Pregnancy: There are no adequate data from the use of ranolazine in pregnant women. Animal studies are insufficient with respect to effects on pregnancy and embryofoetal development (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. The excretion of ranolazine in milk has not been studied in animals. 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.