Abstract:By comprehensively reviewing the origin and history of Niuhuang Jiedu Wan and its “derivatives”, we studied the clinical records of realgar, investigated its clinical usage, dosage, efficacy, and toxicity in the literatures. We pinpointed the factors that might be associated with safety problems of Niuhuang Jiedu Pian (Wan) and other traditional Chinese medicine (TCM) preparations containing arsenic substances. In this article we also put forward suggestions for strengthening the surveillance and administration of similar TCM preparations.