Is Linaclotide 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 Linaclotide, including LINZESS (290 µg, Capsule, SAR 204.10); LINZESS (145 µg, Capsule, SAR 204.10).

Is Linaclotide approved by the US FDA?

Drugs@FDA lists 4 application product lines for Linaclotide, including LINZESS (Prescription); LINACLOTIDE (Prescription); LINACLOTIDE (Discontinued); LINACLOTIDE (Discontinued).

Is Linaclotide authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Linaclotide: Constella.

Are there safety signals or safety updates for Linaclotide?

US FDA: 1 entry (latest 2026-05-21).

Active substance

Linaclotide

SFDA 2
US FDA 4
EMA 1
Health Canada 3
US price lines 3
NHS prices 1
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
LINZESS	290 µg	Capsule · Oral use	30 Bottle	SAR 204.10	NCE · Prescription	Allergan Inc	Valid
LINZESS	145 µg	Capsule · Oral use	30 Bottle	SAR 204.10	NCE · Prescription	Allergan Inc	Valid

Indications — CHI Daman Drug Formulary

CONSTIPATION; IRRITABLE BOWEL SYNDROME

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

Product	Strength	Form · route	Applicant	Status	First approved
LINZESS	145MCG; 290MCG; 72MCG	capsule · oral	ABBVIE	Prescription	30 Aug 2012
LINACLOTIDE	72MCG	capsule · oral	ACTAVIS LABS FL	Prescription	24 Sep 2026
LINACLOTIDE	145MCG; 290MCG	capsule · oral	MYLAN	Discontinued	9 Feb 2021
LINACLOTIDE	145MCG; 290MCG	capsule · oral	AUROBINDO PHARMA	Discontinued	7 Feb 2023

EMA European Union — centrally authorised medicines

Constella AbbVie Deutschland GmbH & Co. KG · Authorised · authorised 26 Nov 2012 · ATC A06AX04

Therapeutic indication (EMA)

Constella is indicated for the symptomatic treatment of moderate to severe irritable-bowel syndrome with constipation (IBS-C) in adults.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
CONSTELLA	02417162	145 MCG	CAPSULE · ORAL	ABBVIE CORPORATION
CONSTELLA	02417170	290 MCG	CAPSULE · ORAL	ABBVIE CORPORATION
CONSTELLA	02469510	72 MCG	CAPSULE · ORAL	ABBVIE CORPORATION

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	LINZESS 145 MCG CAPSULE	$9.01992	per EA	23 Sep 2026
US NADAC	LINZESS 290 MCG CAPSULE	$9.01543	per EA	23 Sep 2026
US NADAC	LINZESS 72 MCG CAPSULE	$9.01079	per EA	23 Sep 2026
NHS Drug Tariff	Linaclotide 290microgram capsules	£37.56	28 capsule	1 Oct 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 21 May 2026 LINZESS — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for linaclotide →

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.