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. 2011 Jan 19;2011(1):CD003626. doi: 10.1002/14651858.CD003626.pub2

1. Adverse events.

Study Pts. in experimental group Pts. in control group AE in experimental group AE in control group Author's conclusion
Beuers 1992 6 8 Diarrhoea (1 pt.) No Ae The symptoms ceased after UDCA treatment termination.
Lo 1992 8 10 No AE No AE UDCA seemed to be well tolerated.
Stiehl 1994 10 10 Diarrhoea (2 pts.) No AE After a reduction of the dose to 500 mg and 250 mg/day, UDCA was well tolerated. Re‐exposure to the higher dose (750 mg) re‐induced diarrhoea.
Lindor 1997 53 52 No AE Diarrhoea (1 pt.), flare of ulcerative colitis (1 pt.) Ursodiol was well tolerated.
Mitchell 2001 13 13 No AE No AE No patients required alteration in the prescribed trial medication for diarrhoea or any other cause.
Olsson 2005 110 109 37 34 There seemed to be no difference between the two groups in the overall frequency of reported side effects attributed to the capsules (UDCA, 38.1%; placebo 33.7%)
Charatcharoenwitthaya 2008 42 No‐controls Flare of ulcerative colitis (1 pt.) No controls UDCA was well tolerated, but one patient stopped medication after four years of therapy because of a flare of ulcerative colitis.

pt(s) = patient(s). 
 AE = adverse events.