Objective: Drawing on the real-world data from the China Hospital Pharmacovigilance System (CHPS)

to evaluate the safety of ceftizoxime used in children of a hospital

and analyze the occurrence of ceftizoxime-related adverse drug reaction (ADR) and its influencing factors. Methods: Based on the CHPS platform

single-center retrospective active monitoring was carried out on the hospitalized children who had ceftizoxime for injection from February 2018 to April 2020. The system monitoring cases were evaluated by double pharmacists

the incidence of ceftizoxime ADR was obtained

and its influencing factors were analyzed. Results: Totally 2

948 children who used ceftizoxime were monitored retrospectively

and 31 cases of ADR occurred

with an incidence of 1. 09%. Multivariate logistic regression analysis showed that the combination of ceftizoxime and flucloxacillin and a single dose were independent influencing factors of ADR in children using ceftizoxime. Conclusion: The incidence of ADR in children with ceftizoxime is not a rare range. Reducing the combined use of flucloxacillin and adjusting the single dose according to the weight of the child will help reduce the clinical risk of medication. The application of the CHPS platform is of great significance for future large-sample real-world medication evaluation.