Dan Roden
Faculty Member
Last active: 3/24/2020

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

Oshikoya KA, Carroll R, Aka I, Roden DM, Van Driest SL
Drugs Real World Outcomes. 2019 6 (2): 59-71

PMID: 30919267 · PMCID: PMC6520321 · DOI:10.1007/s40801-019-0151-7

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.

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