Eluxadoline Side Effects

Medically reviewed by Drugs.com. Last updated on Nov 25, 2024.

Applies to eluxadoline: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

If your symptoms and condition do not improve within a few days, or if they become worse, check with your doctor.

This medicine may increase your risk for sphincter of Oddi spasm. This is more likely to occur if you do not have a gallbladder. Call your doctor right away if you have new or worsening stomach pain or pain in the upper right abdominal or stomach that may move to your back or shoulders, with or without nausea or vomiting.

This medicine may increase your risk for pancreatitis (swelling of the pancreas). Check with your doctor right away if you have the following symptoms: bloating, chills, darkened urine, sudden and severe stomach pain, nausea, vomiting, fever, lightheadedness, or yellow eyes or skin.

This medicine may cause severe constipation, which may require hospitalization. Check with your doctor right away if you have difficulty having a bowel movement.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema. These can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

If you have liver problems, do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Avoid drinking excessive alcohol while using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Common side effects of eluxadoline

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:

Serious side effects of eluxadoline

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:

For healthcare professionals

Applies to eluxadoline: oral tablet.

General adverse events

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

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

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

• Frequency not reported: Euphoric mood^[Ref]

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

Other

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

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

See also:

Frequently asked questions

• How does Viberzi work?

Further information

Eluxadoline side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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