Brand Name

Viberzi

Generic Name
Eluxadoline
View Brand Information
FDA approval date: October 01, 2015
Classification: mu-Opioid Receptor Agonist
Form: Tablet

What is Viberzi (Eluxadoline)?

Viberzi (Eluxadoline): Targeted Relief for Irritable Bowel Syndrome with Diarrhea (IBS-D)

Living with **irritable bowel syndrome with diarrhea (IBS-D)** can be frustrating and unpredictable. For many adults, this chronic condition means frequent, urgent trips to the bathroom, abdominal pain, and the constant fear of flare-ups disrupting daily life. Viberzi (eluxadoline) is a medication designed to help restore control and comfort by targeting the underlying bowel symptoms that make IBS-D so disruptive.

Viberzi is a prescription medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of IBS with diarrhea in adults. It belongs to a class of drugs known as **mixed opioid receptor modulators**, which act directly in the gut rather than the brain. Unlike older treatments that only manage diarrhea or cramping, Viberzi addresses multiple symptoms of IBS-D simultaneously, offering a more balanced and targeted approach.

Introduced in 2015, Viberzi represents a newer generation of IBS-D treatments, designed for patients who have not found adequate relief with dietary changes, over-the-counter remedies, or antidiarrheal medications.


What does Viberzi do?

Viberzi helps relieve the key symptoms of irritable bowel syndrome with diarrhea (IBS-D), including frequent loose stools, abdominal pain, urgency, and discomfort. The goal of treatment is to reduce how often and how severely these symptoms occur, helping patients regain control over their bowel habits and quality of life.

Clinical studies have shown that Viberzi can significantly reduce **diarrhea frequency and abdominal pain** in adults with IBS-D when taken as prescribed (FDA, 2023). Many patients report more predictable bowel patterns and less abdominal cramping after several weeks of treatment.

While Viberzi is not a cure for IBS-D, it offers effective symptom management, allowing individuals to engage more confidently in everyday activities without the constant anxiety of sudden digestive distress.


How does Viberzi work?

Viberzi works by regulating activity in the gut’s nervous system, which controls muscle contractions and fluid movement in the intestines. Its active ingredient, eluxadoline, acts on **opioid receptors** located in the digestive tract—specifically, the mu, delta, and kappa opioid receptors.

Here’s how it helps:

  • Mu-opioid receptor activation slows intestinal movement, reducing diarrhea.
  • Delta-opioid receptor antagonism helps prevent excessive constipation that can occur with other opioid-based treatments.
  • Kappa-opioid receptor effects may help reduce abdominal pain and discomfort.

This balanced mechanism allows Viberzi to normalize bowel function, improving stool consistency and reducing abdominal pain without causing dependency or affecting the brain like traditional opioids.

Clinically, this dual action is important because IBS-D involves both overactive gut motility and heightened sensitivity. By calming intestinal activity while easing pain, Viberzi helps restore a more natural rhythm to digestion.


Viberzi Side Effects and Warnings

As with any medication, Viberzi can cause side effects, though not everyone experiences them. Most are mild and manageable, but some require prompt medical attention.

Common Side Effects may include:

  • Constipation
  • Nausea
  • Abdominal pain or bloating
  • Dizziness

Serious but less common side effects include:

  • Pancreatitis (inflammation of the pancreas): This can occur even after the first few doses, especially in patients **without a gallbladder**. Symptoms may include severe upper abdominal pain, nausea, or vomiting.
  • Sphincter of Oddi spasm: A rare reaction that can cause sudden abdominal or back pain.
  • Severe constipation: If constipation becomes painful or persistent, treatment should be stopped.

Who should avoid Viberzi:

  • People **without a gallbladder**, as they are at increased risk of pancreatitis.
  • Those with a history of pancreatitis, severe liver impairment, or heavy alcohol use.
  • Individuals with biliary duct obstruction or known allergies to eluxadoline.

Patients should seek immediate medical care if they experience severe abdominal pain, nausea, vomiting, or signs of an allergic reaction, such as rash or swelling.

Healthcare providers often monitor patients closely when starting Viberzi to ensure safety and identify any adverse effects early. With proper screening and medical supervision, serious complications are rare.


Viberzi Dosage and Monitoring

Viberzi is a tablet taken **twice daily with food** to aid absorption and reduce stomach discomfort. Dosage is individualized based on liver function, gallbladder presence, and overall health. Take exactly as prescribed; do not adjust or skip doses without consulting a doctor.

Doctors may periodically monitor liver function tests and review any new symptoms to ensure the treatment remains safe and effective.

