Two medicines, side by side
Olmesartan vs valsartan
Olmesartan and valsartan are both labeled for high blood pressure. Drugs@FDA records approvals of olmesartan since 2002 and of valsartan since 1996. Pharmacies paid $0.0805 per olmesartan medoxomil 20 mg tablet and $0.0963 per valsartan 40 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: Olmesartan, “Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE, kininase II).”; Valsartan, “Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II).”
Check it at the source: the olmesartan FDA label on DailyMed (effective September 23, 2025); the valsartan FDA label on DailyMed (effective August 5, 2026).
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
Highlights of the valsartan record
Valsartan (Diovan) · label of August 5, 2026
FETAL TOXICITY
When pregnancy is detected, discontinue valsartan tablets as soon as possible. ( 5.1 )
Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1 ) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue valsartan tablets as soon as possible. ( 5.1 ).
Used for
From the label: indicationsValsartan tablets are an angiotensin II receptor blocker (ARB) indicated for: • Hypertension, to lower blood pressure in adults and children 6 years and older. […]
On the market
- Earliest approval on file
- December 23, 1996
- Generic labelers
- 34 labelers
- Pharmacy cost
- $0.0963 per tablet
Supply and safety
- Shortage
- A presentation being discontinued
- Recalls
- 58
Source: FDA drug labels via openFDA (Olmesartan label of September 23, 2025, Valsartan label of August 5, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do olmesartan and valsartan differ on the record?
How each works, in its label's words: Olmesartan, “Angiotensin II is formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE, kininase II).”; Valsartan, “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: Olmesartan, “Olmesartan appears to be eliminated in a biphasic manner with a terminal elimination half-life of approximately 13 …”; Valsartan, “Valsartan shows bi-exponential decay kinetics following intravenous administration, with an average elimination …”
Both labels carry a boxed warning; the records quote them.
Generics: olmesartan since 2016; valsartan since 2014 (Drugs@FDA).
| Olmesartan | Valsartan | |
|---|---|---|
| Labeled for | High blood pressure | High blood pressure, Heart failure |
| 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 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) | Olmesartan appears to be eliminated in a biphasic manner with a terminal elimination half-life of approximately 13 hours. | Valsartan shows bi-exponential decay kinetics following intravenous administration, with an average elimination half-life of about 6 hours. |
| Earliest approval on file (Drugs@FDA) | April 25, 2002 | December 23, 1996 |
| First generic approved | October 26, 2016 | June 26, 2014 |
| Generic labelers (NDC) | 30 labelers | 34 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.0805 per tablet (Olmesartan medoxomil 20 mg tablet) | $0.0963 per tablet (Valsartan 40 mg tablet) |
| 12-month price change | +1% | -21% |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | A presentation being discontinued |
| Recalls recorded | 2 | 58 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 35,743 | 104,490 |
| 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 olmesartan
- every medicine labeled for the same conditions