FDA-filed SPL labeling · retrieved through openFDA

Eluxadoline

Eluxadoline is a prescription medicine that works on opioid receptors in the gut and is used to treat irritable bowel syndrome with diarrhea (IBS-D) in adults.

Brand name Viberzi
Drug class Mu-opioid Receptor Agonist
Rx Schedule CIV Form 1 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 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 1 clinical label set 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 →

At a glance
Linked label effectiveJul 16, 2024
AvailabilityRx
Earliest approval/marketing year 2015
FDA-listed product records 12
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 17, 2026
Eluxadoline at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Viberzi (eluxadoline) is an effective option for adults with IBS-D, helping reduce diarrhea and abdominal pain by acting on opioid receptors in the gut. It carries serious risks — especially pancreatitis and sphincter of Oddi spasm — that make it unsafe for people without a gallbladder or with certain digestive or liver conditions. Always take it with food, avoid alcohol, and stop immediately if you develop sudden severe abdominal pain.

📖 Eluxadoline: Patient Information Guide

A plain-language walkthrough of Eluxadoline — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Eluxadoline is used to treat irritable bowel syndrome with diarrhea (IBS-D) in adults.

  • Viberzi (eluxadoline oral tablet) is FDA-approved for adults with IBS-D to reduce chronic diarrhea and abdominal pain associated with this condition
⚙️How it works

Eluxadoline targets opioid receptors located in the wall of the intestine. It activates mu and kappa opioid receptors, which helps slow intestinal contractions and reduce diarrhea, and blocks delta opioid receptors, which balances out these effects and helps reduce abdominal pain. Because it acts mainly in the gut rather than the brain, it delivers its benefits locally with minimal systemic (whole-body) opioid effects.

💊How it's taken

Viberzi tablets are taken by mouth twice a day with food. Taking the tablet with a meal is important — a high-fat meal can significantly reduce how much of the drug your body absorbs, so a regular, balanced meal is preferred. Your prescriber may recommend a lower dose if you have mild or moderate liver disease, kidney problems, or if you take certain other medications such as OATP1B1 inhibitors.

  • Take each dose at roughly the same times each day
  • If you miss a dose, skip it and take the next dose at your regular time — never double up
  • Stop taking Viberzi and call your doctor right away if you develop severe constipation
🤒Side effects — in detail

The most common side effects of Viberzi include:

  • Constipation (the most frequently reported reaction — about half of cases occur in the first two weeks)
  • Nausea
  • Abdominal (belly) pain
  • Vomiting
  • Dizziness
  • Bloating or abdominal distention
  • Fatigue
  • Rash or skin reactions
  • Upper respiratory tract infection or nasopharyngitis (cold-like symptoms)

More serious reactions — including pancreatitis, sphincter of Oddi spasm, severe constipation leading to bowel obstruction, and serious allergic reactions (anaphylaxis) — have been reported and require you to stop Viberzi immediately and seek medical care.

⚠️Warnings & precautions
  • Pancreatitis and sphincter of Oddi spasm: These are the most dangerous risks. The sphincter of Oddi is a small muscular valve that controls the flow of bile and digestive enzymes. When it goes into spasm, it can cause severe pain and trigger pancreatitis. Fatal cases have been reported, almost exclusively in people without a gallbladder. Most serious events occurred within the first week of treatment. Stop Viberzi and seek emergency care if you develop sudden severe belly pain, especially if it radiates to the back or shoulder.
  • Severe constipation: Can progress to bowel obstruction, intestinal perforation, or fecal impaction. Stop Viberzi and contact your healthcare provider immediately if constipation becomes severe.
  • Serious allergic reactions: Including anaphylaxis (a severe, potentially life-threatening whole-body allergic reaction) with swollen face/throat, trouble breathing, and chest tightness. Can occur after the first dose. Stop Viberzi immediately and get emergency help.
  • Liver disease: Viberzi is contraindicated in severe liver impairment and requires a dose reduction in mild or moderate liver impairment, as drug levels in the blood increase significantly.
🔀What it interacts with

