Aliskiren / hydrochlorothiazide Pregnancy and Breastfeeding Warnings

Brand names: Tekturna HCT

Medically reviewed by Drugs.com. Last updated on Aug 14, 2023.

Aliskiren / hydrochlorothiazide Pregnancy Warnings

Animal studies with aliskiren have revealed evidence of fetotoxicity. Animal studies with hydrochlorothiazide have failed to reveal evidence of fetal harm. In humans, use of drugs that act on RAS during the second and third trimesters can cause the following: reduced fetal renal function leading to anuria and renal failure, oligohydramnios, fetal lung hypoplasia and skeletal deformations including skull hypoplasia, hypotension, 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.

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: Use of drugs that act on the renin angiotensin system (RAS) during the second and third trimesters increases fetal and neonatal morbidity and death.

Comments: Adequate methods of contraception should be encouraged.

See references

Aliskiren / hydrochlorothiazide Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug.

Excreted into human milk: Unknown (aliskiren); Yes (hydrochlorothiazide)
Excreted into animal milk: Yes (aliskiren)

See references

Further information

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

Medical Disclaimer