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Pregnancy: There are no adequate data from the use of tolvaptan in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). The potential risk for humans is unknown.
Women of childbearing potential must use adequate contraceptive measures during Jinarc use. Jinarc must not be used 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.
The potential risk for humans is unknown. 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.
