Objective To mine adverse drug event (ADE) risk signals of bosutinib based on the U.S. Food and Drug Administration (FDA) Adverse Event Monitoring System (AEMS) database, to provide references for safe clinical medication.

Methods ADE reports related to bosutinib recorded in the AEMS database from inception to March 31, 2026 were retrieved. The ADEs were described, classified and statistically analyzed by system organ class (SOC) and preferred term (PT). The reporting odds ratio (ROR), proportional reporting ratio (PRR), multi-item gamma Poisson shrinker (MGPS) and Bayesian confidence propagation neural network (BCPNN), were applied to excavate and analyze ADE signals.

Results A total of 8,295 ADE reports of bosutinib were retrieved, among which 4,613 were serious adverse drug event reports. The majority of patients were aged 65-85 years (36.84%), with nearly equal proportions of males (44.91%) and females (46.23%). The primary outcome of serious ADEs was hospitalization or prolonged hospitalization (31.24%), and 70.40% of reports were submitted from the United States. A total of 143 ADE risk signals covering 17 SOCs were identified. The PTs with the highest report counts included diarrhea, nausea, fatigue, etc. The PTs with the strongest signal strength encompassed decreased body surface area, increased body surface area, chylothorax and so on.

Conclusion In clinical practice, apart from adverse reactions listed in the drug label, clinicians should pay close attention to risks such as increased/decreased body surface area and chylothorax during bosutinib administration to ensure safe medication for patients.

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