Two medicines, side by side
Irbesartan vs amlodipine
Irbesartan and amlodipine are both labeled for high blood pressure. Drugs@FDA records approvals of irbesartan since 1997 and of amlodipine since 1992. Pharmacies paid $0.107 per irbesartan 150 mg tablet and $0.0102 per amlodipine besylate 5 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. In FDA's classes, irbesartan is an angiotensin 2 receptor blocker and amlodipine a calcium channel blocker.
Check it at the source: the irbesartan FDA label on DailyMed (effective August 6, 2026); the amlodipine FDA label on DailyMed (effective February 15, 2023).
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 amlodipine record
Amlodipine (Norvasc) · label of February 15, 2023
Used for
From the label: indicationsNORVASC is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: • Hypertension ( 1.1 ) o NORVASC is indicated for the treatment of hypertension, 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
- July 31, 1992
- Generic labelers
- 42 labelers
- Pharmacy cost
- $0.0102 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 30
Source: FDA drug labels via openFDA (Irbesartan label of August 6, 2026, Amlodipine label of February 15, 2023); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do irbesartan and amlodipine differ on the record?
In FDA's classes, irbesartan is an angiotensin 2 receptor blocker and amlodipine a calcium channel blocker.
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).”; Amlodipine, “Amlodipine is a dihydropyridine calcium antagonist (calcium ion antagonist or slow‑channel blocker) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac …”
Only the irbesartan label carries a boxed warning.
Generics: irbesartan since 2012; amlodipine since 2005 (Drugs@FDA).
| Irbesartan | Amlodipine | |
|---|---|---|
| Labeled for | High blood pressure, Chronic kidney disease | High blood pressure, Angina, Heart attack and coronary artery disease |
| Pharmacologic class | Angiotensin 2 Receptor Blocker | Calcium Channel Blocker, Dihydropyridine Calcium Channel 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). | Amlodipine is a dihydropyridine calcium antagonist (calcium ion antagonist or slow‑channel blocker) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. |
| Half-life (label) | The terminal elimination half-life of irbesartan averages 11 to 15 hours. | n/a |
| Earliest approval on file (Drugs@FDA) | September 30, 1997 | July 31, 1992 |
| First generic approved | March 30, 2012 | October 3, 2005 |
| Generic labelers (NDC) | 23 labelers | 42 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.107 per tablet (Irbesartan 150 mg tablet) | $0.0102 per tablet (Amlodipine besylate 5 mg tablet) |
| 12-month price change | -8% | -10% |
| Boxed warning | Yes | No |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 10 | 30 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 44,400 | 409,186 |
| 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