Generic Name

Ursodiol

Brand Names
Urso 250, Reltone, Urso
FDA approval date: December 31, 1987
Classification: Bile Acid
Form: Tablet, Capsule

What is Urso 250 (Ursodiol)?

Ursodiol capsules are 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 capsules are indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.

Approved To Treat

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Related Clinical Trials

A Prospective Open-label Randomized Controlled Trial , Evaluating the Efficacy of Ursodeoxycholic Acid (UDCA) as an Adjuvant to Phototherapy in Neonates With Indirect Hyperbilirubinemia
A Prospective Open-label Randomized Controlled Trial , Evaluating the Efficacy of Ursodeoxycholic Acid (UDCA) as an Adjuvant to Phototherapy in Neonates With Indirect Hyperbilirubinemia
Enrollment Status: Recruiting
Publish Date: December 08, 2025
Intervention Type: Procedure, Drug
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Summary: This is a prospective, open-label, randomized controlled trial conducted at Lattakia University Hospital (Tishreen University), aiming to evaluate the efficacy of Ursodeoxycholic Acid (UDCA) as an adjuvant to triple phototherapy in the management of indirect hyperbilirubinemia in neonates ≥34 weeks of gestation. Eligible neonates will be randomly assigned to one of two groups: Group A: continuous ...

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Summary: The goal of this clinical trial is to investigate the efficacy of ursodeoxycholic acid in treating gastric intestinal metaplasia in Helicobacter pylori-negative adults. It will also learn about the safety of ursodeoxycholic acid. The main questions it aims to answer are: Does ursodeoxycholic acid promote the regression of IM in individuals without Helicobacter pylori infection? What medical proble...

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Brand Information

    Urso 250 (Ursodiol)
    1INDICATIONS AND USAGE
    URSO 250 and URSO Forte (ursodiol) tablets are indicated for the treatment of patients with primary biliary cholangitis (PBC).
    2DOSAGE FORMS AND STRENGTHS
    • URSO 250: 250 mg tablet
    • URSO Forte: 500 mg scored tablet
    3CONTRAINDICATIONS
    Patients with complete biliary obstruction and known hypersensitivity or intolerance to ursodiol or any of the components of the formulation.
    4OVERDOSAGE
    There have been no reports of accidental or intentional overdosage with ursodiol. Single oral doses of ursodiol at 10 g/kg in mice and dogs, and 5 g/kg in rats were not lethal. A single oral dose of ursodiol at 1.5 g/kg was lethal in hamsters. Symptoms of acute toxicity were salivation and vomiting in dogs, and ataxia, dyspnea, ptosis, agonal convulsions and coma in hamsters.
    5DESCRIPTION
    URSO 250 (ursodiol, 250 mg) is available as a film-coated tablet for oral administration. URSO Forte (ursodiol, 500 mg) is available as a scored film-coated tablet for oral administration.
    Ursodiol (ursodeoxycholic acid, UDCA) is a naturally occurring bile acid found in small quantities in normal human bile and in larger quantities in the biles of certain species of bears. It is a bitter-tasting white powder consisting of crystalline particles freely soluble in ethanol and glacial acetic acid, slightly soluble in chloroform, sparingly soluble in ether, and practically insoluble in water. The chemical name of ursodiol is 3α,7ß-dihydroxy-5ß-cholan-24-oic (C
    chemical structure
    Inactive ingredients: microcrystalline cellulose, povidone, sodium starch glycolate, magnesium stearate, ethylcellulose, dibutyl sebacate, carnauba wax, hydroxypropyl methylcellulose, PEG 3350, PEG 8000, cetyl alcohol, sodium lauryl sulfate and hydrogen peroxide.
    6PATIENT COUNSELING INFORMATION
    Enteroliths in Patients with Risk for Intestinal Stenosis or Stasis
    Advise patients or their caretaker(s) to notify their healthcare provider if they experience obstructive gastrointestinal symptoms due to the risk of enteroliths
    Drug Interactions
    Patients should be informed that absorption of URSO 250 and URSO Forte may be reduced if they are taking bile acid sequestering agents, such as cholestyramine and colestipol, aluminum-based antacids, or drugs known to alter the metabolism of cholesterol
    Distributed by:
    Allergan USA, Inc.
    Madison, NJ 07940
    www.allergan.com
    A picture containing clipart Description generated with very high confidence
    URSO 250
    v4.0USPI785
    7Principal Display Panel
    - Urso 250 Bottle Label
    NDC 58914-785-10
    100 tablets
    Rx only
    Urso® 250
    (Ursodiol Tablets, USP) 250 mg
    Allergan™
    - Urso 250 Bottle Label NDC 58914-785-10 100 tablets Rx only Urso® 250 (Ursodiol Tablets, USP) 250 mg Allergan™
    8Principal Display Panel
    - Urso 500 Bottle Label
    NDC 58914-790-10
    100 tablets
    Urso Forte®
    (Ursodiol Tablets, USP)
    500 mg
    Rx only
    For the treatment of
    Primary Biliary Cirrhosis
    Allergan™
    Principal Display Panel - Urso 500 Bottle Label NDC 58914-790-10 100 tablets Urso Forte® (Ursodiol Tablets, USP) 500 mg Rx only For the treatment of Primary Biliary Cirrhosis Allergan™
    Urso 250 has been selected.