Hydrochlorothiazide / lisinopril Pregnancy and Breastfeeding Warnings

Brand names: Prinzide, Zestoretic

Medically reviewed by Drugs.com. Last updated on Jan 22, 2025.

Hydrochlorothiazide / lisinopril Pregnancy Warnings

Use is not recommended during the first trimester of pregnancy and is contraindicated during the second and third trimesters.
-Some experts state that 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 of pregnancy increases fetal and neonatal morbidity and death.

Comments:
-Adequate methods of contraception should be encouraged.
-Advise pregnant women and females of reproductive potential of the potential risk to a fetus.
-The manufacturer recommends discontinuing this drug as soon as possible when pregnancy is detected.

Animal studies have revealed evidence of decreased fetal weight and delayed fetal ossification in the presence of maternal weight gain. In humans, use of drugs that act on the RAS during the second and third trimesters increases fetal and neonatal toxicity 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.

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Hydrochlorothiazide / lisinopril 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 (lisinopril)
Excreted into animal milk: Yes (lisinopril)

Comments: The effects in the nursing infant are unknown.

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Further information

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