Abstract: Objective The epidemiological characteristics of acute liver damage induced by Zhixue Capsule was inves-tigated. Methods The severe adverse drug reactions(ADR) reports on liver damage induced by Zhixue Capsule have been analyzed retrospectively. Results 5 patients administered the Zhixue Capsule and the average medication time was(22+12) days. The clinical manifestations of the acute liver damage induced by Zhixue Capsule included jaundice, fatigue, fever, abdominal distension, nausea, anorexia and poor appetite. Liver function examination showed that the alanine aminotransferase(ALT) was between 599~3380 U/L,the total bilirubin(TBIL) was between 5.6~489 mol/L, and the eosinophilic granulocyte also get higher after administration. Conclusion The densefruit pittany root-bark in Zhixue Ca-pasule may be the major cawse of the acute liver damage. So it suggest that clinician should determine the treatment based on differentiation of sym ptoms and signs to Drug-induced liver damage should be evaluated, and promote rational use of drugs, decrease the incidence of adverse drug reactions.

Key words: Zhixue capsule, acute liver damage, adverse drug reaction(ADR)