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Mitotane Pregnancy and Breastfeeding Warnings

Medically reviewed by Last updated on Mar 2, 2023.

Mitotane is also known as: Lysodren

Mitotane Pregnancy Warnings

Abnormal pregnancy outcomes such as preterm births, early pregnancy loss, fetal adrenal abnormalities have been reported in patients exposed to this drug during 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.

Use is not recommended.

US FDA pregnancy category: Not assigned.

Risk Summary: Limited cases report preterm births and early pregnancy loss in women treated with this drug during pregnancy.

-This drug can harm a developing fetus.
-Adequate methods of contraception should be encouraged.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-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.

See references

Mitotane Breastfeeding Warnings

Use is contraindicated.

Excreted into human milk: Yes

-The effects in the nursing infant are unknown.
-Breastfeeding should be discontinued during therapy and after for as long as plasma levels of this drug are detectable.

See references

References for pregnancy information

  1. "Product Information. Lysodren (mitotane)." Bristol-Myers Squibb (2001):

References for breastfeeding information

  1. "Product Information. Lysodren (mitotane)." Bristol-Myers Squibb (2001):

Further information

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