Resources for You
- Report a Serious Medical Product Problem Online
- Report Dietary Supplements and Tobacco Product Problems Online
Reporting Unlawful Sales of Medical Products on the Internet
- Consumer-Friendly Reporting Form 3500B (PDF - 1.2MB)
Current Drug Shortages Index Identifying Recalled Products 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.
Covidien Pipeline Embolization Device and Alligator Retrieval Device: Recall - Coating on Delivery Wire Could Delaminate Use of affected products could potentially lead to embolic occlusion in the cerebral vasculature, with the risk of stroke and/or death. Posted 04/11/2014 Infinity: Public Notification - Undeclared Drug Ingredient Use may increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. Posted 04/11/2014 Lite Fit USA: Public Notification - Undeclared Drug Ingredient Use may increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. Posted 04/11/2014 March 2014 Safety Labeling Changes includes 30 products with revisions to Prescribing Information. Posted 04/11/2014. Zi Xiu Tang Bee Pollen Capsules by Guangzhou Zi Xiu Tang Biotechnology Co., Ltd: Warning - Undeclared Drug Ingredients Risk of increased blood pressure and/or pulse rate. Posted 04/08/2014 PS500 Power Supply Unit by Dräger: Recall - Early Depletion of Battery Charge Battery depletion will require manual ventilation until the device is connected to main power. Posted 04/02/2014
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.