Resources for You
- Report a Serious Medical Product Problem 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 An FDA Guide to Drug Safety Terms[ARCHIVED] 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.
HeartStart Automated External Defibrillators (AED) From Philips Healthcare: Safety Communication - Failure Of An Electrical Component That Could Cause AEDs To Fail To Deliver Appropriate Shock When normal heart rhythms are not restored quickly, sudden cardiac arrest can cause death. Posted 12/03/2013 Onfi (clobazam): Drug Safety Communication - Risk of Serious Skin Reactions Cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) Reported. Posted 12/03/2013 Hydravax Dietary Supplement by IQ Formulations: Recall - Possible Undeclared Drug Ingredient Sample from one lot of Hydravax revealed the presence of a diuretic. Possible effects of using a diuretic include an electrolyte imbalance due to water loss. Posted 12/01/2013
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.