Several medicines and substances can interact with eluxadoline in important ways:

  • OATP1B1 inhibitors (including cyclosporine, gemfibrozil, certain HIV antiretrovirals like ritonavir and atazanavir, rifampin, and eltrombopag): These raise eluxadoline blood levels substantially — a lower Viberzi dose is required and your doctor should monitor you closely
  • Rosuvastatin (cholesterol medicine): Viberzi increases rosuvastatin levels in the blood, which can raise the risk of muscle damage (myopathy or rhabdomyolysis) — use the lowest effective rosuvastatin dose
  • Constipation-causing medicines (opioids, anticholinergics, alosetron): Using these with Viberzi increases the risk of severe constipation and bowel complications — avoid combining them; loperamide may be used occasionally for acute severe diarrhea episodes but not chronically
  • Alcohol: Drinking too much — or drinking regularly — significantly raises the risk of acute pancreatitis; patients should avoid chronic or excessive alcohol use
  • Oral contraceptives: No meaningful interaction — Viberzi does not affect birth control pill levels

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Do not take Viberzi if your gallbladder has been removed — serious and potentially fatal pancreatitis risk
  • Do not take if you have known or suspected bile duct blockage, or sphincter of Oddi disease or dysfunction
  • Do not take if you have a history of pancreatitis, structural pancreatic disease, or known pancreatic duct obstruction
  • Do not take if you have a history of chronic or severe constipation, or bowel obstruction
  • Do not take if you drink more than 3 alcoholic beverages a day, or have alcoholism or alcohol addiction
  • Do not take if you have severe liver disease (Child-Pugh Class C)
  • Liver disease (mild or moderate): A lower dose is required; your doctor will monitor you for side effects and for problems with mental alertness or physical coordination
  • Kidney disease (moderate to severe, or end-stage not yet on dialysis): A lower dose is required, as the drug accumulates in the blood
  • Older adults (65+): May be more likely to experience side effects, including serious ones — close monitoring is advised
  • Pregnancy: No human studies exist; discuss the risks and benefits with your doctor
  • Breastfeeding: It is unknown whether eluxadoline passes into human milk; the drug is present in rat milk — discuss with your doctor before breastfeeding
  • Children: Safety and effectiveness have not been established in pediatric patients
🚑If you take too much

No cases of Viberzi overdose have been formally reported. If an overdose is suspected, the stomach may be emptied and supportive care provided. Because eluxadoline acts on opioid receptors, a reversal agent called naloxone (a mu-opioid antagonist) may be considered, though its shorter duration of action means repeated doses may be needed and the patient should be monitored closely for returning symptoms.

📡Pharmacodynamics — effects in the body

Eluxadoline works directly in the gut, where it activates opioid receptors to slow intestinal movement and reduce diarrhea, while also helping to ease abdominal pain. At doses far above the normal therapeutic range, eluxadoline does not cause meaningful changes to heart rhythm (specifically, it does not prolong the QT interval — a measure of electrical activity in the heart).

🔬Pharmacokinetics — how your body processes it

After swallowing a Viberzi tablet with food, the drug reaches peak blood levels in about 1.5 hours. Taking it with a very high-fat meal can reduce peak levels and overall exposure substantially, which is why consistent meal conditions matter. The drug has a relatively short half-life of roughly 4 to 6 hours and does not build up in the body with twice-daily dosing. It is eliminated primarily through the stool (over 82% excreted in feces), with less than 1% leaving through urine. People with liver or severe kidney impairment clear the drug much more slowly, leading to significantly higher blood levels — which is why dose adjustments are needed for those groups.

📦How to store it

Store VIBERZI tablets at 20°C to 25°C (68°F to 77°F) with excursions permitted to 15°C to 30°C (59°F to 86°F) .

