Drug · FAERS side-effect profile with label screen

Maralixibat side effects: what 950 FDA adverse event reports show

Maralixibat Chloride · 19 reaction terms · 689 drug–reaction co-reports · data 2026-09-14

Drug class

Ileal bile acid transporter (ibat) inhibitor

FDA label, Indications wording of the closest related product

Label matched

Maralixibat Chloride (Livmarli)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

950 reports · 27% serious · 17 with death outcome · 43% female

openFDA FAERS counts, all years, deduplication not applied

Used for

LIVMARLI is an ileal bile acid transporter (IBAT) inhibitor indicated for: • the treatment of cholestatic pruritus in patients 3 months of age and older with Alagille syndrome (ALGS). ( 1.1 ) • the treatment of cholestatic pruritus in patients 12 months of age and older with progressive familial intrahepatic cholestasis (PFIC).

FDA label, Indications and Usage

What it is

LIVMARLI (maralixibat) is an ileal bile acid transporter (IBAT) inhibitor. Maralixibat is present as a chloride salt with the chemical name 1-[[4-[[4-[(4 R ,5 R )-3,3-dibutyl-7-(dimethylamino).

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 17 strongest signals

Labeled adverse reaction 2Labeled (related wording) 2Likely indication confounding 2Reporting / coding artifact 3Lab value / disease marker 2Not in label — unassessed 6

