Is Linaclotide safe?
Large trials, boxed warning under age 2
AStrong human evidenceFDA approvedas of 2026-10-26
Diarrhea is the main side effect. It affected 20 percent of adults in the IBS-C trials (3 percent on placebo) and caused 5 percent to stop. Abdominal pain, gas and bloating are also reported. The label carries a boxed warning. Linaclotide must not be used in children under 2, because young juvenile mice died of dehydration in toxicology studies. 12
Almost none of the drug reaches the bloodstream. So side effects outside the gut and drug interactions are minimal. Pregnancy data in humans are limited. 2
Read the full Linaclotide page
More on Linaclotide
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.