How to Report a Side Effect in the US: MedWatch and the Safety Reporting Portal
How the US FDA describes reporting a problem with a supplement, medicine or cosmetic through MedWatch and the Safety Reporting Portal, and what happens to a report.
Content last updated . This page has not been medically reviewed.
Get care first, then report
FDA says that if you experience an adverse event you should contact your health care professional first and then report the problem to FDA. [1] In an emergency call 911; for a possible poisoning call Poison Help at 1-800-222-1222. This page explains reporting only. It does not give medical advice, and neither does FDA's reporting system. [1]
Two US routes, depending on the product
FDA's pages we read describe more than one route, so the product matters.
| Product | Route named on the FDA page we read |
|---|---|
| Dietary supplements | FDA's consumer update says adverse events with dietary supplements should be reported via the online Safety Reporting Portal. [1] NCCIH gives the same route. [2] |
| Medicines, medical devices, cosmetics and cannabinoid hemp products such as products containing CBD | MedWatch, the FDA program that receives reports from the public. [3] |
| Animal and veterinary products | A separate FDA reporting page for animal products. [4] |
| Tobacco and vaccines | Different pathways; FDA recommends sending those reports to the appropriate portals. [3] |
One FDA page we read also lists dietary supplements among the products covered by MedWatch. [4] Because FDA's pages describe this differently, start from the FDA page for your product and follow what it says. We could not open the Safety Reporting Portal itself this session, so we cannot describe its form.
What MedWatch is for
FDA describes MedWatch as a program for reporting serious reactions, product quality problems, therapeutic inequivalence/failure and product use errors. [4] FDA says it relies on voluntary reporting. [4]
Who can fill in the form
- FDA encourages taking the reporting form to your doctor, because a provider can add clinical information from your medical record. [4]
- Your provider is not required to report. If they do not, FDA says you may complete the online form yourself. [4]
- Reporting by health professionals is voluntary. [1]
What happens to a report
FDA says every MedWatch report is recorded in an FDA database and compared with similar earlier reports; added together, reports can signal a safety problem and lead to an FDA action. [1] Depending on the seriousness, an investigator may visit the person who complained or collect product samples. [1] FDA calls reporting to MedWatch confidential. [1]
What the sources do not tell us
The pages we read did not say what details to gather, or what to do with the leftover product. Ask your clinician, pharmacist or the agency before discarding it. For help describing your use of remedies, see Talking with a health professional and What to do after a reaction. For the overview, see Side effects and reporting.
Frequently asked questions
How do I report a problem with a dietary supplement in the US?
FDA says adverse events with dietary supplements should be reported via the online Safety Reporting Portal. [1]
Does MedWatch cover supplements?
One FDA page lists dietary supplements among MedWatch products, while FDA's consumer update points supplement reports to the Safety Reporting Portal. [4][1] Follow the FDA page for your product.
Do I need my doctor to file the report?
No. FDA says providers are not required to report and you may complete the online form yourself. [4]
Will FDA tell me what caused my reaction?
Not as described in the sources we read. FDA says its reporting systems are not medical advice and reports are used to spot safety problems. [1]
Where do I report a pet's reaction?
FDA lists a separate page for animal and veterinary products. [4] See also Pet and animal poisoning.
References
- U.S. Food and Drug Administration. FDA 101: How to Use the Consumer Complaint System and MedWatch. Consumer update. Read 2026-10-23.
- NCCIH (National Institutes of Health, United States). Using Dietary Supplements Wisely. Read 2026-10-23.
- U.S. Food and Drug Administration. MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Content current as of 10/21/2026. Read 2026-10-23.
- U.S. Food and Drug Administration. Reporting Serious Problems to FDA. Page content current as of 09/26/2025. Read 2026-10-23.