Analysis of pediatric adverse drug reactions reported to regional pharmacovigilance center of a single university hospital

Purpose: Adverse drug reactions (ADRs) are a recurring problem among pediatric patients, and the incidence is increasing. However, there have been only a few studies on the clinical presentation of pediatric ADRs in Korea. This study investigated the clinical presentation of ADRs and the causative drugs in pediatric patients from a single university hospital. Methods: We retrospectively collected the data on pediatric ADRs as reported to the Regional Pharmacovigilance Center in Dong-A University Hospital between March 2013 and July 2016. We analyzed clinical presentations associated with the events. To determinate causality, we evaluated each ADR according to the Naranjo probability scale, the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) criteria and the Korean ADR algorithm. Results: A total of 365 ADR cases were reported. Sixty-eight patients (26.5%) responded to 2 or more drugs. Antibiotics (43.3%) were the most common causative drugs, of whom the third generation cephalosphorins caused most ADRs. The most common clinical presentations were gastrointestinal manifestations (36.6%). A total of 312 ADRs were reported in 257 patients based on both the Naranjo probability scale and the Korean ADR algorithm. In addition, 323 ADRs were reported in 257 patients based on the WHO-UMC criteria. Conclusion: Various drugs are related to ADRs in pediatric patients. Further efforts to improve ADR-reporting systems and to increase awareness of ADRs in pediatric patients are needed.