Skip to Content
Learn about Adcetris a treatment of Hodgkin Lymphoma

Raloxifene Pregnancy and Breastfeeding Warnings

Raloxifene is also known as: Evista

Medically reviewed on October 6, 2017

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 X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Use is contraindicated in women who are or may become pregnant.

AU TGA pregnancy category: X
US FDA pregnancy category: X

See references

Raloxifene Breastfeeding Warnings

US: Use is contraindicated in nursing mothers.
AU, UK: Use is not recommended in breastfeeding women.

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

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Raloxifene (raloxifene)." Prasco Laboratories, Cincinnati, OH.
  3. 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

Further information

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