Abstract: Objective To study the oral ketoconazole adverse reactions in the world, especially the hepatotoxicity. Methods Searching articles using relative terms about ketoconazole, oral administration published on PUBMED, MED LINE, CBM, CNKI, VIP, WANFANG and many other databases by Nov. 2011. Picking up the basic information, method features, interventions and adverse reactions when the studies were included, fixed models were used for the final Results ' Meta-analysis. Results The number of included studies was 195. The top three adverse reactions were intestinal adverse reactions(44.5%), neurological and psychiatric adverse reactions(13.8%), hepatotoxicity(11.0%). The hepatotoxicity incidence proportion was 3.1% ~4.1%. Conclusion Many kinds of oral ketoconazole adverse reactions were observed, relating to all systems, the hepatotoxicity proportion was high(3.1%~4.1%). Because elevated liver enzymes were the most common reporting markers, severe liver injure proportion couldn't be measured. When generalizing the Results one should consider the study qualities and publication bias.

Key words: ketoconazole, oral administration, adverse reaction, hepatotoxicity, systematic review