Serious Adverse Drug Reaction

**Semantic type:** Finding

**Definition:** A noxious and unintended response to a medicinal product occurring at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in a persistent or significant disability/incapacity, or results in a congenital anomaly/birth defect.

**Synonyms:** - Serious ADR - Serious Adverse Drug Reaction (SADR) - serious adverse drug reaction