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Overdose: Doses of ursodiol in the range of 16 to 20 mg/kg/day have been tolerated by 7 patients for 6 to 37 months without symptoms. The LD50 for ursodiol in rats is over 5000 mg/kg given over 7 to 10 days and over 7500 mg/kg for mice.
Single oral doses of ursodiol at 10, 5 and 10 g/kg in mice, rat and dogs, respectively, were not lethal. A single oral dose of ursodiol at 1.5 g/kg was lethal in hamsters. Symptoms of acute toxicity were salivation and vomiting in dogs and ataxia, dyspnea, ptosis, agonal convulsions and coma in hamsters.
Treatment: The most likely manifestation of severe overdose with ursodiol would likely be diarrhea, which should be treated symptomatically.