Special Considerations:

  • Older adults or those with mild to moderate liver problems may require dose adjustments.
  • Patients consuming over three alcoholic drinks daily should avoid Viberzi due to increased pancreatitis risk.
  • Consult your doctor if diarrhea returns or worsens after stopping Viberzi; do not restart independently.
  • Never exceed the prescribed dose to avoid serious side effects.

Does Viberzi have a generic version?

As of 2025, **there is no FDA-approved generic version of Viberzi (eluxadoline)** available in the United States. The medication is currently only sold under the brand name Viberzi, manufactured by Allergan (an AbbVie company). However, international versions may exist in other markets.

Insurance may require prior authorization or recommend alternative IBS-D treatments for Viberzi due to cost. Future generic versions will meet the same safety, quality, and effectiveness standards, offering identical results at a lower price.


Conclusion

Viberzi (eluxadoline) offers a modern, targeted approach to managing irritable bowel syndrome with diarrhea (IBS-D), helping patients regain control over symptoms like abdominal pain and frequent diarrhea. By acting directly on opioid receptors in the gut, it works to normalize bowel function while minimizing discomfort.

While the medication is effective for many, it’s not suitable for everyone, especially those without a gallbladder or with certain liver or pancreas conditions. Open communication with a healthcare provider, careful monitoring, and adherence to dosing instructions are key to using Viberzi safely and effectively.


References

  • U.S. Food and Drug Administration (FDA). (2023). Viberzi (eluxadoline) Prescribing Information. Retrieved from accessdata.fda.gov
  • Mayo Clinic. (2024). Eluxadoline (oral route) description and side effects. Retrieved from mayoclinic.org
  • MedlinePlus. (2024). Eluxadoline: Drug information. National Library of Medicine. Retrieved from medlineplus.gov
  • National Institutes of Health (NIH). (2024). Irritable Bowel Syndrome overview and treatment. Retrieved from nih.gov
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Brand Information

