Abstract: Objective To investigate the incidence and characteristics of drug-induced liver injury (DILI) in Shandong province over the past five years, and provide reference for pharmacovigilance and clinical safety of medication. Methods From the database of Shandong ADR Monitoring Center, cases of DILI reported between January 1, 2013 and July 31, 2018 were retrieved and screened. Data on the gender, age, ethnicity, disease history, varieties of drugs, drug categories, routes of administration, latency, primary diseases and disease outcomes of patients was collected and analyzed. Results Among the 5 530 reported cases, 5 066 cases met DILI diagnostic criteria, who were outpatients, emergency patients or inpatients from 570 medical institutions. The ratio of males to females was about 1.42∶1, and the incidence was the highest (1 991 cases, 39.34%) among patients aged 40 to 59. There were 17 categories and 789 kinds of drugs involved, among which anti-infective drugs (including anti-tuberculosis drugs) accounted for the largest proportion (2 537 cases, 34.81%). Oral administration was the most common (3 411cases, 67.33%). Tuberculosis was the dominating primary disease (933 cases, 18.42%). The median latency was 52.09 (35.12, 104.05) d, while the most common latency was 7~14 d(1 682 cases, 33.23%). The median indexes of main liver function were ALT 130.00（90.00, 215.00）U/L, AST 90.00（65.00, 150.00）U/L,TB 52.09（35.13, 104.05）μmol/L, DB36.07(16.70, 80.00) μmol/L. Most patients recovered or improved after treatment (4 298 cases, 84.84%). Conclusion Clinical medical staff need to improve their comprehensive understanding of DILI and strengthen the monitoring of high-risk groups and high-risk drugs.

Key words: drug induced liver injury, clinical features, retrospective analysis