BACKGROUND Makaradhwaja is a KupipakwaRasayana. Since it contains two heavy metals, namely mercury and gold, it is essential to evaluate its safety. Hence, the present study was undertaken with an objective to evaluate toxicity and target organ of toxicity of Makaradhwaja if so. OBJECTIVE The objective was to evaluate toxicological profile, the target organ of toxicity and to find no observed effect level (NOEL) or no observed adverse effect level (NOAEL) in rats after oral administration for ninety consecutive days. METHODS Makaradhawaja preparation was administered to male and female Wistar rats for ninety consecutive days at 2.7, 13.5, and 27 mg/kg body weight. All relevant biochemical and hematological changes were observed. At termination, all the rats were sacrificed and necropsy was performed. Histopathological evaluation was also performed. METHODS Dunnett's test followed by analysis of variance. RESULTS There was a significant increase in high-dose group kidney weight of both sexes which could not be correlated with histopathology findings and serum biochemistry. Therefore, the change was not considered as an adverse effect. CONCLUSIONS The dose level 27 mg/kg of Makaradhwaja was found as NOAEL and dose level 13.5 mg/kg of Makaradhwaja was found as NOEL.