Correspondence

Abdominal Pain after Taking Ursodiol

N Engl J Med 1993; 328:1502May 20, 1993

Article

To the Editor:

Ursodiol has been approved by the Food and Drug Administration for the dissolution of gallstones, but it is also widely used to treat chronic cholestatic liver diseases, such as primary biliary cirrhosis and sclerosing cholangitis1-4. Despite increasing experience with this medication, there have been remarkably few adverse reactions noted. We report two patients in whom severe right-upper-quadrant pain developed on repeated occasions within hours after taking ursodiol.

A 61-year-old woman was found to have primary biliary cirrhosis in January 1991. As part of her initial therapy, the patient was given 300 mg of ursodiol twice a day. After the third dose, severe right-upper-quadrant pain developed that radiated to the back. The medication was stopped, and the pain resolved. Ten days later the patient took a single 300-mg capsule of ursodiol, and the pain recurred. She was subsequently treated with colchicine without complication. Nine months later the patient tried ursodiol for a third time because her serum alkaline phosphatase level remained elevated and there were no data that implicated ursodiol as a cause of abdominal pain. After a single 300-mg dose, the patient again had incapacitating right-upper-quadrant pain. Ursodiol was discontinued, and the pain has not recurred.

A 46-year-old woman who had had primary biliary cirrhosis since 1985 was referred in September 1992. She had initially been treated with colchicine. In 1990 she was given 300 mg of ursodiol twice a day because of a persistently elevated alkaline phosphatase level. After several days of therapy, the patient experienced severe right-upper-quadrant pain two hours after taking the medication. The pain lasted several hours and then subsided. An identical pain recurred after the next dose. The patient discontinued the medication, and there was no recurrence of pain. Her physician advised her that ursodiol was an unlikely cause of abdominal pain. She therefore took another 300-mg capsule several days later. The severe right-upper-quadrant pain developed within hours. The patient discontinued ursodiol, and the pain has not recurred.

In two controlled trials of ursodiol, only 1 of the 83 patients who received the medication withdrew because of a perceived side effect (increased pruritus)1,2. Although in our patients the cause of the abdominal pain is unclear, we wish to alert physicians that this may be a problem in other patients with primary biliary cirrhosis who are treated with ursodiol.

Daniel S. Pratt, M.D.
Marshall M. Kaplan, M.D.
New England Medical Center, Boston, MA 02111

4 References

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   Poupon RE, Balkau B, Eschwege E, Poupon R, UDCA-PBC Study Group. A multicenter, controlled trial of ursodiol for the treatment of primary biliary cirrhosis. N Engl J Med 1991;324:1548-1554
   Full Text | Web of Science | Medline

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   Leuschner U, Fischer H, Kurtz W, et al. Ursodeoxycholic acid in primary biliary cirrhosis: results of a controlled double-blind trial. Gastroenterology 1989;97:1268-1274
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   Chazouilleres O, Poupon R, Capron JP, et al. Ursodeoxycholic acid for primary sclerosing cholangitis. J Hepatol 1990;11:120-123
   CrossRef | Web of Science | Medline

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   O'Brien CB, Senior JR, Arora-Mirchandani R, Batta AK, Salen G. Ursodeoxycholic acid for the treatment of primary sclerosing cholangitis: a 30-month pilot study. Hepatology 1991;14:838-847
   CrossRef | Web of Science | Medline

Citing Articles (6)

Citing Articles

1. 1

   2006. Bile acids. , 515-517.
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2. 2

   W. Hempfling, K. Dilger, U. Beuers. (2003) Ursodeoxycholic acid - adverse effects and drug interactions. Alimentary Pharmacology and Therapeutics 18:10, 963-972
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3. 3

   Joanna L. Siegel, Roberta Jorgensen, Paul Angulo, Keith D. Lindor. (2003) Treatment With Ursodeoxycholic Acid Is Associated With Weight Gain in Patients With Primary Biliary Cirrhosis. Journal of Clinical Gastroenterology 37:2, 183-185
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   Wiktor Bednarz, Robert Olewiński. (2002) The influence of chronic pancreatitis on carcinogenesis: an experimental study in rats. European Journal of Gastroenterology & Hepatology 14:6, 671-677
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   Susanne Keiding, Krister H??ckerstedt, Kristian Bj??ro, Stig Bondesen, Allan Hjortrup, Helena Isoniemi, Christian Erichsen, Gunnar S??derdahl, Bo-G??ran Ericzon. (1997) THE NORDIC MULTICENTER DOUBLE-BLIND RANDOMIZED CONTROLLED TRIAL OF PROPHYLACTIC URSODEOXYCHOLIC ACID IN LIVER TRANSPLANT PATIENTS1. Transplantation 63:11, 1591-1594
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6. 6

   &NA;. (1993) Ursodeoxycholic acid. Reactions Weekly &NA;:453, 12
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