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MedWatch: The FDA Safety Information and Adverse Event Reporting Program
MedWatch is the reporting system for Consumers and Healthcare Professionals to report adverse event, it was founded in 1993. An adverse event is any undesirable experience associated with the use of a medical product. The MedWatch system collects reports of adverse events/reactions and quality problems, primarily with drugs and medical devices, but also for other FDA-regulated products (e.g., dietary supplements, cosmetics, medical foods, and infant formulas).
The MedWatch system is intended to detect safety hazard signals for medical products. If a signal is detected, the FDA can issue medical product safety alerts or order product recalls, withdrawals, or labeling changes to protect the public health.
What is an Adverse Event or Serious Problem?
An adverse event (AE) is any unexpected side effect related with the use of a medical product (drugs, biologic products, medical devices, dietary supplements, infant formula, and cosmetics) in a patient.
The event is considered serious and should be reported to FDA when the patient outcome is:
- if you suspect that the death was an outcome of the AE
if you think that the:
- person was at a greater risk of dying at the time of the AE.
- person’s use of the device or medical product might have resulted in the death of the patient.
- persons continued use of the device or medical product might have resulted in the death of the patient
Hospitalization (initial or prolonged)
- if the person was admitted to the hospital or if they stayed in the hospital longer than expected because of the AE. (Emergency room visits that do not result in admission to the hospital should be evaluated for one of the other serious outcomes).
Disability or Permanent Damage
- if the AE resulted in a significant disruption of a person's ability to conduct normal life functions. (i.e., the adverse event resulted in a significant change or interfered in the person's body function, physical activities and/or quality of life).
Congenital Anomaly/Birth Defect
- if you suspect that taking or using a medical product prior to becoming pregnant or during pregnancy may have resulted in harm to the baby.
Required Intervention to Prevent Permanent Impairment or Damage (Devices)
- if you believe that medical or surgical intervention was necessary to prevent permanent damage to the person, or prevent permanent damage to a body structure (either situation suspected to be due to the use of a medical product).
Other Serious (Important Medical Events)
- when the event does not fit the other outcomes, but the event may harm the person and may require medical or surgical treatment to prevent one of the other outcomes. (i.e., allergic brochospasm (a serious problem with breathing) requiring treatment in an emergency room, serious blood disorders or seizures/convulsions that do not result in being admitted to the hospital. Drug dependence or drug abuse would also be examples of important medical events
FDA MedWatchLearn teaches students, health professionals, and consumers how to complete the forms necessary to report problems to FDA. Here, you have the opportunity to practice filling out FDA Form 3500 (for health professionals) or FDA Form 3500B (for consumers).
Online Reporting Form
What to Report to FDA MedWatch:
Use the MedWatch form to report adverse events that you observe or suspect for human medical products, including serious drug side effects, product use errors, product quality problems, and therapeutic failures for:
- Prescription or over-the-counter medicines, as well as medicines administered to hospital patients or at outpatient infusion centers
- Biologics (including blood components, blood and plasma derivatives, allergenic, human cells, tissues, and cellular and tissue-based products (HCT/Ps))
- Medical devices (including in vitro diagnostic products)
- Combination products
- Special nutritional products (dietary supplements, infant formulas, and medical foods)
- Foods/beverages (including reports of serious allergic reactions)
What Not to Report to MedWatch:
- Vaccines: Report vaccine events to the Vaccine Adverse Event Reporting System (VAERS)
- Investigational (study) drugs: Report investigational (study) drug adverse events as required in the study protocol and send to the address and contact person listed in the study protocol.
Mandatory reporting by regulated industry:
- Drugs and Biologics
- Dietary supplements
- Reporting on Veterinary Medicine Products
- Reports FDA Does Not Handle (e.g. CPSC, FTC, State Health Departments) and Where to Send Them
Begin Report as a:
MedWatch Consumer Reporting Form (FDA 3500B printable)
This forms is fillable on your computer using the free Adobe Acrobat Reader. You can also choose to print the blank form and fill it out by hand. The Voluntary Form FDA 3500 features a postage-paid pre-addressed mailer.
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MedWatch offers many ways to help you stay informed about the medical products you prescribe, use, or dispense every day. MedWatch sends safety alerts directly to you, as soon as they appear on the web site. Select how you want to receive MedWatch safety alerts:
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