Adverse event
Any untoward medical occurrence in a patient receiving a drug, regardless of causality.
Definition
An adverse event is any unfavourable medical occurrence in a patient receiving a drug, whether or not it is causally related to the drug. AEs are graded by severity (mild/moderate/severe) and seriousness (life-threatening, hospitalisation, disability, congenital anomaly, death). Serious AEs trigger expedited reporting to the FDA via FAERS.
See also
- Boxed warning — The strongest FDA warning, displayed in a black border at the top of a drug label.