From the Guidelines
Viberzi (eluxadoline) can cause several side effects, with the most common being constipation, nausea, and abdominal pain, as reported in a 2022 study published in Gastroenterology 1.
Common Side Effects
- Constipation (8%)
- Nausea (7%)
- Abdominal pain (7%) These side effects are associated with the mechanism of action of eluxadoline, which is a mixed m- and k-opioid receptor agonist and d-opioid receptor antagonist that reduces bowel contractions and diarrhea.
Serious Side Effects
More serious side effects include pancreatitis and sphincter of Oddi spasm, which can cause severe upper abdominal pain that may radiate to the back or shoulder, with or without nausea and vomiting, as noted in the 2022 study 1.
Special Considerations
Viberzi is contraindicated in patients without a gallbladder or those who drink more than 3 alcoholic beverages per day, as stated in the 2022 guideline 1.
Recommendations
Patients taking Viberzi should be aware of the potential side effects and seek immediate medical attention if they experience severe abdominal pain, especially after taking their first dose, or develop signs of liver problems such as yellowing of the skin or eyes, dark urine, or upper right abdominal pain, as advised in the 2022 study 1.
From the FDA Drug Label
VIBERZI can cause serious side effects, including: Inflammation of the pancreas (pancreatitis). Sphincter of Oddi spasm Serious allergic reactions. Constipation. The most common side effects of VIBERZI include: constipation, nausea, and abdominal pain.
Viberzi side effects include:
- Serious side effects:
- Inflammation of the pancreas (pancreatitis)
- Sphincter of Oddi spasm
- Serious allergic reactions
- Constipation
- Common side effects:
- Constipation
- Nausea
- Abdominal pain 2
From the Research
Viberzi Side Effects
- The most common adverse events reported with eluxadoline (Viberzi) use were constipation, nausea, and abdominal pain 3, 4, 5.
- Serious adverse events associated with eluxadoline include sphincter of Oddi spasm (SOS) and pancreatitis, particularly in patients without a gallbladder 3, 4, 5.
- The risk of abuse, dependence, or withdrawal is low 3.
- Clinically apparent SOS events were observed in eluxadoline-treated patients, all of which occurred in patients without a gallbladder 5.
- Pancreatitis had a 0.4% incidence in eluxadoline-treated patients, with most cases occurring in patients without a gallbladder 4.
- Eluxadoline is contraindicated in patients with a history of biliary duct obstruction, sphincter of Oddi dysfunction, active alcohol abuse, history of pancreatitis or known pancreatic duct obstruction, severe hepatic impairment, severe or chronic constipation, or known mechanical gastrointestinal obstruction 3, 4.
Patient Selection and Safety
- Patients who achieve composite response during the first month of therapy were significantly more likely to demonstrate sustained clinical response 3.
- The adverse event profile of eluxadoline helps guide proper selection of IBS-D patients for eluxadoline use, with important contraindications including absence of a gallbladder, biliary duct obstruction or sphincter of Oddi dysfunction, alcoholism, history of pancreatitis, or structural diseases of the pancreas 3, 4.
- Eluxadoline appears safe and effective for treating IBS-D symptoms in patients with an intact gallbladder reporting inadequate relief with prior loperamide use 6.