How do I File an Adverse Event Report with the Food & Drug Administration?

How to report to the FDA
The U.S. Food & Drug Administration (FDA) MedWatch program allows the public to report adverse events related to medical devices, prescription and over-the-counter medications, and other  products regulated by the agency.

How to Report Medication Side Effects and Medical Device Complications

The FDA’s MedWatch Voluntary Online Reporting Form is the easiest way to report adverse events to the agency, including those that involve:

  • Prescription or over-the-counter medications
  • Medications 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)
  • Medical devices (including in vitro diagnostic products)
  • Combination products
  • Special nutritional products
  • Cosmetics
  • Foods/beverages (including reports of serious allergic reactions)

The types of events that may be reported to the MedWatch system include serious drug side effects, product use errors, product quality problems, and therapeutic failures.

MedWatch reports can also be made via Consumer Reporting Form FDA 3500B. For assistance filling out the form, please visit MedWatchLearn.

Telephone reports can also be made by calling 1-800-FDA-1088.

Other Reporting Portals

Other  reporting portals that are available to the public include:

  • The Vaccine Adverse Event Reporting System (VAERS) for problem relating to vaccines.
  • The U.S. Department of Health & Human Services’ Safety Reporting Portal (SRP), which provides a convenient, secure and efficient method for reporting problems to the FDA and the National Institutes of Health. Consumers may use the portal to report issues related to: Marketed human drug and therapeutic biologics; human or animal reportable foods; animal drugs; tobacco products, including e-cigarettes; and dietary supplements.

What to Do If You Suffer Drug or Medical Device Complications

If you or a loved one were harmed by a medication or medical device, the attorneys at Bernstein Liebhard LLP can determine if you have a claim for compensation. To learn more about filing a drug or medical device lawsuit, please call (888) 994-5118.

  1. FDA (N.D.) “MedWatch Online Voluntary Reporting” Form
  2. FDA (N.D.) “Reporting a Serious Problem to the FDA”
Last Modified: June 2, 2016

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