Odevixibat
Odevixibat is a bile acid transporter blocker used to treat the intense itching (pruritus) caused by two rare liver conditions: progressive familial intrahepatic cholestasis (PFIC) and Alagille syndrome (ALGS).
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Odevixibat (Bylvay) is a specialist medicine, on the U.S. market since about 2021, for the intense itching (pruritus) of two rare inherited liver conditions, PFIC (progressive familial intrahepatic cholestasis) and Alagille syndrome; it blocks bile acid reabsorption in the gut, so blood bile acid levels fall. It is generally well tolerated, and because little is absorbed, side effects stay mostly in the gut, with diarrhea, belly pain and vomiting the ones families notice. The real watch point is the liver, so keep up with liver and vitamin blood tests, and call the care team about persistent diarrhea, unusual bleeding or vomiting blood.
Clinical pearls
- Give it in the morning with a meal, and swallow the capsules whole rather than crushing or chewing them.
- Separate it by at least 4 hours from cholestyramine, colesevelam or colestipol, which bind it in the gut.
- Vitamin A, D, E and K supplements are often added, since low levels can cause bleeding, bruising or fracture-prone bones.
- It is not recommended when certain ABCB11 gene variants leave PFIC type 2 patients with no working bile salt export pump.
Patient information guide A plain-language walkthrough of Odevixibat, written from its FDA label.
What Odevixibat is used for
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Odevixibat is used to treat itching caused by two rare liver conditions.
- Bylvay treats pruritus in patients 3 months and older with progressive familial intrahepatic cholestasis (PFIC).
- Bylvay treats cholestatic pruritus in patients 12 months and older with Alagille syndrome (ALGS).
- Bylvay is not recommended for a subgroup of PFIC type 2 patients with specific ABCB11 variants causing non-functional or absent bile salt export pump protein.
How Odevixibat works
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Odevixibat is a reversible inhibitor of the ileal bile acid transporter (IBAT) in the last part of the small intestine. By blocking it, less bile acid is reabsorbed and blood bile acid levels fall.
Itching is a common symptom in PFIC and ALGS. How odevixibat relieves it isn't fully understood, but lowering bile acids may play a role.
Odevixibat dosage
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Bylvay is taken by mouth once a day in the morning with a meal. Dosing is based on body weight, and your prescriber may adjust it. Bylvay capsules are for patients weighing 19.5 kg or more, and the capsules should not be crushed or chewed.
- If you take a bile acid binding resin, space it at least 4 hours from Bylvay.
- Follow your prescriber's directions and the label.
Dosing details from the FDA-approved label
From the Odevixibat prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- PFIC: Patients 3 months and older
- 40 mcg/kg taken orally once daily in the morning with a meal
- If there is no improvement in pruritus after 3 months, the dosage may be increased in 40 mcg/kg increments up to 120 mcg/kg once daily
- Maximum: not to exceed a daily dosage of 6 mg/day
- Oral pellets for patients weighing less than 19.5 kg; capsules for patients weighing 19.5 kg or above; dose by body weight per Table 1 (200 mcg for 7.4 kg and below up to 2,400 mcg for 55.5 kg and above)
- ALGS: Patients 12 months and older
- 120 mcg/kg taken orally once daily in the morning with a meal
- Dose reduction to 40 mcg/kg/day may be considered if tolerability issues occur in the absence of other causes, then increase to 120 mcg/kg/day once stabilized
- Oral pellets for patients weighing less than 19.5 kg; capsules for patients weighing 19.5 kg or above; dose by body weight per Table 2 (600 mcg for 7.4 kg and below up to 7,200 mcg for 55.5 kg and above)
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Recommended Dosage PFIC: Patients 3 months and older: 40 mcg/kg taken orally once daily. ( 2.1 ) If there is no improvement in pruritus after 3 months, the dosage may be increased in 40 mcg/kg increments up to 120 mcg/kg once daily, not to exceed a daily dosage of 6 mg/day. ( 2.1 ) ALGS: Patients 12 months and older: 120 mcg/kg taken orally once daily. ( 2.2 ) Preparation and Administration Instructions Administer BYLVAY in the morning with a meal. ( 2.4 ) Do not crush or chew capsules. ( 2.4 ) See full prescribing information for preparation and administration instructions. ( 2.4 ) 2.1 Recommended Dosage for Progressive Familial Intrahepatic