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Glossary · Tier 1

Adverse Event Report

Also known as: AE report, adverse event, adverse drug event report

Verified from FDA on 06-02-2026
Quick answer

An adverse event report is the formal record used to notify the FDA about an undesirable patient experience involving a medical product. Reports are categorized as serious based on the patient outcome, which determines when reporting to the agency is warranted. The FDA's own definition, reproduced verbatim below, sets the baseline for what counts as an adverse event and when reporting applies.

MedivaScan summary. The authoritative source quote follows below.

FDA definition

An adverse event is any undesirable experience associated with the use of a medical product in a patient. The event is serious and should be reported to FDA when the patient outcome is:

U.S. Food and Drug AdministrationView on source ›Verbatim quote. Last verified 06-02-2026.
For information only. MedivaScan summarizes public FDA data and is not medical advice. Consult a healthcare professional before changing any medication. If you experience a serious reaction, contact your doctor or call 911.