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Pregnancy: There is limited amount of data from the use of linaclotide in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). As a precautionary measure, it is preferable to avoid the use during pregnancy.
Breast-feeding: As systemic exposure to linaclotide is minimal, excretion in breast milk is not likely, although it has not been evaluated. Although at therapeutic doses no effects on the breastfed newborn/infant are anticipated, in the absence of human data, the use during breast-feeding is not recommended.
Fertility: Animal studies indicate that there is no effect on male or female fertility.
