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MedsAcross

Molecule

Eluxadoline

Mu-Opioid Receptor Agonist
Available on requestControlled substanceGastroenterology
Presentations
2
Brands
1
Manufacturers
1
Available from stock
0

Eluxadoline is a mu-opioid receptor agonist indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D). It is available as tablets for oral use. MedsAcross supplies Eluxadoline for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Mu-Opioid Receptor Agonist, Opioid mu-Receptor Agonists
ATC classification
A07DA06 Eluxadoline · Antipropulsive
US FDA first approval
27 May 2015
EU status
Withdrawn
Orphan designation
No
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Tablet
Identifiers
UNII 45TPJ4MBQ1RxCUI 1653781CAS 864821-90-9DrugBank DB09272Q20539232

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

VIBERZI is indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D). VIBERZI is a mu-opioid receptor agonist, indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D).

Source: US FDA prescribing information

How it works

Eluxadoline is a mu-opioid receptor agonist, eluxadoline is also a delta opioid receptor antagonist and a kappa opioid receptor agonist. The binding affinities (Ki) of eluxadoline for the human mu and delta opioid receptors are 1.8 nM and 430 nM, respectively. The binding affinity (Ki) of eluxadoline for the human kappa opioid receptor has not been determined, however, the Ki for guinea pig cerebellum kappa opioid receptor is 55 nM. In animals, eluxadoline interacts with opioid receptors in the gut.

Source: US FDA prescribing information

Dosing overview

The recommended dosage of VIBERZI is 100 mg taken orally twice daily with food. The recommended dosage of VIBERZI is 75 mg taken orally twice daily with food in patients: unable to tolerate the 100 mg dose of VIBERZI. receiving concomitant OATP1B1 inhibitors. with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. with moderate or severe renal impairment (eGFR less than 60 mL/min/1.73 m 2 ), and in patients with end stage renal disease (ESRD) not yet on dialysis (eGFR less than 15 mL/min/1.73 m 2 ). Discontinue VIBERZI in patients who develop severe constipation. Instruct patients if they miss a dose, take the next dose at the regular time and not to take 2 doses at the same time to make up for a missed dose. The recommended dosage in adults is 100 mg twice daily taken with food.

Source: US FDA prescribing information

Contraindications

VIBERZI is contraindicated in patients: Without a gallbladder. These patients are at increased risk of developing serious adverse reactions of pancreatitis and/or sphincter of Oddi spasm With known or suspected biliary duct obstruction, or sphincter of Oddi disease or dysfunction. These patients are at increased risk for sphincter of Oddi spasm. With alcoholism, alcohol abuse or alcohol addiction, or in patients who drink more than 3 alcoholic beverages per day. These patients are at increased risk for acute pancreatitis. With a history of pancreatitis, or structural diseases of the pancreas, including known or suspected pancreatic duct obstruction.

Source: US FDA prescribing information

Warnings and precautions

Pancreatitis and Sphincter of Oddi Spasm: Monitor patients for new or worsening abdominal pain, with or without nausea and vomiting, or acute biliary pain with liver or pancreatic enzyme elevations, immediately discontinue VIBERZI and seek medical attention if symptoms develop. Hypersensitivity Reactions, including anaphylaxis: Immediately discontinue VIBERZI and seek medical attention if symptoms develop. Constipation: Instruct patients to stop VIBERZI and immediately contact their healthcare provider if they develop severe constipation. Avoid use with other drugs that may cause constipation

Source: US FDA prescribing information

Side effects

The following adverse reactions described below and elsewhere in the labeling include: Pancreatitis Sphincter of Oddi Spasm Hypersensitivity Reactions Constipation Most common adverse reactions (>5%) are constipation, nausea and abdominal pain.

Source: US FDA prescribing information

Interactions

Tables 2 and 3 include drugs which demonstrated a clinically important drug interaction with VIBERZI or which potentially may result in clinically relevant interactions. Table 2: Established and Other Potentially Clinically Relevant Interactions Affecting VIBERZI OATP1B1 Inhibitors Clinical Impact: Increased exposure to eluxadoline when coadministered with cyclosporine Intervention: Administer VIBERZI at a dose of 75 mg twice daily and monitor patients for impaired mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery and for other eluxadoline-related adverse reactions.

Source: US FDA prescribing information

Storage

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).

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

2 presentations of Eluxadoline, sorted by availability.

MedicineManufacturerRegisterAvailability
Viberzi 100 mg tabletOralAllerganUS FDAAvailable on request
Viberzi 75 mg tabletOralAllerganUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 27 May 2015Drugs@FDA
EU (EMA)WithdrawnEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Eluxadoline available for export from India?

Yes, on request. MedsAcross lists 2 presentations of Eluxadoline and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Eluxadoline have?

The catalogue lists 1 brand names for Eluxadoline, including Viberzi.

Is Eluxadoline approved by the US FDA?

Yes. The US FDA first approved Eluxadoline on 27 May 2015, according to Drugs@FDA.

Does Eluxadoline need cold chain shipping?

No listed presentation of Eluxadoline is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Eluxadoline in?

Eluxadoline is classified under ATC code A07DA06 (Eluxadoline).

References

  1. Viberzi prescribing information (Allergan). U.S. National Library of Medicine, DailyMed. Retrieved 16 July 2024

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