Abstract: Objective To study the patterns and characteristics of adverse drug reactions(ADR) among the real-world pediatric inpatients in order to provide reference for clinical rational drug use and for safety evaluation of drugs in pediatric populations. Methods In this retrospective study, the data on pediatric inpatients treated with intravenous administration and reports about adverse drug reactions in a tertiary children's hospital collected between 2018 to 2019 were analyzed in terms of patients' age, medications, time of occurrence, and organs/systems involved. Results Among the 50 194 pediatric inpatients who had received intravenous administration, a total of 423 ADR reports in our hospital were collected. The incidence of adverse reactions of intravenous medicines averaged 8.43%. The incidence of ADR was the highest among patients ages 7 to 12 (10.24‰) and 4 to 6 (8.93‰), but was the lowest in newborns (3.40‰). The 423 ADR reports involved 61 types of drugs. 259 of these ADR involved anti-infectious drugs, accounting for 61.23%, 35 involved drugs for regulation of electrolytes and acid-base balance and nutritional drugs, accounting for 8.27%, and 24 were related to traditional Chinese medicine injections, accounting for 5.67%. Intravenous ADR mainly occurred within one hour of medication (67.38%), and 51.88% of the ADR occurred within 30 minutes of injection. ADR involving organs/systems were mostly the damage to the skin and its accessories (62.27%), followed by gastrointestinal side effects (20.61%) and systemic damage (5.56%). Conclusion More attention should be paid to the regularity and characteristics of adverse reactions during intravenous administration in children. Preventive measures should be taken to ensure the safety and effectiveness of pediatric drugs.

Key words: adverse drug reaction, children, intravenous medicine, hospitalization