Objective: To analyze the occurrence of adverse drug reactions (ADR) induced by traditional Chinese medicine injections in children

so as to provide reference for rational drug use in clinic. Methods: A total of 1

356 cases of ADR induced by Chinese patent medicines were collected from the National ADR Monitoring System from 2006 and 2021. Totally 104 cases of ADR induced by traditional Chinese medicine injections in the pediatric population were selected for analysis. The characteristics and causes of ADR were analyzed from three perspectives: patient factors

drug factors and clinical factors. Results: Of the 104 cases

65 cases (62. 50%) were males and 39 cases (37. 50%) were females. In the age group of ⩽5 years

there were 59 cases (56. 73%). Composite formulations accounted for 63 cases (60. 58%)

while single-component formulations accounted for 41 cases (39. 42%). ADR occurred within 30 minutes after administration in 86 cases (82. 69%). Conclusion: As children are still in the stage of growth and development

attention should be paid to the use of traditional Chinese medicine injections. Prudent drug use

enhanced monitoring

and measures to reduce or avoid ADR are recommended.