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
- 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
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]
