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Pregnancy: There are no or limited amount of data from the use of tolvaptan in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). Jinarc is not recommended in women of childbearing potential not using contraception. Jinarc is contraindicated during pregnancy (see Contraindications).
Breast-feeding: It is unknown whether tolvaptan is excreted in human breast milk. Studies in rats have shown excretion of tolvaptan in milk. A risk for the newborns/infants cannot be excluded. Jinarc is contraindicated during breast-feeding (see Contraindications).
Fertility: Studies in animals showed effects on fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions). The potential risk for humans is unknown.
