Drug
Obeticholic Acid
Pronounced
"oh-BET-i-KOE-lik AS-id"
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.
Tell your doctor right away if you have any serious side effects, including: new or worsening skin itching.
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 nausea/vomiting/diarrhea that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine, black stools, vomit that looks like coffee grounds, swollen abdomen, unusual decreased urination, dizziness/lightheadedness, fever, chills, or mental/mood changes.
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.
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.