📄 Written from Eluxadoline’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

23

Supplements & herbs that interact with Eluxadoline

23 supplements and herbal products have documented interactions with Eluxadoline in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 1
  • Moderate · 13
  • Minor · 9
Every supplement checked against Eluxadoline — ranked by severity The full interaction hub: 1 major · 13 moderate · 9 minor · every one linked to its full report. Check Eluxadoline against your exact supplements

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.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Eluxadoline — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly does Viberzi do for my IBS-D?
Viberzi targets opioid receptors in your intestine — not in your brain — to help slow down gut contractions and reduce pain signals. The result is fewer episodes of diarrhea and less abdominal cramping. It's taken twice a day with meals as an ongoing treatment, not something you take only when symptoms flare up.
Is it safe to take Viberzi if I've had my gallbladder out?
No — this is one of the most important safety points with Viberzi. If you no longer have a gallbladder, you should not take this medication at all. People without a gallbladder face a significantly higher risk of developing serious and even life-threatening pancreatitis or a dangerous muscle spasm near the bile duct. Make sure your doctor knows your surgical history before prescribing this.
What side effects should I actually expect, and which ones mean I need to stop right away?
The most common side effects are constipation, nausea, and belly pain — these affect some people, especially in the first few weeks. However, stop Viberzi immediately and get emergency help if you develop sudden severe stomach pain that spreads to your back or shoulder, if you can't breathe or your throat swells up, or if your constipation becomes severe and won't budge. Those are signs of serious problems that need prompt medical attention.
Can I drink alcohol while taking Viberzi?
You really need to be careful here. Alcohol — especially in larger amounts or on a regular basis — significantly raises your risk of acute pancreatitis while on Viberzi. The label says to avoid chronic or excessive alcohol use. If you have a history of alcohol problems, Viberzi isn't appropriate for you at all. Even occasional drinking should be discussed with your doctor.
Are there any medications I should avoid while taking Viberzi?
Yes, a few important ones. Medicines that also cause constipation — like opioid pain relievers, certain bladder medicines (anticholinergics), and the IBS drug alosetron — should be avoided because the combination can lead to dangerous constipation. Cyclosporine and certain other medicines can raise Viberzi levels in your blood considerably, so your doctor may need to adjust your dose. If you take rosuvastatin for cholesterol, Viberzi can push rosuvastatin levels higher and increase muscle risk — your doctor should use the lowest effective dose. Always share your full medication list with your prescriber.
Is Viberzi safe during pregnancy or while breastfeeding?
There aren't enough human studies to know for certain how Viberzi affects a developing baby or a breastfed infant. Animal studies didn't show birth defects, but the drug was found in rat milk, so it may pass into human breast milk too. If you're pregnant, planning to become pregnant, or breastfeeding, have an honest conversation with your doctor about whether the benefits of treatment outweigh the unknowns for you and your baby.
Is Eluxadoline available over the counter?
Eluxadoline is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
Is Eluxadoline a controlled substance?
Yes — Eluxadoline is a federally controlled substance (Schedule IV) in the United States, so how it is prescribed, refilled and dispensed is regulated by the DEA.
When was Eluxadoline first available?
Eluxadoline has been available in the United States since at least 2015, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Eluxadoline?
Eluxadoline is supplied by 5 manufacturers listed in the FDA NDC Directory, including Allergan, Inc., Aurobindo Pharma Limited, Honour Lab Limited.

💬 Answers drafted from Eluxadoline’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Eluxadoline comes

Eluxadoline 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.

Tablet

By mouth
Brands Viberzi
How this form is used
What it may be used for
  • Viberzi tablets are used to treat irritable bowel syndrome with diarrhea (IBS-D) in adults
  • Viberzi is for ongoing, twice-daily use — not as a one-time or as-needed treatment
Important instructions
  • Viberzi tablets should be taken by mouth twice daily with food
  • Viberzi should not be taken with a high-fat meal, as this can substantially reduce absorption
  • If you miss a dose of Viberzi, take your next dose at the regular time — do not take two doses at once
  • Viberzi should be stopped immediately if severe constipation develops, and a prescriber should be contacted
Available strengths 2 strengths
8 FDA-listed product records

📊 Eluxadoline across the U.S. market

How Eluxadoline 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.

