Eluxadoline side effects: what 2,928 FDA adverse event reports show
Drug class
mu-Opioid Receptor Agonist
Brand names
Viberzi
Who reports
2,928 reports · 38% serious · 66 with death outcome · 76% female
Used for
VIBERZI is indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D). VIBERZI is a mu-opioid receptor agonist, indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D). ( 1 )
What it is
The active ingredient in VIBERZI is eluxadoline, a mu-opioid receptor agonist. The full chemical name is 5-[[[(2S)-2-amino-3-[4-(aminocarbonyl)-2,6-dimethylphenyl]-1-oxopropyl][(1S)-1-(4-phenyl-1H-imidazol-2-yl)ethyl]amino]methyl]-2-methoxybenzoic acid.
Boxed warning
None in the current label
Causality screen of the 26 strongest signals
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 21 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Pancreatitis (pancreas inflammation) | 278 | 37.8 33.8–42.3ROR 41.7 · χ² 9,900 / p <1e-300 | 37.5 EB05 34.0 · IC025 +4.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 57.4 · 81% consumer | no trial data cached |
| Pancreatitis acute | 77 | 24.8 19.9–30.9ROR 25.4 · χ² 1,731 / p <1e-300 | 24.6 EB05 20.3 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 37.2 · 72% consumer | no trial data cached |
| Contraindicated product administered | 75 | 17.8 14.3–22.3ROR 18.3 · χ² 1,175 / p 9e-258 | 17.7 EB05 14.6 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 13.7 · 80% consumer | no trial data cached |
| Inappropriate schedule of drug administration | 162 | 16.1 13.9–18.7ROR 17.0 · χ² 2,284 / p <1e-300 | 16.0 EB05 14.1 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 7.8 · 91% consumer | no trial data cached |
| Euphoric mood | 21 | 14.6 9.5–22.4ROR 14.7 · χ² 253 / p 3e-57 | 14.0 EB05 9.3 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | 86% consumer | no trial data cached |
| Drug prescribing error | 32 | 11.8 8.3–16.6ROR 11.9 · χ² 305 / p 2e-68 | 11.3 EB05 8.1 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious n=5 · 78% consumer | no trial data cached |
| Irritable bowel syndrome | 34 | 11.4 8.2–15.9ROR 11.5 · χ² 312 / p 3e-70 | 10.9 EB05 7.9 · IC025 +2.7 3/3 methods agree | Likely indication confounding term in indications | serious PRR 8.9 · 76% consumer | no trial data cached |
| Abdominal pain | 352 | 10.9 9.8–12.0ROR 12.2 · χ² 3,171 / p <1e-300 | 10.8 EB05 9.9 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.1 · 79% consumer | no trial data cached |
| Constipation | 283 | 9.4 8.4–10.5ROR 10.3 · χ² 2,129 / p <1e-300 | 9.3 EB05 8.4 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.9 · 82% consumer | no trial data cached |
| Gastrointestinal pain | 14 | 9.2 5.4–15.5ROR 9.2 · χ² 94 / p 2e-22 | 7.7 EB05 4.6 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.4 | no trial data cached |
| Abdominal pain upper | 210 | 7.3 6.4–8.3ROR 7.8 · χ² 1,151 / p 1e-252 | 7.2 EB05 6.4 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.1 · 79% consumer | no trial data cached |
| Flatulence (gas) | 50 | 6.3 4.8–8.3ROR 6.4 · χ² 220 / p 6e-50 | 6.0 EB05 4.7 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 · 94% consumer | no trial data cached |
| Impaired gastric emptying | 11 | 6.2 3.4–11.2ROR 6.2 · χ² 43 / p 3e-11 | 5.0 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 | no trial data cached |
| Abdominal distension (bloating) | 69 | 4.8 3.8–6.0ROR 4.8 · χ² 202 / p 4e-46 | 4.6 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 · 79% consumer | no trial data cached |
| Intestinal obstruction | 21 | 4.0 2.6–6.2ROR 4.0 · χ² 45 / p 1e-11 | 3.7 EB05 2.6 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.2 · 81% consumer | no trial data cached |
| Gallbladder disorder | 10 | 4.0 2.2–7.4ROR 4.0 · χ² 20 / p 5e-6 | 3.5 EB05 2.0 · IC025 +0.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.9 | no trial data cached |
| Frequent bowel movements | 15 | 4.0 2.4–6.6ROR 4.0 · χ² 31 / p 1e-8 | 3.6 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Diarrhoea (diarrhea) | 345 | 3.8 3.5–4.2ROR 4.2 · χ² 745 / p 2e-164 | 3.8 EB05 3.5 · IC025 +1.8 3/3 methods agree | Likely indication confounding term in indications | serious PRR 3.1 · 77% consumer | no trial data cached |
| Wrong technique in product usage process | 108 | 3.8 3.2–4.6ROR 3.9 · χ² 225 / p 3e-51 | 3.8 EB05 3.2 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 4.8 · 84% consumer | no trial data cached |
| Feeding disorder | 10 | 3.6 1.9–6.7ROR 3.6 · χ² 16 / p 3e-5 | 3.2 EB05 1.9 · IC025 +0.6 | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Incorrect dose administered | 90 | 2.9 2.3–3.5ROR 2.9 · χ² 109 / p 1e-25 | 2.8 EB05 2.4 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 5.6 · 81% consumer | no trial data cached |
