Two medicines, side by side
Irbesartan vs olmesartan
Irbesartan and olmesartan are both labeled for high blood pressure. Drugs@FDA records approvals of irbesartan since 1997 and of olmesartan since 2002. Pharmacies paid $0.107 per irbesartan 150 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: Irbesartan, “Angiotensin II is a potent vasoconstrictor formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase 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 irbesartan FDA label on DailyMed (effective August 6, 2026); the olmesartan FDA label on DailyMed (effective September 23, 2025).
Highlights of the irbesartan record
Irbesartan (Avapro) · label of August 6, 2026
FETAL TOXICITY
When pregnancy is detected, discontinue irbesartan tablets 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.
Used for
From the label: indicationsIrbesartan is an angiotensin II receptor blocker (ARB) indicated for: • Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) Treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. […]
On the market
- Earliest approval on file
- September 30, 1997
- Generic labelers
- 23 labelers
- Pharmacy cost
- $0.107 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 10
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 (Irbesartan label of August 6, 2026, Olmesartan label of September 23, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do irbesartan and olmesartan differ on the record?
How each works, in its label's words: Irbesartan, “Angiotensin II is a potent vasoconstrictor formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase 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: Irbesartan, “The terminal elimination half-life of irbesartan averages 11 to 15 hours.”; 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: irbesartan since 2012; olmesartan since 2016 (Drugs@FDA).
| Irbesartan | Olmesartan | |
|---|---|---|
| Labeled for | High blood pressure, Chronic kidney disease | High blood pressure |
| Pharmacologic class | Angiotensin 2 Receptor Blocker | Angiotensin 2 Receptor Blocker |
| How it works (label) | Angiotensin II is a potent vasoconstrictor formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). | Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE, kininase II). |
| Half-life (label) | The terminal elimination half-life of irbesartan averages 11 to 15 hours. | 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) | September 30, 1997 | April 25, 2002 |
| First generic approved | March 30, 2012 | October 26, 2016 |
| Generic labelers (NDC) | 23 labelers | 30 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.107 per tablet (Irbesartan 150 mg tablet) | $0.0805 per tablet (Olmesartan medoxomil 20 mg tablet) |
| 12-month price change | -8% | +1% |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 10 | 2 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 44,400 | 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 irbesartan
- every medicine labeled for the same conditions