Abstract: Objective Through investigating the characteristics and mechanism of adverse reactions induced by topiramate, to find its risk factors and provide technical support for safe and rational use of drugs in clinic. Methods The patients who experienced adverse drug reactions(ADRs) induced by topiramate and reported by the department of pharmacy in Beijing Tiantan Hospital from March 1999 to March 2018 were included. At the same time articles in the CNKI database, Wanfang database, VIP Chinese full-text database and CBM database were searched, and the patients in the references which met the inclusion criteria were extracted. Then the ADR information of the patients both from Beijing Tiantan Hospital and the literatures were analyzed together. Results Most of the reactions occurred in patients under the age of 18. The major illness was epilepsy. ADRs occurred more frequently within 1 to 3 months after topiramate treatment. Systems and organs mainly involved in adverse reactions were neurological disorders, skin and appendages disorders, etc. Cognitive disorders and hypohidrosis were the most commonly reported adverse reactions, followed by anorexia and weight decrease. There were ten serious ADRs among which skin and appendages disorders were the most common, and then urinary tract disorders. No case died because of ADRs induced by topiramate, and most ADRs were fully recovered or relieved by stopping or reducing the use of topiramate. Conclusion The family history of nephrocalcinosis and allergy history should be asked before using topiramate. Start using topiramate with a small dose and increase the dose slowly. Blood routine test、liver function、ammonia、electrolyte、urinary system ultrasound test of patients should be monitored. Once ADRs occur, diagnosis and treatment should be carried out as soon as possible to ensure the safe drug use.

Key words: topiramate, adverse drug reactions, literature review