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Cyclophosphamide Pregnancy and Breastfeeding Warnings

Cyclophosphamide is also known as: Cytoxan, Cytoxan Lyophilized, Neosar

Medically reviewed by Last updated on Sep 14, 2020.

Cyclophosphamide Pregnancy Warnings

Use is contraindicated.

AU TGA pregnancy category: D
US FDA pregnancy category: D

-This drug can cause fetal harm when administered to a pregnant woman.
-Advise female patients of reproductive potential to avoid becoming pregnant and to use effective contraception during treatment and for up to 1 year after completion of 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.
-This drug may cause sterility in both males and females.

Malformations of the skeleton, palate, limbs, and eyes as well as miscarriage have been reported after exposure to this drug during the first trimester. Fetal growth retardation and toxic effects manifesting in the newborn, including leukopenia, anemia, pancytopenia, severe bone marrow hypoplasia, and gastroenteritis have been reported after exposure to this drug.

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 D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Cyclophosphamide Breastfeeding Warnings

The American Academy of Pediatrics considers breastfeeding to be contraindicated during maternal antineoplastic drug therapy (especially alkylating agents). Neutropenia, thrombocytopenia, and immune suppression have been observed in infants whose mothers were receiving this drug during lactation. The drug also has an unacceptable risk of carcinogenesis.

Use should be avoided.

Excreted into human milk: Yes

-This drug can harm a nursing infant.
-Chemotherapy may adversely affect the normal microbiome and chemical makeup of breastmilk.
-Women who receive chemotherapy during pregnancy are more likely to have difficulty nursing their infant.

See references

References for pregnancy information

  1. "Product Information. Cyclophosphamide (cyclophosphamide)." Amneal Biosciences LLC, Bridgewater, NJ.

References for breastfeeding information

  1. "Product Information. Cyclophosphamide (cyclophosphamide)." Amneal Biosciences LLC, Bridgewater, NJ.
  2. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):

Further information

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