ursodiol

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

What is ursodiol?

Ursodiol is a bile acid that decreases the amount of cholesterol produced by the liver and absorbed by the intestines. Ursodiol helps break down cholesterol that has formed into stones in the gallbladder. Ursodiol also increases bile flow in patients with primary biliary cirrhosis.

Ursodiol is used to treat primary biliary cirrhosis.

Ursodiol capsules are used to treat small gallstones in people who cannot have gallbladder surgery, and to prevent gallstones in overweight patients undergoing rapid weight loss. Ursodiol capsules are not for treating gallstones that are calcified

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

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

To make sure ursodiol is safe for you, tell your doctor if:

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

FDA pregnancy category B. Ursodiol is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

How should I take ursodiol?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may need to break a tablet in half to get your correct dose. Each tablet is scored in the middle and should break apart easily.

Use ursodiol regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

To treat gallstones, you may have to take ursodiol for several months before your gallstones dissolve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Not all gallstones completely dissolve with ursodiol treatment, and you may develop new gallstones within 5 years after treatment. Talk to your doctor about your specific risks.

While using ursodiol, you may need gallbladder ultrasound exams, or frequent blood tests to check your liver function. Your doctor may also want to check your liver function every 6 months after you stop using ursodiol.

If you split your tablets, keep them separate from any whole tablets.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

What should I avoid while taking ursodiol?

Ask your doctor before using an antacid, and use only the type your doctor recommends. Some antacids can make it harder for your body to absorb ursodiol.

If you also take cholestyramine or colestipol, avoid taking ursodiol at the same time. Ask your doctor how many hours apart you should take your medicines.

What are the possible side effects of ursodiol?

• 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:

• headache, dizziness;
• mild stomach pain or discomfort;
• nausea, diarrhea, constipation;
• cold symptoms such as stuffy nose, sneezing, sore throat;
• hair loss; or
• mild itching or rash.

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?

Other drugs may interact with ursodiol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about ursodiol.