Undesirable effects: The evaluation of undesirable effects is based on the following frequency data: Very common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Very rare / Not known (< 1/10,000 / cannot be estimated from available data) Gastrointestinal disorders: In clinical trials, reports of pasty stools or diarrhea during ursodeoxycholic acid therapy were common. Very rarely, severe right upper abdominal pain has occurred during the treatment of primary biliary cirrhosis. Ursodeoxycholic acid may give rise to nausea and vomiting. The frequency of these effects are not known. Hepatobiliary disorders: During treatment with ursodeoxycholic acid, calcification of gallstones can occur in very rare cases making them unable to be dissolved by bile acid therapy and resulting in surgery for some patients. During therapy of the advanced stages of primary biliary cirrhosis, in very rare cases decompensation of hepatic cirrhosis has been observed, which partially regressed after the treatment was discontinued. Skin and subcutaneaous disorders: Very rarely, urticaria can occur. Ursodeoxycholic acid may give rise to pruritus. The frequency of this effect is not known. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form (http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic @moh.health.gov.il ).
Dissolution or reduction in size of radiolucent cholesterol in patient with a functioning gallbladder. Treatment of chronic liver diseases including primary billiary cirrhosis, primary sclerosing cholangitis, cystic fibrosis associated liver disease, billiary atresia, chronic hepatitis, and alcohol cirrhosis.