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Drugs and Lactation Database (LactMed®) [Internet]. Bethesda (MD): National Institute of Child Health and Human Development; 2006-.

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Drugs and Lactation Database (LactMed®) [Internet].

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Last Revision: September 19, 2022.

Estimated reading time: 1 minute

CASRN: 851199-59-2

image 135264508 in the ncbi pubchem database

Drug Levels and Effects

Summary of Use during Lactation

Linaclotide is minimally absorbed from the gastrointestinal tract and the drug and its active metabolite are not measurable in milk following administration of doses up to 290 mcg daily. Linaclotide appears to be acceptable in nursing mothers and no special precautions are required.

Drug Levels

Linaclotide is metabolized in the gastrointestinal tract to its active metabolite, MM-419447.

Maternal Levels. In a multicenter study, 7 lactating women were taking linaclotide in doses of 72 mcg (n = 5), 145 mcg (n = 1) or 290 mcg (n = 1) once daily. Milk was pumped on day 1 and day 3 of the study. Over 24-hours of milk collection on day 3, concentrations of linaclotide and MM-419447 in milk samples were below the quantitation limits (<0.25 mcg/L and <1 mcg/L, respectively) at all time points in all participants.[1]

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

(Irritable Bowel Syndrome) Lubiprostone, Plecanatide, Polyethylene Glycol, Psyllium, Tenapanor


Crittenden N, McGeeney D, Assouline-Dayan Y, et al. Linaclotide is not detectable in breast milk of lactating women: An open-label, phase 1 study. J Can Assoc Gastroenterol 2021;4 (Suppl 1):Abstract A236.

Substance Identification

Substance Name


CAS Registry Number


Drug Class

Breast Feeding


Milk, Human

Gastrointestinal Agents


Guanylate Cyclase C Agonists


Disclaimer: Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

Copyright Notice

Attribution Statement: LactMed is a registered trademark of the U.S. Department of Health and Human Services.

Bookshelf ID: NBK500873PMID: 29999932


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