What the label lists and what reports show
Eluxadoline side effects
Eluxadoline's FDA label: “Most common adverse reactions (>5%) are constipation, nausea and abdominal pain.” FAERS holds 2,928 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is abdominal pain (352 reports).
- No generic listed
- DEA Schedule IV
Check it at the source: the eluxadoline FDA label on DailyMed (effective July 16, 2024, Allergan, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of VIBERZI?See “What is the most important information I should know about VIBERZI?” The most common side effects of VIBERZI include: constipation, nausea, and abdominal pain. Stop taking VIBERZI right away and immediately call your doctor if you have constipation that is severe. These are not all the possible side effects of VIBERZI. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. […] Stop taking VIBERZI right away and get emergency medical care if you have signs or symptoms of an allergic reaction, including: ○ swelling of your face, lips, mouth or tongue ○ itching ○ shortness of breath or other breathing problems ○ rash ○ hives Constipation. Constipation, including severe constipation that can lead to hospitalization has happened after taking VIBERZI. Stop taking VIBERZI and call your doctor right away if you develop severe constipation while taking VIBERZI.
Source: FDA drug label, NDA206940 (Abbvie), as published by Allergan, Inc., effective July 16, 2024 (SPL set 7821bd40-4c84-4984-951b-6436ae20421a), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (>5%) are constipation, nausea and abdominal pain.
Table 1: Common* Adverse Reactions in the Placebo-Controlled Studies in IBS-D Patients
| Adverse Reactions | VIBERZI 100 mg twice daily (N= 1032) % | VIBERZI 75 mg twice daily (N=807) % | Placebo (N=975) % |
|---|---|---|---|
| Constipation | 8 | 7 | 2 |
| Nausea | 7 | 8 | 5 |
| Abdominal Pain | 7 | 6 | 4 |
| Upper Respiratory Tract Infection | 5 | 3 | 4 |
| Vomiting | 4 | 4 | 1 |
| Nasopharyngitis | 3 | 4 | 3 |
| Abdominal Distention | 3 | 3 | 2 |
| Bronchitis | 3 | 3 | 2 |
| Dizziness | 3 | 3 | 2 |
| Flatulence | 3 | 3 | 2 |
| Rash | 3 | 3 | 2 |
| Increased ALT | 3 | 2 | 1 |
| Fatigue | 2 | 3 | 2 |
| Viral gastroenteritis | 1 | 3 | 2 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions described below and elsewhere in the labeling include: Pancreatitis [see Warnings and Precautions ( 5.1 )] Sphincter of Oddi Spasm [ see Warnings and Precautions ( 5.2 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.3 )] Constipation [see Warnings and Precautions ( 5.4 )] Most common adverse reactions (>5%) are constipation, nausea and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1- 800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial s Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Over 1700 patients with IBS-D have been treated with 75 or 100 mg of VIBERZI twice daily in controlled trials. Exposures from placebo-controlled clinical trials in adult patients with IBS-D included 1391 exposed for 3 months, 1001 exposed for 6 months and 488 exposed for one year. Demographic characteristics were comparable between the treatment groups [see Clinical Studies ( 14 )]. Data described below represent pooled data compared to placebo across the randomized trials. …
Source: FDA drug label, NDA206940 (Abbvie), as published by Allergan, Inc., effective July 16, 2024 (SPL set 7821bd40-4c84-4984-951b-6436ae20421a), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,928 reports list eluxadoline among the medicines taken, each a report of something that happened, not proof the medicine caused it; 66 are coded as a death and 563 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Eluxadoline: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions