eluxadoline Side Effects
Also known as: Viberzi
Analysis of 2,870 adverse event reports submitted to the FDA from 2012 to 2025.
Total Reports
2,870
Death-Related
63
2.2% of reports
Hospitalizations
546
19.0% of reports
Top Indication
Irritable Bowel Syndrome
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 63 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 37 |
| COMPLETED SUICIDE | 9 |
| VOMITING | 5 |
| CARDIAC ARREST | 4 |
| DIARRHOEA | 4 |
| LETHARGY | 4 |
| PANCREATITIS | 4 |
| SUSPECTED SUICIDE | 4 |
| ABDOMINAL PAIN | 3 |
| ABDOMINAL PAIN UPPER | 3 |
| ACUTE KIDNEY INJURY | 3 |
| HEART RATE INCREASED | 3 |
| NAUSEA | 3 |
| OFF LABEL USE | 3 |
| RENAL FAILURE | 3 |
| RESPIRATORY FAILURE | 3 |
| UNEVALUABLE EVENT | 3 |
| ABDOMINAL DISTENSION | 2 |
| ASCITES | 2 |
| BLOOD PRESSURE DECREASED | 2 |
Reactions in Hospitalization Reports
Top reactions in 546 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| PANCREATITIS | 148 |
| PANCREATITIS ACUTE | 64 |
| ABDOMINAL PAIN | 63 |
| OFF LABEL USE | 48 |
| DIARRHOEA | 46 |
| VOMITING | 41 |
| SPHINCTER OF ODDI DYSFUNCTION | 39 |
| NAUSEA | 30 |
| PAIN | 28 |
| CONSTIPATION | 27 |
| ABDOMINAL PAIN UPPER | 26 |
| DEHYDRATION | 23 |
| FALL | 23 |
| FATIGUE | 23 |
| PNEUMONIA | 23 |
| DYSPNOEA | 22 |
| CHEST PAIN | 19 |
| WEIGHT DECREASED | 19 |
| CONTRAINDICATED PRODUCT ADMINISTERED | 17 |
| DIZZINESS | 15 |
Nearby — Related Medications
What the FAERS Data Reveals About eluxadoline Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 2,870 voluntary reports linked to eluxadoline and its brand equivalents (Viberzi), spanning 2012 through 2025. Of those, 63 (2.2%) listed death as an outcome and 546 (19.0%) involved hospitalization. The most common indication reported alongside adverse events was Irritable Bowel Syndrome.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 76% were female and 24% male; age distribution skews toward 45-64, with 428 reports in that bracket. The single most reported reaction is off label use with 355 submissions, followed by abdominal pain and diarrhoea.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.