Objective: By collecting all adverse drug reaction (ADR) reports of patients under 18 years old reported by a hospital from 2011 to 2020

to investigate the situation and characteristics of ADR in juvenile patients

and to provide references for ADR monitoring and rational drug use of children. Methods: A retrospective analysis was used to analyze the types of ADR reports

patients’ gender

age

the names of main drugs causing ADR

drug varieties

routes of administration

drug combination

and involved organs. Results: A total of 389 cases of qualified ADR were reported

of which 270 cases (69. 41%) were “normal”

78 cases (20. 05%) were “new normal”

32 cases (8. 23%) were “severe” and 9 cases (2. 31%) were “new severe”. The age of the patients with ADR mainly ranged from 28 days to 7 years old. The main routes of ADR were intravenous infusion in 279 cases (71. 72%)

and intravenous injection in 55 cases (14. 14%). The first three kinds of drugs causing ADR were antibacterial drugs in 193 cases (38. 91%)

Chinese patent medicine in 136 cases (27. 22%) and antiviral drugs in 33 cases (6. 65%). The highest number of the first three antibiotics were 33 cases of cefoperazone sodium and sulbactam sodium for injection

31 cases of cefuroxime sodium for injection and 28 cases of ceftriaxone sodium for injection. The first three kinds of Chinese patent medicines were Shuanghuanglian injection (lyophilized) in 34 cases

Tanreqing injection in 29 cases and Reduning injection in 26 cases. The most common system/ organ involvements caused by ADR were damage of skin and its appendages (343 times

61. 58%)

and then the gastrointestinal (78 times

14. 00%) and cardiovascular system (31 times

5. 57%). Conclusion: The situation and characteristics of ADR among children in this hospital are similar to those reported in China. By strengthening the monitoring of ADR among children

the supervision of medical workers on intravenous administration

combined use of drugs

antibacterial drugs and Chinese patent medicine injections

and the monitoring of ADR by clinical pharmacists

the occurrence of ADR in children can be reduced

and the safety of drug use can also be ensured.