Ursodiol

Ursodiol is a prescription medication used to non-surgically treat and prevent gallstones. Ursodiol is a bile acid, a natural substance produced by the liver. It helps to decrease the formation of gallstones by dissolving the cholesterol necessary to make gallstones and suppressing production of cholesterol in the liver and absorption in the intestines. 

Ursodiol comes in capsule and tablet form. It is taken 2 or 3 times daily, with food.

Common side effects include upset stomach, headache, and upper respiratory tract infections.

Usodiol can cause dizziness. Do not drive or operate heavy machinery until you know how it affects you.

Ursodiol is a prescription medication used to dissolve small gallstones (non-surgically) and to prevent gallstone formation in very overweight patients experiencing rapid weight loss. It is also used to treat primary biliary cirrhosis.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Ursodiol may be found in some form under the following brand names:

• Actigall

• Urso 250

• Urso Forte

Common side effects include:

• diarrhea
• constipation
• upset stomach
• indigestion
• dizziness
• vomiting
• cough
• sore throat
• runny nose
• back pain
• muscle and joint pain
• hair loss

This is not a complete list of ursodiol side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• antacids containing aluminum such as Amphojel, Gaviscon, Maalox, and Mylanta
• cholestryramine (LoCHOLEST, Prevalite, Questran)
• clofibrate (Atromid-S)
• colestipol (Colestid)
• medications that lower cholesterol levels
• medications that contain estrogen, including birth control pills

This is not a complete list of ursodiol drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with ursodiol including the following:

• frequent urination or pain when you urinate
• cough with fever

Ursodiol can cause dizziness. Do not drive or operate heavy machinery until you know how ursodiol affects you.

Do not take ursodiol if you:

• are allergic to ursodiol or to any of its ingredients
• are allergic to bile acids
• have calcified cholesterol stones, radiopaque stones, or radiolucent bile pigment stones
• have compelling reasons for a cholecystectomy (surgical removal of the gall bladder) such as unremitting acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, or biliary-gastrointestinal fistula

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain food. In the case of ursodiol, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking ursodiol, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to ursodiol or to any of its ingredients
• have or have had diseases of the liver, gallbladder, pancreas, or bile duct
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Ursodiol falls into category B. There are no well-done studies that have been done in humans with ursodiol. In animal studies, pregnant animals were given this medication and the babies did not show any medical issues related to this medication.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if ursodiol crosses into human milk. Because many medications can cross into human milk, caution should be exercised when ursodiol is administered to a nursing mother.

Take ursodiol exactly as prescribed.

Ursodiol comes in oral tablet and capsule form and is taken 2 to 3 times a day.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of ursodiol at the same time.

Dissolution of gallstones may take months to years of therapy, and complete dissolution does not occur in all patients.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• how you respond to this medication
• your weight

The recommended dosage of ursodiol for the treatment of gallstones is 8-10 mg/kg/day divided in 2 or 3 doses. 

The recommended dosage of ursodiol for the prevention of gallstones in patients undergoing rapid weight loss is 300 mg 2 times a day.

The recommended dosage of ursodiol for the treatment of biliary cirrhosis is 13-15 mg/kg/day divided in 2 or 4 doses. 

If you take too much ursodiol, call your healthcare provider or local Poison Control Center or seek emergency medical attention right away.

If ursodiol is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose if suspected, seek emergency medical attention.

• Store ursodiol at room temperature.
• Keep this and all medications out of the reach of children.