Two medicines, side by side
Irbesartan vs valsartan
Irbesartan and valsartan are both labeled for high blood pressure. Drugs@FDA records approvals of irbesartan since 1997 and of valsartan since 1996. Pharmacies paid $0.107 per irbesartan 150 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: Irbesartan, “Angiotensin II is a potent vasoconstrictor 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 irbesartan FDA label on DailyMed (effective August 6, 2026); the valsartan FDA label on DailyMed (effective August 5, 2026).
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 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 (Irbesartan label of August 6, 2026, Valsartan label of August 5, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do irbesartan and valsartan 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).”; 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: Irbesartan, “The terminal elimination half-life of irbesartan averages 11 to 15 hours.”; 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: irbesartan since 2012; valsartan since 2014 (Drugs@FDA).
| Irbesartan | Valsartan | |
|---|---|---|
| Labeled for | High blood pressure, Chronic kidney disease | High blood pressure, Heart failure |
| 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. | 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) | September 30, 1997 | December 23, 1996 |
| First generic approved | March 30, 2012 | June 26, 2014 |
| Generic labelers (NDC) | 23 labelers | 34 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.107 per tablet (Irbesartan 150 mg tablet) | $0.0963 per tablet (Valsartan 40 mg tablet) |
| 12-month price change | -8% | -21% |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | A presentation being discontinued |
| Recalls recorded | 10 | 58 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 44,400 | 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 irbesartan
- every medicine labeled for the same conditions