OpenClaim

Maralixibat Side Effects

The most commonly reported side effects of maralixibat include pruritus, off label use, and diarrhoea, based on 871 FDA adverse event reports from 2014 to 2025. 8.6% of reports found the drug to be ineffective.

Maralixibat side effects

Percentages show how often each reaction appears relative to total reports for maralixibat.

1
Pruritus26.6%232
2
Off Label Use14.0%122
3
Diarrhoea9.3%81
4
Drug Ineffective8.6%75
5
Liver Transplant7.3%64
6
Hepatic Enzyme Increased7.3%64
7
Blood Bilirubin Increased4.9%43
8
Bile Acids Increased4.4%38
9
Alanine Aminotransferase Increased4.1%36
10
Jaundice4.1%36
11
Vomiting4.0%35
12
Aspartate Aminotransferase Increased3.8%33
13
Nasopharyngitis3.4%30
14
Abdominal Pain3.1%27
15
Product Dose Omission Issue3.1%27

These are voluntary reports and do not establish that maralixibat caused these reactions.

Report severity

24.2%Serious211 reports
11.9%Hospitalizations104 reports
1.8%Fatal16 reports

Seriousness is determined by the reporter, not by OpenClaim.

Maralixibat drug interactions

Other drugs that appear in adverse event reports alongside maralixibat. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Ursodiol0.9%8
2
Ribociclib0.5%4
3
Rifampin0.5%4
4
Anastrozole0.3%3
5
Leuprolide0.2%2
6
Enzalutamide0.2%2
7
Docetaxel0.2%2
8
Cholestyramine0.2%2
9
Odevixibat0.2%2
10
Adalimumab0.1%1
11
Oxcarbazepine0.1%1
12
Empagliflozin0.1%1
13
Exemestane0.1%1
14
Butorphanol-tartrate0.1%1
15
Burosumab-twza0.1%1

Taken alongside

1
Ursodiol18.0%157
2
Rifampin9.3%81
3
Ergocalciferol6.1%53
4
Hydroxyzine5.5%48
5
Vitamin-k3.6%31
6
Naltrexone2.2%19
7
Vitamin-e2.1%18
8
Cholestyramine2.0%17
9
Aspirin1.7%15
10
Omeprazole1.6%14
11
Phytonadione1.3%11
12
Calcitriol1.0%9
13
Cyproheptadine-hydrochloride1.0%9
14
Cholecalciferol1.0%9
15
Furosemide0.9%8

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports maralixibat side effects

30.0% of maralixibat adverse event reports involve female patients and 38.7% involve male patients. The largest age group is child at 58%. These figures reflect who reports side effects, not underlying risk.

Sex

Female30.0%
Male38.7%
Unknown31.3%

Age group

< 219.7%
2–1158.4%
12–1711.5%
18–647.5%
65+2.9%

What is maralixibat used for

Conditions and purposes for which patients were taking maralixibat when the adverse event was reported.

Alagille SyndromeBenign Recurrent Intrahepatic CholestasisBile Acids AbnormalBiliary CirrhosisBiliary ObstructionBiliary Tract DisorderBilirubin Excretion DisorderCholestatic PruritusCholangitis SclerosingCholestasisCholestasis Of PregnancyCholestatic PruritusCongenital Absence Of Bile DuctsCongenital AnomalyCongenital Hepatobiliary Anomaly

Showing 15 of 34 indications

Maralixibat brand names and reporting trend

Maralixibat is sold under the brand name Livmarli.

Brand names

Livmarli124

Quarterly reports (20142025)

201420242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking maralixibat with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.