Adverse Events Associated with Risperidone Use in Pediatric Patients: A Retrospective Biobank Study

BACKGROUND: Although risperidone is increasingly used for behavioral indications in children, the associated adverse events (AEs) are not well defined in this population. OBJECTIVE: We determined the incidence of and risk factors for AEs among children treated with risperidone at our institution, an academic medical center with inpatient, outpatient, generalist, and specialist pediatric care. METHODS: The study included children aged ≤ 18 years with ≥ 4 weeks of risperidone exposure. Data were obtained using de-identified electronic health records. AEs were defined as any untoward event attributed to risperidone reported by the patient, parent/guardian, or physician or detected following a laboratory investigation. Associations between AEs and clinical variables were determined using univariate and multivariate analyses. RESULTS: The study cohort included 371 individuals (median age 7.8 years [interquartile range 5.9-10.2]; 271 [73.0%] male). The two most common primary diagnoses were attention-deficit/hyperactivity disorder (160 [43.1%]) and autism (102 [27.5%]). The most frequent indications for risperidone were aggression (166 [44.7%]) and behavioral problems (114 [30.7%]). Altogether, 110 (29.6%) individuals had 156 AEs. Weight gain (32 [20.5%]) and extrapyramidal symptoms (23 [14.7%]) were the most common AEs. Aggression, irritability, and self-injurious behavior were positively associated with AEs, and concomitant analgesics and antibiotics were negatively associated. In multivariate analysis, associations remained significant for self-injurious behavior (adjusted odds ratio [aOR] 3.1; 95% confidence interval [CI] 1.7-5.4) and concomitant antibiotics (aOR 0.2; 95% CI 0.1-0.9). CONCLUSIONS: Nearly one in three children treated with risperidone for ≥ 1 month experienced one or more AEs. Particular vigilance is warranted for children with self-injurious behavior.