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.
What's New
Nexterone (amiodarone HCl) 150 mg/100 mL Premixed Injection: Recall - Presence Of Particulate Matter UPDATED 01/23/2018. Recall expanded to include a second lot (NC109123). Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences. Originally posted 11/15/2017 Multiple Drug Products by Flawless Beauty: Recall - Misbranded or Unapproved Misbranded or unapproved new drugs present serious public health risks. Posted 01/22/2018 Basic Drugs Brand of Senna Laxative by Magno-Humphries Laboratories: Recall - Mislabeling Unintentional consumption of naproxen sodium potentially could result in fatal adverse events in patients with underlying illnesses. Posted 01/22/2018 Levofloxacin in 5 Percent Dextrose 250mg/50mL by AuroMedics: Recall - Presence of Visible Particulate Matter Use of a non-sterile injectable product could result in fatal infections. Posted 01/18/2018 Zoll LifeVest 4000 Wearable Cardioverter Defibrillator: FDA Safety Communication - Potential Lack of Treatment (Shock) Delivery Due to Device Failure Failure to immediately replace the device after Message Code 102 appears may result in serious patient harm or death of the patient because the device may fail to deliver therapy when needed. Posted 01/17/2018
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 specific 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.
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