Safety
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
Report a Serious Medical Product Problem Online
 |
Your FDA gateway for clinically important safety information and reporting serious problems with human medical products. |
What's New
Effexor XR 150 Mg Extended-Release Capsules (Pfizer) and Venlafaxine HCl 150 Mg Extended-Release Capsules (Greenstone): Recall - Possible Presence of Tikosyn Capsules The use of Tikosyn by an Effexor XR/Venlafaxine HCl patient could cause serious adverse health consequences that could be fatal. Posted 03/07/2014 Doribax (doripenem): Drug Safety Communication - Risk When Used to Treat Pneumonia on Ventilated Patients Increased risk of death and lower clinical cure rates compared to use of imipenem and cilastatin. Posted 03/06/2014 DIANEAL PD-2 Peritoneal Dialysis Solution with 1.5 Percent Dextrose 6000mL: Recall - Contamination With Mold Administration of a product contaminated with mold could result in life-threatening fungal peritoneal infection or sepsis. Posted 03/06/2014 HeartMate II LVAS Pocket System Controller by Thoratec Corporation: Medical Device Correction - Updated Labeling and Training Materials Reports of four deaths and five incidents of loss of consciousness or other symptoms of hypoperfusion, occurring in patients who were converted to the Pocket Controller after being originally trained on an older model. Posted 03/05/2014 GE Healthcare Resuscitation Systems: Class I Recall - Oxygen and Air Inlet Fittings Reversed During Assembly Recalled products may interfere with oxygen delivery, resulting in inaccurate oxygen regulation in neonates. This may cause death in neonates, particularly those who are critically ill. Posted 02/28/2014
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.)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.
