-
Safety
-
Resources for You
Report a Serious Medical Product Problem Online Reporting Unlawful Sales of Medical Products on the Internet Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) Index to Drug-Specific Information DailyMed (National Institutes of Health) Medication Guides Current Drug Shortages An FDA Guide to Drug Safety Terms
-
-
MedWatch: The FDA Safety Information and Adverse Event Reporting Program
![]() |
Your FDA gateway for finding clinically important safety information and reporting serious problems with human medical products. |
-
What's New
Evamist (estradiol transdermal spray): Drug Safety Communication - Unintended Exposure of Children and Pets to Topical Estrogen Reports of adverse effects in children who may have been unintentionally exposed to the drug through skin contact with women using this product. Posted 07/29/2010 Cubicin (daptomycin): Drug Safety Communication - Risk of Eosinophilic Pneumonia Cases of serious, potentially fatal pneumonia associated with the IV antibacterial drug Cubicin. Posted 07/29/2010 Cook brand Ciaglia Blue Rhino/Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays Recall due to balloon inflation assembly that may not hold air. Posted 07/222010 Joyful Slim Herb Supplement : Recall-Undeclared Drug Ingredient Product contains sibutramine; may increase blood pressure/pulse rate with risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, stroke. Posted 07/22/2010 CONSTELLATION Vision System: Recall Software and hardware problems associated with unexpected system loss of power, unintended system error messages, unresponsive touchscreens, and system setting and infusion performance problems. Posted 07/20/2010 Vialipro Dietary Supplement: Recall-Undeclared Drug Ingredient Lab analyses found that certain batches of Vialipro contain Sulfoaildenafil, an analogue of Sildenafil. Posted 07/20/2010 Slim- 30 Herb Supplement: Undeclared Drug Ingredient Product found to contain undeclared N-Desmethyl Sibutramine and traces of Sibutramine. Posted 07/19/2010. Advair Diskus (fluticasone propionate and salmeterol inhalation powder): Stolen Product Warning Certain inhalers stolen from a distribution warehouse in 2009 have been found in some pharmacies. The safety and effectiveness of the stolen inhalers cannot be assured and they should not be used. Posted 07/16/2010
-
-
Spotlight
-
-
Recalls & Alerts
-
-
Stay Informed
-
Contact Us
Report a Serious Problem
- 1-800-332-1088
- 1-800-FDA-0178 Fax
Regular Mail: Use postage-paid FDA Form 3500
Mail to: MedWatch 5600 Fishers Lane
Rockville, MD 20857
-
-
-


