Skip to Content

Danazol Pregnancy and Breastfeeding Warnings

Danazol is also known as: Danocrine

Danazol Pregnancy Warnings

Use is contraindicated. AU TGA pregnancy category: D US FDA pregnancy category: X Comments: -Use of adequate methods of non-hormonal contraception should be encouraged. -If the patient becomes pregnant while taking this drug, treatment should be discontinued and the patient should be apprised of the potential harm to the fetus.

One animal model failed to reveal evidence of embryotoxicity or teratogenicity at doses 7 to 15 times the human dose, while a different animal model revealed evidence of fetal development inhibition at doses 2 to 4 times the human dose given on days 6 to 18 of gestation. Exposure to female fetuses may result in virilization (e.g., clitoral hypertrophy, labial fusion, urogenital sinus defect, vaginal atresia, ambiguous genitalia). There are no controlled data in human pregnancy. Modest reductions in spermatogenesis and abnormalities in semen volume, viscosity, sperm count, and motility have occurred in male patients receiving long-term treatment. 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.

See references

Danazol Breastfeeding Warnings

Breastfed infants exposed to this drug may be at risk of developing androgenic effects.

Use is contraindicated. Excreted into human milk: Data not available Excreted into animal milk: Unknown Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Danocrine (danazol)." Sanofi Winthrop Pharmaceuticals, New York, NY.

References for breastfeeding information

  1. "Product Information. Danocrine (danazol)." Sanofi Winthrop Pharmaceuticals, New York, NY.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.

Hide