Two medicines, side by side
Amlodipine/valsartan vs simvastatin
Amlodipine/valsartan is labeled for high blood pressure; simvastatin for heart attack and coronary artery disease, high cholesterol and high triglycerides. Their labels share no use, so they are not alternatives to each other. Drugs@FDA records approvals of amlodipine/valsartan since 2007 and of simvastatin since 1991. Pharmacies paid $0.330 per unit (Amlodipine-valsartan 10-160 mg) and $0.0321 per simvastatin 20 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. In FDA's classes, amlodipine/valsartan is a calcium channel blocker and simvastatin a hmg-coa reductase inhibitor.
Check it at the source: the amlodipine/valsartan FDA label on DailyMed (effective February 17, 2026); the simvastatin FDA label on DailyMed (effective March 28, 2025).
Highlights of the amlodipine and valsartan record
Amlodipine and valsartan (Exforge) · label of February 17, 2026
FETAL TOXICITY When pregnancy is detected, discontinue Exforge 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 Exforge as soon as possible. ( 5.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
Used for
From the label: indicationsExforge is the combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB). […]
On the market
- Earliest approval on file
- June 20, 2007
- Generic labelers
- 9 labelers
- Pharmacy cost
- $0.330 per unit
Supply and safety
- Shortage
- No current entry
- Recalls
- 20
Highlights of the simvastatin record
Simvastatin (Zocor) · label of March 28, 2025
Used for
From the label: indicationsZOCOR ® is indicated: To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. […]
On the market
- Earliest approval on file
- December 23, 1991
- Generic labelers
- 27 labelers
- Pharmacy cost
- $0.0321 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 26
Source: FDA drug labels via openFDA (Amlodipine/valsartan label of February 17, 2026, Simvastatin label of March 28, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do amlodipine/valsartan and simvastatin differ on the record?
In FDA's classes, amlodipine/valsartan is a calcium channel blocker and simvastatin a hmg-coa reductase inhibitor.
How each works, in its label's words: Amlodipine/valsartan, “Amlodipine Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle.”; Simvastatin, “Simvastatin is a prodrug and is hydrolyzed to its active β-hydroxyacid form, simvastatin acid, after administration.”
Only the amlodipine/valsartan label carries a boxed warning.
Generics: amlodipine/valsartan since 2013; simvastatin since 2006 (Drugs@FDA).
| Amlodipine/valsartan | Simvastatin | |
|---|---|---|
| Labeled for | High blood pressure | Heart attack and coronary artery disease, High cholesterol, High triglycerides |
| Pharmacologic class | Angiotensin 2 Receptor Blocker, Calcium Channel Blocker, Dihydropyridine Calcium Channel Blocker | HMG-CoA Reductase Inhibitor |
| How it works (label) | Amlodipine Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. | Simvastatin is a prodrug and is hydrolyzed to its active β-hydroxyacid form, simvastatin acid, after administration. |
| Half-life (label) | Elimination of amlodipine from the plasma is biphasic with a terminal elimination half-life of about 30 to 50 hours. | n/a |
| Earliest approval on file (Drugs@FDA) | June 20, 2007 | December 23, 1991 |
| First generic approved | March 28, 2013 | June 23, 2006 |
| Generic labelers (NDC) | 9 labelers | 27 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.330 per unit (Amlodipine-valsartan 10-160 mg) | $0.0321 per tablet (Simvastatin 20 mg tablet) |
| 12-month price change | -35% | +5% |
| Boxed warning | Yes | No |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 20 | 26 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 11,192 | 248,728 |
| 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)
Do their labels mention each other?
Amlodipine/valsartan label, drug interactionsImpact of Amlodipine on Other Drugs Simvastatin Coadministration of simvastatin with amlodipine increases the systemic exposure of simvastatin.
Source: FDA drug labels via openFDA
What next?
- Alternatives to amlodipine/valsartan
- every medicine labeled for the same conditions