Objective: To discover and analyze the adverse drug reactions (ADR) in children and its regularity

to provide references for the safe medication of children. Methods: The 11

904 children’s ADR data reported to ADR Monitoring Center through the spontaneous reporting system in the year of 2020 were retrieved

and statistical analysis was performed on the report type

source

reporter’s occupation and patient’s gender

age

ADR outcome and relevance evaluation

combined drugs

suspected drug categories

and involved organs/ systems. Results: Among the 11

904 cases of children’s ADR reports

general ADR accounted for 81. 75% (9

732 cases)

serious ADR accounted for 9. 60% (1

143 cases)

and new ADR accounted for 8. 64% (1

029 cases). The reports were mainly from medical institutions (99. 70%)

and the majority of reporters were physicians (47. 60%). Most of children were mainly 3 to 7 years old (26. 89%). The main outcomes were recovery and improvement (99. 11%)

and the relevance evaluation was mainly “probable” (78. 56%). Drug combination accounted for 22. 88%

and the intravenous drip (71. 72%) was the main route of administration. The top five drugs suspected were anti-infection-related drugs (59. 32%)

traditional Chinese medicine preparations (10. 63%)

respiratory system drugs (7. 69%)

water

electrolyte and acid-base balance regulating drugs (5. 58%) and central nervous system drugs (2. 82%)

involving 94

188

40

81 and 101 varieties

respectively. The organs/ systems involved were mainly skin and its accessories (47. 98%). Conclusion: It is recommended to regulate children’s medication

pay attention to the regular characteristics of children’s ADR

and strengthen the monitoring of children’s ADR of medication

in order to ensure the safety and rationality of children’s medication.