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
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.
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 All Sterile Drug Products Made and Distributed By NuVision Pharmacy Dallas Facility: Recall - Lack Of Sterility Assurance If a drug product marketed as sterile has microbial contamination, patient is at risk of serious infection. Posted 05/18/2013 Compounded Prescription Therapies By Pentec Health Inc.: Recall - Lack Of Sterility Assurance Patients are at increased risk of infection in the event a sterile product is compromised. Posted 05/17/2013 April 2013 Safety Labeling Changes includes 48 products with revisions to Prescribing Information. Posted 05/15/2013 Zolpidem Containing Products: Drug Safety Communication - FDA Requires Lower Recommended Doses UPDATED 05/14/2013. FDA has approved label changes specifying new dosing recommendations for zolpidem products. Originally posted 01/10/2013 Atriphen dietary supplement (Xymogen brand): Recall - Potential Allergic Reaction Due to Milk and Soy risk of serious or life-threatening allergic reaction. Posted 05/09/2013 The Compounding Shop: FDA News Release - Lack of Sterility Assurance of Drug Products UPDATED 05/13/2013. Additional Recall information available. Risk of serious infection to patients. Originally posted 05/08/2013 SexVoltz, Velextra, and Amerect by Beomonstar Products: Recall - Undeclared Drug Ingredient Undeclared tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Posted 05/08/2013
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.)
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.