Azilsartan
Azilsartan is an angiotensin II receptor blocker (ARB) used to treat high blood pressure in adults.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 3 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Azilsartan (Edarbi) is an ARB (angiotensin receptor blocker) that lowers high blood pressure in adults by keeping the hormone angiotensin II from tightening blood vessels, a newer member of a standard first-choice family, on the U.S. market since about 2011 and available as a generic. Most people tolerate it well, and the usual complaints are mild diarrhea or lightheadedness on standing. The boxed warning is about pregnancy, because it can injure or kill a developing baby, so stop it and call your prescriber as soon as you know you are pregnant. Expect a blood test of kidney function after starting, particularly if you are 75 or older or take a water pill.
Clinical pearls
- With diabetes, never combine it with aliskiren, and pairing it with an ACE inhibitor also raises potassium and kidney risks.
- Regular ibuprofen or naproxen can blunt its effect and strain the kidneys, and acetaminophen is usually the gentler choice for headaches.
- If you take lithium, expect extra blood level checks, because azilsartan can push lithium toward toxic levels.
- Store it in the original container to shield it from light and moisture, and it works the same with or without food.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
WARNING: This drug can harm or kill an unborn baby. If you find out you are pregnant while taking azilsartan medoxomil, stop taking it as soon as possible and call your doctor right away. Medicines that affect the renin-angiotensin system — the hormone pathway this drug targets — can cause severe kidney problems, low blood pressure, skull malformations, and even death in a developing fetus, especially during the second and third trimesters of pregnancy.
Patient information guide A plain-language walkthrough of Azilsartan, written from its FDA label.
What Azilsartan is used for
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Azilsartan is an angiotensin II receptor blocker (ARB) approved to treat high blood pressure in adults. Both the generic product Azilsartan Medoxomil and the brand Edarbi share this indication.
- Azilsartan Medoxomil tablets: treatment of high blood pressure (hypertension) in adults, to lower blood pressure and reduce the risk of stroke and heart attack.
- Edarbi tablets: treatment of high blood pressure (hypertension) in adults, to lower blood pressure and reduce the risk of stroke and heart attack.
- Both products may be used as a single therapy or combined with other antihypertensive (blood pressure-lowering) medicines.
How Azilsartan works
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Your body uses a hormone called angiotensin II to tighten blood vessels and raise blood pressure. Azilsartan selectively blocks the AT1 receptor — the main docking site angiotensin II uses to cause that tightening. With that receptor blocked, blood vessels stay more relaxed, and blood pressure falls. Because azilsartan works directly at the receptor rather than stopping angiotensin II from being produced (the way ACE inhibitors do), it does not interfere with bradykinin, a separate compound that ACE inhibitors can build up and that often causes a persistent dry cough.
Azilsartan has a very high preference for the AT1 receptor — more than 10,000 times stronger affinity for it than for the AT2 receptor — which helps focus its action on blood pressure control.
Azilsartan dosage
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Azilsartan medoxomil tablets are taken once a day by mouth. They can be taken with or without food — eating does not change how much of the drug your body absorbs. Steady, consistent drug levels build up within about five days of starting treatment.
- If you are already on a high-dose diuretic (water pill), your prescriber may start you at a lower dose to reduce the chance of a blood pressure drop.
- Store tablets in the original container — both Azilsartan Medoxomil and Edarbi packaging is designed to protect against light and moisture.
- Never stop taking it without talking to your doctor, even if you feel well — high blood pressure often has no symptoms.
