Is Eluxadoline registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Eluxadoline, including VIBERZI 100 MG FILM COATED TABLETS (100 mg, Film-coated tablet, SAR 238.35); VIBERZI 75MG FILM COATED TABLETS (75 mg, Film-coated tablet, SAR 238.35).

Is Eluxadoline approved by the US FDA?

Drugs@FDA lists 4 application product lines for Eluxadoline, including VIBERZI (Prescription); ELUXADOLINE (Prescription); ELUXADOLINE (Discontinued); ELUXADOLINE (Discontinued).

Is Eluxadoline authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Eluxadoline.

Are there safety signals or safety updates for Eluxadoline?

US FDA: 1 entry; MHRA: 1 entry (latest 2020-06-17).

Active substance

Eluxadoline

SFDA 2
US FDA 4
EMA 1
Health Canada 2
US price lines 2
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
VIBERZI 100 MG FILM COATED TABLETS	100 mg	Film-coated tablet · Oral use	25 Blister	SAR 238.35	NCE · Prescription	ALLERGAN PHARMACEUTICALS LTD	Valid
VIBERZI 75MG FILM COATED TABLETS	75 mg	Film-coated tablet · Oral use	28 Blister	SAR 238.35	NCE · Prescription	ALLERGAN PHARMACEUTICALS LTD	Valid

Indications — CHI Daman Drug Formulary

DIARRHEA; IRRITABLE BOWEL SYNDROME

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
VIBERZI	75MG; 100MG	tablet · oral	ABBVIE	Prescription	27 May 2015
ELUXADOLINE	75MG; 100MG	tablet · oral	ASCEND LABORATORIES, LTD	Prescription
ELUXADOLINE	75MG; 100MG	tablet · oral	ZYDUS PHARMS	Discontinued	14 Mar 2025
ELUXADOLINE	75MG; 100MG	tablet · oral	AUROBINDO PHARMA	Discontinued	2 Jun 2026

EMA European Union — centrally authorised medicines

Truberzi Allergan Pharmaceuticals International Limited · Withdrawn · authorised 19 Sep 2016 · ATC A07

Therapeutic indication (EMA)

Truberzi is indicated in adults for the treatment of irritable bowel syndrome with diarrhoea (IBS D).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
VIBERZI	02460890	75 MG	TABLET · ORAL	ABBVIE CORPORATION
VIBERZI	02460904	100 MG	TABLET · ORAL	ABBVIE CORPORATION

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	VIBERZI 100 MG TABLET	$28.09348	per EA	23 Sep 2026
US NADAC	VIBERZI 75 MG TABLET	$28.10375	per EA	23 Sep 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 17 Jun 2020 VIBERZI — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
MHRA 14 Dec 2017 Eluxadoline (Truberzi▼): risk of pancreatitis; do not use in patients who have undergone cholecystectomy or in those with biliary disorders
Cases of pancreatitis, with or without sphincter of Oddi spasm, have been reported in patients taking eluxadoline. Some cases have resulted in hospitalisation and death, primarily in patients who have undergone cholecystectomy.

All safety entries for eluxadoline →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.