Abstract: Objective To analyze one case of adverse drug reactions–gastrointestinal bleeding–caused by sunitinib Malate Lepsules, and to provide a reference for safe use of sunitinib in clinical practice. Methods Based on a clinical case of a 62-year-old female patient who developed lower gastrointestinal bleeding after taking sunitinib capsules due to gastrointestinal stromal tumor with liver metastasis, clinical pharmacists consulted related literature and analyzed the causes of bleeding. Results Gastrointestinal bleeding of the patient was determined as a “probable” adverse drug reaction to sunitinib capsules. The mechanism might be that vascular endothelial growth factors were inhibited by sunitinib, leading to the impairment of normal vascular physiological functions and the inhibition of platelet function and fibrin formation. Conclusion Clinicians should remain vigilant on gastrointestinal bleeding caused by sunitinib during medication. When a therapy with this drug is used a second time, the risks and benefits must be weighed, and patients should be monitored to ensure the safety of medication.

Key words: Sunitinib Malate Capsules, Tyrosine Kinase Inhibitors, Lower Gastrointestinal Bleeding, Adverse Drug Reaction