What it isAngiotensin AT1 receptor antagonist; hypertension.
Why this oneIt generally produces greater blood-pressure reduction than older ARBs, but has less long-term outcomes experience.
What limits itHyperkalemia and a hemodynamic creatinine rise require monitoring; contraindicated in pregnancy.
FDA-approved for
FDA label
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BOXED WARNING Fetal toxicity — discontinue as soon as pregnancy is detected; RAAS-acting drugs can injure and kill the developing fetus.
| FDA dosing | Population | Start | Target | Max |
| Hypertension | Adult | 80 mg QD (40 mg if on high-dose diuretics) | 80 mg QD | 80 mg QD |
Renal No adjustment needed (mild-to-severe impairment or ESRD)
Hepatic No adjustment for mild-moderate impairment; not studied in severe
Instructions
- Take once daily with or without food
- Dispense/store in original container to protect from light and moisture; do not repackage
- May be given with other antihypertensives
Contraindications
- Do not co-administer aliskiren-containing products in patients with diabetes
Cautions
- Fetal toxicity — discontinue when pregnancy detected (boxed)
- Symptomatic hypotension in volume-/salt-depleted patients — correct depletion or start at 40 mg
- Worsening renal function in RAAS-dependent patients (renal artery stenosis, severe CHF, volume depletion)
Adverse reactions
- Diarrhea (2%)
- Nausea, asthenia/fatigue, muscle spasm, dizziness, cough
- Postmarketing: angioedema, rash, pruritus
Pregnancy Can cause fetal harm (oligohydramnios, fetal/neonatal renal failure, death); discontinue when pregnancy detected
Lactation Breastfeeding not recommended
Cost, est. cash$300–$2,500/month
Generic entry2022
Classes and tags
Clinical profile
Therapeutic safety burden2 / 4
Overdose danger2 / 4
Weight-gain liability0 / 4
Sedation liability0 / 4
QT / Torsades0 / 4
Direct muscarinic antagonism0 / 4
Embryofetal risk4 / 4
Legacy pregnancy categoryD
Defining liabilityHyperkalemia, kidney injury, fetal toxicity and increased lithium exposure.
Mechanism of action: Azilsartan ballicule
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Memory aids: mascots and interaction avatars
“A zillion sartans Eat at Arby’s”
Box: minimal PK interactions
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