Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Eluxadoline
Drug ID BADD_D00761
Description Eluxadoline is a mixed mu-opioid receptor agonist, kappa-opioid receptor agonist, and a-delta opioid receptor antagonist indicated for use in diarrhea-predominant irritable bowel syndrome (IBS-D). The mu-, kappa-, and delta-opioid receptors mediate endogenous and exogenous opioid response in the central nervous system and peripherally in the gastrointestinal system. Agonism of peripheral mu-opioid receptors results in reduced colonic motility, while antagonism of central delta-opioid receptors results in improved analgesia, making eluxadoline usable for the symptoms of both pain and diarrhea characteristic of IBS-D. Marketed under the tradename Viberzi (FDA), eluxadoline is an antimotility agent that decreases bowel contractions, inhibits colonic transit, and reduces fluid/ion secretion resulting in improved symptoms of abdominal pain and reductions in the Bristol Stool Scale.
Indications and Usage For the treatment of irritable bowel syndrome with diarrhea (IBS-D).
Marketing Status approved; investigational
ATC Code A07DA06
DrugBank ID DB09272
KEGG ID D10403
MeSH ID C583636
PubChem ID 11250029
TTD Drug ID D09ZXR
NDC Product Code 59651-330; 61874-100; 61874-075; 69766-020; 69037-0042
UNII 45TPJ4MBQ1
Synonyms eluxadoline | Viberzi
Chemical Information
Molecular Formula C32H35N5O5
CAS Registry Number 864821-90-9
SMILES CC1=CC(=CC(=C1CC(C(=O)N(CC2=CC(=C(C=C2)OC)C(=O)O)C(C)C3=NC=C(N3)C4=CC=CC=C4)N)C) C(=O)N
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.0010.000444%-
Abdominal distension07.01.04.0010.000270%
Abdominal pain07.01.05.0020.004582%
Abdominal pain upper07.01.05.0030.001379%
Alanine aminotransferase increased13.03.04.005--
Aspartate aminotransferase increased13.03.04.011--
Asthma10.01.03.010; 22.03.01.002---
Bronchitis11.01.09.001; 22.07.01.001--
Bronchospasm10.01.03.012; 22.03.01.004--
Chest discomfort02.02.02.009; 08.01.08.019; 22.12.02.0020.000119%-
Chest pain02.02.02.011; 08.01.08.002; 22.12.02.0030.000753%-
Colitis07.08.01.0010.000174%
Constipation07.02.02.0010.002101%
Diarrhoea07.02.01.0010.001292%
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
Drug ineffective08.06.01.0060.001752%-
Euphoric mood19.04.02.0060.000270%
Fatigue08.01.01.002--
Feeling abnormal08.01.09.0140.000523%-
Feeling drunk08.01.09.015---
Flatulence07.01.04.002--
Flushing08.01.03.025; 23.06.05.003; 24.03.01.0020.000404%
Gait disturbance08.01.02.002; 15.03.05.013; 17.02.05.0160.000270%
Gastrooesophageal reflux disease07.02.02.003--
Gastroenteritis viral07.19.03.005; 11.05.04.005---
Hypersensitivity10.01.03.0030.000270%
Hypoaesthesia17.02.06.023; 23.03.03.0810.000270%-
Insomnia17.15.03.002; 19.02.01.0020.000404%
Muscle spasms15.05.03.0040.000444%
Nasopharyngitis11.01.13.002; 22.07.03.002---
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