Obeticholic acid can cause serious or life-threatening liver damage, especially if the dose of obeticholic acid is not adjusted when liver disease worsens. If you experience any of the following symptoms while taking obeticholic acid, call your doctor immediately: yellowing of the skin or eyes, dark urine, black tarry stools, coughing up or vomiting blood, nausea, vomiting, abdominal pain, swelling in and around the stomach area, weight loss, loss of appetite, fatigue, diarrhea, confusion, slurred speech, anxiety, mood swings, changes in personality, or less frequent urination.
Keep all appointments with your doctor and the laboratory. Your doctor may order certain tests before and during your treatment to check your liver function and your body's response to obeticholic acid.
WHY is this medicine prescribed?
Obeticholic acid is used alone or in combination with ursodiol (Actigall, Urso) to treat primary biliary cholangitis (PBC; a type of liver disease that destroys bile ducts, which allows bile to stay in the liver and cause damage) in people who cannot take ursodiol or in people who were not treated successfully with ursodiol alone. Obeticholic acid is in a class of medications called farnesoid X receptor agonists. It works by decreasing the production of bile in the liver and increasing the removal of bile from the liver.
HOW should this medicine be used?
Obeticholic acid comes as a tablet to take by mouth. It is taken usually once a day with or without food. Take obeticholic acid at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take obeticholic acid exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Your doctor may need to temporarily or permanently stop your treatment or decrease your dose of obeticholic acid during your treatment. This will depend on how well the medication works for you or if you experience certain side effects. Continue to take obeticholic acid even if you feel well. Do not stop taking obeticholic acid without talking to your doctor.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.
Are there OTHER USES for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before taking obeticholic acid,
tell your doctor and pharmacist if you are allergic to obeticholic acid, any other medications, or any of the ingredients in obeticholic acid tablets. Ask your pharmacist for a list of the ingredients.
tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: caffeine (found in certain medications to treat drowsiness and headaches), theophylline (Elixophyllin, Theo-24, Theochron, others), tizanidine (Zanaflex), or warfarin (Coumadin, Jantoven). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with obeticholic acid, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
if you are taking cholestyramine (Prevalite), colestipol (Colestid), or colesevelam (Welchol), take them at least 4 hours before or 4 hours after obeticholic acid.
tell your doctor if you have bile duct obstruction (blockage in the tubes that carry bile from the liver to the gallbladder and small intestine). Your doctor may tell you not to take obeticholic acid.
tell your doctor if you have or have ever had high cholesterol or thyroid disease.
tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking obeticholic acid, call your doctor.
What SPECIAL DIETARY instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do IF I FORGET to take a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What SIDE EFFECTS can this medicine cause?
Obeticholic acid may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
mouth or throat pain
fast, irregular, or pounding heartbeat
swelling of the hands, feet, ankles, or lower legs
tiredness or weakness
joint or muscle pain
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:
fever, chills, or other signs of infection
dryness, irritation, redness, crusting or drainage of the skin
Obeticholic acid may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( Web Site ) or by phone (1-800-332-1088).
What should I know about STORAGE and DISPOSAL of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. Web Site
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website ( Web Site) for more information if you do not have access to a take-back program.
What should I do in case of OVERDOSE?
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at Web Site. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
Symptoms of overdose may include the following:
yellowing of the skin or eyes
dark colored urine
loss of appetite
pain in the upper right part of the stomach
swelling in the area around the stomach
What OTHER INFORMATION should I know?
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
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This content is reviewed regularly and is updated when new and relevant evidence is made available. This information is neither intended nor implied to be a substitute for professional medical advice. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with questions regarding a medical condition.
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