Animal studies have not been reported. Epidemiological data have failed to reveal an increased risk of birth defects when this drug was taken before pregnancy nor evidence of teratogenicity when patients inadvertently used this drug in early pregnancy. There are no controlled data in human pregnancy.

US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Use is contraindicated.

US FDA pregnancy category: X

Comments:
-This drug is intended to prevent pregnancy and should not be used in women who are already pregnant or suspect they may be pregnant.
-Pregnancy should be considered at the first missed period and ruled out before continuing use in any patient that has missed 2 consecutive periods.
-Patients who become pregnant should discontinue this drug.

See references

Breastfeeding is not recommended during use of this drug.

Excreted into human milk: Yes

Comments:
-Women should avoid use of oral contraceptives and use other forms of contraception until the child is completely weaned.
-Postpartum women who are breastfeeding should not use combined hormonal contraceptives during the first 3 weeks after delivery due increased risk for venous thromboembolism.
-Postpartum women who are breastfeeding with other risk factors for venous thromboembolism should not use combined hormonal contraceptives 4 to 6 weeks after delivery.
-Nursing mothers should not use combined hormonal contraceptives during the fourth week postpartum due to the potential to adversely affect the milk supply.
-The World Health Organization suggest that combined oral contraceptives should not be used in nursing mothers before 42 days postpartum and the disadvantages of using the method generally outweigh the advantages between 6 weeks and 6 months postpartum.

Jaundice and breast enlargement have been reported have been reported in the nursing infant when the mother was using oral contraceptives during breastfeeding.

See references