| Drug dose omission | 61 | 2.6 2.0–3.3ROR 2.6 · χ² 59 / p 7e-15 | 2.6 EB05 2.1 · IC025 +0.9 3/3 methods agree | Reporting / coding artifact | serious PRR 2.2 · 77% consumer | no trial data cached |
| Expired product administered | 12 | 2.6 1.5–4.6ROR 2.6 · χ² 10 / p 7e-4 | 2.4 EB05 1.5 · IC025 +0.3 | Reporting / coding artifact | serious n=3 | no trial data cached |
| Therapeutic response decreased | 20 | 2.4 1.5–3.7ROR 2.4 · χ² 15 / p 7e-5 | 2.3 EB05 1.6 · IC025 +0.4 | Reporting / coding artifact | 90% consumer | no trial data cached |
| Product dose omission | 20 | 2.2 1.4–3.3ROR 2.2 · χ² 11 / p 4e-4 | 2.1 EB05 1.5 · IC025 +0.3 | Reporting / coding artifact | serious PRR 2.0 · 75% consumer | no trial data cached |
| Inappropriate schedule of product administration | 53 | 2.1 1.6–2.8ROR 2.2 · χ² 32 / p 9e-9 | 2.1 EB05 1.7 · IC025 +0.6 | Reporting / coding artifact | serious PRR 2.3 · 87% consumer | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Abdominal pain | 352 | 10.9 9.8–12.0ROR 12.2 · χ² 3,171 / p <1e-300 | 10.8 EB05 9.9 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.1 · 79% consumer | no trial data cached |
| Diarrhoea (diarrhea) | 345 | 3.8 3.5–4.2ROR 4.2 · χ² 745 / p 2e-164 | 3.8 EB05 3.5 · IC025 +1.8 3/3 methods agree | Likely indication confounding term in indications | serious PRR 3.1 · 77% consumer | no trial data cached |
| Constipation | 283 | 9.4 8.4–10.5ROR 10.3 · χ² 2,129 / p <1e-300 | 9.3 EB05 8.4 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.9 · 82% consumer | no trial data cached |
| Pancreatitis (pancreas inflammation) | 278 | 37.8 33.8–42.3ROR 41.7 · χ² 9,900 / p <1e-300 | 37.5 EB05 34.0 · IC025 +4.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 57.4 · 81% consumer | no trial data cached |
| Abdominal pain upper | 210 | 7.3 6.4–8.3ROR 7.8 · χ² 1,151 / p 1e-252 | 7.2 EB05 6.4 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.1 · 79% consumer | no trial data cached |
| Inappropriate schedule of drug administration | 162 | 16.1 13.9–18.7ROR 17.0 · χ² 2,284 / p <1e-300 | 16.0 EB05 14.1 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 7.8 · 91% consumer | no trial data cached |
| Wrong technique in product usage process | 108 | 3.8 3.2–4.6ROR 3.9 · χ² 225 / p 3e-51 | 3.8 EB05 3.2 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 4.8 · 84% consumer | no trial data cached |
| Incorrect dose administered | 90 | 2.9 2.3–3.5ROR 2.9 · χ² 109 / p 1e-25 | 2.8 EB05 2.4 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 5.6 · 81% consumer | no trial data cached |
| Pancreatitis acute | 77 | 24.8 19.9–30.9ROR 25.4 · χ² 1,731 / p <1e-300 | 24.6 EB05 20.3 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 37.2 · 72% consumer | no trial data cached |
| Contraindicated product administered | 75 | 17.8 14.3–22.3ROR 18.3 · χ² 1,175 / p 9e-258 | 17.7 EB05 14.6 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 13.7 · 80% consumer | no trial data cached |
| Abdominal distension (bloating) | 69 | 4.8 3.8–6.0ROR 4.8 · χ² 202 / p 4e-46 | 4.6 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 · 79% consumer | no trial data cached |
| Drug dose omission | 61 | 2.6 2.0–3.3ROR 2.6 · χ² 59 / p 7e-15 | 2.6 EB05 2.1 · IC025 +0.9 3/3 methods agree | Reporting / coding artifact | serious PRR 2.2 · 77% consumer | no trial data cached |
| Inappropriate schedule of product administration | 53 | 2.1 1.6–2.8ROR 2.2 · χ² 32 / p 9e-9 | 2.1 EB05 1.7 · IC025 +0.6 | Reporting / coding artifact | serious PRR 2.3 · 87% consumer | no trial data cached |
| Flatulence (gas) | 50 | 6.3 4.8–8.3ROR 6.4 · χ² 220 / p 6e-50 | 6.0 EB05 4.7 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 · 94% consumer | no trial data cached |
| Irritable bowel syndrome | 34 | 11.4 8.2–15.9ROR 11.5 · χ² 312 / p 3e-70 | 10.9 EB05 7.9 · IC025 +2.7 3/3 methods agree | Likely indication confounding term in indications | serious PRR 8.9 · 76% consumer | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Abdominal distension — n=69, PRR 4.8
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Eluxadoline?
In FDA FAERS, the most frequently co-reported reaction terms for Eluxadoline are abdominal pain, diarrhoea, constipation, pancreatitis, abdominal pain upper, pancreatitis acute. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Eluxadoline have an FDA boxed warning?
No. The FDA label retrieved for Eluxadoline has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Eluxadoline causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 7821bd40-4c84-4984-951b-6436ae20421a, effective 20240716; matched on
openfda.generic_name.exact:"ELUXADOLINE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 47 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.