Use in Pregnancy: As for any drug that also acts directly on the RAAS, valsartan should not be used during pregnancy (see Contraindications). Due to the mechanism of action of angiotensin II antagonists, a risk for the fetus cannot be excluded. In utero exposure to ACE inhibitors (a specific class of drugs acting on the RAAS) during the second and third trimesters has been reported to cause injury and death to the developing fetus. In addition, in retrospective data, first trimester use of ACE inhibitors has been associated with a potential risk of birth defects. There have been reports of spontaneous abortion, oligohydramnios and newborn renal dysfunction, when pregnant women have inadvertently taken valsartan. If pregnancy is detected during therapy, valsartan should be discontinued as soon as possible (see Pharmacology: Toxicology: Preclinical Safety Data under Actions).
Women of Child-Bearing Potential: As for any drug that also acts directly on the RAAS, valsartan should not be used in women planning to become pregnant. Healthcare professionals prescribing any agents acting on the RAAS should counsel women of childbearing potential about the potential risk of these agents during pregnancy.
Fertility: There is no information on the effects of valsartan on human fertility. Studies in rats did not show any effects of valsartan on fertility (see Pharmacology: Toxicology: Preclinical Safety Data under Actions).
Use in Lactation: It is not known whether valsartan is excreted in human milk. Since valsartan was excreted in the milk of lactating rats, it is not advisable to use valsartan in breast-feeding mothers.