Maternal administration of high-dose estrogen in animal studies has produced urogenital malformations in their offspring. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects when women have been exposed to combined estrogen and progestin oral contraceptives before conception or during early pregnancy. There are no adequate and well-controlled studies in pregnant women.

AU TGA pregnancy category B 3: 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 shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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.

This drug is not indicated for use during pregnancy

AU TGA pregnancy category: B 3
US FDA pregnancy category: Not assigned

Risk Summary: There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins as an oral contraceptive inadvertently during early pregnancy.

Comments:
-If pregnancy occurs, this drug should be discontinued.

See references

Not indicated for use in females of reproductive potential

Excreted into human milk: Yes

Comments: Estrogen administration to nursing women has been shown to decrease the quantity and quality of breast milk.

See references