Objective To evaluate the incidence of Ketoconazole associated hepatotoxicity and related factors. Methods Literature retrieval was conducted by using multi-databases for meta-analysis on Ketoconazole associated hepatotoxicity. The data were collected with a standardized form. Overall estimation of incidence of hepatotoxicity for specific study type was calculated by using a DerSimonian-Laird random-effects model owing to the substantial differences among the studies. Results Totally 204 eligible studies were included in the analysis. The incidence of Ketoconazole associated hepatotoxicity was 3.6%-4.2%. The dosage and duration specific subgroup analyses did not show any significant difference among groups, while the age specific subgroup analysis showed the incidence in children and people aged >60 years was 1.4% (95% CI: 0.5%-4.2%) and 3.2% (95% CI: 1.1%-8.7%) respectively. Additionally, the incidence of the hepatotoxicity was higher in people who had oral administration of ketoconazole beyond the provisions of the usage instructions, and the incidence was 5.7% (95% CI: 4.5%-7.2%). Conclusion Ketoconazole associated hepatotoxicity was common. Off-label use might increase the risk of liver damage. Well-designed large sample studies are needed to identify the risk factors in future. Objective To evaluate the incidence of Ketoconazole associated hepatotoxicity and related factors. Methods Data retrieval was conducted by using multi-databases for meta-analysis on Ketoconazole associated hepatotoxicity. The data were collected with a standardized form. type was calculated by using a DerSimonian-Laird random-effects model due to the substantial differences among the studies. Results Totally 204 eligible studies were included in the analysis. The incidence of Ketoconazole associated hepatotoxicity was 3.6% -4.2%. The dosage and duration specific subgroup analyzes did not show any significant difference among groups, while the age specific subgroup analysis showed the incidence in children and people aged> 60 years was 1.4% (95% CI: 0.5% -4.2%) and 3.2% (95% CI : 1.1% -8.7%) respectively. The incidence of the hepatotoxicity was higher in people who had oral administration of ketoconaz ole beyond the provisions of the usage instructions, and the incidence was 5.7% (95% CI: 4.5% -7.2%). Conclusion Ketoconazole associated hepatotoxicity was common. Off-label use might increase the risk of liver damage. Well-designed large sample studies are needed to identify the risk factors in future.