Abstract: Objective To investigate the clinical characteristics of drug-induced liver injury (DILI) caused by Traditional Chinese Medicine (TCM) or Western medicine. Methods Total of 78 cases with DILI were collected in Jiangsu Province Hospital of TCM during the period from 2008 July to 2014 July, then the clinical characteristics of DILI caused by TCM or Western medicine as well as the differences between the indexes of laboratory were analyzed retrospectively. Results The mainly patients were middle-aged and elder. The number of female patients was twice more than that of male ones, and the most common is liver cell type (about 74.49%). Further analysis found that DILI caused by TCM account for about 39.74%, while the Western medicine ones were about 60.26%. There were no differences in age, gender, the onset of disease, clinical classification, and clinical immunological characteristics between DILI induced by TCM and Western medicine (P ＞ 0.05), but showed significant statistical difference in clinical efficacy between such two drug types (P ＜ 0.05), the prognosis was poor in TCM-induced compared to the Western medicine ones. During the initial onset time, hepatic function indexes such as the levels of TBil, ALT, AST, TBA of TCM-induced DILI were significantly higher compared to the Western medicine ones (P ＜ 0.05). However, the levels of TP, ALB, ALP, GGT and PT induced by two types of drug showed no significant differences (P ＞ 0.05). The hepatic function of TCM or Western medicine-induced DILI showed significantly improved after treatment for two weeks compared to that of pre-treatment (P ＜ 0.05) except the level of PT (P ＞ 0.05). The results also showed that only TBA was higher in DILI patients induced by TCM compared to that of the Western medicine (P ＜ 0.05). Conclusions The hepatotoxicity and the degree of hepatocyte necrosis-induced by TCM is higher than that of the Western medicine, also its prognosis is worse and recovery is slower compared to the Western medicine ones.