Analysis of the adverse events of axitinib in patients with urinary system tumors and other systemic diseases
Objective To explore the risk signals associated with axitinib and to provide references for safe and rational clinical drug use. Methods Data on adverse event reports related to axitinib from the FAERS database from January 1,2012 to June 30,2024 were collected. Proportional reporting odds ratio (ROR) and Bayesian confidence propagation neural network (BCPNN) methods were used for data mining. The preferred system organ classification and preferred terms from the adverse drug reaction terminology set were used to classify and describe the mined risk signals. Results A total of 12927 adverse event reports involving acitinib as the primary suspect drug were collected,including 8428 male patients (65.2％) and 3493 female patients (27.0％). A total of 63 positive signals were identified,with the most commonly reported systemic organ conditions being kidney and urinary system diseases,gastrointestinal disorders,and various tumors (including benign,malignant,and unspecified types,such as cysts and polyps). The new adverse events exhibiting strong signal intensity included diarrhea,progressive tumors,hypertension,oral mucositis,oral pain,and renal function impairment. Conclusion The adverse events associated with axitinib in the treatment of urinary system tumors significantly impact patients' quality of life and should be carefully considered in clinical practice to ensure patient safety.
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