ABSTRACT: BACKGROUND:Short-course chemotherapy comprising isoniazid, rifampicin, ethambutol, and pyrazinamide has proved to be highly effective in the treatment of tuberculosis (TB). However, the most common adverse effect of this regimen leading to interruption of therapy is hepatotoxicity. There is a paucity of evidence in Tigray region on anti-tuberculosis drug-induced hepatitis. Therefore, this study aims to determine the magnitude, outcomes, and associated factors of drug-induced hepatitis in Ayder specialized comprehensive hospital tuberculosis clinic. METHODS:An institution-based cross-sectional study was done on 188 cases of patients who took anti-tuberculosis drugs from August 4, 2015 to June 30, 2018 in tuberculosis clinic, Ayder Comprehensive Specialized Hospital, Northern Ethiopia. Data on socio-demography, clinical characteristics and magnitude of the incidence and outcome of anti-tuberculosis drugs-induced hepatitis were collected using structured checklist from patients' records using census method. Then, we entered and analyzed the data using statistical packages for social sciences (SPSS) statistical software version 21. Descriptive statistics were done in tables, counts, proportions, median and range. Bivariate and multivariable regression analyses were done to identify factors that are associated with drug-induced hepatitis. Confidence interval was taken at 95% and p-value of less than 0.05 was used to denote significance. RESULTS:We approached a total of 226 patients' records, and we collected data from188 records (83.2%response rate). Anti-tuberculosis drug-induced hepatitis was found in 26 (13.8%) of the patients, of which 3 (11.54%) have died. Using multivariable logistic regression analyses, preexisting liver disease (AOR: 42.01, 95% CI: 4.22-417.49), taking other hepatotoxic drugs (AOR: 23.66, 95% CI: 1.77-314.79), and having lower serum albumin (AOR: 10.55, 95% CI: 2.57-43.32) were found to be significantly associated with the development of anti-tuberculosis drug-induced hepatitis. CONCLUSION AND RECOMMENDATION:The incidence of anti-tuberculosis drug-induced hepatitis was high. Patients with low baseline serum albumin, taking other hepatotoxic drugs and having preexisting liver disease should be followed with serial liver enzymes after initiation of anti-tuberculosis medications. These patients should be followed with frequent measurement of liver enzymes to assess for the development of drug-induced hepatitis.