Ursodiol

Generic name: Ursodiol
Drug class: Gallstone solubilizing agents

Usage of Ursodiol

Ursodiol capsules are used to dissolve small gallstones that cannot be removed with surgery, or to prevent gallstones that may occur during rapid weight loss. Ursodiol will not dissolve calcified gallstones.

Ursodiol tablets are used to treat primary biliary cirrhosis, an autoimmune disorder that causes progressive destruction of the bile ducts in your liver.

Ursodiol may also be used for purposes not listed in this medication guide.

Ursodiol side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Ursodiol may cause serious side effects. Call your doctor at once if you have:

  • pain or burning when you urinate;
  • stomach pain or discomfort, constipation, vomiting;
  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • signs of a new infection--sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, skin sores, trouble swallowing.

    • Common side effects of ursodiol may include:

  • upset stomach, nausea, vomiting;
  • diarrhea, constipation;
  • cough, sore throat;
  • painful urination;
  • hair loss; or
  • back pain.

    • This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Before taking Ursodiol

    You should not use ursodiol if you are allergic to it, or if you have an obstruction in your liver or gallbladder.

    Tell your doctor if:

  • you have been coughing up blood; or
  • you have gained weight rapidly, especially in your face and midsection.

    • Tell your doctor if you are pregnant or breastfeeding.

    Not approved for use by anyone younger than 18 years old.

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    How to use Ursodiol

    Usual Adult Dose for Biliary Cirrhosis:

    Tablets: 13 to 15 mg/kg orally per day, given in 2 to 4 divided doses with foodComments:-The dose should be adjusted to the patient's needs.-Scored tablets may be broken in half to provide recommended doses.Use: Treatment of patients with primary biliary cirrhosis (PBC)

    Usual Adult Dose for Gallbladder Disease:

    Capsules:Gallstone dissolution: 8 to 10 mg/kg orally per day, given in 2 to 3 divided dosesGallstone prevention: 300 mg orally 2 times a day-Maximum dose: 600 mg/dayComments:-Safety in the dissolution of gallstones has not been established in patients using this drug beyond 24 months.-Ultrasound images should be obtained every 6 months for the first year.-If gallstones appear to have dissolved, treatment should be continued, and dissolution should be cOnfirmed on a repeat ultrasound in 1 to 3 months.-Most patients who achieve complete dissolution show partial or complete dissolution at the first on-treatment reevaluation.-If partial stone dissolution is not observed after 12 months of treatment, the likelihood of treatment is significantly reduced.Uses:-Patients with radiolucent, noncalcified gallbladder stones less than 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to advanced age, idiosyncratic reaction to general anesthesia, systemic disease, or those who refuse surgery-For the prevention of gallstone formation in obese patients experiencing rapid weight loss

    Warnings

    Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

    What other drugs will affect Ursodiol

    It may be harder for your body to absorb ursodiol if you take certain cholesterol-lowering medicines, such as:

  • antacids that contain aluminum;
  • cholestyramine; or
  • colestipol.

    • Tell your doctor about all your other medicines, especially birth control pills, clofibrate, and other estrogens.

    Other drugs may affect ursodiol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

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