Efficacy and Safety of Aripiprazole in Children and Adolescents With Autism Spectrum Disorder: A Meta-Analysis

Aripiprazole is one of the few pharmacological agents approved for managing irritability in children and adolescents with autism spectrum disorder (ASD).

Randomized controlled trials comparing oral aripiprazole with placebo or active drugs in participants under 18 years were systematically searched in major databases through September 2025 (last search: September 15, 2025). The primary outcome was change in Aberrant Behavior Checklist-Irritability (ABC-I) scores; data were synthesized using random-effects models.

Eleven trials ( N = 1,135) were included. Aripiprazole significantly reduced irritability (mean difference = -5.18; 95% CI = -6.72 to -3.64; I 2 = 0%) and improved global ratings versus placebo. Common adverse effects were weight gain, sedation, and extrapyramidal symptoms, though discontinuation rates were comparable to placebo.

Aripiprazole effectively and safely reduces irritability in pediatric ASD. Although adverse effects are frequent, they are generally manageable, supporting individualized dosing and long-term monitoring.