Prescription medicine
Azilsartan Brand names: Edarbi
Azilsartan (Edarbi) is a prescription medicine with an FDA approval on record since 2011. FDA's NDC Directory lists it from 1 generic labeler, and pharmacies paid $5.47 per azilsartan medoxomil 40 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the azilsartan FDA label on DailyMed (effective January 23, 2024, Azurity Pharmaceuticals, Inc.); the NDA 200796 record on Drugs@FDA; every azilsartan label on DailyMed.
Highlights of the record
FDA label of January 23, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
FETAL TOXICITY.
When pregnancy is detected, discontinue Edarbi as soon as possible [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ]. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ]. WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue Edarbi as soon as possible. ( 5.1 , 8.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
Used for
From the label: indications and usageEdarbi is indicated for the treatment of hypertension in adults, to lower blood pressure.
Forms and strengths
- 40 mg
- 80 mg
Tablet.
On the market
- Earliest approval on file
- February 25, 2011 Edarbi, Azurity; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first July 20, 2022; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 1 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- March 26, 2028 Edarbi tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $5.47 per tablet Azilsartan medoxomil 40 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2021 0 Class I among all firms' recalls; latest March 15, 2021
- FAERS reports
- 2,982 through July 30, 2026
What is azilsartan used for?
From the label: indications and usageEdarbi is indicated for the treatment of hypertension in adults, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with Edarbi. […]
Conditions named in the indications of azilsartan's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Angiotensin 2 Receptor Blocker.
Source: FDA drug label (Edarbi), Azurity Pharmaceuticals, Inc., effective January 23, 2024 (SPL set 52b27c75-9f5a-4816-bafd-dace9d7d2063), via openFDA; the full label on DailyMed
What does the patient leaflet for azilsartan say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about Edarbi?Edarbi can cause harm or death to your unborn baby. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. If you become pregnant while taking Edarbi, tell your doctor right away. Your doctor may switch you to a different medicine to treat your high blood pressure.
Source: FDA drug label (Edarbi), Azurity Pharmaceuticals, Inc., effective January 23, 2024 (SPL set 52b27c75-9f5a-4816-bafd-dace9d7d2063), via openFDA; the full label on DailyMed
Is there a generic for azilsartan (Edarbi)?
The FDA approved the first generic azilsartan on July 20, 2022. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists azilsartan from 1 labeler under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 1 patent for Edarbi tablets, the last expiring on March 26, 2028. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2011 earliest approval on file
- 2022 first generic approved
- 2028 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for azilsartan (Edarbi)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $5.47 per Azilsartan medoxomil 40 mg tablet. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Azilsartan medoxomil 40 mg tablet (generic)
- Edarbi 40 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Azilsartan medoxomil 40 mg tablet | Generic | $5.47 per tablet | $164.00 | n/a |
| Azilsartan medoxomil 80 mg tablet | Generic | $5.81 per tablet | $174.31 | n/a |
| Edarbi 40 mg tablet | Brand | $8.28 per tablet | $248.55 | -0.2% |
| Edarbi 80 mg tablet | Brand | $9.01 per tablet | $270.27 | +0.2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has azilsartan been recalled?
The FDA's Enforcement Report lists 1 recall naming azilsartan since 2021: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the azilsartan label say about other medicines?
The azilsartan label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name azilsartan. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aliskiren | drug interactions | 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. |
| Lithium | drug interactions | Increases in serum lithium concentrations and lithium toxicity. |
Source: FDA drug label (Edarbi), Azurity Pharmaceuticals, Inc., effective January 23, 2024 (SPL set 52b27c75-9f5a-4816-bafd-dace9d7d2063), via openFDA; the full label on DailyMed
What do FAERS reports show for azilsartan?
The FDA Adverse Event Reporting System holds 2,982 reports that list azilsartan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 250 are coded as a death and 1,110 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as azilsartan?
71 other medicines are given the same way (oral) and in the same FDA class as azilsartan or labeled mainly for the same use (high blood pressure), the same class first. High blood pressure lists all 88 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Losartan | High blood pressure | 44 labelers | $0.0327 per tablet 50 mg tablet | No current entry |
| Valsartan | High blood pressure | 34 labelers | $0.0963 per tablet 40 mg tablet | A presentation being discontinued |
| Olmesartan | High blood pressure | 31 labelers | $0.0805 per tablet 20 mg tablet | No current entry |
| Hydrochlorothiazide and losartan | High blood pressure | 29 labelers | $0.0762 per tablet 100-12.5 mg tablet | No current entry |
| Hydrochlorothiazide and valsartan | High blood pressure | 18 labelers | $0.101 per tablet 160-12.5 mg tablet | No current entry |
| Irbesartan | High blood pressure | 23 labelers | $0.107 per tablet 150 mg tablet | No current entry |
| Telmisartan | High blood pressure | 28 labelers | $0.106 per tablet 20 mg tablet | No current entry |
| Hydrochlorothiazide and olmesartan | High blood pressure | 17 labelers | $0.165 per tablet 20-12.5 mg tablet | No current entry |
Every medicine labeled for the same conditions as azilsartan
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does azilsartan compare with medicines for the same use?
2 side-by-side pages set azilsartan beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to azilsartan
- 71 medicines for the same use
- Other ARBs
- the pharmacologic class, with prices and generics
- Azilsartan side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other