OBJECTIVE  To analyze the regularity and the characteristics of adverse drug reactions associated with antibacterial drugs in pediatric patients at Capital Center For Children's Health, Capital Medical University, and to provide reference for safe medication in children.

METHODS  A total of 382 ADR reports related to antibacterial drugs in children, submitted to the National ADR Monitoring Center from our hospital between Jan 2005 and Dec 2024 were collected. The gender, age, route of administration, drug category, system/organ involved and clinical manifestations, ADR occurrence time, outcome and reporting personnel were classified,and analyzed by Pareto principle.

RESULTS  Among 382 ADR reports,157 cases(41.10%) were female and 223 cases(58.38%) were male. 2 cases(0.52%) were gender unknown.The age distribution were mainly school age(30.37%), early childhood(22.51%) and pre-school age(24.35%). Most of the cases of ADR were induced by intravenous injection, accounting for 85.19%. Cephalosporins(22.72%), Macrolides(21.48%) and glycopeptides(13.58%) caused the majority of ADR. The injury to the skin and adnexa was the most common ADR, which accounted for 199 cases(50.38%). ADR mainly occurred within 1 day and 1-2 day after medication. Among the reporting staff, 307 cases were reported by pharmacists, 71 cases by physicians and 4 cases by nurses. The most of ADR were improved or recovered after treatment.

CONCLUSION The application of antibacterial drugs in children should fully consider ADR, strengthen monitoring, and ensure the safety of clinical medication.