ursodiol

What is the most important information I should know about ursodiol?

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

What is 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.

What should I discuss with my healthcare provider before taking ursodiol?

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.

How should I take ursodiol?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may need to break a tablet in half to get your correct dose.

After breaking a tablet, keep it separate from the whole tablets and use it within 28 days after breaking.

Use ursodiol regularly for the best results.

Doses are based on weight. Your dose may change if you gain or lose weight.

You may need medical tests, including gallbladder ultrasound exams and blood tests to check your liver function. You may also need liver function tests every 6 months after you stop using ursodiol.

To treat gallstones, you may have to take ursodiol for several months. Some gallstones may not completely dissolve, and you may develop new gallstones within 5 years after treatment. Ask your doctor about your risk.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

What should I avoid while taking ursodiol?

Ask your doctor before taking an antacid, and take only the type your doctor recommends.

What are the possible side effects of ursodiol?

• pain or burning when you urinate;
• 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 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.

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:

• cholestyramine; or
• colestipol.

Tell your doctor about all your other medicines, especially birth control pills 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.

Where can I get more information?

Your doctor or pharmacist can provide more information about ursodiol.