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
Canagliflozin (Invokana, Invokamet): Drug Safety Communication - Clinical Trial Results Find Increased Risk of Leg and Foot Amputations FDA is currently investigating this new safety issue. Patients should not stop or change their diabetes medicines. Posted 05/18/2016 Well Care Compounding Pharmacy Sterile Compounded Products: Recall - Lack Of Sterility Assurance Administration of a drug product intended to be sterile that is compromised may result in serious and potentially life-threatening infections or death. Posted 05/18/2016 April 2016 Drug Safety Labeling Changes includes 29 products with revisions to Prescribing Information. Posted 05/13/2016 SOS Telecom Products: Recall - Undeclared Drug Ingredient Sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Posted 05/13/2016 BiCNU (carmustine for injection): FDA Alert - Counterfeit Product Discovered in Some Foreign Countries FDA urges health care professionals to purchase drug products only from legitimate suppliers. Posted 05/13/2016
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.