FDA label
What is Linzess used for?
Linzess contains linaclotide. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “LINZESS is indicated for the treatment of: irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older; chronic idiopathic constipation (CIC) in adults; functional constipation (FC) in pediatric patients 2 years of age and older.”
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Linzess, capsule, gelatin coated
Indications and Usage, quoted from the label by Allergan, Inc. (NDA202811). Cross-references to other label sections are left out.
LINZESS is indicated for the treatment of:
- irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older
- chronic idiopathic constipation (CIC) in adults
- functional constipation (FC) in pediatric patients 2 years of age and older
Source: DailyMed label, set id 09beda19-56d6-4a56-afdc-9a77b70b2ef3, version 40, effective October 9, 2026. NDC 0456-1201, one of 4 listings for this product.
Questions
What is Linzess used for?
The FDA label says: “LINZESS is indicated for the treatment of: irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older; chronic idiopathic constipation (CIC) in adults; functional constipation (FC) in pediatric patients 2 years of age and older.”
What drug class is Linzess?
FDA lists linaclotide in the Guanylate Cyclase-C Agonist established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.