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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 Tolvaptan (JINARC®) use. Tolvaptan (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. Tolvaptan (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.