Dosing details from the FDA-approved label
From the Azilsartan prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Adults (recommended dose)
- 80 mg taken orally once daily
- May be taken with or without food; may be administered with other antihypertensive agents
- Patients treated with high doses of diuretics
- Consider a starting dose of 40 mg
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION The recommended dose in adults is 80 mg taken once daily. Consider a starting dose of 40 mg for patients who are treated with high doses of diuretics. ( 2.1 ) Azilsartan medoxomil tablets may be administered with or without food. ( 2.1 ) Azilsartan medoxomil may be administered with other antihypertensive agents. ( 2.1 ) 2.1 Recommended Dose The recommended dose in adults is 80 mg taken orally once daily. Consider a starting dose of 40 mg for patients who are treated with high doses of diuretics. 2.2 Handling Instructions Do not repackage azilsartan medoxomil tablets. Dispense and store azilsartan medoxomil tablets in its original container to protect azilsartan medoxomil tablets from light and moisture.
Read the full Dosage and Administration section on DailyMed →
Azilsartan side effects
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Most people tolerate azilsartan well. The most commonly reported side effects include:
Common side effects
- Diarrhea
- Nausea
- Dizziness or lightheadedness
- Low blood pressure when standing up (postural dizziness)
- Fatigue or weakness
- Muscle spasm
- Cough
- Rash or itching (reported after market release)
When to get medical help
- Call your doctor right away if you feel faint, very dizzy, or lightheaded — especially when standing up — as this may signal a dangerous drop in blood pressure.
- Seek emergency care if you notice swelling of the face, lips, tongue, or throat (angioedema — a rare but serious allergic reaction).
- Tell your doctor immediately if you notice a significant decrease in urination, which could signal kidney problems.
- Stop taking this medicine and contact your doctor as soon as you find out you are pregnant — this drug can cause serious harm or death to a developing baby.
Azilsartan warnings and precautions
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- Pregnancy: This is the most critical warning. Azilsartan can seriously harm or kill an unborn baby, especially if taken in the second or third trimester. Stop the medicine as soon as pregnancy is confirmed and call your doctor immediately.
- Low blood pressure: People who are dehydrated, on a low-sodium diet, or taking high-dose diuretics may experience a sudden, significant blood pressure drop when starting azilsartan. Your prescriber may adjust your starting dose to reduce this risk.
- Kidney function: In people whose kidneys depend heavily on the renin-angiotensin system — such as those with severe heart failure, kidney artery narrowing (renal artery stenosis), or severe dehydration — this drug can cause worsening kidney function or, rarely, acute kidney failure. Kidney function should be monitored in these patients.
- Angioedema (severe swelling): Swelling of the face, lips, tongue, or throat has been reported after the drug came to market. Seek emergency help immediately if this happens.
Azilsartan interactions
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Tell your prescriber and pharmacist about all medicines, vitamins, and supplements you take. Key interactions to know about include:
- Aliskiren (another blood pressure medicine that also acts on the renin-angiotensin system): must not be combined in patients with diabetes; should be avoided in patients with kidney disease due to risk of low blood pressure, high potassium, and kidney problems.
- ACE inhibitors or other ARBs: combining two drugs that both block the renin-angiotensin system raises the risk of low blood pressure, high potassium (hyperkalemia), and kidney damage — generally avoid this combination.
- NSAIDs and COX-2 inhibitors (like ibuprofen, naproxen, or celecoxib): can reduce azilsartan's blood pressure-lowering effect and may worsen kidney function, particularly in older adults or those who are dehydrated.
- Lithium: azilsartan may cause lithium to build up in the blood, increasing the risk of lithium toxicity.
Interactions listed in the FDA-approved label
From the Azilsartan prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension and hyperkalemia.
- Lithium: Increases in serum lithium concentrations and lithium toxicity.
- Non-steroidal anti-inflammatory agents, including selective COX-2 inhibitors: In patients who are elderly, volume-depleted (including those on diuretic therapy) or who have compromised renal function, coadministration may result in deterioration of renal function, including possible acute renal failure, and may attenuate the antihypertensive effect of azilsartan. Monitor renal function periodically in patients receiving azilsartan and NSAID therapy.
- Dual blockade of the RAS with ACE inhibitors, other angiotensin receptor blockers or aliskiren: Associated with increased risks of hypotension, hyperkalemia and changes in renal function (including acute renal failure) compared to monotherapy; most patients do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes. Do not coadminister aliskiren in patients with diabetes. Avoid use of aliskiren in patients with renal impairment.
