serious adverse reaction
Serious ADRs are those which result in death, life-threatening conditions, persistent or significant disability or incapacity, hospitalization, prolonged hospitalization, congenital anomalies
An adverse drug reaction (ADR) is called serious if at any dose it: results in death, is life-threatening (at risk of death at the time of the adverse event, not an event which ‘could’ hypothetically have caused death if it were more severe), requires hospitalisation or extension of existing inpatients’ hospitalisation, results in a persistent or significant disability or incapacity, or is a congenital anomaly or birth defect.
- Abbreviation(s): SAR
- Synonym(s): serious ADR
- Categories: Pharmacokinetics, Pharmacovigilance