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eluxadoline

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Brand names: Viberzi

Mu-Opioid Receptor Agonist (IBS-D) Rx

Viberzi is a medicine used to treat irritable bowel syndrome with diarrhea (IBS-D) in adults. It helps to reduce diarrhea associated with IBS-D.

Drug Pricing (NADAC)

Brand Price

$25.60/unit

Generic Available

No

ABBVIE

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

What it does

Viberzi is used to treat irritable bowel syndrome with diarrhea, also known as IBS-D, in adults.

Common side effects

Constipation, Nausea, Abdominal pain

Key warnings

Viberzi can cause serious side effects, including pancreatitis and sphincter of Oddi spasm.

How It Works

Viberzi works by acting on opioid receptors in your gut. It slows down bowel movements. This helps to reduce diarrhea and abdominal pain.

How to Take It

Take Viberzi twice a day with food. The usual dose is 100 mg twice daily. Your doctor may prescribe a lower dose of 75 mg twice daily if you have certain health conditions or are taking other medicines. If you miss a dose, take your next dose at the regular time.

Pregnancy & Breastfeeding

It is not known if Viberzi can harm an unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. It is also not known if Viberzi passes into breast milk. Talk to your doctor about the best way to feed your baby if you take Viberzi.

Missed Dose

If you miss a dose of Viberzi, take your next dose at the regular time. Do not take two doses at the same time to make up for the missed dose.

Storage

Store Viberzi tablets at room temperature, between 68°F and 77°F.

Side Effects (from patient reports)

Based on 2,535 FDA adverse event reports.

Using the medicine for something it's not approved for
355
Stomach pain
348
Diarrhea
340
Constipation
281
Inflammation of the pancreas
276
Feeling sick to your stomach
216
The medicine is not working
215
Pain in the upper stomach
207
Taking the medicine at the wrong times
162
Throwing up
135

FDA Adverse Event Report Analysis

Detailed analysis of 2,870 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2012–2025.

Total Reports

2,870

Death-Related Reports

63

Hospitalization Reports

546

Top Indication

Irritable Bowel Syndrome

Gender Distribution

Female 1,984 (76%)
Male 638 (24%)

Age Distribution

0–17 127
18–44 258
45–64 428
65–74 283
75+ 198

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 OFF LABEL USE 355
2 ABDOMINAL PAIN 348
3 DIARRHOEA 340
4 CONSTIPATION 281
5 PANCREATITIS 276
6 NAUSEA 216
7 DRUG INEFFECTIVE 215
8 ABDOMINAL PAIN UPPER 207
9 INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 162
10 VOMITING 135
11 FATIGUE 118
12 DIZZINESS 108
13 WRONG TECHNIQUE IN PRODUCT USAGE PROCESS 107
14 PAIN 103
15 INCORRECT DOSE ADMINISTERED 88

Reactions in Death Reports

DEATH 37
COMPLETED SUICIDE 9
VOMITING 5
CARDIAC ARREST 4
DIARRHOEA 4
LETHARGY 4
PANCREATITIS 4
SUSPECTED SUICIDE 4
ABDOMINAL PAIN 3
ABDOMINAL PAIN UPPER 3

Reactions in Hospitalization Reports

PANCREATITIS 148
PANCREATITIS ACUTE 64
ABDOMINAL PAIN 63
OFF LABEL USE 48
DIARRHOEA 46
VOMITING 41
SPHINCTER OF ODDI DYSFUNCTION 39
NAUSEA 30
PAIN 28
CONSTIPATION 27

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Viberzi can cause serious side effects, including pancreatitis and sphincter of Oddi spasm. These conditions can cause severe abdominal pain, nausea, and vomiting. If you have new or worsening abdominal pain, stop taking Viberzi and get medical help right away. Do not take Viberzi if you do not have a gallbladder.

Known Drug Interactions

Increased exposure to rosuvastatin when co-administered with VIBERZI with a potential for increased risk of myopathy/rhabdomyolysis [ see Clinical Pharmacology ( 12.3 ) ] Intervention: Use the lowest effective dose of rosuvastatin (see prescribing information of rosuvastatin for additional information on recommended dosing).

Mechanism: Eluxadoline can increase the amount of rosuvastatin in your blood, which may lead to a higher risk of muscle damage.

What to do: Use the lowest effective dose of rosuvastatin and watch for any muscle pain or weakness.

moderate rifampin

Examples: cyclosporine, gemfibrozil, antiretrovirals (atazanavir, lopinavir, ritonavir, saquinavir, tipranavir), rifampin, eltrombopag Drugs that Cause Constipation Clinical Impact: Increased risk for constipation related adverse reactions and potential for constipation related serious adverse reactions Intervention: Avoid use with other drugs that may cause constipation (see below); loperamide may be used occasionally for acute management of severe diarrhea but avoid chronic use.