Read the label’s full interactions text
7 DRUG INTERACTIONS Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension and hyperkalemia. ( 7 ) Lithium: Increases in serum lithium concentrations and lithium toxicity. ( 7 ) 7.1 Non-steroidal Anti-Inflammatory Agents, including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors) In patients who are elderly, volume-depleted (including those on diuretic therapy) or who have compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including azilsartan, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving azilsartan and NSAID therapy. The antihypertensive effect of angiotensin II receptor antagonists, including azilsartan, may be attenuated by NSAIDs, including selective COX-2 inhibitors. 7.2 Dual Blockade of the Renin-Angiotensin System (RAS) Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors or aliskiren is associated with increased risks of hypotension, hyperkalemia and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function and electrolytes in patients on azilsartan medoxomil tablets and other agents that affect the RAS. Do not coadminister aliskiren with azilsartan medoxomil tablets in patients with diabetes. Avoid use of aliskiren with azilsartan medoxomil tablets in patients with renal impairment (GFR <60 mL/min). 7.3 Lithium Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor agonists. Monitor serum lithium levels during concomitant use.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Azilsartan
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- Pregnancy: Do not take azilsartan if you are pregnant or may become pregnant — it can seriously harm or kill the baby. Use effective contraception and tell your doctor immediately if you become pregnant.
- Breastfeeding: Breastfeeding is not recommended while taking this drug due to potential risk to the nursing infant.
- Children under 2: This drug is not recommended for children younger than 2 years of age.
- Children and adolescents: Safety and effectiveness in pediatric patients have not been established.
- Adults 75 and older: More likely to have elevated creatinine levels (a sign of kidney stress); kidney function should be checked regularly.
- Diabetes: Do not take azilsartan together with aliskiren if you have diabetes.
- Kidney disease: Dose adjustment is not required for mild-to-severe kidney impairment, but kidney function should be monitored. Avoid combining with aliskiren if you have kidney impairment.
- Liver disease: No dose adjustment is needed for mild or moderate liver impairment. The drug has not been studied in severe liver impairment.
- Dehydration or low-sodium diet: Tell your doctor — you may be at higher risk for a blood pressure drop when starting treatment.
Azilsartan overdose
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There is limited information on azilsartan overdose in humans. In clinical studies, higher-than-normal doses given to healthy subjects for one week were generally well tolerated. If an overdose is suspected, supportive care based on the person's condition is the recommended approach. Importantly, azilsartan cannot be removed from the body by dialysis.
What Azilsartan does in the body
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Azilsartan blocks the blood-vessel-tightening effects of angiotensin II in a dose-related way — meaning higher doses produce a stronger effect. After a single dose, it can block most of the blood-pressure-raising response to angiotensin II at peak effect, with meaningful blockade still present 24 hours later. The drug lowers aldosterone levels (a hormone that promotes sodium retention) without causing clinically significant changes in blood potassium or sodium levels. Studies in healthy volunteers found no evidence that azilsartan prolongs the QT interval — the heart's electrical recovery time — even at very high doses.
How your body processes Azilsartan
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After you swallow an azilsartan medoxomil tablet, it is converted in the gut to its active form, azilsartan — the prodrug itself is not detectable in the blood. Peak blood levels of azilsartan are reached within about 1.5 to 3 hours, and food does not affect absorption. The drug is eliminated slowly, with a half-life of about 11 hours, which is why once-daily dosing maintains steady coverage. Azilsartan is processed mainly by a liver enzyme called CYP2C9 and cleared roughly half through feces and half through urine; it cannot be removed by dialysis.
How to store Azilsartan
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Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) . Protect from moisture and light. store in original container.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Azilsartan
182 supplements and herbal products have documented interactions with Azilsartan in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 4
- Moderate · 145
- Minor · 33
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Nutrient depletion considerations
Azilsartan has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
Azilsartan: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Azilsartan — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is azilsartan used for?
