URSODIOL CAPSULES, USP
Ursodiol is a bile acid available as 300-mg capsules suitable for oral administration. Ursodiol USP (ursodeoxycholic acid) is a naturally occurring bile acid found in small quantities in normal human bile and in the biles of certain other mammals. It is a bitter-tasting, white powder freely soluble in ethanol, methanol, and glacial acetic acid; sparingly soluble in chloroform; slightly soluble in ether; and insoluble in water.
Ursodiol is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of ursodiol beyond 24 months is not established.
Ursodiol is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.
Media Articles Related to Ursodiol
Primary Biliary Cirrhosis Treatment (PBC)
Source: MedicineNet cholestyramine Specialty [2014.04.30]
Title: Primary Biliary Cirrhosis Treatment (PBC)
Category: Diseases and Conditions
Created: 8/21/2001 12:00:00 AM
Last Editorial Review: 4/30/2014 12:00:00 AM
Primary Biliary Cirrhosis (PBC)
Source: MedicineNet Liver Cancer Specialty [2014.04.23]
Title: Primary Biliary Cirrhosis (PBC)
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 4/23/2014 2:58:18 PM
Published Studies Related to Ursodiol
Colchicine or methotrexate, with ursodiol, are effective after 20 years in a subset of patients with primary biliary cirrhosis. [2011.09]
BACKGROUND & AIMS: The combination of ursodeoxycholic acid (UDCA), colchicine, and methotrexate (MTX) is effective therapy for a subset of patients with primary biliary cirrhosis (PBC) who do not respond to UDCA. However, the durability of the response is unclear. We investigated whether the response to combination therapy was durable... CONCLUSIONS: Treatment with the combination of UDCA and MTX or UDCA and colchicine led to sustained clinical remission in a subset of patients with PBC. The response to the combination of UDCA and MTX appeared to be more durable than to UDCA and colchicine. Copyright (c) 2011 AGA Institute. Published by Elsevier Inc. All rights reserved.
Clinical Trial: Randomized controlled trial of zidovudine and lamivudine for patients with primary biliary cirrhosis stabilized on ursodiol. [2008.07.09]
Background: A human betaretrovirus has been characterized in patients with primary biliary cirrhosis (PBC)... Accordingly, more potent anti-viral regimens will be required to confirm the efficacy of antiviral therapy in PBC patients with human betaretrovirus infection.
Clinical Trials Related to Ursodiol
Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates [Recruiting]
The purpose of this study is to determine whether ursodiol is effective in the treatment of
parenteral nutrition associated cholestasis in neonates.
Ursodiol in Treating Patients With Barrett Esophagus and Low-Grade Dysplasia [Recruiting]
This phase II trial is studying how well ursodiol works in treating patients with Barrett
esophagus or low-grade dysplasia. Chemoprevention is the use of certain drugs to keep cancer
from forming. The use of ursodiol may in patients with Barrett esophagus or low-grade
Ursodiol, Combination Chemotherapy, and Bevacizumab in Treating Patients With Stage IV Colorectal Cancer [Recruiting]
RATIONALE: Drugs used in chemotherapy, such as ursodiol, oxaliplatin, leucovorin, and
fluorouracil, work in different ways to stop the growth of tumor cells, either by killing
the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can
block tumor growth in different ways. Some block the ability of tumor cells to grow and
spread. Others find tumor cells and help kill them or carry tumor-killing substances to
PURPOSE: This phase I trial is studying the side effects and best dose of ursodiol when
given together with combination chemotherapy and bevacizumab in treating patients with stage
IV colorectal cancer.
Ursodiol in Huntington's Disease [Recruiting]
The purpose of this study is to evaluate the safety of the drug ursodiol (ursodeoxycholic
acid, UDCA) in people with Huntington's disease (HD) and to explore how the compound is
processed by the body.
Phase II Pilot Study to Compare the Bioavailability of Buffered, Enteric-Coated Ursodiol With Unmodified Ursodiol for Chronic Cholestatic Liver Disease and Cystic Fibrosis-Associated Liver Disease [Active, not recruiting]
OBJECTIVES: I. Compare the bioavailability of polymer-coated and buffered ursodiol
(ursodeoxycholic acid) to unmodified ursodiol in patients with cystic fibrosis-associated
liver disease or chronic cholestatic liver disease.
II. Compare the differences in pruritus, weight gain, and liver function for both
Reports of Suspected Ursodiol Side Effects
Interstitial Lung Disease (7),
Maternal Exposure During Pregnancy (5),
Hepatic Function Abnormal (4),
Maternal Drugs Affecting Foetus (4),
Bile Duct Stone (4),
Foetal Exposure During Pregnancy (4), more >>
Page last updated: 2014-04-30