1
Dose forms
5
Manufacturers
1
Brand names
12
FDA-listed product records
2015
First marketed

Also listed with the FDA, not a patient dose form: Powder (4) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Allergan, Inc.67%
Aurobindo Pharma Limited8%
Honour Lab Limited8%
MSN Life Sciences Private Limited8%
Piramal Pharma Limited8%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Eluxadoline is used

A general measure of how commonly Eluxadoline 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 Eluxadoline 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.

7,211
Medicaid prescriptions filled (Q1–Q4 2025)
$11.4M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Eluxadoline prescribed? Of the 1,596 medications we measure, Eluxadoline ranks #987 by Medicaid prescriptions — more than 38% of them.

Where Eluxadoline ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Eluxadoline 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.

The 100 mg oral tablet is the most-dispensed Eluxadoline product — about 70% of these Medicaid prescriptions.

eluxadoline 100 MG Oral Tablet Most dispensed

5,057 Medicaid prescriptions (Q1–Q4 2025) 70% of Eluxadoline prescriptions shown $8.2M gross reimbursement (before rebates) ≈ $1,621 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1719764

eluxadoline 75 MG Oral Tablet

2,154 Medicaid prescriptions (Q1–Q4 2025) 30% of Eluxadoline prescriptions shown $3.2M gross reimbursement (before rebates) ≈ $1,495 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1653786

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 Eluxadoline, 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 2 of 6 listed Eluxadoline NDCs with Medicaid activity.

🔍 Compare Eluxadoline products

A representative set of FDA-listed product records for Eluxadoline — 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
💊Tablet
75 mg Oral Allergan, Inc. × 4 listings NDA View NDC →
100 mg Oral Allergan, Inc. × 4 listings NDA View NDC →
💊Bulk drug substance
50 kg/50 kg Aurobindo Pharma Limited BULK INGREDIENT View NDC →
1 kg/kg Honour Lab Limited BULK INGREDIENT View NDC →
1 kg/kg MSN Life Sciences Private Limited BULK INGREDIENT View NDC →
1 kg/kg Piramal Pharma Limited DRUG FOR FURTHER PROCESSING View NDC →

Showing 12 of 12 products — FDA National Drug Code Directory. See every product, package size and price: browse all 12 Eluxadoline NDCs →

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.

Ingredient (IN) Eluxadoline RxCUI 1653781 1 dose form · 2 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 1653785 In current FDA listings
    Clinical drug / strength (SCD) 75 MG RxCUI 1653786 100 MG RxCUI 1719764

Look up RxCUI 1653781 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.

🏷️ Sold under these brand names

Viberzi

🏭 Manufacturers & labelers

Allergan, Inc. 8 Aurobindo Pharma Limited 1 Honour Lab Limited 1 MSN Life Sciences Private Limited 1 Piramal Pharma Limited 1

RxNorm drug class

Eluxadoline belongs to the mu-Opioid Receptor Agonist class.

Pharmacologic class mu-Opioid Receptor Agonist
Drug family (ATC) Antipropulsives
How it works Opioid mu-Receptor Agonists

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.

🔬 Where this comes from

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.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jul 16, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Eluxadoline.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Eluxadoline after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
12
Distinct labelers/manufacturers represented
5
Linked representative label
Allergan, Inc.
Linked label effective
Jul 16, 2024
Composite sections available
24
Linked SPL Set ID
7821bd40-4c84-4984-951b-6436ae20421a
Linked SPL Document ID
772a8af8-21e9-46bb-af21-34365ae0c477
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Allergan, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.