Safety
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Resources for You
Report a Serious Medical Product Problem Online Reporting Unlawful Sales of Medical Products on the Internet Current Drug Shortages Index Index to Drug-Specific Information Identifying Recalled Products An FDA Guide to Drug Safety Terms Voluntary Adverse Event Reporting Contact Information MedWatch Partners
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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. |
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What's New
Main Street Family Pharmacy in Tennessee: FDA Alerts Health Care Providers of Adverse Reactions Associated with Steroid Injections Reports of adverse events are all from patients who received preservative free methylprednisolone acetate (80 mg/mL) by injection. Posted 05/24/2013 Cook Medical, Inc Zilver PTX Drug-Eluting Peripheral Stent: Class 1 Recall - Complaints of Delivery System Tip Separation Inner delivery catheter breakage can lead to vascular occlusion, thrombosis, amputation, possible cardiac arrest, or death. Posted 05/24/2013 Methotrexate Sodium, USP Injectable Vials by Sandoz US: Recall - Particulate Matter In Vials Particulate matter in parenteral drugs has been recognized as a potential health hazard. Posted 05/21/2013 Abbott Diabetes Care: Class 1 Recall - FreeStyle InsuLinx Blood Glucose Meters - Risk of Incorrect Test Result Incorrect test results at extremely high blood glucose levels. Posted 05/20/2013
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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) (formerly AERS) Postmarket Drug and Biologic Safety Evaluations
Evaluations performed 18 months after drug approval, or after its use by 10,000 individuals.
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