Fluoxymesterone Pregnancy and Breastfeeding Warnings

Brand names: Androxy, Halotestin

Fluoxymesterone Pregnancy Warnings

This drug is contraindicated in women who are or may become pregnant.

US FDA pregnancy category: X

Comments:
-This drug may cause virilization of the external genitalia of a female fetus; apprise patients of this potential hazard if they become pregnant during treatment.
-Oligospermia may occur at high dosages.

When administered to pregnant women, androgens can cause virilization of the external genitalia of a female fetus. Virilization effects include clitoromegaly, abnormal vaginal development, and fusion of genital folds to form a scrotal-like structure. The degree of masculinization is related to the drug amount given and the age of the female fetus, and is most likely to occur when the androgen is given in the first trimester.

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

Fluoxymesterone Breastfeeding Warnings

A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments: The effects in the nursing infant are unknown.

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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