ABSTRACT Objective: To explore the characteristics and related factors of adverse drug reactions(ADRs) caused by compound acetaminophen tablets(Ⅱ).Methods:370 cases of compound acetaminophen tablets(Ⅱ) caused ADRs report in Zhejiang province were collected from 2010 to 2015. Respectively statisitical analysised according to the case of gender, age, medication, medication situation, the types of adverse reactions, adverse outcomes ,and statisticed report unit of adverse reactions. Results:Compound acetaminophen tablets(Ⅱ) caused ADRs mostly occurred in the patients aged between 20 50 years old(74.59% ); General ADRs were mainly reported by business enterprises, but serious ADRs were mostly reported by hospitals; ADRs involved organs/systems were mainly the digestive system, skin and its accessories, systemic reaction; serious ADRs involved organs/systems were mainly skin and its accessories, systemic reaction, hepatic and biliary system, urinary system. Conclusion: We should pay more attention to ADRs caused by compound acetaminophen tablets (Ⅱ), especially the severe adverse reactions such as allergic shock. Production enterprises should promptly revise and improve the safety information of drug instructions. |