Ursodeoxycholic Acid (Ursodiol): Uses, How to Take, Dosing & Side Effects

Ursodeoxycholic acid is a prescription medication used to treat certain cholesterol gallstones and primary biliary cholangitis. It works by reducing the amount of cholesterol in bile and helping improve bile flow.

In the United States, ursodeoxycholic acid is known as ursodiol. It is available in several prescription formulations, including 300 mg capsules and 250 mg and 500 mg tablets.

Ursodeoxycholic acid should only be used as directed by a gastroenterologist or another prescribing healthcare professional. The dose and length of treatment depend on the condition being treated.

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What it is used for

Ursodeoxycholic acid is used to treat certain liver and gallbladder conditions, including:

  • Certain cholesterol gallstones in people who cannot undergo gallbladder surgery or who choose not to have surgery;

  • Primary biliary cholangitis;

  • Prevention of gallstones during rapid weight loss, including following certain weight-loss procedures.

This medication helps cholesterol remain dissolved in bile, which can prevent certain cholesterol gallstones from forming or gradually help dissolve existing stones.

How to take it and dosage

Ursodeoxycholic acid should be taken by mouth according to the schedule and treatment duration prescribed by a healthcare professional.

The dosage of ursodeoxycholic acid for adults varies depending on the condition being treated:

Indication Dosage
Cholesterol gallstones 8 to 10 mg/kg of body weight per day, divided into 2 or 3 doses. Treatment may continue for several months depending on the response to therapy.
Primary biliary cholangitis 13 to 15 mg/kg of body weight per day, divided into 2 to 4 doses with food.
Prevention of gallstones during rapid weight loss 600 mg per day, generally divided into two 300 mg doses.

The dose may be adjusted by the prescribing healthcare professional based on the condition being treated and the response to treatment. FDA labeling supports 13 to 15 mg/kg/day for primary biliary cholangitis, while ursodiol capsule labeling includes dosing for cholesterol gallstone dissolution and prevention during rapid weight loss.

During treatment for gallstones, imaging tests may be performed periodically to determine whether the stones are dissolving. For primary biliary cholangitis, liver function tests and bilirubin levels should be monitored during treatment.

What to do if a dose is missed

If a dose is missed, take it as soon as remembered. However, if it is almost time for the next dose, skip the missed dose and continue with the regular dosing schedule.

Do not take a double dose to make up for a missed dose.

Possible side effects

Possible side effects of ursodeoxycholic acid include abdominal pain or discomfort, diarrhea, nausea, headache, dizziness, indigestion, constipation, itching, rash, and hair loss.

Other reactions may also occur and should be reported to the healthcare professional responsible for treatment if they are persistent, severe, or concerning.

Emergency medical care should be sought if symptoms of a serious allergic reaction occur, such as difficulty breathing, throat tightness, swelling of the mouth, tongue, or face, or hives.

Who should not use it

Ursodeoxycholic acid should not be used in people with:

  • Complete blockage of the bile ducts;

  • A known allergy or intolerance to ursodiol, other bile acids, or any ingredient in the prescribed product.

For gallstone treatment, ursodeoxycholic acid is not appropriate for certain types of gallstones or gallbladder complications, including:

  • Calcified or radiopaque gallstones;

  • Pigment gallstones;

  • Acute inflammation of the gallbladder;

  • Cholangitis;

  • Gallstone-related pancreatitis;

  • A biliary-gastrointestinal fistula.

Ursodeoxycholic acid therefore should not be used to dissolve calcified gallstones.

Pregnancy and breastfeeding are not listed as absolute contraindications in current US ursodiol labeling. Treatment during pregnancy or breastfeeding should be evaluated individually by the prescribing healthcare professional.

Inactive ingredients vary depending on the ursodiol product and manufacturer. Anyone with a known allergy or intolerance to an inactive ingredient should check the specific product labeling.