Objective To investigate the etiology and clinical features of drug-induced liver injury (DILI).Methods A total of 194 DILI in patients,who underwent liver biopsy in our hospital from January 2015 to December 2015,were enrolled in the study.The etiology,laboratory markers (such as alanine transaminase,aspartate aminotransferase,total bilirubin,gammaglutamyl transferase and alkaline phosphatase),and the pathological features were analyzed retrospectively.Then,all of the patients were followed up every 3 or 6 months,with a mean of 34.5 months.The risk factors associated with relapse,which was defined as liver enzymes (such as ALT or TBIL) rising at least 2 times of its upper limit of normal value (ULN),were analyzed with a logistic regression model.Results In terms of etiology,Traditional Chinese medicine (TCM) was the most common cause of DILI,which accounted for 46.9％ of patients,in return followed by acetaminophen-containing drugs (14.4％),antibiotics (9.3％),environmental toxins (4.6％),antidepressant (4.6％),dietary supplement (3.1％),lipid-lowering drugs (3.1％),chemotherapeutic agents (2.6％,and others unknown (11.3％).Of 194 DILI patients,hepatocellular type was observed in 78(40.2％) patients,cholestatic type in 63(32.5％),and mixed type in 53(27.3％).Histological findings showed that 70(36.1％) patients had an acute injury,124(63.9％) chronic damages,which composed by G0(9.8％),G,(19.1％),G2(21.6％),G3(9.8％),and G4(3.6％) in terms of inflammation level.Twenty-seven cases (21.8％) relapsed after discharge from hospital,multivariate analysis showed that cholinesterase is an independent risk factor which might predict the relapse of DILI patients.Conclusions The incidence of DILI is increasing,especially induced by TCM,therefore clinicians should master the clinical features of the disease in order to achieve correct diagnosis and establish the optimal treatment strategy.