This drug is not indicated for use in women. Safety has not been established.

Revatio (R):
This drug should be used only if clearly needed. (UK)

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned

Risk Summary: There are risks to the mother and fetus from untreated pulmonary arterial hypertension.

Comments: Revatio (R) is not recommended for women of childbearing potential unless using appropriate contraceptive measures.

No evidence of teratogenicity, embryotoxicity, or fetotoxicity was observed in pregnant rats or rabbits during organogenesis at doses 32- and 68-times the recommended human dose (RHD) of this drug. There were no observed adverse effects in pre and postnatal rats at 5-times the RHD. There are no adequate and well-controlled studies of this drug in pregnant women.

AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Amounts of this drug ingested by a breastfed infant would not be expected to cause any adverse effects.

Use should be avoided.

Excreted into human milk: Yes

Comments: The effects in the nursing infant are unknown.

See references