Mechanism: Both of these medications can slow down your digestive tract, which increases the risk of severe constipation.

What to do: Avoid taking these two drugs together to prevent serious constipation problems.

moderate loperamide

Examples: cyclosporine, gemfibrozil, antiretrovirals (atazanavir, lopinavir, ritonavir, saquinavir, tipranavir), rifampin, eltrombopag Drugs that Cause Constipation Clinical Impact: Increased risk for constipation related adverse reactions and potential for constipation related serious adverse reactions Intervention: Avoid use with other drugs that may cause constipation (see below); loperamide may be used occasionally for acute management of severe diarrhea but avoid chronic use. Discontinue loperamide immediately if constipation occurs.

Mechanism: These medicines both work to slow down your bowels, and using them together can cause dangerous levels of constipation.

What to do: Do not use loperamide long-term with this drug, and stop it immediately if you become constipated.

moderate gemfibrozil

Examples: cyclosporine, gemfibrozil, antiretrovirals (atazanavir, lopinavir, ritonavir, saquinavir, tipranavir), rifampin, eltrombopag Drugs that Cause Constipation Clinical Impact: Increased risk for constipation related adverse reactions and potential for constipation related serious adverse reactions Intervention: Avoid use with other drugs that may cause constipation (see below); loperamide may be used occasionally for acute management of severe diarrhea but avoid chronic use.

Mechanism: Both drugs can cause constipation as a side effect, making it much more likely to happen if they are taken at the same time.

What to do: Avoid using these medications together to reduce the risk of serious bowel issues.

Table 2: Established and Other Potentially Clinically Relevant Interactions Affecting VIBERZI OATP1B1 Inhibitors Clinical Impact: Increased exposure to eluxadoline when coadministered with cyclosporine [ see Clinical Pharmacology ( 12.3 ) ] Intervention: Administer VIBERZI at a dose of 75 mg twice daily [see Dosage and Administration ( 2 )] 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 [see Adverse Reactions ( 6.1 )] . Examples:...

Mechanism: Cyclosporine blocks a specific protein that helps remove eluxadoline from your system, which causes eluxadoline levels to rise in your body.

What to do: Your doctor should lower your eluxadoline dose to 75 mg twice daily and monitor you for side effects like extreme tiredness or trouble driving.

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Common Questions

What is Viberzi used for?
Viberzi is used to treat irritable bowel syndrome with diarrhea (IBS-D) in adults.
How should I take Viberzi?
Take Viberzi twice a day with food.
What should I do if I miss a dose?
Take your next dose at the regular time. Do not double your dose.
What are the common side effects of Viberzi?
The most common side effects are constipation, nausea, and abdominal pain.
Can Viberzi cause serious side effects?
Yes, Viberzi can cause serious side effects, including pancreatitis and sphincter of Oddi spasm.
Can I drink alcohol while taking Viberzi?
Avoid excessive alcohol use while taking Viberzi, as it can increase the risk of pancreatitis.
Can I take Viberzi if I don't have a gallbladder?
No, you should not take Viberzi if you do not have a gallbladder.
What should I do if I develop severe constipation?
Stop taking Viberzi and contact your doctor right away if you develop severe constipation.
Is Viberzi safe to take during pregnancy?
It is not known if Viberzi is safe to take during pregnancy. Talk to your doctor if you are pregnant or plan to become pregnant.
How should I store Viberzi?
Store Viberzi tablets at room temperature.
What are the common side effects of eluxadoline?
The most commonly reported side effects of eluxadoline include Constipation, Nausea, Abdominal pain. Based on 2,535 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does eluxadoline interact with other medications?
Yes, eluxadoline has 6 known drug interactions. Notable interactions include rosuvastatin, rifampin, loperamide. Always inform your doctor about all medications you are taking.
What drug class is eluxadoline?
eluxadoline belongs to the Mu-Opioid Receptor Agonist (IBS-D) drug class. It requires a prescription (Rx). Viberzi is used to treat irritable bowel syndrome with diarrhea, also known as IBS-D, in adults.
Is eluxadoline safe during pregnancy?
It is not known if Viberzi can harm an unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

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What the FDA Data Shows for eluxadoline

The FDA label for eluxadoline (sold under brand names such as Viberzi) classifies it as a prescription-only medication in the Mu-Opioid Receptor Agonist (IBS-D) class. Viberzi is used to treat irritable bowel syndrome with diarrhea, also known as IBS-D, in adults. Official labeling lists 3 commonly reported side effects, including Constipation, Nausea, Abdominal pain.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 2,535 voluntary reports. The database also lists 6 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS.

Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: July 16, 2024

All federal data sources used on this page