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 diarrhoea 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 subcutaneous disorders: Very rarely, urticaria can occur.
Ursodeoxycholic acid may give rise to pruritus. The frequency of this effect is not known.