Abstract: Objective To study the patterns and characteristics of adverse drug reactions (ADRs) related to new antineoplastic drugs, and provide a reference for clinical medication. Methods A total of 691 cases of ADRs caused by new antineoplastic drugs were collected in a cancer hospital between October 2020 and October 2025. Data on gender, age, types of drugs, systems-organs involved in ADRs, clinical manifestations, off-label medication, grading and outcomes of ADRs and correlations was analyzed via the Microsoft Excel. Results Among the 691 cases, 374 (54.12%) were males and 317 (45.88%) females, and the average age was (57.02±12.34) years. There were 397 (57.45%) cases of serious ADRs and 32 (4.63%) cases of new ADRs. A total of 70 new antineoplastic drugs were involved. Immune checkpoint inhibitors were responsible for 271 cases (35.61%),and tislelizumab was the leading cause (72 cases). There were 121 cases involved in off-label medication and 20 systems-organs involved. The most frequently affected systems were blood and the lymphatic system (48.59%). Most of these ADRs were mitigated (78.00%). Conclusion Data on pharmacovigilance concerning new antineoplastic drugs remains lacking. ADRs associated with these agents can involve multiple systems-organs. Therefore, it is recommended that patients undergo baseline and dynamic monitoring. Off-label medications pose a risk to safety. Multidisciplinary collaboration and ethical review should be enforced to reconcile the conflict between delayed generation of evidence and pressing clinical needs.

Key words: New Antitumor Drugs, Immune Checkpoint Inhibitors, Macromolecular Monoclonal Antibody, Off-Label Medication, Adverse Drug Reaction