Medical Product Safety Information
MedWatch - your FDA gateway for clinically important safety information and reporting serious problems with human medical products
Safety Alerts for Human Medical Products (Drugs, Biologics, Medical Devices, Cannabinoid Hemp Products and Cosmetics). These alerts contain actionable information that may impact both treatment and diagnostic choices for healthcare professional and patient.
MedWatch alerts provide timely new safety information on:
- Prescription and over-the-counter medicines including those administered in a hospital or outpatient infusion centers.
- Biologics such as blood components, blood/plasma derivatives, blood transfusions, gene therapies, and human cells and tissue transplants.
- Medical devices such as diabetes glucose-test kit, hearing aids, breast pumps, and many more products.
- Combination products such as prefilled drug syringe, auto-injectors, metered-dose inhalers, contact lens coated with a drug and nasal-spray.
- Cannabinoid hemp products such as products containing CBD.
- Cosmetics such as moisturizers, shampoos, conditioners, hair dyes and tattoos.
Reporting can be done through our online reporting portal or by downloading, completing and then submitting FDA Form 3500 (health professional) or 3500B (consumer/patient) to MedWatch:The FDA Safety Information and Adverse Event Reporting Program.
| For Use By | Form |
|---|---|
| Health Professionals, Patients, and Consumers Easy online, voluntary reporting for health professionals, patients, and consumers. | Online Reporting Form |
| Health Professionals For use by healthcare professionals, consumers, and patients. | |
| Patients and Consumers A consumer-friendly version of the 3500 reporting form. | Form FDA 3500B - Voluntary Reporting for Consumers (pdf) |
| Denuncia Voluntaria del Consumidor Formulario Siga las instrucciones en el formulario para mandarlo por fax o enviarlo por correo. | Formulario FDA 3500B (En Español) |
DailyMed (FDA/National Library of Medicine)
Comprehensive, up-to-date, look-up and download resource of medication content and labeling as found in medication package inserts
Drug Products
- Index to Drug-Specific Information
- Medication Guides: FDA-approved patient information for selected prescription drugs that pose a serious and significant public health concern
- Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS): Drugs for which FDA has identified a potential safety issue, but not a causal relationship between the drug and the listed risk.
- Medication Errors
- Drug Shortages
- FDA Drug Info Rounds: Training videos for practicing clinical and community pharmacists.
Medical Devices
Biological Products
Main FDA Information Telephone Number
1-888-INFO-FDA (1-888-463-6332)
Drugs
Contact Drug Information, call 855-543-3784 or 301-796-3400 or email: Druginfo@fda.hhs.gov
Medical Devices
Contact Division of Industry and Consumer Education, call 800-638-2041 or email: DICE@fda.hhs.gov
Special Nutritional Products, Cosmetics and Foods/Beverages
Contact Food, Nutrition, and Cosmetics Questions, call 888-723-3366 or email: Consumer@fda.gov
Vaccines, Blood products, other Biologics
Contact Center for Biologics Evaluation and Research, call 800-835-4709 or email: ocod@fda.hhs.gov
Animal Food, Drugs and Devices
Contact Center for Veterinary Medicine, call 1-888-463-6332 or 240-276-9300 or email: AskCVM@fda.hhs.gov
Tobacco
Contact Center for Tobacco Products, call 1-877-CTP-1373 or 301-796-9200 or email: AskCTP@fda.hhs.gov
- FDA Adverse Event Reporting System (FAERS)
FAERS collects information about adverse events, medication errors and product problems that occur after the administration of approved drug and therapeutic biologic products. The FAERS website provides two methods to access the public extract of the FAERS data.- Quarterly (noncumulative) data files since January 2004 are available for downloading
- FAERS Public Dashboard is a highly interactive web-based tool that allows for querying of cumulative FAERS data in a user friendly fashion
- Vaccine Adverse Event Reporting System (VAERS)
VAERS is a cooperative program for vaccine safety of the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS collects information about adverse events that occur after the administration of U.S. licensed vaccines. - Manufacturer and User Facility Device Experience Database (MAUDE)
Search database information of all voluntary reports since June, 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August, 1996. (MDR Data files, 1992-1996)