Eluxadoline

VIBERZI

What it isMu- and kappa-opioid agonist acting mainly in the gut; irritable bowel syndrome with diarrhea.

Why this oneLow systemic exposure slows bowel transit with relatively little central opioid effect.

What limits it⚑ Pancreatitis and sphincter-of-Oddi spasm can be fatal; avoid without a gallbladder or with heavy alcohol use.

FDA-approved for

FDA dosing	Population	Start	Target	Max
Irritable bowel syndrome with diarrhea (IBS-D)	Adults	100 mg BID	100 mg BID	100 mg BID
IBS-D (reduced-dose population)	Intolerant of 100 mg; on OATP1B1 inhibitor; mild-moderate hepatic impairment; moderate-severe renal impairment or ESRD not on dialysis	75 mg BID	75 mg BID	75 mg BID

Renal Moderate-severe renal impairment or ESRD not yet on dialysis: 75 mg BID

Hepatic Mild-moderate (Child-Pugh A/B): 75 mg BID; severe (Child-Pugh C): contraindicated

Absence of a gallbladder
Known or suspected biliary duct obstruction, or sphincter of Oddi disease or dysfunction
Alcoholism, alcohol abuse/addiction, or >3 alcoholic drinks per day
History of pancreatitis or structural pancreatic disease (incl. known/suspected pancreatic duct obstruction)
Severe hepatic impairment (Child-Pugh C)
History of chronic or severe constipation or its sequelae, or known/suspected mechanical GI obstruction

Pregnancy No human data; no teratogenicity in animal studies.

Lactation No human data; eluxadoline present in rat milk.

NO BOXED WARNINGS

Principal riskPancreatitis; contraindicated without a gallbladder

Cost, est. cash$300–$2,500/month

Generic entry2033 est.

Therapeutic safety burden2 / 4

Overdose danger3 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk1 / 4

Legacy pregnancy categoryUnknown / historical label unavailable

Defining liabilityPancreatitis and sphincter-of-Oddi spasm are defining risks; misuse and opioid toxicity can occur.