What the label lists and what reports show
Maralixibat side effects
Maralixibat's FDA label: “Most common adverse reactions (≥5%) are: • ALGS: diarrhea, abdominal pain, vomiting, fat-soluble vitamin deficiency, liver test abnormalities, and bone fractures.” FAERS holds 950 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is liver transplant (92 reports).
- No generic listed
Check it at the source: the maralixibat FDA label on DailyMed (effective April 10, 2025, Mirum Pharmaceuticals Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of LIVMARLI?LIVMARLI can cause serious side effects, including: • Liver injury. Changes in certain liver tests are common in patients with ALGS and in patients with PFIC but may worsen during treatment with LIVMARLI. These changes may be a sign of liver injury and can be serious or may lead to liver transplant or death. Your healthcare provider should do blood tests and physical exams before starting and during treatment with LIVMARLI to check your liver function. […]
Source: FDA drug label, Mirum Pharmaceuticals Inc., effective April 10, 2025 (SPL set 64000394-1ef6-4e76-8ba8-11f25ba1b167), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥5%) are: • ALGS: diarrhea, abdominal pain, vomiting, fat-soluble vitamin deficiency, liver test abnormalities, and bone fractures.
Table 5: Adverse Reactions Occurring in ≥ 5% of Patients Treated with LIVMARLI in the ALGS Clinical Development Program
| Adverse Reaction | Any Grade n (%) | Number of events per 100 person‑years 1 |
|---|---|---|
| Diarrhea | 48 (55.8%) | 41.6 |
| Abdominal pain | 46 (53.5%) | 38.6 |
| Vomiting | 35 (40.7%) | 19.8 |
| Nausea | 7 (8.1%) | 2.9 |
| Fat-Soluble Vitamin deficiency | 22 (25.6%) | 11.1 |
| Transaminases increased (ALT, AST) | 16 (18.6%) | 6.9 |
| Bone Fractures | 8 (9.3%) | 3.3 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in labeling: • Hepatotoxicity [see Warnings and Precautions (5.1) ] • Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.2) ] • Fat Soluble Vitamin (FSV) Deficiency [see Warnings and Precautions (5.3) ] Most common adverse reactions (≥5%) are: • ALGS: diarrhea, abdominal pain, vomiting, fat-soluble vitamin deficiency, liver test abnormalities, and bone fractures. ( 6.1 ) • PFIC: diarrhea, fat soluble vitamin deficiency, abdominal pain, liver test abnormalities, hematochezia, and bone fractures. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mirum Pharmaceuticals at 1-855-MRM-4YOU or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. ALGS: In the Alagille syndrome clinical development program, which includes five clinical studies comprising 86 patients, patients received doses of LIVMARLI up to 760 mcg/kg per day with a median duration of exposure of 32.3 months (range: 0.03 – 60.9 months). In Trial 1, the 4-week placebo control period occurred after 18 weeks of LIVMARLI treatment. …
Source: FDA drug label, Mirum Pharmaceuticals Inc., effective April 10, 2025 (SPL set 64000394-1ef6-4e76-8ba8-11f25ba1b167), via openFDA; the full label on DailyMed
What do FAERS reports show?
950 reports list maralixibat among the medicines taken, each a report of something that happened, not proof the medicine caused it; 17 are coded as a death and 132 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Maralixibat: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions