Prescription medicine
Amlodipine and valsartan Brand names: Exforge
Amlodipine and valsartan (Exforge) is a prescription medicine with an FDA approval on record since 2007. FDA's NDC Directory lists it from 9 generic labelers, and pharmacies paid $0.330 per unit (Amlodipine-valsartan 10-160 mg) in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the amlodipine and valsartan FDA label on DailyMed (effective February 17, 2026, Novartis Pharmaceuticals Corporation); the NDA 21990 record on Drugs@FDA; every amlodipine and valsartan label on DailyMed.
Highlights of the record
FDA label of February 17, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 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: indications and usageExforge is the combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB).
Forms and strengths
- 5 mg / 160 mg
- 5 mg / 320 mg
- 10 mg / 320 mg
- 10 mg / 160 mg
Film-coated tablet; tablet.
On the market
- Earliest approval on file
- June 20, 2007 Exforge, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 10 first March 28, 2013; 7 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 10 of which 9 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.330 per unit Amlodipine-valsartan 10-160 mg
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 20 since 2018 0 Class I among all firms' recalls; latest December 31, 2018
- FAERS reports
- 11,192 through July 30, 2026
What is amlodipine and valsartan used for?
From the label: indications and usageExforge is the combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB). Exforge is indicated for the treatment of hypertension, to lower blood pressure: In patients not adequately controlled on monotherapy ( 1 ) As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals ( 1 ) Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. […]
Conditions named in the indications of amlodipine and valsartan's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Angiotensin 2 Receptor Blocker, Calcium Channel Blocker and Dihydropyridine Calcium Channel Blocker.
Source: FDA drug label (Exforge), Novartis Pharmaceuticals Corporation, effective February 17, 2026 (SPL set d0caec89-96ec-411d-a933-63eda74a6da7), via openFDA; the full label on DailyMed
What does the patient leaflet for amlodipine and valsartan say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about EXFORGE?EXFORGE can cause harm or death to an unborn baby. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. If you get pregnant while taking EXFORGE, tell your doctor right away.
From the patient leaflet: What should I avoid while taking EXFORGE?You should not take EXFORGE during pregnancy. See “What is the most important information I should know about EXFORGE?”
From the patient leaflet: How should I store EXFORGE?Store EXFORGE at room temperature between 59°F and 86°F (15°C and 30°C). Keep EXFORGE dry (protect it from moisture). Keep EXFORGE and all medicines out of the reach of children. General Information about EXFORGE Medicines are sometimes prescribed for conditions that are not mentioned in the patient information leaflet. Do not use EXFORGE for a condition for which it was not prescribed. Do not give EXFORGE to other people, even if they have the same symptoms that you have. It may harm them. This patient information leaflet summarizes the most important information about EXFORGE. If you would like more information about EXFORGE, talk with your doctor. You can ask your doctor or pharmacist for information about EXFORGE that is written for health professionals. For more information, call 1-888-669-6682.
Source: FDA drug label (Exforge), Novartis Pharmaceuticals Corporation, effective February 17, 2026 (SPL set d0caec89-96ec-411d-a933-63eda74a6da7), via openFDA; the full label on DailyMed
Is there a generic for amlodipine and valsartan (Exforge)?
The FDA approved the first generic amlodipine and valsartan on March 28, 2013. 10 generic applications are approved; 7 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists amlodipine and valsartan from 9 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2007 earliest approval on file
- 2013 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for amlodipine and valsartan (Exforge)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.330 per unit (Amlodipine-valsartan 10-160 mg), down 35% from $0.507 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Amlodipine-valsartan 5-160 mg (generic)
- Exforge 5-160 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Amlodipine-valsartan 10-160 mg | Generic | $0.330 per unit | n/a | -35% |
| Amlodipine-valsartan 10-320 mg | Generic | $0.432 per unit | n/a | -35% |
| Amlodipine-valsartan 5-160 mg | Generic | $0.264 per unit | n/a | -44% |
| Amlodipine-valsartan 5-320 mg | Generic | $0.351 per unit | n/a | -34% |
| Exforge 10-320 mg tablet | Brand | $15.39 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $461.83 | +3% |
| Exforge 5-160 mg tablet | Brand | $10.65 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $319.52 | +3% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has amlodipine and valsartan been recalled?
The FDA's Enforcement Report lists 20 recalls naming amlodipine and valsartan since 2018: 0 Class I (the most serious), 20 Class II, 0 Class III; 20 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| December 31, 2018 | Class II | Aurobindo Pharma USA Inc. | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim … |
| December 31, 2018 | Class II | Aurobindo Pharma USA Inc. | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. |
| December 4, 2018 | Class II | Mylan Laboratories Limited, (Nashik FDF) | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. |
| November 27, 2018 | Class II | Teva Pharmaceuticals USA | CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. |
| November 20, 2018 | Class II | Mylan Pharmaceuticals Inc. | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product. |
| August 17, 2018 | Class II | Torrent Pharma Inc. | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the amlodipine and valsartan label say about other medicines?
The amlodipine and valsartan label names 10 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aliskiren | contraindications | Do not coadminister aliskiren with Exforge in patients with diabetes [see Drug Interactions (7)]. |
| Amiloride | drug interactions | Valsartan Agents Increasing Serum Potassium: Concomitant use of valsartan with other agents that block the renin-angiotensin system, potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, salt substitutes containing potassium or other drugs that may increase potassium levels … |
| Cyclosporine | drug interactions | Immunosuppressants Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when coadministered. |
| Heparin | drug interactions | … supplements, salt substitutes containing potassium or other drugs that may increase potassium levels (e.g., heparin) may lead to increases in serum potassium and in heart failure patients to increases in serum creatinine. |
| Lithium | drug interactions | Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists. |
| Sildenafil | drug interactions | Sildenafil Monitor for hypotension when sildenafil is coadministered with amlodipine [see Clinical Pharmacology (12.2)]. |
| Simvastatin | drug interactions | Impact of Amlodipine on Other Drugs Simvastatin Coadministration of simvastatin with amlodipine increases the systemic exposure of simvastatin. |
| Spironolactone | drug interactions | Valsartan Agents Increasing Serum Potassium: Concomitant use of valsartan with other agents that block the renin-angiotensin system, potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, salt substitutes containing potassium or other drugs that may increase potassium levels … |
| Tacrolimus | drug interactions | Immunosuppressants Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when coadministered. |
| Triamterene | drug interactions | Valsartan Agents Increasing Serum Potassium: Concomitant use of valsartan with other agents that block the renin-angiotensin system, potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, salt substitutes containing potassium or other drugs that may increase potassium levels … |
Source: FDA drug label (Exforge), Novartis Pharmaceuticals Corporation, effective February 17, 2026 (SPL set d0caec89-96ec-411d-a933-63eda74a6da7), via openFDA; the full label on DailyMed
What do FAERS reports show for amlodipine and valsartan?
The FDA Adverse Event Reporting System holds 11,192 reports that list amlodipine and valsartan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,285 are coded as a death and 3,930 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as amlodipine and valsartan?
62 other medicines are given the same way (oral) and in the same FDA class as amlodipine and valsartan or labeled mainly for the same use (high blood pressure), the same class first. High blood pressure lists all 88 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Diltiazem | High blood pressure | 42 labelers | $0.144 per capsule 24h ER(cd) 120 mg capsule | A presentation being discontinued |
| Losartan | High blood pressure | 44 labelers | $0.0327 per tablet 50 mg tablet | No current entry |
| Nifedipine | High blood pressure | 32 labelers | $0.130 per tablet 30 mg tablet | No current entry |
| Olmesartan | High blood pressure | 31 labelers | $0.0805 per tablet 20 mg tablet | No current entry |
| Hydrochlorothiazide and losartan | High blood pressure | 29 labelers | $0.0762 per tablet 100-12.5 mg tablet | No current entry |
| Verapamil | High blood pressure | 24 labelers | $0.191 per tablet 180 mg tablet | A presentation being discontinued |
| Irbesartan | High blood pressure | 23 labelers | $0.107 per tablet 150 mg tablet | No current entry |
| Telmisartan | High blood pressure | 28 labelers | $0.106 per tablet 20 mg tablet | No current entry |
Every medicine labeled for the same conditions as amlodipine and valsartan
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does amlodipine and valsartan compare with medicines for the same use?
1 side-by-side page set amlodipine and valsartan beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to amlodipine and valsartan
- 62 medicines for the same use
- Other ARBs
- the pharmacologic class, with prices and generics
- Amlodipine and valsartan side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other