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MedWatch Reporting by Consumers

MedWatch is the Food and Drug Administration's (FDA) program for reporting serious reactions, product quality problems, therapeutic inequivalence/failure, and product use errors with human medical products, such as drugs and medical devices.

If you think you or someone in your family has experienced a serious reaction to a medical product, you are encouraged to take the reporting form to your doctor. Your health care provider can provide clinical information based on your medical record that can help us evaluate your report.

However, we understand that for a variety of reasons, you may not wish to have the form filled out by your health care provider, or your health care provider may choose not to complete the form. Your health care provider is NOT required to report to the FDA. In these situations, you may complete the Online Reporting Form yourself via the internet.

You will receive an acknowledgement from FDA after we receive your report. You will be personally contacted only if we need additional information.

Related Information for Consumers

  • Report suspected unlawful sale of medical products on the Internet

  • For information about a medical product, please call the FDA's toll-free information line, 1-888-INFO-FDA (1-888-463-6332) Press 2, followed by 1 for information, then:
    • for dietary supplements, select 2
    • for drug products, select 3
    • for medical devices, select 4
    • for biologics, including human cells, tissues, and cellular and tissue-based products, select 6
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