Your FDA gateway for clinically important safety information and reporting serious problems with human medical products.
Phenobarbital 15 mg Tablets, USP by C.O. Truxton: Recall - Labeling Error on Declared Strength Mislabeled product could expose the consumer or their pet(s) to potential overdosing that can cause severe intoxication which may lead to cardiogenic shock, renal failure, coma or death. Posted 04/21/2017 Codeine and Tramadol Medicines: Drug Safety Communication - Restricting Use in Children, Recommending Against Use in Breastfeeding Women New and strengthened WARNINGS and CONTRAINDICATIONS on drug labels describing serious risks, including slowed or difficult breathing and death. Posted 04/20/2017 Organic Herbal Supply Supplement Products: Recall - Undeclared Drug Ingredients Use of these products may pose a threat to consumers because the undeclared ingredients may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels. Posted 04/19/2017 Certain Homeopathic Teething Products: Recall - Confirmed Elevated Levels of Belladonna Updated 04/13/2017. Homeopathic teething products containing belladonna pose an unnecessary risk to infants and children. Originally posted 01/27/2017 StrataMR Adjustable Valves and Shunts by Medtronic: Recall - Potential for Under-Drainage of Cerebrospinal Fluid If left untreated, under-drainage can potentially lead to coma and death. Posted 04/08/2017
FDA Approved Safety Information
DailyMed (National Library of Medicine)
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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) Postmarket Drug and Biologic Safety Evaluations
Evaluations performed 18 months after drug approval, or after its use by 10,000 individuals.