Abstract: Objective Through investigating the characteristics and mechanism of adverse reactions induced by montelukast, to find its risk factors and provide technical support for safe and rational use of drugs in clinic. Methods Using 'montelukast', 'adverse reaction'and 'caused by', as key words to search and retrieve articles in the CNKI and VIP database. Thirty-two references which met the inclusion and exclusion criteria were extracted and analyzed. Results Children and old patients appear to have higher ADR occurrence rate by using montelukast. Systems and Organs mainly involved in adverse reactions are nervous system, skin and its appendages, urinary system, gastrointestinal system, blood system, liver and skeletal system damage, etc. Conclusion It is important to pay attention to the adverse reactions caused by montelukast, as well as the clinical use beyond indications, specially to strengthen post-marketing surveillance in old patients and children, in order to prevent adverse drug reactions and ensure the safe drug use in clinic.

Key words: montelukast, adverse drug reactions, literature review