Ursodiol (ur-soe-DYE-ol)

Dissolves gallstones when they cannot be removed by surgery. Also treats primary biliary cirrhosis (PBC), a liver disorder.

Brand Name(s):

Reltone, URSO Forte, Urso 250

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule, Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• It is best to take this medicine with food or milk.
• Urso Forte® tablet can be broken in half, if needed. Place the tablet on a flat surface with the score (groove) on top. Hold the tablet with your thumbs close to the groove then apply gentle pressure until the tablet breaks apart. Swallow the half tablet with water. Do not chew.
• Gallstone treatment: Keep using the medicine for your full treatment time. It may take several months for the medicine to dissolve gallstones.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Half tablets can be used for up to 28 days when kept in the medicine bottle. Store half tablets separately from whole tablets, because the half tablets have a bitter taste.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how ursodiol works. Tell your doctor if you are using an antacid that contains aluminum, medicine to lower cholesterol (including cholestyramine, clofibrate, colestipol), estrogen, or birth control pills.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease, bowel problems, or pancreas problems.
• This medicine should not be used to treat bleeding varices, hepatic encephalopathy, or ascites.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain
• Fever, chills, cough, sore throat, body aches
• Severe nausea and vomiting
• Severe stomach pain especially on the right upper side
• Swelling in your hands, ankles, or feet
• Unusual bleeding or bruising

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, constipation, loss of appetite, stomach upset, or gas
• Hair loss
• Headache
• Indigestion or bitter taste in your mouth
• Weakness

If you notice other side effects that you think are caused by this medicine, tell your doctor

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