Adults  |  Medicines  |  Medication safety

Risks and Side Effects of Eluxadoline for IBS

The Bottom Line

Eluxadoline is a medication used for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. The most common side effects of eluxadoline are mild constipation, nausea, and abdominal pain. There are important safety considerations for eluxadoline, including rare but serious side effects and a potential for drug-drug interactions.

The Full Story

What is eluxadoline and how does it work?

Eluxadoline (Viberzi) is a medication used for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. It acts by binding to specific opioid receptors. Opioid receptors are found in the brain, spinal cord, and gastrointestinal tract. Opioid receptors in the gut help regulate gastrointestinal motility, secretions, and sensations. This is the reason why one of the most common side effects of opioid pain medications like codeine and morphine is constipation.

Unlike the traditional opioids, eluxadoline is specific to opioid receptors in the gut rather than the central or peripheral nervous system. Because of this, symptoms like fatigue, euphoria, or drowsiness are uncommon.

Eluxadoline is a schedule IV drug, which means that it has a low potential for abuse and low risk of dependence.

What are important safety concerns for eluxadoline? 

The most common side effects of eluxadoline are mild constipation, nausea, and abdominal pain. It's important to note the following rare but potentially serious side effects:

  • Severe constipation requiring hospitalization has been reported. Stop taking eluxadoline and inform your doctor if you experience severe constipation.
  • Risk for pancreatitis and spasm of the sphincter of Oddi: In March 2017, The US Food and Drug Administration issued a warning, stating that eluxadoline should not be used in patients who do not have gallbladders due to the risk for potentially life-threatening pancreatitis. To date, two deaths have occurred in patients who developed pancreatitis shortly after starting eluxadoline; both patients did not have gallbladders. There is also an increased risk of spasm of the sphincter of Oddi, the valve that regulates the movement of bile and digestive juices from the pancreas into the small intestine. This can result in pancreatitis. Stop taking eluxadoline and inform your doctor right away if you develop new or worsening abdominal pain or right upper abdominal pain (that can sometimes radiate to back or shoulder) with or without nausea and vomiting.
  • Use with alcohol: Eluxadoline should not be taken by those with alcohol abuse, alcoholism, or alcohol addiction or by patients who drink more than 3 alcoholic beverages per day. This is due to an increased risk for pancreatitis.
  • Drug-drug interactions: There is potential for drug-drug interactions between eluxadoline and certain classes of medications that share the same metabolic pathways. It's important to notify your doctor and pharmacist of any medications or supplements you're taking before you start eluxadoline. Similarly, if you're already taking eluxadoline ask your doctor and pharmacist to check for potential drug-drug interactions before you start any new medication or supplement.
  • Use in children: Eluxadoline has not been studied in children. Therefore, its safety profile in children is not known. Children might be more susceptible to more serious central nervous system effects.
If you are concerned about an exposure to eluxadoline, check the webPOISONCONTROL® online tool for guidance or call Poison Control at 1-800-222-1222.

Serkalem Mekonnen, RN, BSN, MPH
Certified Specialist in Poison Information


For More Information

FDA Drug Safety Communication: FDA warns about increased risk of serious pancreatitis with irritable bowel drug Viberzi (eluxadoline) in patients without a gallbladder. Silver Spring (MD): US Food and Drug Administration; 2017 Mar 20 [cited 2020 Aug 30].

Irritable bowel syndrome (MedLinePlus). Bethesda: National Library of Medicine; 2018 Apr 5 [cited 2020 Aug 30].

Irritable bowel syndrome: a global perspective. Milwaukee: World Gastroenterology Organisation; 2015 Sep [cited 2020 Aug 30].


References

Lembo AJ, Lacy BE, Zuckerman MJ, Schey R, Dove LS, et al. Eluxadoline for irritable bowel syndrome with diarrhea. N Engl J Med. 2016 Jan 21;374(3):242-53.

Maltz F, Fidler B. Eluxadoline (Viberzi): a mu-opioid receptor agonist for the treatment of irritable bowel syndrome with diarrhea. P&T. 2017 Jul;42:438-42.

VIBERZI (eluxadoline) prescribing information. Madison (NJ): Allergan USA; 2015 May [cited 2020 Aug 30].

Poisoned?

Call 1-800-222-1222 or

HELP ME online

Prevention Tips

  • Keep eluxadoline out of sight and reach of children and pets.
  • Take eluxadoline as prescribed.
  • Stop taking eluxadoline and inform your doctor immediately if you develop severe constipation, new or worsening abdominal symptoms, or symptoms of an allergic reaction.
  • Always inform your doctor of your medical and surgical history and all medications and supplements you currently take or plan to take.
  • Do not drink alcohol chronically or in excess while taking eluxadoline.

This Really Happened

A 42-year-old woman started taking eluxadoline 100 mg daily. A week after starting it, she called Poison Control for advice about possible side effects. She reported feeling tired and heavy. Because of this, she could not tolerate taking it during the day and so was taking it at night. Poison Control offered some information about the medication's mechanism of action and the incidence of the symptoms she was reporting and advised her to inform her doctor. During follow-up, she reported that her doctor decided to discontinue the medication. Her symptoms resolved after discontinuation.