many prescription medicines. Medication Guides address issues specific to particular drugs and drug classes. They contain FDA-approved information that can help patients avoid serious adverse events.Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS) Postmarket Drug and Biologic Safety Evaluations
Evaluations performed 18 months after drug approval, or after its use by 10,000 individuals.