Drug-specific and developmental heterogeneity in adverse event profiles of atypical antipsychotics in the pediatric population: A FAERS pharmacovigilance study.

OBJECTIVE

To characterize the safety profile of atypical antipsychotics (AAPs) in the pediatric population using the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS), focusing on signal distribution, drug-specific patterns, developmental heterogeneity, and time-to-onset (TTO).

METHODS

Adverse event (AE) reports involving AAPs were extracted from FAERS, and pediatric cases aged 0-17 years were identified. Descriptive analyses summarized reporting characteristics and system organ class (SOC) distributions. Signal detection was performed using the reporting odds ratio (ROR), proportional reporting ratio (PRR), empirical Bayes geometric mean (EBGM), and information component (IC). Subgroup analyses were conducted by age and sex, and TTO analyses assessed temporal patterns.

RESULTS

Among 463,131 AAP-related AE reports, 24,575 involved pediatric patients. Reports were predominantly from males and adolescents. The top 50 robust pediatric risk signals mainly included gynaecomastia, galactorrhoea, hyperprolactinaemia, abnormal weight gain, and extrapyramidal disorder, with clear drug-specific clustering. At the SOC level, signals were concentrated in reproductive system and breast disorders, psychiatric disorders, metabolism and nutrition disorders, and nervous system disorders. Age-stratified analyses showed more nervous system-related signals in younger children, prolactin-related abnormalities in school-age children, and psychiatric and nervous system-related signals in adolescents. TTO analyses indicated that some events occurred early, whereas others accumulated during longer-term treatment.

CONCLUSIONS

Pediatric AAP-related AEs showed marked drug specificity, developmental heterogeneity, and distinct temporal patterns. These findings support stratified safety monitoring according to drug characteristics and developmental stage.