Is Linaclotide legal in the US?
Yes, FDA approved for constipation and irritable bowel syndrome with constipation.
Approved. Linaclotide (Linzess) was approved in 2012 for irritable bowel syndrome with constipation and chronic idiopathic constipation in adults. The current label also covers IBS with constipation in children 7 and older and functional constipation in children 2 and older, the latter extended from age 6 in May 2026. It is contraindicated in children under 2. 2
IBS with constipation in adults and children 7 and older, chronic idiopathic constipation in adults, and functional constipation in children aged 2 and older. 2
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Citations
- Chey 2012, Am J Gastroenterol: linaclotide for irritable bowel syndrome with constipation, 26-week randomized placebo-controlled trial doi.org
- AbbVie: Linzess US prescribing information, revised 2026 rxabbvie.com
Reference information only, not medical advice. Drawn from the Linaclotide article, fact-checked against the cited sources. No dosing anywhere on this site.