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Eluxadoline Side Effects

In Summary

More frequently reported side effects include: abdominal pain, constipation, lower abdominal pain, nausea, upper abdominal pain, and vomiting. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to eluxadoline: oral tablet

Along with its needed effects, eluxadoline may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking eluxadoline:

Rare Incidence not known
  • Cough
  • difficulty swallowing
  • dizziness
  • hives, itching, skin rash
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • tightness in the chest
  • unusual tiredness or weakness

Some side effects of eluxadoline may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Body aches or pain
  • cough producing mucus
  • difficulty with breathing
  • ear congestion
  • excess air or gas in the stomach or bowels
  • fever
  • full feeling
  • headache
  • loss of voice
  • muscle aches
  • passing gas
  • pressure in the stomach
  • sneezing
  • sore throat
  • stuffy or runny nose
  • swelling of abdominal or stomach area

For Healthcare Professionals

Applies to eluxadoline: oral tablet

General

The most commonly reported adverse reactions included constipation, nausea, and abdominal pain.[Ref]

Gastrointestinal

Common (1% to 10%): Constipation, nausea, abdominal pain, vomiting, abdominal distention, flatulence, viral gastroenteritis
Uncommon (0.1% to 1%): Sphincter of Oddi spasm, pancreatitis
Frequency not reported: Gastroesophageal reflux disease
Postmarketing reports: Hospitalizations and deaths due to pancreatitis, particularly in patients without a gallbladder[Ref]

As of February 2017, the US FDA has received 120 reports of serious pancreatitis or death associated with this drug; 76 of these patients were hospitalized and 2 died. Both patients who died did not have a gallbladder; 56 of the 68 patients who reported gallbladder status did not have a gallbladder and had been receiving the recommended dose. Also reported among these cases were 6 with sphincter of Oddi spasm and 16 with abdomen pain.

Sphincter of Oddi spasm occurred in 0.2% (n=807) and 0.8% (n=1032) of patients receiving 75 mg and 100 mg twice a day, respectively. Sphincter of Oddi spasm manifested as abdominal pain with lipase elevation of less than 3 times the upper limit of normal in 1 patient, and elevated hepatic enzymes associated with abdominal pain in the second patient. For the 8 patients taking 100 mg twice a day, sphincter of Oddi spasm manifested in 1 patient as pancreatitis and as elevated hepatic enzymes associated with abdominal pain in the other 7 patients. Of 1317 patients with a gallbladder, no patients experienced a sphincter of Oddi spasm, while 2 of 165 patients and 8 of 184 patients in the 75 mg and 100 mg twice a day groups, respectively, experienced sphincter of Oddi spasm. Onset of symptoms occurred within the first week in 80% (8 of 10) of patients and no cases occurred greater than 1 month after treatment onset. The 1 case of sphincter of Oddi spasm-induced pancreatitis occurred within minutes of taking the first dose of the drug and resolved within 24 hours of discontinuation.

Pancreatitis not associated with sphincter of Oddi spasm was reported in 0.2% (n=807) and 0.3% (n=1032) of patients receiving 75 mg and 100 mg twice a day, respectively. Of these 5 cases, 3 were associated with excessive alcohol intake, 1 with biliary sludge, and 1 was reported 2 weeks after the patient discontinued therapy. All resolved within 1 week of therapy discontinuation.

Constipation was the most commonly reported adverse event in clinical trials with 50% of case reported within the first 2 weeks, and the majority within the first 3 months. Rates of severe constipation were less than 1%. After 3 months, the incidence of constipation was similar across active treatment and placebo groups.

Gastroesophageal reflux disease was reported in 2% or less of patients in clinical trials.[Ref]

Hepatic

Increased AST was reported in 2% or less of patients in clinical trials.[Ref]

Frequency not reported: Increased AST, increased ALT[Ref]

Respiratory

Common (1% to 10%): Upper respiratory tract infection, nasopharyngitis, bronchitis
Frequency not reported: Asthma, bronchospasm, respiratory failure, wheezing[Ref]

Asthma, bronchospasm, respiratory failure, and wheezing were reported in 2% or less of patients in clinical trials.[Ref]

Dermatologic

Common (1% to 10%): Rash[Ref]

Rash included terms such as dermatitis, dermatitis allergic, rash, rash erythematous, rash generalized, rash maculopapular, rash popular, rash pruritic, urticaria, and idiopathic urticaria.[Ref]

Nervous system

Common (1% to 10%): Dizziness
Frequency not reported: Sedation, somnolence[Ref]

Sedation and somnolence was reported in 2% or less of patients in clinical trials.[Ref]

Psychiatric

Euphoric mood was reported in 2% or less of patients in clinical trials.[Ref]

Frequency not reported: Euphoric mood[Ref]

Other

Feeling drunk was reported in 2% or less of patients in clinical trials.[Ref]

Common (1% to 10%): Fatigue
Frequency not reported: Feeling drunk[Ref]

References

1. "Product Information. Viberzi (eluxadoline)." Actavis Pharma, Inc., Parsippany, NJ.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. US Food and Drug Administration "Viberzi (eluxadoline): drug safety communication - increased risk of serious pancreatitis in patients without a gallbladder. Available from: URL: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm546771.htm." ([2017, Mar 15]):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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