Eluxadoline: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: June 23, 2025🚩 Report this page

Eluxadoline

Antipropulsives

Sold as VIBERZI

CA Health Canada

Drug class: Antipropulsives
Availability: See label
Routes: Oral
Markets covered: 1
Products on record: 2

Overview

Eluxadoline is an active pharmaceutical ingredient in the Antipropulsives group (A07DA). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
CA Canada	Health Canada	2	June 23, 2025

CACanada· Health Canada

2 products

Uses

CAOfficial regulatory label· revised June 23, 2025[1]

VIBERZI (eluxadoline tablets) is indicated for: • treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. In clinical trials VIBERZI improved abnormal stool consistency more prominently than abdominal pain. 1 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
2 Geriatrics VIBERZI was not studied in patients 65 years and older in a specifically dedicated study. 2 Recommended Dose and Dosage Adjustment).

How to take

Drug interactions

Known interactions involving Eluxadoline. Select one for details. This list is informational and not a complete interaction checker.

Artesunate Atazanavir Bexarotene Cobicistat Cyclosporine Daclatasvir Darolutamide Eltrombopag Ethanol Gemfibrozil Grazoprevir Lapatinib Rifampin Ritonavir Saquinavir Simeprevir Tipranavir Abiraterone Aclidinium Acrivastine Alfentanil Alosetron Amitriptyline Amoxapine Amprenavir Aripiprazole Astemizole Atorvastatin Atropine Azatadine Benzhydrocodone Biperiden Boceprevir Bosentan Brompheniramine Buprenorphine Bupropion Butorphanol Carbinoxamine Cerivastatin Chlorcyclizine Chlorpheniramine Chlorpromazine Cinacalcet Ciprofloxacin Cisapride Clarithromycin Clemastine Clidinium Clomipramine Clopidogrel Clozapine Codeine Colchicine Conivaptan Cyclizine Cyclobenzaprine Cyproheptadine Darifenacin Delavirdine Desipramine Dexbrompheniramine Dezocine Dicyclomine Dihydrocodeine Dihydroergotamine Dimenhydrinate Diphenhydramine Disopyramide Doxepin Doxylamine Empagliflozin Enoxacin Ergotamine Erythromycin Everolimus Ezetimibe Fentanyl Fesoterodine Fexofenadine Flavoxate Fluconazole Fluoxetine Fluphenazine Fluvoxamine Fosamprenavir Glyburide Glycopyrronium Haloperidol Hydrocodone Hydromorphone Hydroxyzine Hyoscyamine Idelalisib Imipramine Indinavir Ipratropium Irinotecan Itraconazole Ivacaftor Ketoconazole Levorphanol Lonafarnib Loperamide Lovastatin Loxapine Maprotiline Meclizine Mepenzolate Meperidine Mesoridazine Methadone Methdilazine Methotrexate Methotrimeprazine Methscopolamine Methysergide Midazolam Mifepristone Molindone Morphine Nalbuphine Nefazodone Nelfinavir Nifedipine Nortriptyline Olanzapine Olaparib Oliceridine Olmesartan Opium Orphenadrine Oxybutynin Oxycodone Oxymorphone Paroxetine Pentazocine Perphenazine Phenindamine Phenyltoloxamine Pimozide Pitavastatin Posaconazole Pravastatin Procainamide Prochlorperazine Procyclidine Promazine Promethazine Propantheline Propiomazine Propoxyphene Protriptyline Pyrilamine Quetiapine Quinidine Remifentanil Repaglinide Revefenacin Risperidone Rosuvastatin Scopolamine Sildenafil Simvastatin Sirolimus Solifenacin Stiripentol Sufentanil Tacrolimus Talazoparib Tapentadol Telaprevir Telithromycin Temsirolimus Terfenadine Thiethylperazine Thioridazine Thiothixene Ticlopidine Tiotropium Tolterodine Tramadol Triazolam Trifluoperazine Triflupromazine Trihexyphenidyl Trimeprazine Trimipramine Tripelennamine Triprolidine Troleandomycin Trospium Ubrogepant Umeclidinium Valsartan Voriconazole Voxilaprevir Probenecid

Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.

