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Estradiol / levonorgestrel Pregnancy and Breastfeeding Warnings

Brand names: Climara Pro

Medically reviewed by Drugs.com. Last updated on Aug 28, 2023.

Estradiol / levonorgestrel Pregnancy Warnings

There appears to be little or no increased risk of birth defects in children born to mothers who have used estrogens and progestins as oral contraceptives inadvertently during early pregnancy. 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.

Use is not indicated during pregnancy

US FDA pregnancy category: Not assigned

Comments:
-If pregnancy occurs, discontinue treatment immediately.

See references

Estradiol / levonorgestrel Breastfeeding Warnings

Use is not recommended.

Excreted into human milk: Yes

Comments:
-Estrogen use during lactation has been shown to decrease the quantity and quality of breast milk.
-Detectable amounts of estrogens and progestins have been found in breast milk.

See references

See also

References for pregnancy information

  1. Product Information. Climara Pro (estradiol-levonorgestrel). Berlex Laboratories. 2003.
  2. Cerner Multum, Inc. UK Summary of Product Characteristics.

References for breastfeeding information

  1. Product Information. Climara Pro (estradiol-levonorgestrel). Berlex Laboratories. 2003.
  2. Cerner Multum, Inc. UK Summary of Product Characteristics.

Further information

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

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