Objective: To analyze the characteristics of new/severe adverse drug reaction (ADR) in children in Ma’anshan Maternal and Child Health Care Hospital, so as to provide reference for ensuring drug the safety of children’s medication and promoting the rational use of children’s medicines. Methods: Retrospective statistical analysis of 104 cases of new/severe ADR in children reported to the National ADR Monitoring Center by hospital ADR evaluators from January 1, 2019 to December 30, 2020 in Ma’anshan Maternal and Child Health Care Hospital. The contents of the report include report type, relevance evaluation, gender, age/month, previous history of ADR, family history of ADR, underlying disease, drug species, dosage form and route of administration involved in ADR, systems/organs involved in ADR, results, and outcomes. Results: Between January 1, 2019 and December 30, 2020, 104 new/severe ADR were reported in children, of which 2 cases (1.92%) were severe; new 99 cases (95.19%); three cases (1.92%) were newly severe. The correlation evaluation was positive in 5 cases (4.81%); probable in 75 cases (75.96%); probable in 19 cases (19.23%). The proportion of new/severe ADR in 1–3 years old children was the highest, reaching 47.12%. The main route of administration was intravenous drip (72.11%). Drugs related to new/severe ADRs included 27 types of drugs in 7 categories, of which anti-infective drugs accounted for the most, accounting for 65.38%. The systems/organs involved in ADR were mainly systemic reactions and digestive system reactions, and the primary diseases of the children were not affected by adverse reactions. Conclusion: Drug ADR monitoring can prevent and reduce the occurrence of new/severe ADRs in children, reduce the burden of children’s injuries and families, and ensure that children’s medication is safe, effective, and reasonable.