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Azilsartan medoxomil / chlorthalidone Pregnancy and Breastfeeding Warnings

Brand names: Edarbyclor

Medically reviewed by Last updated on May 20, 2024.

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: Not assigned.

Risk Summary: Discontinue this drug as soon as possible if pregnancy is detected.

Comments: Adequate methods of contraception should be encouraged.

Animal studies have revealed evidence of toxicity. In humans, use of drugs that act on the renin angiotensin system (RAS) during the second and third trimesters reduces fetal renal function and increases fetal and neonatal morbidity and death. 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

Azilsartan medoxomil / chlorthalidone Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug.

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. (2012) "Product Information. Edarbyclor (azilsartan-chlorthalidone)." Takeda Pharmaceuticals America

References for breastfeeding information

  1. (2012) "Product Information. Edarbyclor (azilsartan-chlorthalidone)." Takeda Pharmaceuticals America
  2. United States National Library of Medicine (2013) Toxnet. Toxicology Data Network.

Further information

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