Two medicines, side by side
Azilsartan vs olmesartan
Azilsartan and olmesartan are both labeled for high blood pressure. Drugs@FDA records approvals of azilsartan since 2011 and of olmesartan since 2002. Pharmacies paid $5.47 per azilsartan medoxomil 40 mg tablet and $0.0805 per olmesartan medoxomil 20 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. How each works, in its label's words: Azilsartan, “Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzymes (ACE, kinase II).”; Olmesartan, “Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE, kininase II).”
Check it at the source: the azilsartan FDA label on DailyMed (effective January 23, 2024); the olmesartan FDA label on DailyMed (effective September 23, 2025).
Highlights of the azilsartan record
Azilsartan (Edarbi) · label of January 23, 2024
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.
Used for
From the label: indicationsEdarbi 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. […]
On the market
- Earliest approval on file
- February 25, 2011
- Generic labelers
- 1 labeler
- Pharmacy cost
- $5.47 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 1
Highlights of the olmesartan record
Olmesartan (Benicar) · label of September 23, 2025
FETAL TOXICITY When pregnancy is detected, discontinue Benicar 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 ( 5.1 , 8.1 ). WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue Benicar as soon as possible ( 5.1 , 8.1 ).
Used for
From the label: indicationsBenicar is indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. […]
On the market
- Earliest approval on file
- April 25, 2002
- Generic labelers
- 30 labelers
- Pharmacy cost
- $0.0805 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 2
Source: FDA drug labels via openFDA (Azilsartan label of January 23, 2024, Olmesartan label of September 23, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do azilsartan and olmesartan differ on the record?
How each works, in its label's words: Azilsartan, “Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzymes (ACE, kinase II).”; Olmesartan, “Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE, kininase II).”
Both are in FDA's class angiotensin 2 receptor blockers.
Half-life, in each label's words: Azilsartan, “The elimination half-life of azilsartan is approximately 11 hours and renal clearance is approximately 2.3 mL/min.”; Olmesartan, “Olmesartan appears to be eliminated in a biphasic manner with a terminal elimination half-life of approximately 13 …”
Both labels carry a boxed warning; the records quote them.
Generics: azilsartan since 2022; olmesartan since 2016 (Drugs@FDA).
| Azilsartan | Olmesartan | |
|---|---|---|
| Labeled for | High blood pressure | High blood pressure |
| Pharmacologic class | Angiotensin 2 Receptor Blocker | Angiotensin 2 Receptor Blocker |
| How it works (label) | Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzymes (ACE, kinase II). | Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE, kininase II). |
| Half-life (label) | The elimination half-life of azilsartan is approximately 11 hours and renal clearance is approximately 2.3 mL/min. | Olmesartan appears to be eliminated in a biphasic manner with a terminal elimination half-life of approximately 13 hours. |
| Earliest approval on file (Drugs@FDA) | February 25, 2011 | April 25, 2002 |
| First generic approved | July 20, 2022 | October 26, 2016 |
| Generic labelers (NDC) | 1 labeler | 30 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $5.47 per tablet (Azilsartan medoxomil 40 mg tablet) | $0.0805 per tablet (Olmesartan medoxomil 20 mg tablet) |
| 12-month price change | n/a | +1% |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 1 | 2 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 2,982 | 35,743 |
| DEA schedule | none | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
What next?
- Alternatives to azilsartan
- every medicine labeled for the same conditions