Ursodiol is used to treat a group of conditions known as cholestatic liver diseases (e.g., primary biliary cirrhosis). Cholestatic liver diseases are characterized by a decrease in bile secretion and bile flow.

Ursodiol is a natural component of bile and helps to increase the amount of bile and to increase bile flow. This helps symptoms associated with cholestatic liver diseases.

Ursodiol may be available under multiple brand names and/or in several different forms. Any specific brand name of Ursodiol may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of Ursodiol may not be used for all of the conditions discussed here.

Your doctor may have suggested Ursodiol for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking Ursodiol, speak to your doctor. Do not stop taking Ursodiol without consulting your doctor.

Do not give Ursodiol to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take Ursodiol if their doctor has not prescribed it.

To treat cholestatic liver diseases, the recommended adult dose of ursodiol is based on body weight. Your doctor will calculate a dose of 13 mg to 15 mg per kilogram of body weight per day, taken by mouth in 2 to 4 divided doses.

Ursodiol should be taken with food.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important that Ursodiol be taken exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store the medication at room temperature, protect from light and moisture, and keep it out of reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Ursodiol.If you are concerned about side effects, discuss the risks and benefits of Ursodiol with your doctor.

The following side effects have been reported by at least 1% of people taking Ursodiol. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• Constipation
• cough
• dizziness
• headache
• rapid or pounding heartbeat
• stomach pain
• sun sensitivity

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• burn caused by increased sensitivity to sunlight
• Diarrhea
• Fever
• signs of Anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
• signs of bleeding (e.g., bloody nose, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
• signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
• signs of lung problems (e.g., shortness of breath, made worse by exerting yourself; Dry Cough)
• signs of worsening liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• swelling in the ankles or feet
• symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
• symptoms of a Anaphylaxis (severe allergic reaction) (e.g., difficulty breathing, Hives, itchy skin rash, or swelling of the mouth or throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Ursodiol.

250 mg
Each white-to-off-white, oval, film-coated tablet debossed with “G72” on one side and “250” on the other contains 250 mg of urosdiol. Nonmedicinal ingredients: carnauba wax, dibutyl sebacate, cetyl alcohol, ethylcellulose, sodium lauryl sulfate, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, Polyethylene Glycol 3350, polyethylene glycol 8000, povidone, and sodium starch glycolate.

500 mg
Each white-to-off-white, oval, film-coated tablet, plain with score line on one side and debossed with "U11" on the other, contains 500 mg of ursodiol. Nonmedicinal ingredients: carnauba wax, dibutyl sebacate, cetyl alcohol, ethylcellulose, sodium lauryl sulfate, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 3350, polyethylene glycol 8000, povidone, and sodium starch glycolate.

Do not take Ursodiol if you:

• are allergic to ursodiol or any ingredients of the medication
• have a blockage of bile flow due to liver disease or other disease outside the liver

There may be an interaction between ursodiol and any of the following:

• antacids that contain aluminum
• Bezafibrate
• Cholestyramine
• Colesevelam
• Colestipol
• Cyclosporine
• Dapsone
• estrogens
• Fenofibrate
• Gemfibrozil

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Ursodiol. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Ursodiol.

Liver disease: Ursodiol is broken down by the liver. Liver disease or reduced liver function may cause Ursodiol to build up in the body, causing side effects and possibly worsen liver damage. If you have liver disease, discuss with your doctor how Ursodiol may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Ursodiol, and whether any special monitoring is needed.

Monitoring: Your doctor should order monthly liver function tests for the first 3 months you are taking Ursodiol, and every 6 months after that. Improvements in the results of these blood tests do not always mean that the disease is improving. Do not stop taking Ursodiol without talking to your doctor.

Pregnancy: Ursodiol should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Ursodiol, contact your doctor immediately.

Breast-feeding: It is not known if ursodiol passes into breast milk. If you are a breast-feeding mother and are taking Ursodiol, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Ursodiol have not been established for children.