Pregnancy: There are limited amount of data from the use of ranolazine in pregnant women. Studies in animals showed embryo toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). The potential risk for humans is unknown. Ranexa should not be used during pregnancy unless clearly necessary.
Breast-feeding: It is unknown whether ranolazine is excreted in human breast milk. Available pharmacodynamic/toxicological data in rats have shown excretion of ranolazine in milk (for details see Pharmacology: Toxicology: Preclinical safety data under Actions). A risk to the suckling child cannot be excluded. Ranexa should not be used during breast-feeding.
Fertility: In animals, reproduction studies indicated no adverse effects on fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions). The effect of ranolazine on human fertility is unknown.