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Glossary

What is an adverse event report for a supplement?

Written by the Full Measure editorial team, which sells supplements. Approved for publication by the Full Measure owners. Updated .

Drafted with AI assistance from the sources listed below. How we write these

Quick answer

An adverse event report tells FDA about a harmful health event linked to a supplement. Anyone can file one through FDA's Safety Reporting Portal. Companies named on the label must send FDA the serious reports they receive, generally within 15 business days, and keep records of every report for six years.1,2

Key facts

  • The law defines an adverse event as any health related event associated with using a dietary supplement that is adverse.1
  • Supplement labels must give a U.S. address or phone number where serious adverse events can be reported to the company.3
  • Filing a report is not an admission that the supplement caused the event, and FDA keeps the identity of the patient and the reporter confidential.1,3
  • FDA scientists estimated that only about 2% of supplement adverse events reach its reporting system.4
  • A CDC and FDA study estimated about 23,000 emergency department visits a year in the U.S. linked to supplements.5

Who reports, and how

  • Consumers and health professionals: voluntary reports through the Safety Reporting Portal, or on MedWatch Form FDA 3500.1,2
  • Companies named on the label as manufacturer, packer or distributor: mandatory reports of serious events, on Form FDA 3500A or through the portal.1
  • Retailers: usually not required, unless their name is on the label and no agreement passes the duty to the maker or packer.1

FDA wants to hear about a problem even if you are not sure the product caused it, and even if you did not see a doctor. It also takes reports of product problems such as foreign objects in the package.3

What makes an event serious

Under the law, a serious adverse event is one that results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, or a congenital anomaly or birth defect, or that needs medical or surgical intervention to prevent one of those outcomes.1

FDA lists reactions worth reporting, including itching, rash or swelling of the throat, lips or tongue, fainting or chest pain, severe vomiting or diarrhea, dark urine, yellowing of the skin or eyes, and marked changes in mood or behavior.2

If you think a supplement caused a serious reaction, stop using it and contact a health care provider first. Then report it.2,3

What a company must send FDA

A mandatory report needs five basic elements: an identifiable patient, an identifiable reporter, the company's contact details, the suspect product and the serious event itself.1

The 15 business day clock starts once the company has all five. New medical information received within a year of the first report must also be sent, and records of serious and non-serious reports are kept for six years.1

An adverse event report is different from a product complaint, which FDA's manufacturing rule defines as any concern about a supplement's quality, such as a foul odor, an off taste, the wrong ingredient or contamination.6

What the reports are for

Because FDA does not approve supplements before sale, reports from people and companies are one of the main ways it learns about unsafe products once they are on the market.2,7

Mandatory reporting took effect on December 22, 2007. In FDA data from 2004 to 2013, about two thirds of supplement reports were mandatory company reports and about a third were voluntary.1,4

Questions people ask

Do I need proof that the supplement caused my reaction?

No. FDA asks for reports even when you are unsure the product was the cause, and a report is not taken as proof that it was.1,3

Will my name be shared?

FDA keeps the identity of the patient and of the person reporting confidential.3

What happens if I report to the company instead?

If the event is serious and the report reaches the company named on the label, the company must pass it to FDA. You can also report directly to FDA yourself.1,2

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Sources

  1. U.S. Food and Drug Administration. Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. September 2013. Opened 2026-10-07.
  2. U.S. Food and Drug Administration. How to Report a Problem with Dietary Supplements. Content current as of March 13, 2025. Opened 2026-10-07.
  3. U.S. Food and Drug Administration. Questions and Answers on Dietary Supplements. Content current as of August 27, 2026. Opened 2026-10-07.
  4. Timbo BB, Chirtel SJ, Ihrie J, et al. Dietary supplement adverse event report data from the FDA Center for Food Safety and Applied Nutrition Adverse Event Reporting System (CAERS), 2004-2013. Ann Pharmacother. 2018;52(5):431-438. Opened 2026-10-07.
  5. Geller AI, Shehab N, Weidle NJ, et al. Emergency department visits for adverse events related to dietary supplements. N Engl J Med. 2015;373(16):1531-1540. Opened 2026-10-07.
  6. 21 CFR 111.3. What definitions apply to this part? Opened 2026-10-07.
  7. U.S. Food and Drug Administration. FDA 101: Dietary Supplements. Consumer Update. Opened 2026-10-07.

This page is information, not medical advice. Talk to your doctor or pharmacist about your own situation.