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Obeticholic Acid

Warning

Although this medication is used to treat a certain liver disease, it has caused serious (even fatal) worsening of liver function, especially when taken at a higher dose than recommended. Your doctor should prescribe your dose based on your medical condition and response to treatment. To lower your chance of side effects, follow your doctor's dosage instructions carefully.

Before starting treatment with this medication, your doctor should order lab tests to see if you have severe liver disease. This medication should not be used by people with certain types of liver disease. Consult your doctor for more details. Your doctor should also order lab tests and watch for symptoms of worsening liver function during treatment (see also Side Effects section).

Precautions

See also Warning section.

Before taking obeticholic acid, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bile duct blockage.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Side Effects

Tiredness, mouth/throat pain, or fast/pounding heartbeat may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Although this medication is used to treat primary biliary cholangitis (PBC), it may also cause worsening of some liver symptoms. Get medical help right away if you have symptoms such as new or worsening skin itching, nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine, muscle/joint pain, swelling legs/feet/abdomen, or mental/mood changes. Your doctor may prescribe other medications such as bile acid-binding resins or antihistamines, or temporarily stop/adjust your dose of medication to help manage some side effects. Talk with your doctor about the risks and benefits of taking this medication.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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Drug information is selected from data included with permission and copyrighted by First DataBank, Inc. This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your healthcare professional. Always seek the advice of your healthcare professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your healthcare professional. This information does not contain any assurances that this product is safe, effective or appropriate for you.

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