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Hydrochlorothiazide / irbesartan Pregnancy and Breastfeeding Warnings

Hydrochlorothiazide / irbesartan is also known as: Avalide

Medically reviewed on Aug 16, 2018

Hydrochlorothiazide / irbesartan Pregnancy Warnings

Animal studies with hydrochlorothiazide have failed to reveal evidence of fetal harm. Animal studies with irbesartan have revealed evidence of fetotoxicity. Early resorption and abortion occurred in rabbits at an irbesartan dose which produced maternal mortality. 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.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

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.

AU: Use is contraindicated.
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.

AU TGA pregnancy category: D
US FDA pregnancy category: D

Comments: Adequate methods of contraception should be encouraged.

See references

Hydrochlorothiazide / irbesartan 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: Yes (hydrochlorothiazide); Unknown (irbesartan)
Excreted into animal milk: Yes (irbesartan)

See references

References for pregnancy information

  1. "Product Information. Avalide (hydrochlorothiazide-irbesartan)." Bristol-Myers Squibb, Princeton, NJ.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Avalide (hydrochlorothiazide-irbesartan)." Bristol-Myers Squibb, Princeton, NJ.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

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

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