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Desogestrel / ethinyl estradiol Pregnancy and Breastfeeding Warnings

Brand names: Apri, Averi, Azurette, Bekyree, Caziant, Cesia, Cyred, Cyred EQ, Desogen, Emoquette, Enskyce, Isibloom, Juleber, Kalliga, Kariva, Kimidess, Mircette, Ortho-Cept, Pimtrea, Reclipsen, Simliya, Solia, Velivet, Viorele, Volnea

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

Desogestrel / ethinyl estradiol Pregnancy Warnings

Use is contraindicated.

AU TGA pregnancy category: B3
US FDA pregnancy categories: 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:
-Female patients of childbearing potential should be advised to avoid becoming pregnant while receiving this medication.
-Patients who become pregnant should discontinue this drug.
-Avoid administration to induce withdrawal bleeding as a test for pregnancy.
-Avoid administration during pregnancy to treat threatened or habitual abortion.

Animal studies of estrogen at high doses have revealed evidence of urogenital malformations. There are no controlled data for either drug in human pregnancy. Epidemiological data have failed to reveal an increased risk of birth defects when this drug was taken before pregnancy, and teratogenicity when patients inadvertently used this drug in early pregnancy.

AU TGA pregnancy category B3: 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.

See references

Desogestrel / ethinyl estradiol Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug.

Excreted into human milk: Yes

Comments:
-Patients should avoid use until the infant has been weaned.
-Some experts recommend using nonhormonal forms of contraception during breastfeeding; in breastfeeding patients, progestin-only contraceptives are preferred over combined contraceptive drugs, especially up to 4 weeks postpartum.
-Neonatal jaundice and breast enlargement have been reported in patients who received oral contraceptives.

Use during lactation may decrease the quality and quantity of breastmilk.

See references

Does Desogestrel/ethinyl estradiol interact with my other drugs?

Enter medications to view a detailed interaction report using our Drug Interaction Checker.

References for pregnancy information

  1. (2001) "Product Information. Ortho-Cept (desogestrel-ethinyl estradiol)." Ortho McNeil Pharmaceutical
  2. (2001) "Product Information. Cyclessa (desogestrel-ethinyl estradiol)." Organon
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  4. Cerner Multum, Inc. "Australian Product Information."
  5. (2024) "Product Information. Azurette (28 Day) (desogestrel-ethinyl estradiol)." Dr. Reddy's Laboratories Inc
  6. (2025) "Product Information. Marvelon (desogestrel-ethinylestradiol)." Organon (Australia) Pty Ltd
  7. (2021) "Product Information. Apri (28 Day) (desogestrel-ethinyl estradiol)." Teva Pharmaceuticals USA
  8. (2024) "Product Information. Cyred EQ (28 Day) (desogestrel-ethinyl estradiol)." Afaxys Inc.
  9. (2023) "Product Information. Isibloom (28 Day) (desogestrel-ethinyl estradiol)." Xiromed LLC
  10. (2024) "Product Information. Juleber (28 Day) (desogestrel-ethinyl estradiol)." Northstar Rx LLC
  11. (2024) "Product Information. Kalliga (28 Day) (desogestrel-ethinyl estradiol)." Aurobindo Pharma USA Inc
  12. (2024) "Product Information. Kariva (28 Day) (desogestrel-ethinyl estradiol)." Teva Pharmaceuticals USA
  13. (2023) "Product Information. Madeline (desogestrel-ethinylestradiol)." Apotex Pty Ltd
  14. (2024) "Product Information. Pimtrea (28 Day) (desogestrel-ethinyl estradiol)." Northstar Rx LLC
  15. (2022) "Product Information. Reclipsen (28 Day) (desogestrel-ethinyl estradiol)." Teva Pharmaceuticals USA
  16. (2022) "Product Information. Velivet (28 Day) (desogestrel-ethinyl estradiol)." Teva Pharmaceuticals USA
  17. (2023) "Product Information. Enskyce (28 Day) (desogestrel-ethinyl estradiol)." Lupin Pharmaceuticals Inc
  18. (2024) "Product Information. Viorele (28 Day) (desogestrel-ethinyl estradiol)." Glenmark Pharmaceuticals Inc

References for breastfeeding information

  1. (2001) "Product Information. Ortho-Cept (desogestrel-ethinyl estradiol)." Ortho McNeil Pharmaceutical
  2. (2001) "Product Information. Cyclessa (desogestrel-ethinyl estradiol)." Organon
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  4. Cerner Multum, Inc. "Australian Product Information."
  5. United States National Library of Medicine (2013) Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.