Skip to main content

Raloxifene Pregnancy and Breastfeeding Warnings

Medically reviewed by Last updated on Mar 20, 2023.

Raloxifene is also known as: Evista

Raloxifene Pregnancy Warnings

Animal studies have revealed fetal malformations, reproductive system abnormalities, and impaired reproductive function in female offspring. Adverse effects observed in animals included abortion, fetal heart anomalies, hydrocephaly, retardation of fetal development, delayed and disrupted parturition, decreased neonatal survival, altered physical development, sex- and age-specific reductions in growth, changes in pituitary hormone content, developmental abnormalities, decreased lymphoid compartment size, uterine hypoplasia, and reduced fertility. There are no controlled data in human pregnancy.

AU TGA pregnancy category X: Drugs which have such a high risk of causing permanent damage to the fetus that they should not be used in pregnancy or when there is a possibility of 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 contraindicated.

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

Risk Summary: Based on mechanism of action, this drug may block the important functions that estrogen has during all stages of pregnancy.

-This drug is only for use in post-menopausal women.
-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

Raloxifene Breastfeeding Warnings

Use is contraindicated.

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

Comments: This drug may affect the development of the nursing infant.

Animal studies have revealed oral administration of this drug during lactation and pregnancy caused suppression of pup growth during lactation; histopathological changes in the reproductive system and impaired fertility of female offspring were also observed.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Raloxifene (raloxifene)." Prasco Laboratories (2016):

References for breastfeeding information

  1. Althouse R, Maynard C, Cerqueira MD, Olsufka M, Ritchie JL, Kennedy JW "The Western Washington Myocardial Infarction Registry and Emergency Department Tissue Plasminogen Activator Treatment Trial." Am J Cardiol 66 (1990): 1298-303
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Raloxifene (raloxifene)." Prasco Laboratories (2016):

Further information

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