Ethinyl estradiol / norgestimate Pregnancy and Breastfeeding Warnings

Brand names: Estarylla, Femynor, Mili, Mono-Linyah, Mononessa, Nymyo, Ortho Cyclen, Ortho Tri-Cyclen, Ortho Tri-Cyclen Lo, Sprintec, Tri Femynor, Tri-Estarylla, Tri-Linyah, Tri-Lo-Estarylla, Tri-Lo-Linyah, Tri-Lo-Marzia, Tri-Lo-Mili, Tri-Lo-Sprintec, Tri-Mili, Tri-Sprintec, Tri-VyLibra, Tri-Vylibra Lo, TriNessa, TriNessa Lo, VyLibra

Medically reviewed by Drugs.com. Last updated on May 7, 2025.

Ethinyl estradiol / norgestimate Pregnancy Warnings

Use is contraindicated.

US FDA pregnancy category: Not assigned.

Risk summary: There is no use for combined oral contraceptives (COC) in pregnancy. Inadvertent exposure to low-dose COCs during conception and early pregnancy did not show an increased risk of genital or non-genital birth defects.

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.
-Discontinue use if pregnancy is confirmed.
-Avoid administration to induce withdrawal bleeding as a test for pregnancy.
-Avoid administration during pregnancy to treat threatened or habitual abortion.

Animal studies have failed to reveal evidence of adverse developmental effects. Epidemiological data have failed to reveal an increased risk of birth defects following maternal exposure oral contraceptives prior to conception or when taken inadvertently during early pregnancy. There are no controlled data in human pregnancy.

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.

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Ethinyl estradiol / norgestimate Breastfeeding Warnings

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 and other authorities 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. Combined oral contraceptives have also been known to reduce milk production.

See references

Further information

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