adverse event

Intermediate 🏥 Healthcare / Medical

Definition

Any undesirable medical occurrence in a patient, whether or not it's related to treatment—basically the healthcare equivalent of 'well, that wasn't supposed to happen.' Ranges from mild side effects to major complications.

Example Usage

We had to report the adverse event to the IRB, even though the patient's rash was probably from eating shellfish, not our drug.

Origin

FDA regulatory terminology established in late 20th century

Fun Fact

Pharmaceutical companies must report serious adverse events to the FDA within 15 days, creating a small industry of medical safety officers.

Source: FDA and clinical trial terminology

Related Terms

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