Temozolomide Pregnancy and Breastfeeding Warnings

Brand names: Temodar

Medically reviewed by Drugs.com. Last updated on Jun 2, 2025.

Temozolomide Pregnancy Warnings

Use is not recommended in women who are pregnant or contemplating pregnancy.
-According to some authorities: Use is contraindicated in women who are pregnant or contemplating pregnancy.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned

Risk summary: Based on the mechanism of action and findings in animals, this drug can cause fetal harm when administered to a pregnant woman.

Comments: Encourage use of adequate methods of contraception in male and female patients during treatment and for at least 6 months following the last dose.

Animal studies have shown teratogenicity at doses higher than the maximum dose used clinically. Fetal malformations of the external organs, soft tissues, and skeleton occurred. Embryolethality occurred in animal studies as indicated by increased resorptions. There are no controlled data in human pregnancy.

Male patients should be advised to seek advice regarding cryopreservation of sperm prior to treatment due to the possibility of irreversible infertility.

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 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

Temozolomide Breastfeeding Warnings

AU: Use is contraindicated.
UK and US: Breastfeeding is not recommended during use of this drug.

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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