Can I take irbesartan while pregnant or breastfeeding?

8.1 Pregnancy Pregnancy Category D Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue irbesartan as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimesters of pregnancy. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus. In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus.

Prescribing label, section “8.1 Pregnancy” (opening excerpt): Irbesartan (oral), Bryant Ranch Prepack. Read the full section on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.

Because no information is available on the use of irbesartan during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

“Summary of Use during Lactation”, LactMed record “Irbesartan” (LM728), quoted verbatim. Everything LactMed reports about Irbesartan while breastfeeding.

Nursing Mothers It is not known whether irbesartan is excreted in human milk, but irbesartan or some metabolite of irbesartan is secreted at low concentration in the milk of lactating rats. Because of the potential for adverse effects on the nursing infant, discontinue nursing or discontinue irbesartan.

Prescribing label, section “Nursing Mothers”: Irbesartan (oral), Bryant Ranch Prepack. Label on DailyMed. Quoted verbatim; US labels are written for US prescribers and patients.