Maralixibat Side Effects

Medically reviewed by Drugs.com. Last updated on May 24, 2024.

Applies to maralixibat: oral solution.

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:

More common side effects

• bloody or black, tarry stools
• bone fractures
• chills
• constipation
• dark urine
• diarrhea
• dizziness
• fever
• headache
• itching, rash
• light-colored stools
• loss of appetite
• nausea
• stomach pain
• unpleasant breath odor
• unusual tiredness or weakness
• vomiting
• vomiting of blood or material that looks like coffee grounds
• yellow eyes or skin

For healthcare professionals

Applies to maralixibat: oral solution.

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]

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