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Fulvestrant Pregnancy and Breastfeeding Warnings

Fulvestrant is also known as: Faslodex

Medically reviewed by Last updated on Apr 16, 2019.

Fulvestrant Pregnancy Warnings

Animal studies have shown reproductive toxicity including an increased incidence of fetal abnormalities and deaths. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.

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.


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

Risk Summary: Based on findings from animal studies and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, administration during organogenesis caused embryofetal toxicity, including skeletal malformations and fetal loss, at daily doses that were 6% and 30% of the maximum recommended human dose based on mg/m2, respectively.

-Adequate methods of contraception should be encouraged.
-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.
-Pregnancy testing is recommended for females of reproductive potential within 7 days prior to initiating this drug.
-Advise females of reproductive potential to use effective contraception during therapy and for one year after the last dose.

See references

Fulvestrant Breastfeeding Warnings


Excreted into human milk: Unknown
Excreted into animal milk: Yes

-This drug can potentially harm a nursing infant.

This drug is found in rat milk at levels significantly higher than plasma after administration of 2 mg/kg.

See references

References for pregnancy information

  1. "Product Information. Faslodex (fulvestrant)." Astra-Zeneca Pharmaceuticals, Wilmington, DE.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Faslodex (fulvestrant)." Astra-Zeneca Pharmaceuticals, Wilmington, DE.

Further information

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