Sources & citations

[1]Health Canada (DPD) · 02460890 · revised June 23, 2025

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

CAOfficial regulatory label· Adverse reactions· revised June 23, 2025[1]

). Instruct patients to immediately stop VIBERZI and seek medical attention if they experience symptoms suggestive of a hypersensitivity reaction (see 2 CONTRAINDICATIONS). 1 Pregnant Women Eluxadoline was not studied in pregnant women, therefore, VIBERZI should not be used during pregnancy.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see 16 NON-CLINICAL TOXICOLOGY). 2 Breast-feeding Eluxadoline was not studied in nursing women; therefore, VIBERZI should not be used in nursing women.
It is unknown if VIBERZI is excreted in human milk. Precaution should be exercised because many drugs can be excreted in human milk. In animal studies, eluxadoline was excreted in the milk of lactating rats after oral administration (See Reproductive and Developmental Toxicology).
3 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 8%) were at least 75 years old. There were no overall differences in the types of adverse reactions observed between elderly and younger patients; however, a higher proportion of elderly patients than younger patients experienced adverse reactions (66% vs 59%), serious adverse reactions (9% vs 4%), and gastrointestinal adverse reactions (39% vs 28%).
2 Recommended Dose and Dosage Adjustment). 1 Adverse Reaction Overview Exposure in placebo-controlled clinical trials in adult patients with IBS-D included 1032 patients exposed to 100 mg BID (505 for 6 months, and 243 for 1 year), and 807 patients exposed to 75 mg BID (496 for 6 months, and 245 for 1 year).
In the Phase 3 trials, the proportion of patients treated with 100 mg VIBERZI who reported mild, moderate, and severe adverse events were 24%, 25% and 10%, respectively. The most common adverse reactions (incidence of >5%) reported were constipation, nausea and abdominal pain.
6% of patients treated with placebo. There were no serious adverse events of constipation. Serious adverse reactions of pancreatitis and sphincter of Oddi spasm may occur uncommonly (less than 1% of patients). 3% 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.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. The data below describes adverse events that occurred in the 3 double-blind, placebo-controlled clinical trials involving over 1700 adult patients with IBS-D treated with 75 mg or 100 mg of VIBERZI twice daily for up to 52 weeks in one phase 3 study, up to 26 weeks in another phase 3 study, and up to 12 weeks in a phase 2 study (See Table 2).
1) 24. 5) Psychiatric Disorders […]

CAOfficial regulatory label· Warnings and precautions· revised June 23, 2025[1]

Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Dependence/Tolerance In a 52-week clinical study, no evidence of physical dependence or withdrawal from VIBERZI was detected based on adverse event reporting or administration of the subjective opiate withdrawal scale (SOWS).
2 Pharmacodynamics). 8%). 2 Pharmacodynamics). Driving and Operating Machinery Due to events of somnolence and sedation observed in clinical studies, caution should be exercised when driving or operating a vehicle or potentially dangerous machinery.
Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Tablet 75 mg and 100 mg Colloidal silica, crospovidone, magnesium stearate, mannitol, Opadry II (iron oxide red, iron oxide yellow, polyethylene glycol, partially hydrolyzed polyvinyl alcohol, talc and titanium dioxide) and silicified microcrystalline cellulose VIBERZI® (eluxadoline) Page 7 of 28 Gastrointestinal Constipation Constipation, sometimes requiring hospitalization, has been reported following VIBERZI administration, sometimes after one or two doses.
In postmarketing experience, severe cases with development of intestinal obstruction, ileus, fecal impaction and ischemic colitis, including rectal hemorrhage, requiring intervention, have also been reported. Instruct patients to stop VIBERZI and immediately contact their healthcare provider if they experience symptoms suggestive of severe constipation, which may present with an abrupt onset of abdominal pain, nausea, vomiting, and abdominal distention.
4 Drug-drug Interactions). Hepatic/Biliary/Pancreatic Pancreatitis Pancreatitis, with or without sphincter of Oddi spasm, including serious cases resulting in hospitalization, have been reported in patients taking either the 75 mg or 100 mg dosage of VIBERZI, primarily in patients without a gallbladder.
Fatal cases have also been reported in patients without a gallbladder. VIBERZI is contraindicated in patients without a gallbladder (see 2 CONTRAINDICATIONS). Most of the reported cases of serious pancreatitis occurred within a week of starting treatment with VIBERZI and some developed symptoms after one or two doses.
In patients with a gallbladder, evaluate a patient’s alcohol intake prior to starting VIBERZI. Instruct patients to avoid chronic or acute excessive alcohol use while taking VIBERZI. Monitor for signs and symptoms of pancreatitis. Instruct patients to stop VIBERZI immediately and seek medical attention if they experience symptoms suggestive of pancreatitis such as new or worsening acute abdominal or epigastric pain radiating to the back or shoulder, with or without nausea and vomiting (see 2 CONTRAINDICATIONS).

This is not medical advice. Consult a qualified healthcare professional.

Overview

Regulatory status by market

CACanada· Health Canada

Drug interactions

Drugs in the same class

Sources & citations