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