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Gastrointestinal disorders: abdominal discomfort, abdominal pain, constipation, diarrhea, dyspepsia, nausea, vomiting. General disorders and administration site conditions: malaise, peripheral edema, pyrexia. Hepatobiliary disorders: jaundice (or aggravation of preexisting jaundice). Immune System Disorders: Drug hypersensitivity to include facial edema, urticaria, angioedema and laryngeal edema. Abnormal Laboratory Tests: ALT increased, AST increased, blood alkaline phosphatase increased, blood bilirubin increased, ?-GT increased, hepatic enzyme increased, liver function test abnormal, transaminases increased. Musculoskeletal and connective tissue disorders: myalgia Nervous system disorders: dizziness, headache. Respiratory, thoracic and mediastinal disorders: cough. Skin and subcutaneous tissue disorder: alopecia, pruritus, rash. Bile Acid Sequestering Agents. Bile acid sequestering agents such as cholestyramine and colestipol may interfere with the action of URSO 250 and URSO Forte by reducing its absorption. Aluminum-based antacids have been shown to adsorb bile acids in vitro and may be expected to interfere with URSO 250 and URSO Forte in the same manner as the bile acid sequestering agents. Drugs Affecting Lipid Metabolism. Estrogens, oral contraceptives, and clofibrate (and perhaps other lipid-lowering drugs) increase hepatic cholesterol secretion and encourage cholesterol gallstone formation and hence may counteract the effectiveness of URSO 250 and URSO Forte. Included as part of the PRECAUTIONS section. Patients with variceal bleeding, hepatic encephalopathy, ascites or in need of an urgent liver transplant, should receive appropriate specific treatment. Abnormal Liver Function Tests. Liver function tests (?-GT, alkaline phosphatase, AST, ALT) and bilirubin levels should be monitored every month for three months after start of therapy, and every six months thereafter. This monitoring will allow the early detection of a possible deterioration of the hepatic function. Treatment discontinuation should be considered if the above parameters increase to a level considered clinically significant in patients with stable historical liver function test levels. Caution has to be exercised to maintain the bile flow of the patients taking ursodiol, best steroid for raw strength. Carcinogenicity, Mutagenicity and Impairment of Fertility. In two 24-month oral carcinogenicity studies in mice, ursodiol at doses up to 1,000 mg/kg/day (3,000 mg/m?/day) was not tumorigenic. Based on body surface area, for a 50 kg person of average height (1. In a two-year oral carcinogenicity study in Fischer 344 rats, ursodiol at doses up to 300 mg/kg/day (1,800 mg/m?/day, 3. In a life-span (126-138 weeks) oral carcinogenicity study, Sprague-Dawley rats were treated with doses of 33 to 300 mg/kg/day, 0.
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