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Ospemifene Pregnancy and Breastfeeding Warnings

Brand names: Osphena

Medically reviewed by Last updated on Jan 22, 2024.

Ospemifene Pregnancy Warnings


US FDA pregnancy category: Not assigned

Risk Summary: This drug is contraindicated in women who are or may become pregnant as it may cause fetal harm.

-This drug is not indicated in women of childbearing potential.
-If pregnancy occurs while taking this drug, the patient should be advised of the potential hazard to the fetus.

Animal studies found embryofetal lethality, neonatal mortality, and difficult labor at maternally toxic doses. Animals given doses of 0.8% to 4% the human exposure based on surface area mg/m2, had prolonged and difficult gestation, increased postimplantation loss, increased number of offspring deaths, and an increased incidence of postnatal loss. The effect on fertility was not directly evaluated, but female animals experienced decreases in ovarian and uterine weights, decreased corpora lutea number, increased ovarian cysts, uterine atrophy, and disrupted cycles; and atrophy of the prostate and seminal vesicles was observed in male animals. There are no controlled data in human 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.

See references

Ospemifene Breastfeeding Warnings

A nonclinical study detected this drug in animal milk at concentrations higher than in maternal plasma.

Not recommended

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

-This drug is not indicated in women who are breastfeeding.

See references

References for pregnancy information

  1. Product Information. Osphena (ospemifene). Shionogi USA Inc. 2013.

References for breastfeeding information

  1. Product Information. Osphena (ospemifene). Shionogi USA Inc. 2013.

Further information

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