The safety of amlodipine in human pregnancy or lactation has not been established. Amlodipine does not demonstrate toxicity in animal reproductive studies other than delay in parturition and prolongation of labor in rats at a dose level 50 times the maximum recommended dose in humans. Accordingly, use in pregnancy is only recommended when there is no safer alternative and when the disease itself carries greater risk for the mother and fetus. There was no effect on the fertility of rats treated with amlodipine (see Pharmacology: Toxicology: Preclinical safety data under Actions).
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