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Azilsartan medoxomil / chlorthalidone Pregnancy and Breastfeeding Warnings

Azilsartan medoxomil / chlorthalidone is also known as: Edarbyclor

Medically reviewed on October 30, 2017

Azilsartan medoxomil / chlorthalidone Pregnancy Warnings

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.

Animal studies have not been reported. 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.

See references

Azilsartan medoxomil / chlorthalidone Breastfeeding Warnings

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 (azilsartan); Yes (chlorthalidone)
Excreted into animal milk: Yes (azilsartan)

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Edarbyclor (azilsartan-chlorthalidone)." Takeda Pharmaceuticals America, Lincolnshire, IL.

References for breastfeeding information

  1. "Product Information. Edarbyclor (azilsartan-chlorthalidone)." Takeda Pharmaceuticals America, Lincolnshire, IL.
  2. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):

Further information

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

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