Maralixibat Side Effects

Medically reviewed by Drugs.com. Last updated on Apr 6, 2025.

Applies to maralixibat: oral solution.

Precautions

It is very important that your doctor check your progress at regular visits to see if the medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for any unwanted effects.

Check with your doctor right away if you have dark urine, clay-colored stools, stomach pain, or yellow eyes or skin. These may be symptoms of a serious liver problem.

This medicine may cause stomach or bowel problems, including diarrhea, stomach pain, or vomiting. If you have any questions or if these symptoms continues or gets worse, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of maralixibat

Along with its needed effects, maralixibat may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking maralixibat:

For healthcare professionals

Applies to maralixibat: oral liquid, oral tablet.

General adverse events

The most commonly reported side effects included diarrhea, abdominal pain, vomiting, and fat-soluble vitamin deficiency.^[Ref]

Gastrointestinal

• Very common (10% or more): Diarrhea (up to 55.8%), abdominal pain (up to 53.5%), vomiting, (up to 40.7%), gastrointestinal bleeding (up to 10.4%)
• Common (1% to 10%): Nausea
• Frequency not reported: Abdominal discomfort, abdominal distention, gastrointestinal hemorrhage, hematemesis, hematochezia, lower abdominal pain, melena, upper abdominal pain^[Ref]

Musculoskeletal

• Common (1% to 10%): Bone fractures
• Frequency not reported: Clavicle fracture, forearm fracture, hand fracture, humerus fracture, pathological fracture, rib fracture, tibia fracture^[Ref]

Hematologic

• Frequency not reported: INR increase^[Ref]

Metabolic

• Very common (10% or more): Fat-soluble vitamin deficiency (up to 25.6%)
• Frequency not reported: Vitamin A deficiency, vitamin D deficiency, vitamin E deficiency, vitamin K deficiency^[Ref]

Hepatic

• Very common (10% or more): Transaminases increased/ALT/AST (up to 18.6%)
• Common (1% to 10%): Bilirubin increases above baseline
• Frequency not reported: Abnormal ALT, abnormal AST, ALT increased, AST increased^[Ref]

See also:

Further information

Maralixibat side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer