Abstract: Objective To analyze adverse drug reactions (ADR) caused by Yinzhihuang preparations in order to grasp the characteristics of ADR of Yinzhihuang preparations and provide reference for rational clinical use. Methods A total of 385 reports of ADR/adverse drug events (ADE) of Yinzhihuang preparations were collected by Hubei Center for ADR Monitoring between January 1, 2012 and December 31, 2018. Dosage forms that patients used, patients' age and gender, preexisting diseases, dosages, times of occurrence, system-organs involved, and clinical manifestations were recorded and analyzed. Results Among these cases, the ratio of males to females was 1.60∶1.00, and the incidence was higher in patients aged 40 to 59 (42.86%). There were 301 reports that documented the time ADR occurred (mainly within 30min). The affected systems-organs were mostly the skin and its accessories while the main clinical manifestations were pruritus and rash. Conclusion Yinzhihuang preparations can cause ADR/ADE of varying degrees, but patients can generally improve after drug withdrawal or symptomatic treatment. Enough attention should be paid to the condition of patients after medication.

Key words: Yinzhihuang preparations, adverse drug reaction/adverse drug event, safety