Cholestasis (PFIC) in Patients Aged 3 Months and Older The recommended dosage of BYLVAY is 40 mcg/kg taken orally once daily in the morning with a meal. Table 1 below shows the recommended once daily dosage by body weight. If there is no improvement in pruritus after 3 months, the dosage may be increased in 40 mcg/kg increments up to 120 mcg/kg once daily not to exceed a daily dosage of 6 mg/day. BYLVAY oral pellets are intended for use by patients weighing less than 19.5 kilograms. BYLVAY capsules are intended for use by patients weighing 19.5 kilograms or above. Table 1. Recommended Dosage for PFIC in Patients aged 3 months and older (40 mcg/kg/day) Body Weight (kg) Once Daily Dosage (mcg) 7.4 and below 200 7.5 to 12.4 400 12.5 to 17.4 600 17.5 to 25.4 800 25.5 to 35.4 1,200 35.5 to 45.4 1,600 45.5 to 55.4 2,000 55.5 and above 2,400 2.2 Recommended Dosage for Alagille Syndrome (ALGS) in Patients Aged 12 Months and Older The recommended dosage of BYLVAY is 120 mcg/kg taken orally once daily in the morning with a meal. Table 2 below shows the recommended once daily dosage by body weight. BYLVAY oral pellets are intended for use by patients weighing less than 19.5 kilograms. BYLVAY capsules are intended for use by patients weighing 19.5 kilograms or above. Table 2.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Odevixibat side effects
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The most common side effects reported include:
Common side effects
- Diarrhea
- Abdominal (belly) pain
- Vomiting
- Liver test abnormalities
- Fat-soluble vitamin deficiency (vitamins A, D, E, K)
- Hematoma (bruising)
- Weight loss
When to get medical help
- Call your doctor if you notice signs of liver problems or hepatitis, or if liver tests change.
- Get medical help for signs of liver decompensation such as vomiting blood, fluid buildup in the belly (ascites), or confusion (hepatic encephalopathy).
- Call your doctor if diarrhea is persistent or you show signs of dehydration.
- Tell your doctor about any bleeding, as treatment may need to be paused.
- Report any bone fracture to your doctor.
- Tell your doctor about signs of low fat-soluble vitamin levels.
Odevixibat warnings and precautions
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- Liver injury: Drug-induced liver injury can occur, and some patients in trials needed liver transplant. Liver tests are monitored often in the first 6 to 8 months.
- Diarrhea: Can cause dehydration. Treatment may be paused or stopped if it persists.
- Vitamin deficiency: Fat-soluble vitamins A, D, E and K may be absorbed less, with a risk of bleeding and fractures.
Odevixibat interactions
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Few interactions matter, but these are important.
- Bile acid binding resins (cholestyramine, colesevelam, colestipol): they may bind Bylvay in the gut and reduce how well it works, so separate doses by at least 4 hours.
- Fat-soluble vitamins: Bylvay may reduce absorption, so supplements may be needed.
Interactions listed in the FDA-approved label
From the Odevixibat prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Bile acid binding resins (e.g., cholestyramine, colesevelam, or colestipol): Bile acid binding resins may bind odevixibat in the gut, which may reduce BYLVAY efficacy. Administer bile acid binding resins at least 4 hours before or 4 hours after administration of BYLVAY.
Read the label’s full interactions text
7 DRUG INTERACTIONS 7.1 Bile Acid Binding Resins Administer bile acid binding resins (e.g., cholestyramine, colesevelam, or colestipol) at least 4 hours before or 4 hours after administration of BYLVAY [see Dosage and Administration (2.3) ] . Bile acid binding resins may bind odevixibat in the gut, which may reduce BYLVAY efficacy.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Odevixibat
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- Do not use with prior or active liver decompensation.
- Use closer monitoring with compensated cirrhosis or portal hypertension.
- Pregnancy: animal data show possible heart malformations; discuss risks and vitamin monitoring with your doctor.
- Breastfeeding: infant exposure is not expected, but vitamin levels should be monitored.
- Children: established for PFIC at 3 months to 17 years and ALGS at 12 months to 17 years.
- Older adults: not studied in people 65 and older.
What Odevixibat does in the body
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Odevixibat lowers serum bile acids in people with PFIC and ALGS. In trials, levels dropped within about 4 to 8 weeks (PFIC) or as early as week 4 (ALGS) and generally stayed lower through 24 weeks.
