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
Your FDA gateway for clinically important safety information and reporting serious problems with human medical products.
Super Arthgold by Nano Well-being Health: Recall - Undeclared Drug Ingredients Risk of myocardial infarction, stroke, congestive heart failure, renal toxicity, and bleeding, ulceration, or perforation of the stomach or intestines. Posted 04/24/2014 Epidural Corticosteroid Injection: Drug Safety Communication - Risk of Rare But Serious Neurologic Problems Injection of corticosteroids into the epidural space of the spine may result in loss of vision, stroke, paralysis, and death. Posted 04/23/2014 Marcaine (Bupivacaine HCI Injection, USP) 0.25 percent, 10 ml, Single-Dose, Preservative-Free Vial: Recall - Visible Particulates Injected particulate could result in local inflammation, mechanical disruption of tissue or immune response to the particulate. Posted 04/22/2014 Lidocaine HCI Injection, USP, by Hospira: Recall - Visible Particulates Risk of local inflammation, and/or mechanical disruption of tissue or immune response to the particulate, and/or a delay in therapy. Posted 04/18/2014 CUBICIN (daptomycin for injection) by Cubist Pharmaceuticals: Recall - Presence of Particulate Matter Potential risk of thromboembolism, pulmonary emboli, phlebitis, mechanical block of the capillaries or arterioles, activation of platelets, subsequent generation of microthrombi, and emboli. Posted 04/18/2014
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.)
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.