Abstract: Objective To analyze reports of adverse drug reactions (ADR) caused by new antineoplastic drugs in a hospital in order to provide a reference for safe clinical use of drugs. Methods ADR reports related to new antineoplastic drugs submitted by a hospital between January 1, 2022 and October 31, 2024 were retrieved. The demographic data of patients, categories of drugs, affected systems and organs, clinical manifestations and off-label drug use were analyzed. Results Among the patients involved in the 211 ADR reports, the male-to-female ratio was 1.03∶1, and those over 60 years old accounted for 70.62%. There were 106 reports of mild cases (50.24%) and 105 reports of severe ones (49.76%). The blood system and hematopoietic system were the most frequently involved, accounting for 61.14% (129 cases). There were 18 ADR reports related to off-label drug use, including 13 severe cases (72.22%). Conclusion The proportion of reports of severe cases among ADR reports caused by new antineoplastic drugs is relatively high, pointing to the need for early clinical identification and intervention. It is imperative for medical institutions to enhance the regulation of off-label drug use in order to ensure patients’ safety.

Key words: New Antineoplastic Drugs, Immune Checkpoint Inhibitor, Adverse Drug Reaction, Immune-Related Adverse Events, Blood System, Hematologic System