In this retrospective study, 56 cases of adverse reactions caused by Niuhuang Jiedu tablet (pill) were statistically analyzed in respects of genders, ages, routes of administration, clinical manifestations, etc. We pinpointed that the main factors related to safety problems of Niuhuang Jiedu tablet (pill) are irrational drug use and drug quality, and put forward suggestions for strengthening the surveillance and administration of Niuhuang Jiedu tablet (pill) and improving clinical rational use.