Sildenafil Pregnancy and Breastfeeding Warnings

Brand names: Liqrev, Revatio, Viagra

Medically reviewed by Drugs.com. Last updated on Oct 6, 2023.

Sildenafil Pregnancy Warnings

Erectile dysfunction (ED): This drug is not indicated for use in female patients.
Pulmonary arterial hypertension (PAH): Safety has not been established during pregnancy.
-According to some authorities: Avoid use in pregnant women unless strictly necessary; use in women of childbearing potential is not recommended unless also using appropriate contraceptive measures.

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

Risk summary: Insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-There are risks to the mother and fetus associated with untreated PAH during pregnancy.

Animal studies have failed to reveal evidence of embryofetal toxicity or teratogenicity when this drug was administered during organogenesis at doses up to 32 and 65 times the recommended human dose (RHD). In pre- and post-natal development studies, the no observed adverse effect dose was equivalent up to 2 and 5 times the RHD. There was no evidence of impaired fertility in animal studies. There are no controlled data in human pregnancy.

Pregnant women with untreated PAH are at risk for heart failure, stroke, preterm delivery, and maternal and fetal death.

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

Sildenafil Breastfeeding Warnings

Safety has not been established.

Excreted into human milk: Yes

Comments:
-Limited data in patients with PAH indicate that this drug and its active metabolite are poorly excreted into breastmilk at very low levels; there is no information on the effects of this drug on milk production.
-According to some experts, amounts ingested by the breastfeeding infant are far below the dose given to treat infants and are not expected to cause any adverse effects.
-The ability to make a clear determination of risk during lactation is precluded by insufficient data on the effects of this drug on the breastfed infant or availability of controlled studies in lactating women.
-In patients with PAH, health care providers should carefully assess the mother's clinical need for this drug and any potential adverse effects on the breastfed child.

See references

Further information

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