Abstract: Objective To explore the characteristics of serious adverse drug reactions (ADRs) induced by bevacizumab injection and provide references for safe medications. Methods A total of 445 reports of serious ADRs induced by bevacizumab injection collected in 2019-2025 were retrieved from the Adverse Drug Reaction Monitoring System of Henan Province. Statistical analysis was conducted of the patients' age, gender, outcomes and severity of serious ADRs, primary diseases, routes and dosages of administration, systems-organs involved and clinical manifestations, grading of ADRs, and combined medications. Results Among the 445 reports of serious ADRs, female patients outnumbered male ones at a ratio of 1.75∶1. The incidence was high among patients ages 51 to 60. In terms of patient outcomes, a total of 586 cases (84.69%) recovered or improved. Intravenous drip was the dominating administration route (422 cases, 94.83%), with the dosages ranging from 25 mg to 1,100 mg. The primary diseases were indications that were not recorded in package inserts in 45 patients (10.11%). Combined medications included antimetabolites, platinum compounds, and paclitaxel-based agents (130 cases, 72.22%). Serious ADRs primarily involved the circulatory and lymphatic system and the gastrointestinal system. The common clinical manifestations were bone marrow suppression (115 cases, 18.31%), decreased white blood cell count (68 cases, 10.83%), nausea (45 cases, 7.17%), hypertension (33 cases, 5.25%), vomiting (30 cases, 4.78%), and decreased platelet count (29 cases, 4.62%). The severity of serious ADRs was predominantly grade 1 to 3, with no fatal cases reported. Conclusion Serious ADRs induced by bevacizumab injection are more common in middle-aged and elderly patients, especially in females. Most of the patients have favorable outcomes after clinical interventions. Improper administration routes and off-label drug use may occur in clinical practice. Severe ADRs involve multiple systems and organs. Clinicians should be well aware of the characteristics of related ADRs and effectively manage common serious ADRs.

Key words: Bevacizumab Injection, New Antineoplastic Drugs, Myelosuppression, Adverse Drug Reaction, Off-Label Drug Use