Norethindrone Pregnancy and Breastfeeding Warnings

Brand names: Affodel, Aygestin, Camila, Deblitane, Emzahh, Errin, Gallifrey, Heather, Incassia, Jencycla, Jolivette, Lyleq, Lyza, Meleya, Nor-QD, Nora-Be, Norlyda, Norlyroc, Orquidea, Ortho Micronor, Sharobel, Tulana

Medically reviewed by Drugs.com. Last updated on Apr 21, 2025.

Norethindrone Pregnancy Warnings

Use is contraindicated.

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

Risk summary: This drug may cause fetal harm when administered to pregnant women. No data are available on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Women of childbearing potential should be advised to avoid becoming pregnant while receiving this medication.

Animal reproduction studies have not been conducted with this drug. Use during the first trimester of pregnancy may be associated with congenital malformations in male and female fetuses and virilization of the external genitalia of the female fetus. There are no controlled data from human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

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

Norethindrone Breastfeeding Warnings

Caution is recommended.
-According to some authorities: Use is contraindicated.

Excreted into human milk: Yes

Comments:
-The effects in the nursing infant are unknown.
-The WHO states that use is compatible with breastfeeding from 6 weeks postpartum.

This drug may slow neonatal bilirubin degradation; withholding of breastfeeding should be considered in neonates with severe/persistent jaundice requiring medical treatment.

See references

Further information

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

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