Revatio Use In Pregnancy & Lactation

Women of childbearing potential and contraception in males and females: Due to lack of data on effects of Revatio in pregnant women, Revatio is not recommended for women of childbearing potential unless also using appropriate contraceptive measures.
Pregnancy: There are no data from the use of sildenafil in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy and embryonal/foetal development. Studies in animals have shown toxicity with respect to post-natal development (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Due to lack of data, Revatio should not be used in pregnant women unless strictly necessary.
Breast-feeding: There are no adequate and well controlled studies in lactating women. Data from one lactating woman indicate that sildenafil and its active metabolite N-desmethylsildenafil are excreted into breast milk at very low levels. No clinical data are available regarding adverse events in breast-fed infants, but amounts ingested would not be expected to cause any adverse effects. Prescribers should carefully assess the mother's clinical need for sildenafil and any potential adverse effects on the breast-fed child.
Fertility: Non-clinical data revealed no special hazard for humans based on conventional studies of fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).