OBJECTIVE： To provide reference for safe use of sunitinib in clinic. METHODS： Using “sunitinib”“ADR” as retrieval words， retrieved from PubMed， VIP， CNKI and Wanfang database during Jan. 2006-Mar. 2017， case reports and case series reports about sunitinib-induced ADR were collected and screened. In retrospective study， general information of patients， disease information， involved organs or systems， clinical manifestations， ADR association evaluation and outcomes were analyzed statistically. RESULTS： A total of 57 literatures were included， involving 66 cases， among which there were 15 new ADR. There were 34 male （51.52％） and 32 female （48.48％）， with ratio of 1.06 ∶ 1. Average age of patients was（63.4±10.5） years old. Sunitinib was mainly used for suprarenal epithelioma， accounting for 65.15％； followed by gastrointestinal stromal tumors， accounting for 21.21％. The incidence of ADR was the highest during 8-14 d （27.27％） and 22-28 d （22.73％） of medication. Organs/systems involved in ADR mostly were endocrine system （accounting for 25.76％）. Main clinical manifestation was hypothyroidism， followed by diseases of skin and subcutaneous tissue （21.21％）， diseases of the blood lymphatic system （16.67％） which mainly manifested as hand foot syndrome and thrombocytopenia （mainly being 4 degree bone marrow suppression）. There were 9 cases of definite causal relationship and 57 cases of probable causal relationship. Fourteen cases of sunitinib-induced ADR were recovered after drug withdrawal （21.21％）； 27 cases were recovered after drug withdrawal and drug therapy （40.91％）； 17 cases had sequel after surgery， prolonging disease course and therapy （25.76％）； there were 8 death cases （12.12％）. CONCLUSIONS： Sunitinib-induced ADR involve various organs/systems， and there are fatal cases. In the process of clinical medication， we should strengthen the observation and monitoring， timely ADR disposal to guarantee the safety of patients.