Eluxadoline Side Effects
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
- darkened urine
- fast heartbeat
- loss of appetite
- pains in the stomach, side, or abdomen, possibly radiating to the back
- 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
- cough producing mucus
- difficulty with breathing
- ear congestion
- excess air or gas in the stomach or intestines
- full feeling
- loss of voice
- muscle aches
- passing gas
- pressure in the stomach
- 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
The most commonly reported adverse reactions included constipation, nausea, and abdominal pain.[Ref]
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]
Increased AST was reported in 2% or less of patients in clinical trials.[Ref]
Frequency not reported: Increased AST[Ref]
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]
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]
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]
Euphoric mood was reported in 2% or less of patients in clinical trials.[Ref]
Frequency not reported: Euphoric mood[Ref]
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]
1. "Product Information. Viberzi (eluxadoline)." Actavis Pharma, Inc., Parsippany, NJ.
2. 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]):
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.
More about eluxadoline
- Side Effects
- During Pregnancy
- Dosage Information
- Drug Interactions
- Support Group
- En Español
- 120 Reviews – Add your own review/rating
- Drug class: peripheral opioid receptor mixed agonists/antagonists
Other brands: Viberzi
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