How your body processes Odevixibat
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Odevixibat is minimally absorbed, and most of it stays in the gut. In healthy adults, about 83% of a dose was found in feces, nearly all unchanged, and almost none in urine. Its half-life was about 2.4 hours, and it does not build up with once-daily dosing. Food or sprinkling the pellets on soft food changed blood levels, but this was not considered clinically significant.
How to store Odevixibat
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Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (between 59°F and 86°F) .
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Odevixibat
17 supplements and herbal products have documented interactions with Odevixibat in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 7
- Minor · 9
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Odevixibat: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Odevixibat — the kind of thing our pharmacy team would talk through with you at the counter.
What is Bylvay for?
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How should I take it?
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Can I take it with my other medicines?
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What side effects should I expect?
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Why do I need blood tests?
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Is it safe in pregnancy?
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Is Odevixibat available over the counter?
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When was Odevixibat first available?
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Who makes Odevixibat?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Odevixibat on HelloPharmacist
Odevixibat forms and strengths (how it comes)
Odevixibat is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Odevixibat inactive ingredients by manufacturer.
Capsule
How this form is used
- Bylvay treats pruritus in PFIC in people 3 months and older.
- Bylvay treats cholestatic pruritus in ALGS in people 12 months and older.
- Bylvay capsules are intended for patients weighing 19.5 kg or more.
- Bylvay is taken once daily in the morning with a meal.
- Do not crush or chew Bylvay capsules.
- Take Bylvay at least 4 hours before or after a bile acid binding resin.
Odevixibat on the U.S. market: products, makers and brands
How Odevixibat appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
2 companies list 8 Odevixibat product records with the FDA, mostly as capsule; the earliest marketing or approval year on record is 2021. Brand names on the directory include Bylvay; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Odevixibat is used (Medicaid data)
A general measure of how commonly Odevixibat is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Odevixibat is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Odevixibat prescribed? Of the 1,601 medications we measure, Odevixibat ranks #1,534 by Medicaid prescriptions — more than 4% of them.
Utilization by Odevixibat product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
odevixibat 0.4 MG Oral Capsule Most dispensed
Summed across the 2 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2563997
odevixibat 1.2 MG Oral Capsule
Summed across the 2 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2564003
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Odevixibat, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 4 of 4 listed Odevixibat NDCs with Medicaid activity.
Compare Odevixibat products
A representative set of FDA-listed product records for Odevixibat — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 200 mcg | Oral | Albireo Pharma, Inc. | NDA | View NDC → |
| 400 mcg | Oral | Albireo Pharma, Inc. | NDA | View NDC → |
| 600 mcg | Oral | Albireo Pharma, Inc. | NDA | View NDC → |
| 1200 mcg | Oral | Albireo Pharma, Inc. | NDA | View NDC → |
| 200 mcg | Oral | Ipsen Biopharmaceuticals, Inc. | NDA | View NDC → |
| 400 mcg | Oral | Ipsen Biopharmaceuticals, Inc. | NDA | View NDC → |
| 600 mcg | Oral | Ipsen Biopharmaceuticals, Inc. | NDA | View NDC → |
| 1200 mcg | Oral | Ipsen Biopharmaceuticals, Inc. | NDA | View NDC → |
Showing 8 of 8 products — FDA National Drug Code Directory. See every product, package size and price: browse all 8 Odevixibat NDCs →
Odevixibat side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Odevixibat — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Odevixibat in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Odevixibat FDA approval history
How Odevixibat went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Odevixibat recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Odevixibat recalls since July 2021.
✅No Odevixibat recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2563966 2 dose forms · 4 strengths
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Dose form (SCDF) Oral Capsule RxCUI 2563996In current FDA listings -
Dose form (SCDF) Oral Pellet RxCUI 2563982No current FDA listing
Look up RxCUI 2563966 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Odevixibat supply and shortage status
Whether Odevixibat is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Odevixibat brand names
Odevixibat is sold under one brand name in the FDA directory — Bylvay. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Odevixibat: manufacturers and labelers
2 companies list Odevixibat products with the FDA. By number of product records, the largest are Albireo Pharma, Inc., Ipsen Biopharmaceuticals, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Odevixibat drug class (RxNorm)
Odevixibat belongs to the Ileal Bile Acid Transporter Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Odevixibat page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Albireo Pharma, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →