SAR

A Serious Adverse Reaction (SAR) is an adverse reaction to a medicinal product that meets specific criteria of severity. It is characterized by one or more of the following conditions: the reaction results in death, is life-threatening, necessitates in-patient hospitalization or extends an existing hospital stay, leads to persistent or significant disability or incapacity, or involves the occurrence of a congenital anomaly or birth defect.

The term “reaction” signifies that there is at least a reasonable possibility of a causal relationship between the medicinal product and the adverse event. SARs are of significant concern in pharmacovigilance and require careful evaluation and reporting to ensure patient safety.