Lupibile Adverse Reactions

Tab: Ursodeoxycholic acid may cause nausea, vomiting and other gastrointestinal disturbances; diarrhoea is reported to occur less frequently than with chenodeoxycholic acid. Increased liver enzyme values are also less likely. Pruritus may occur. Treatment with ursodeoxycholic acid may cause more calcification of cholesterol stones than chenodeoxycholic acid.
Ursodeoxycholic acid should not be given to patients with intestinal and hepatic disorders that interfere with entero-hepatic circulation of bile salts. It is ineffective for the dissolution of calcified and pigment gallstones and is of no value in patients without a patent and functioning gallbladder. Licensed product information recommends that its use should be avoided in pregnancy.
FC tab: The following adverse reactions have been reported during clinical trials and are ranked using the following frequency: 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 (<1/10,000); not known (cannot be estimated from the available data).
Gastrointestinal disorders: In clinical studies, reports of pasty stools or diarrhea during treatment with ursodeoxycholic acid were common.
In very rare cases, severe right upper abdominal pain has occurred during the treatment of primary biliary cholangitis.
Hepatobiliary disorders: During treatment with ursodeoxycholic acid calcification of gallstones can occur in very rare cases.
During the treatment of advanced stages of primary biliary cholangitis decompensation of cirrhosis has been observed in very rare cases, which partially regressed after treatment discontinuation.
Hypersensitivity reactions: Very rarely urticaria may occur.