Women of childbearing potential and contraception in males and females: Due to lack of data on effects of Sildenafil in pregnant women, Sildenafil 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.
Due to lack of data, Sildenafil should not be used in pregnant women unless strictly necessary.
Breastfeeding: 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 breastfed 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 breastfed child.
Fertility: Non-clinical data revealed no special hazard for humans based on conventional studies of fertility.