Abstract: Objective In order to improve the treatment and early diagnosis of acute drug-induced liver disease, we analyzed the causative drugs, clinical manifestation and pathological characteristics of the disease.Methods From January 2000 to December 2005, 275 cases confirmed acute drug-induced liver disease according to Maria Criterion and hospitalized in Zhongshan hospital Fudan university were retrospectively reviewed.Each was examined by drug history, clinical symptom and signs, laboratory tests and therapeutic effect.In 41 cases, hepatic biopsy was carried out to help diagnosis.Results The incidence of acute drug-induced liver disease among all of the acute liver injury was annually increased.The most common drugs which induced acute liver injury were traditional Chinese medicine (23.3%, 64/275cases) , antineoplastics (15.3%, 42/275) , hormones and other immunosuppressant agents (13.8%, 38/275) , antihypertensive drugs and other cardiovascular drugs (10.2%, 28/275) , NSAIDs (8.7%, 24/275) .Hepatocellular injury was the predominant type in these cases (48%, 132cases) .The principal clinical manifestation included nausea (54.8%) , fatigue (50.2%) , jaundice (35.6%) and 27.9% patients had no symptoms.Most patients were cured with good prognosis.The total effect was 94.2% after treatment.Conclusion The clinicians should draw attention to the prevention, diagnosis and therapy of drug-induced liver disease.