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# FDA Approves Expanded Age for Ironwood’s Linzess
- URL: https://www.fdaweb.com/fda-approves-expanded-age-for-ironwoods-linzess/
- Published: 2021-08-26T12:00:00.000Z
- Updated: 2026-09-14T17:12:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150021

FDA has approved an updated label for Ironwood Pharmaceuticals’ Linzess (linaclotide) that expands the potential off-label use of the drug to more children under age 18\. The company [says](https://investor.ironwoodpharma.com/press-releases/press-release-details/2021/Ironwood-Pharmaceuticals-Announces-FDA-Approval-of-Revised-LINZESS-linaclotide-Label/default.aspx?ref=fdaweb.com) the updated label modifies the Boxed Warning for risk of serious dehydration and the Contraindication against use in children to those less than two years old. The Boxed Warning previously applied to all children under age 18 and the Contraindication previously applied to all children less than six years old, the company says. The safety and effectiveness of Linzess in patients less than 18 years old have not been established.

Linzess is indicated for use in adults to treat irritable bowel syndrome with constipation and chronic idiopathic constipation.