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 2 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Blood bilirubin increased	60	49.0 38.3–62.6ROR 52.2 · χ² 2,771 / p <1e-300	48.2 EB05 38.8 · IC025 +4.7 3/3 methods agree	Lab value / disease marker	serious PRR 42.5 · 75% consumer	no trial data cached
Jaundice (yellowing of skin/eyes)	42	34.4 25.6–46.2ROR 35.9 · χ² 1,329 / p 4e-291	33.9 EB05 26.1 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious PRR 26.2 · ♀ 22% (drug 43%) · 83% consumer	no trial data cached
Scratch	16	34.2 21.0–55.5ROR 34.7 · χ² 482 / p 4e-107	32.9 EB05 21.5 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=1	no trial data cached
Hepatic enzyme increased	72	23.4 18.7–29.2ROR 25.2 · χ² 1,525 / p <1e-300	23.3 EB05 19.1 · IC025 +3.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.2 · ♀ 18% (drug 43%) · 86% consumer	no trial data cached
Blood alkaline phosphatase increased	26	23.1 15.8–33.7ROR 23.7 · χ² 528 / p 5e-117	22.7 EB05 16.3 · IC025 +3.4 3/3 methods agree	Lab value / disease marker	serious PRR 17.7	no trial data cached
Aspartate aminotransferase increased	55	22.9 17.7–29.6ROR 24.2 · χ² 1,131 / p 3e-248	22.7 EB05 18.1 · IC025 +3.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 12.4	no trial data cached
Gamma-glutamyltransferase increased	22	21.9 14.5–33.1ROR 22.4 · χ² 418 / p 3e-93	21.5 EB05 14.9 · IC025 +3.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 15.7	no trial data cached
Alanine aminotransferase increased	60	21.6 16.9–27.6ROR 23.0 · χ² 1,159 / p 2e-254	21.4 EB05 17.2 · IC025 +3.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 13.4	no trial data cached
Prescribed underdose	15	16.6 10.1–27.4ROR 16.9 · χ² 205 / p 1e-46	15.9 EB05 9.6 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 16.4	no trial data cached
Pruritus (itching)	251	14.7 13.2–16.3ROR 19.6 · χ² 3,240 / p <1e-300	14.6 EB05 13.2 · IC025 +3.6 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 16.4 · 81% consumer	no trial data cached
Faeces discoloured	14	14.3 8.5–24.0ROR 14.5 · χ² 160 / p 7e-37	13.2 EB05 7.6 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 10.0	no trial data cached
Premature delivery	10	13.8 7.4–25.6ROR 13.9 · χ² 106 / p 3e-25	11.9 EB05 5.9 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 27.5	no trial data cached
Insurance issue	7	10.4 5.0–21.8ROR 10.5 · χ² 50 / p 6e-13	7.5 EB05 3.5 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 33.2	no trial data cached
Liver function test abnormal	13	9.8 5.7–16.8ROR 9.9 · χ² 94 / p 1e-22	8.2 EB05 4.8 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Post procedural haemorrhage	5	9.5 3.9–22.7ROR 9.5 · χ² 30 / p 2e-8	6.0 EB05 2.6 · IC025 +0.9 3/3 methods agree	Reporting / coding artifact	serious PRR 22.8	no trial data cached
Product use complaint	6	8.5 3.8–19.0ROR 8.6 · χ² 33 / p 5e-9	5.8 EB05 2.7 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious n=2	no trial data cached
Cholestasis (bile flow blockage)	7	8.1 3.9–16.9ROR 8.1 · χ² 37 / p 7e-10	5.8 EB05 2.9 · IC025 +1.2 3/3 methods agree	Likely indication confounding term in indications	serious PRR 17.7	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Pruritus (itching)	251	14.7 13.2–16.3ROR 19.6 · χ² 3,240 / p <1e-300	14.6 EB05 13.2 · IC025 +3.6 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 16.4 · 81% consumer	no trial data cached
Hepatic enzyme increased	72	23.4 18.7–29.2ROR 25.2 · χ² 1,525 / p <1e-300	23.3 EB05 19.1 · IC025 +3.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.2 · ♀ 18% (drug 43%) · 86% consumer	no trial data cached
Alanine aminotransferase increased	60	21.6 16.9–27.6ROR 23.0 · χ² 1,159 / p 2e-254	21.4 EB05 17.2 · IC025 +3.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 13.4	no trial data cached
Blood bilirubin increased	60	49.0 38.3–62.6ROR 52.2 · χ² 2,771 / p <1e-300	48.2 EB05 38.8 · IC025 +4.7 3/3 methods agree	Lab value / disease marker	serious PRR 42.5 · 75% consumer	no trial data cached
Aspartate aminotransferase increased	55	22.9 17.7–29.6ROR 24.2 · χ² 1,131 / p 3e-248	22.7 EB05 18.1 · IC025 +3.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 12.4	no trial data cached
Jaundice (yellowing of skin/eyes)	42	34.4 25.6–46.2ROR 35.9 · χ² 1,329 / p 4e-291	33.9 EB05 26.1 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious PRR 26.2 · ♀ 22% (drug 43%) · 83% consumer	no trial data cached
Blood alkaline phosphatase increased	26	23.1 15.8–33.7ROR 23.7 · χ² 528 / p 5e-117	22.7 EB05 16.3 · IC025 +3.4 3/3 methods agree	Lab value / disease marker	serious PRR 17.7	no trial data cached
Gamma-glutamyltransferase increased	22	21.9 14.5–33.1ROR 22.4 · χ² 418 / p 3e-93	21.5 EB05 14.9 · IC025 +3.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 15.7	no trial data cached
Scratch	16	34.2 21.0–55.5ROR 34.7 · χ² 482 / p 4e-107	32.9 EB05 21.5 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=1	no trial data cached
Prescribed underdose	15	16.6 10.1–27.4ROR 16.9 · χ² 205 / p 1e-46	15.9 EB05 9.6 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 16.4	no trial data cached
Faeces discoloured	14	14.3 8.5–24.0ROR 14.5 · χ² 160 / p 7e-37	13.2 EB05 7.6 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 10.0	no trial data cached
Liver function test abnormal	13	9.8 5.7–16.8ROR 9.9 · χ² 94 / p 1e-22	8.2 EB05 4.8 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Premature delivery	10	13.8 7.4–25.6ROR 13.9 · χ² 106 / p 3e-25	11.9 EB05 5.9 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 27.5	no trial data cached
Cholestasis (bile flow blockage)	7	8.1 3.9–16.9ROR 8.1 · χ² 37 / p 7e-10	5.8 EB05 2.9 · IC025 +1.2 3/3 methods agree	Likely indication confounding term in indications	serious PRR 17.7	no trial data cached
Insurance issue	7	10.4 5.0–21.8ROR 10.5 · χ² 50 / p 6e-13	7.5 EB05 3.5 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 33.2	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Jaundice — n=42, PRR 34.4

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Maralixibat?

In FDA FAERS, the most frequently co-reported reaction terms for Maralixibat are pruritus, hepatic enzyme increased, alanine aminotransferase increased, blood bilirubin increased, aspartate aminotransferase increased, jaundice. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Maralixibat have an FDA boxed warning?

No. The FDA label retrieved for Maralixibat has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Maralixibat causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 64000394-1ef6-4e76-8ba8-11f25ba1b167, effective 20250410; matched on openfda.generic_name.exact:"MARALIXIBAT CHLORIDE")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 19 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.