Objective To analyze the clinical characteristics of drug- induced liver injury ( DILI) . Methods A retrospective analysis was performed on the clinical data of 394 patients with DILI who were admitted to our hospital from 2009 to 2011. The studied factors included age, sex, names and categories of toxic drugs, time of onset, liver function, whether liver biopsy was performed, treatment, and prognosis. Results There is an upward trend in cases of DILI. Among the 394 patients with DILI, 170 ( 43. 15%) were males, and 224 ( 56. 85%) were females; the male- to- female ratio was 1∶ 1. 3; the peak ages were 41- 50 years ( 25. 63%) and 51- 60 years ( 25. 13%) . A variety of drugs could cause DILI, with traditional Chinese medicines ( TCMs) ( 45. 43%) as the most common one, followed by a combination of drugs ( 11. 42%) and antitubercular drugs ( 7. 61%) . The TCM category mainly included those for treating osteoarthrosis ( 11%) and dermatosis ( 11%) , and the drug names and components were mostly unknown. Forty- three cases ( 10. 91%) were confirmed by pathological examination, and the common pathological changes included infiltration of neutrophils and eosinophils ( 65. 01%) and cholestasis of capillary bile ducts ( 39. 93%) , which had no specificity for clinical diagnosis, but provided some hint. Among the 394 patients, 102 ( 25. 89%) were cured, 184 ( 46. 70%) showed an improvement, and 7 ( 1. 78%) progressed to liver failure and death. The overall prognosis was good; the prognostic factors included age, clinical classification, and peak level of total bilirubin. Conclusion A variety of drugs can cause DILI, which has no specific clinical manifestations and gold diagnostic criteria, often leading to misdiagnosis; most cases have good prognosis, but liver failure may occur in some cases.