Efficacy and Safety of Aripiprazole in Children and Adolescents With Autism Spectrum Disorder

AIM: Aripiprazole is one of the few pharmacological agents approved for managing irritability in children and adolescents with autism spectrum disorder (ASD). METHODS: 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. RESULTS: Eleven trials (N = 1,135) were included. Aripiprazole significantly reduced irritability (mean difference = -5.18; 95% CI = -6.72 to -3.64; I2 = 0%) and improved global ratings versus placebo. Common adverse effects were weight gain, sedation, and extrapyramidal symptoms, though discontinuation rates were comparable to placebo. CONCLUSIONS: 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.