Azilsartan

The Basics

What is Azilsartan?

Indicated for the treatment of mild to moderate essential hypertension.

Brand names for Azilsartan

Edarbi

How Azilsartan is classified

Antihypertensive Agents, Angiotensin II Type 1 Receptor Blockers, Angiotensin Receptor Blockers, ARBs

Azilsartan During Pregnancy

Azilsartan pregnancy category

Category D

Note that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Azilsartan while pregnant

Use of drugs that affect 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 Edarbi as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimester 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. Perform serial ultrasound examinations to assess the intra-amniotic environment. If oligohydramnios is observed, discontinue Edarbi, unless it is considered lifesaving for the mother. Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe infants with histories of in utero exposure to Edarbi for hypotension, oliguria, and hyperkalemia [see Use in Specific Populations].

Taking Azilsartan While Breastfeeding

What are recommendations for lactation if you're taking Azilsartan?

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

Maternal / infant drug levels

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

Possible effects of Azilsartan on milk supply

Relevant published information was not found as of the revision date.

Possible alternatives to Azilsartan

Captopril, Benazepril, Enalapril, Quinapril.