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Azilsartan medoxomil Pregnancy and Breastfeeding Warnings

Azilsartan medoxomil is also known as: Edarbi

Azilsartan medoxomil Pregnancy Warnings

Animal studies have revealed evidence of higher mortality among postnatal offspring. In humans, use of drugs that act on the renin angiotensin system (RAS) during the second and third trimesters increases fetal and neonatal morbidity and death. There are no controlled data in human pregnancy.

US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

UK: Use is not recommended during the first trimester of pregnancy and is contraindicated during the second and third trimesters.
US: This drug should not be used during pregnancy unless there are no alternatives and the benefit outweighs the risk to the fetus.

US FDA pregnancy category: D

Comments: Adequate methods of contraception should be encouraged.

See references

Azilsartan medoxomil Breastfeeding Warnings

Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Edarbi (azilsartan)." Takeda Pharmaceuticals America, Lincolnshire, IL.

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Edarbi (azilsartan)." Takeda Pharmaceuticals America, Lincolnshire, IL.

Further information

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

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