[11][12] UDCA helps reduce the cholesterol saturation of bile and leads to gradual dissolution of cholesterol-rich gallstones.
[15] However analyses that exclude trials of short duration (i.e. < 2 years) have demonstrated a survival benefit and are generally considered more clinically relevant.
[16] A Cochrane systematic review in 2012 found no significant benefit in reducing mortality, the rate of liver transplantation, pruritus or fatigue.
[28] In cystic fibrosis there is insufficient evidence to justify routine use of UDCA, especially as there is a lack of available data for long-term outcomes such as death or need for liver transplantation.
Right upper quadrant abdominal pain and exacerbation of pruritus was occasionally reported in trials in patients with PBC.
[34] Ursodeoxycholic acid has been shown to exert anti-inflammatory and protective effects in human epithelial cells of the gastrointestinal tract.
[41] UDCA is most commonly produced from cholic acid (CA) derived from bovine bile, a by-product of the beef industry.
[43] Ursodeoxycholic acid can be chemically synthesized and is marketed under multiple trade names, including Ursetor, Udikast, Actibile, Actigall, Biliver, Deursil, Egyurso, Heptiza 300/150, Stener, Udcasid, Udiliv, Udinorm, Udoxyl, Urso, Urso Forte, Ursocol, Ursoliv, Ursofalk,[44] Ursosan, Ursoserinox, Udimarin, and Ursonova.
[citation needed] Bear bile, a natural source of UDCA, is used in traditional Chinese medicine since the seventh century.
[40] The earliest reference to UDCA in PubMed dates to 1957 under an alternative spelling "ursodesoxycholic acid", in a small-scale clinical trial.
[45] Ursodeoxycholic acid (application filed by Allergan) was approved for use in the United States in December 1987,[46] and was designated an orphan drug.