Abstract: Objective To explore the clinical characteristics and mechanism of rare systemic skin adverse reactions caused by donafenib tosilate tablets (donafenib). Methods Rare skin toxicity caused by donafenib in a patient with gallbladder malignant tumor was analyzed while the manifestations and pathogenesis were summarized based on literature review. Results The clinical manifestations of this patient including atypical target erythema, pruritus and fever were similar to those of erythema multiforme drug eruption. After discontinuation of donafenib and treatment with hormone, human immunoglobulin and antihistamine drugs, the symptoms were significantly relieved. Conclusion Erythema multiforme drug eruption induced by donafenib is rare but severe, which deserves more attention. There have been no related reports at home and abroad. Donafenib is a derivative of sorafenib so that the pathogenesis is similar.

Key words: donafenib, donafenib tosilate tablets, adverse drug reaction, erythema multiforme, drug eruption, cutaneous, gallbladder malignant tumor