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Does it matter if I take it with food or on an empty stomach?
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What side effects should I actually watch for?
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I take ibuprofen sometimes for headaches. Is that a problem?
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I just found out I'm pregnant. What do I do?
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Do I need to keep taking this even when my blood pressure feels normal?
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Is Azilsartan available over the counter?
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When was Azilsartan first available?
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Who makes Azilsartan?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Azilsartan on HelloPharmacist
Azilsartan forms and strengths (how it comes)
Azilsartan is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Azilsartan Medoxomil tablets are used to treat high blood pressure (hypertension) in adults.
- Edarbi tablets are used to treat high blood pressure (hypertension) in adults.
- Both products may be used alone or combined with other blood pressure medicines.
- Lowering blood pressure with these tablets reduces the risk of stroke and heart attack.
- Azilsartan Medoxomil tablets are taken by mouth once daily, with or without food.
- Edarbi tablets are taken by mouth once daily, with or without food.
- Azilsartan Medoxomil tablets must be stored in their original container to protect them from light and moisture — do not repackage.
- Edarbi tablets must be stored in their original container to protect them from light and moisture — do not repackage.
Azilsartan on the U.S. market: products, makers and brands
How Azilsartan appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
3 companies list 6 Azilsartan product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2011. Brand names on the directory include Edarbi, Azilsartan Medoxomil; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (6) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Azilsartan is used (Medicaid data)
A general measure of how commonly Azilsartan is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Azilsartan is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Azilsartan prescribed? Of the 1,601 medications we measure, Azilsartan ranks #1,104 by Medicaid prescriptions — more than 31% of them.
Utilization by Azilsartan product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
azilsartan medoxomil 80 MG Oral Tablet Most dispensed
Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1091652
azilsartan medoxomil 40 MG Oral Tablet
Summed across the 1 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1091646
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Azilsartan, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 12 listed Azilsartan NDCs with Medicaid activity.
Compare Azilsartan products
A representative set of FDA-listed product records for Azilsartan — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 40 mg | Oral | Azurity Pharmaceuticals, Inc. | NDA | View NDC → |
| 80 mg | Oral | Azurity Pharmaceuticals, Inc. | NDA | View NDC → |
| 40 mg | Oral | Lupin Pharmaceuticals, Inc. | ANDA | View NDC → |
| 80 mg | Oral | Lupin Pharmaceuticals, Inc. | ANDA | View NDC → |
| 40 mg | Oral | Wilshire Pharmaceuticals, Inc. | NDA | View NDC → |
| 80 mg | Oral | Wilshire Pharmaceuticals, Inc. | NDA | View NDC → |
Showing 6 of 6 products — FDA National Drug Code Directory. See every product, package size and price: browse all 6 Azilsartan NDCs →
Azilsartan side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Azilsartan — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Azilsartan in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Azilsartan FDA approval history
How Azilsartan went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Azilsartan recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Azilsartan recalls since July 2021.
✅No Azilsartan recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1091643 1 dose form · 2 strengths
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Dose form (SCDF) Oral Tablet RxCUI 1091645In current FDA listings
Look up RxCUI 1091643 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Azilsartan supply and shortage status
Whether Azilsartan is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Azilsartan costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet · Oral | 40 mg | $5.47 per tablet | NDC details & price history |
| Tablet · Oral | 80 mg | $5.81 per tablet | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Azilsartan brand names
Azilsartan is sold under 2 brand names in the FDA directory — Edarbi, Azilsartan Medoxomil. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Azilsartan: manufacturers and labelers
3 companies list Azilsartan products with the FDA. By number of product records, the largest are Azurity Pharmaceuticals, Inc., Lupin Pharmaceuticals, Inc., Wilshire Pharmaceuticals, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Azilsartan drug class (RxNorm)
Azilsartan belongs to the Angiotensin 2 Receptor Blocker class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Azilsartan page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Wilshire Pharmaceuticals, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →