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Pregnancy: A moderate amount of data on pregnant women (between 300-1,000 pregnancy outcomes) indicated no malformative or fetal/neonatal toxicity of varenicline (see Pharmacology: Pharmacodynamics under Actions).
Animal studies have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). As a precautionary measure, it is preferable to avoid the use of varenicline during pregnancy (see Pharmacology: Pharmacodynamics under Actions).
Lactation: It is unknown whether varenicline is excreted in human breast milk. Animal studies suggest that varenicline is excreted in breast milk. A decision on whether to discontinue breast-feeding or to discontinue therapy with varenicline should be made taking into account the benefit of breast-feeding to the child and the benefit of varenicline therapy to the woman.
