Mitotane Pregnancy and Breastfeeding Warnings

Brand names: Lysodren

Medically reviewed by Drugs.com. Last updated on Mar 3, 2025.

Mitotane Pregnancy Warnings

Caution is recommended.
-According to some authorities: This drug should be used during pregnancy only if clearly needed and if the benefit outweighs the risk to the fetus.

US FDA pregnancy category: Not assigned

Risk summary: This drug can cause fetal harm when administered to a pregnant woman; limited postmarketing cases report preterm births and early pregnancy loss in patients treated during pregnancy.

Comments:
-Female patients of reproductive potential should be advised to use effective contraception during treatment and after discontinuation of this drug for as long as drug plasma levels are detectable.
-Pregnant women should be apprised of the potential risk to the fetus.
-The prolonged elimination of this drug from the body after discontinuation should be considered in women of childbearing potential.

Animal studies have not been conducted with this drug. However, animal studies that have been reported with similar substances have shown deleterious effects on fertility, pregnancy and development. In humans, fetal abnormalities were detected on the adrenals in a limited number of exposed pregnancies; other abnormal pregnancy outcomes included preterm births and early pregnancy loss. There are no controlled data in human pregnancy.

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

Mitotane Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and after treatment discontinuation as long as drug plasma levels are detectable.
-According to some authorities: Use is contraindicated.

Excreted into human milk: Yes

Comments:
-The effects in the nursing infant or on milk production are unknown; there is a potential for serious adverse reactions.

See references

Further information

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

Medical Disclaimer