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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

In addition to its needed effects, some unwanted effects may be caused by eluxadoline. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking eluxadoline:

Rare
  • Bloating
  • chills
  • constipation
  • darkened urine
  • fast heartbeat
  • fever
  • indigestion
  • loss of appetite
  • nausea
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • vomiting
  • yellow eyes or skin

Minor Side Effects

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

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

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[Ref]

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[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.

Not all side effects for eluxadoline may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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