Viberzi (Eluxadoline)
1INDICATIONS AND USAGE
VIBERZI
2DOSAGE AND ADMINISTRATION
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
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.
3DOSAGE FORMS AND STRENGTHS
  • 75 mg tablets: capsule-shaped tablets are coated in pale-yellow to light tan color debossed with “FX75” on one side. Each tablet contains 75 mg eluxadoline.
  • 100 mg tablets: capsule-shaped tablets are coated in pink-orange to peach color debossed with “FX100” on one side. Each tablet contains 100 mg eluxadoline.
4CONTRAINDICATIONS
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. These patients are at increased risk for acute pancreatitis 
  • With a known hypersensitivity reaction to VIBERZI
  • With severe hepatic impairment (Child-Pugh Class C). These patients are at risk for significantly increased plasma concentrations of eluxadoline
  • With a history of chronic or severe constipation or sequelae from constipation, or known or suspected mechanical gastrointestinal obstruction. These patients may be at risk for severe complications of bowel obstruction 
5ADVERSE REACTIONS
The following adverse reactions described below and elsewhere in the labeling include:
  • Pancreatitis
  • Sphincter of Oddi Spasm 
  • Hypersensitivity Reactions 
  • Constipation
5.1Clinical TrialsExperience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates 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.
Over 1700 patients with IBS-D have been treated with 75 or 100 mg of VIBERZI twice daily in controlled trials. Exposures from placebo-controlled clinical trials in adult patients with IBS-D included 1391 exposed for 3 months, 1001 exposed for 6 months and 488 exposed for one year. 
Demographic characteristics were comparable between the treatment groups
Pancreatitis
Cases of pancreatitis, not associated with sphincter of Oddi spasm, were reported in 2/807 (0.2%) of patients receiving 75 mg and 3/1032 (0.3%) of patients receiving 100 mg VIBERZI twice daily in clinical trials. Of these 5 cases, 3 were associated with excessive alcohol intake, one was associated with biliary sludge, and in one case the patient discontinued VIBERZI 2 weeks prior to the onset of symptoms. All pancreatic events resolved with lipase normalization upon discontinuation of VIBERZI, with 80% (4/5) resolving within 1 week of treatment discontinuation. The case of sphincter of Oddi spasm-induced pancreatitis resolved within 24 hours of discontinuation.
Sphincter of Oddi Spasm
In clinical trials, sphincter of Oddi spasm
  • Among patients receiving 75 mg, 1/807 (0.1%) patient experienced a sphincter of Oddi spasm presenting with abdominal pain but with lipase elevation less than 3 times the upper limit of normal (ULN) and 1/ 807 (0.1%) patient experienced a sphincter of Oddi spasm manifested as elevated hepatic enzymes associated with abdominal pain
  • Among patients receiving 100 mg, 1/1032 (0.1%) patient experienced a sphincter of Oddi spasm manifested as pancreatitis and 7/1032 (0.7%) patients experienced sphincter of Oddi spasm manifested as elevated hepatic enzymes associated with abdominal pain
Of those patients who experienced a sphincter of Oddi spasm, 80% (8/10) reported their first onset of symptoms within the first week of treatment. The case of sphincter of Oddi spasm-induced pancreatitis occurred within minutes of taking the first dose of VIBERZI. No cases of sphincter of Oddi spasm occurred greater than 1 month after treatment onset. All events resolved upon discontinuation of VIBERZI, with symptoms typically improved by the following day.
Common Adverse Reactions
Table 1 provides the incidence of common adverse reactions reported in > 2% of IBS-D patients in either VIBERZI treatment group and at an incidence greater than in the placebo group.
*
**
***
Constipation was the most commonly reported adverse reaction in VIBERZI-treated patients in these trials. Approximately 50% of constipation events occurred within the first 2 weeks of treatment while the majority occurred within the first 3 months of therapy. Rates of severe constipation were less than 1% in patients receiving 75 mg and 100 mg VIBERZI. Similar rates of constipation occurred between the active and placebo arms beyond 3 months of treatment.
Adverse Reactions Leading to Discontinuation
Eight percent of patients treated with 75 mg, 8% of patients treated with 100 mg VIBERZI and 4% of patients treated with placebo discontinued prematurely due to adverse reactions. In the VIBERZI treatment groups, the most common reasons for discontinuation due to adverse reactions were constipation (1% for 75 mg and 2% for 100 mg) and abdominal pain (1% for both 75 mg and 100 mg). In comparison, less than 1% of patients in the placebo group withdrew due to constipation or abdominal pain.
Less Common Adverse Reactions
Adverse reactions that were reported in ≤ 2% of VIBERZI-treated patients are listed below by body system.
Gastrointestinal:gastroesophageal reflux disease
General Disorders and administration site conditions: feeling drunk
Investigations: increased AST
Nervous system: sedation,somnolence
Psychiatric disorders:euphoric mood
Respiratory:asthma, bronchospasm, respiratory failure, wheezing
5.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of VIBERZI. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Hypersensitivity: anaphylaxis, angioedema (e.g. swollen face and throat), dyspnea, throat tightness, and chest pain/tightness [see Warnings and Precautions (5.3)].
6DRUG 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.
7OVERDOSAGE
No reports of overdosage with VIBERZI have been reported.
In the event of acute overdose, the stomach should be emptied and adequate hydration maintained. The patient should be carefully observed and given standard supportive treatment as required. Given eluxadoline’s action at opioid receptors, administration of a narcotic mu-opioid antagonist, such as naloxone, should be considered. Considering the short half-life of naloxone, repeated administration may be necessary. In the event of naloxone administration, subjects should be monitored closely for the return of overdose symptoms, which may indicate need for repeated naloxone injection.
