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Norethindrone Pregnancy and Breastfeeding Warnings

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

Medically reviewed by Drugs.com. Last updated on Aug 4, 2023.

Norethindrone Pregnancy Warnings

Animal reproduction studies have not been conducted with this drug. There are no controlled data from human pregnancy studies. 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.

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 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.

AU TGA pregnancy category: D
US FDA pregnancy category: X

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.

See references

Norethindrone Breastfeeding Warnings

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

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.

See references

See also

References for pregnancy information

  1. Product Information. Micronor (norethindrone). Ortho McNeil Pharmaceutical. 2001;PROD.
  2. Product Information. Nor-QD (norethindrone). Watson Laboratories Inc. 2001;PROD.
  3. Product Information. Aygestin (norethindrone). Lederle Laboratories. 2001;PROD.
  4. Cerner Multum, Inc. UK Summary of Product Characteristics.
  5. Cerner Multum, Inc. Australian Product Information.

References for breastfeeding information

  1. Product Information. Micronor (norethindrone). Ortho McNeil Pharmaceutical. 2001;PROD.
  2. Product Information. Nor-QD (norethindrone). Watson Laboratories Inc. 2001;PROD.
  3. Product Information. Aygestin (norethindrone). Lederle Laboratories. 2001;PROD.
  4. Cerner Multum, Inc. UK Summary of Product Characteristics.
  5. Cerner Multum, Inc. Australian Product Information.
  6. United States National Library of Medicine. Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT 2013.
  7. Department of Adolescent and Child Health and Development. UNICEF. World Health Organization. Breastfeeding and maternal medication: recommendations for drugs in the eleventh Who model list of essential drugs. http://whqlibdoc.who.int/hq/2002/55732.pdf?ua=1 2014.

Further information

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

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