Evaluating the Real-World Safety of Atypical Antipsychotics in Paediatric Autism Spectrum Disorder: Lessons from Saudi Arabia's Pharmacovigilance System.

The study analyzed the safety of atypical antipsychotics used in children with autism spectrum disorder based on data from the Saudi Food and Drug Authority database from 2021 to 2024. A total of 701 adverse drug reaction reports were analyzed, with the majority involving boys (59.91%) and children aged 0-9 years (82.88%). Olanzapine had the highest proportion of serious reports (44.44%). The research identified specific signals associated with individual medications: risperidone was linked to nervous system disorders, quetiapine to cardiovascular disorders, olanzapine to hematological and metabolic disorders, and aripiprazole to gastrointestinal disorders. The analysis demonstrated significant differences in adverse effects according to age, but not by gender. The results suggest the need for age-specific safety monitoring when using these medications in children.