OBJECTIVE  To evaluate the evidence-based medical evidence and clinical use of aripiprazole in treating mental disorders in children and adolescents.

METHODS  Collected drug package inserts from both China and abroad, clinical guideline consensus, diagnosis and treatment standards, and medical literature and data; screened and adopted the highest-level evidence-based medicine evidence to establish an evidence-based evaluation table for the off-label use of aripiprazole in mental disorders among children and adolescents. Extracted outpatient and inpatient cases of children and adolescents treated with aripiprazole from The Affiliated Bozhou Hospital of Anhui Medical University from January 1, 2023 to October 31, 2024, and the clinical off-label drug use in accordance with the established evidence-based evaluation table was analyzed and evaluated.

RESULTS A total of 23 off-label indications were included, including 7 “strongly recommended”, 3 “moderately strongly recommended”, 1 “weakly recommended”, and 12 “not recommended”. Among the 507 outpatient and inpatient patients, the proportion of off-label indications drug use was 66.86%, and the proportion of “moderately strongly recommended” and above recommended levels was 66.08%.

CONCLUSION  Aripiprazole has a wide range of off-label drug use in mental diseases of children and adolescents, and most common diseases have a high recommendation grade. However, attention should still be paid to the problems of off-label drug use with insufficient evidence-based evidence. Meanwhile, it is necessary to strengthen the management of off-label drug use to improve the safety and rationality of medication.