8DESCRIPTION
The active ingredient in VIBERZI is eluxadoline, a mu-opioid receptor agonist.
The full chemical name is 5-[[[(2S)-2-amino-3-[4-(aminocarbonyl)-2,6-dimethylphenyl]-1-oxopropyl][(1S)-1-(4-phenyl-1H-imidazol-2-yl)ethyl]amino]methyl]-2-methoxybenzoic acid.
Eluxadoline has a molecular weight of 569.65 and a molecular formula of C
The chemical structure of eluxadoline is Eluxadoline has a molecular weight of 569.65 and a molecular formula of C32H35N5O5.
VIBERZI is available as 75 mg and 100 mg tablets for oral administration. In addition to the active ingredient, eluxadoline, each tablet contains the following inactive ingredients: silicified microcrystalline cellulose, colloidal silica, crospovidone, mannitol, magnesium stearate, and Opadry II (partially hydrolyzed polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow, and iron oxide red).
9CLINICAL STUDIES
The efficacy and safety of VIBERZI in IBS-D patients was established in two randomized, multi-center, multi-national, double-blind, placebo-controlled trials (Studies 1 and 2). A total of 1281 patients in Study 1 and 1145 patients in Study 2 received treatment with VIBERZI 75 mg, VIBERZI 100 mg or placebo twice daily [overall, patients had a mean age of 45 years (range 18 to 80 years with 10% at least 65 years of age or older), 66% female, 86% white, 11% black, and 27% Hispanic].
All patients met Rome III criteria for IBS-D (loose [mushy] or watery stools ≥25% and hard or lumpy stools <25% of bowel movements) and were required to meet both of the following criteria:
  • an average of worst abdominal pain scores in the past 24 hours of >3.0 on a 0 to 10 scale over the week prior to randomization.
  • an average daily stool consistency score (Bristol Stool Scale or BSS) of ≥5.5 and at least 5 days with a BSS score ≥5 on a 1 to 7 scale over the week prior to randomization.
Pertinent exclusion criteria included: prior pancreatitis, alcohol abuse, cholecystitis prior 6 months, sphincter of Oddi dysfunction, inflammatory bowel disease, intestinal obstruction, gastrointestinal infection or diverticulitis within prior 3 months, lipase greater than 2 xULN, ALT or AST greater than 3 xULN.
Study 1 and Study 2 included identical 26-week double-blind, placebo-controlled treatment periods. Study 1 continued double-blinded for an additional 26 weeks for long-term safety (total of 52 weeks of treatment), followed by a 2-week follow-up. Study 2 included a 4-week single-blinded, placebo-withdrawal period upon completion of the 26-week treatment period. During the double-blind treatment phase and the single-blinded placebo withdrawal phase, patients were allowed to take loperamide rescue medication for the acute treatment of uncontrolled diarrhea, but were not allowed to take any other antidiarrheal, antispasmodic agent or rifaximin for their diarrhea. Additionally, patients were allowed to take aspirin-containing medications or nonsteroidal anti-inflammatory drugs, but no narcotic or opioid containing agents.
Efficacy of VIBERZI was assessed in both trials using an overall composite responder primary endpoint. The primary endpoint was defined by the simultaneous improvement in the daily worst abdominal pain score by ≥30% as compared to the baseline weekly average AND a reduction in the BSS to <5 on at least 50% of the days within a 12-week time interval. Improvement in daily worst abdominal pain in the absence of a concurrent bowel movement was also considered a response day. Results for endpoints were based on electronic daily diary entries by patients.
The proportion of composite responders over 12 weeks is shown in
1Composite= Simultaneous improvement of Worst Abdominal Pain (WAP) by ≥30% and Bristol Stool Score (BSS) < 5 on the same day for ≥ 50% of days over the interval
2P<0.01
3P<0.001
4P<0.05
Additionally, the proportion of patients who were composite responders to VIBERZI at each 4-week interval was numerically higher than placebo for both doses as early as month 1 through month 6 demonstrating that efficacy is maintained throughout the course of treatment.
During the 4 week single-blind withdrawal period in Study 2, no evidence of worsening of diarrhea or abdominal pain compared to baseline was demonstrated at either dose.
10HOW SUPPLIED/STORAGE AND HANDLING
VIBERZI is available as: 
  • 75 mg tablets: capsule-shaped tablets, coated in pale-yellow to light tan color, debossed with “FX75” on one side.
  • 100 mg tablets: capsule-shaped tablets, coated in pink-orange to peach color, debossed with “FX100” on one side. 
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) [see USP Controlled Room Temperature]
11PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
Instruct patients to:
  • stop VIBERZI immediately and seek medical attention if unusual or severe abdominal pain that may radiate to the back or shoulder with or without nausea and vomiting, develops 
  • avoid chronic or acute excessive alcohol use while taking VIBERZI 
  • stop VIBERZI immediately and seek medical attention if symptoms of a hypersensitivity reaction develop
  • stop VIBERZI and immediately call their health care provider if they experience severe constipation
  • take one tablet twice daily with food
  • if they miss a dose, take the next dose at the regular time. Do not take 2 doses at the same time to make up for a missed dose.
  • call their healthcare provider if they are unable to tolerate VIBERZI 
  • not take alosetron with VIBERZI or not take loperamide on a
Distributed by:
VIBERZI and its design are trademarks of Allergan Holdings Unlimited Company, an AbbVie company.
© 2024 AbbVie. All rights reserved.
12PRINCIPAL DISPLAY PANEL
NDC 61874-075-60
PRINCIPAL DISPLAY PANEL
NDC 61874-075-60
Viberzi®
(eluxadoline) tablets
75 MG PER TABLET
Dispense the accompanying
Medication Guide to each patient
60 TABLETS
Rx Only
13PRINCIPAL DISPLAY PANEL
NDC 61874-100-60
PRINCIPAL DISPLAY PANEL
NDC 61874-100-60
Viberzi®
(eluxadoline) tablets
100 MG PER TABLET
Dispense the accompanying
Medication Guide to each patient
60 TABLETS
Rx Only