Prescription medication · CCB / ARB Combination

amlodipine/valsartan

Also sold as Exforge. Exforge HCT is used to treat high blood pressure.

Data updated 2026-05-15

86
FDA reports
14
InteractionsSeveral interactions
$11.49
Brand price (NADAC)

What the data shows

amlodipine/valsartan (Exforge) is a prescription CCB / ARB Combination, with 86 FDA adverse-event reports on file, with 14 documented drug interactions.

Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.

amlodipine/valsartan (Exforge) is a prescription CCB / ARB Combination. Exforge HCT is used to treat high blood pressure.

Exforge HCT is a combination medicine used to treat high blood pressure. It contains amlodipine, valsartan, and hydrochlorothiazide to help lower your blood pressure.

Verify with FDA → · CMS NADAC pricing →

Drug Pricing (NADAC)

Brand Price

$11.49/unit

Generic Available

No

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

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What it does

Exforge HCT is used to treat high blood pressure.

Common side effects

Dizziness, Swelling in your arms, hands, legs, and feet, Headache

Key warnings

If you are pregnant, stop taking Exforge HCT right away.

The sections below are summarized in plain English from amlodipine/valsartan's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.

How It Works

This medicine works in three ways to lower blood pressure. Amlodipine relaxes your blood vessels. Valsartan blocks a substance that tightens blood vessels. Hydrochlorothiazide helps your body get rid of extra salt and water.

Side Effects (from patient reports)

Based on 86 FDA adverse event reports.

Most-reported reactions

Adverse reactions in FAERS for amlodipine/valsartan, by number of reports

reports

What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.

Source FDA Adverse Event Reporting System (FAERS)

Serious Warnings

If you are pregnant, stop taking Exforge HCT right away. This medicine can harm or kill your unborn baby.

Known Drug Interactions

major simvastatin

Impact of Amlodipine on Other Drugs Simvastatin Coadministration of simvastatin with amlodipine increases the systemic exposure of simvastatin. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily [see Clinical Pharmacology (12.3)] . If simvastatin is coadministered with amlodipine, do not exceed doses greater than 20 mg daily of simvastatin.

Mechanism: Amlodipine interferes with how the body processes simvastatin, leading to higher amounts of the cholesterol drug in your blood. This can increase your risk of experiencing muscle pain or damage.

major aliskiren

Dual Blockade of the Renin-Angiotensin System (RAS): Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Do not coadminister aliskiren with valsartan in patients with diabetes. Avoid use of aliskiren with valsartan in patients with renal impairment (GFR < 60 mL/min).

Mechanism: Using these two medicines together can over-block the system that regulates blood pressure and kidney health. This can lead to dangerously low blood pressure, high potassium, or sudden kidney failure.

moderate cyclosporine

Immunosuppressants Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when coadministered. Frequent monitoring of trough blood levels of cyclosporine and tacrolimus is recommended and adjust the dose when appropriate [see Clinical Pharmacology (12.3)] . Cyclosporine: Concomitant treatment with cyclosporine may increase the risk of hyperuricemia and gout-type complications.

Mechanism: Amlodipine can slow down how your body breaks down cyclosporine, which raises the amount of the drug in your system. This combination can also increase your risk of high uric acid and gout.

moderate lithium

Valsartan – Hydrochlorothiazide Lithium: Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists or thiazides. Monitor lithium levels in patients taking Exforge HCT. ( 12.3 ) Lithium: Increased risk of lithium toxicity.

Mechanism: Valsartan can make it harder for your kidneys to clear lithium from your body. This can cause lithium to build up to levels that are poisonous to your system.

minor amlodipine

Amlodipine Impact of Other Drugs on Amlodipine CYP3A Inhibitors Coadministration with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction. Monitor for symptoms of hypotension and edema when amlodipine is coadministered with CYP3A inhibitors to determine the need for dose adjustment [see Clinical Pharmacology (12.3)] . CYP3A Inducers No information is available on the quantitative effects of CYP3A inducers on amlodipine.

Mechanism: Both of these drugs contain amlodipine, so taking them together results in a double dose. This can cause your blood pressure to drop too low and may cause swelling in your ankles.

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This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.

Common Questions

Can I start taking Exforge HCT if I just found out I have high blood pressure?
No, Exforge HCT is not for the initial treatment of high blood pressure.
What should I do if I feel dizzy after taking Exforge HCT?
Dizziness is a common side effect. Get up slowly when rising from a sitting or lying position.
Can I take Exforge HCT with my other medications?
Exforge HCT can be taken with other blood pressure medicines, but talk to your doctor about all the medicines you take.
How long does it take for Exforge HCT to fully lower my blood pressure?
It may take up to 2 weeks to see the full effect of Exforge HCT.
What is the highest dose of Exforge HCT I can take?
The maximum recommended dose of Exforge HCT is 10/320/25 mg.
What should I do if I miss a dose of Exforge HCT?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose.
Can I drink alcohol while taking Exforge HCT?
Talk to your doctor about drinking alcohol while taking Exforge HCT, as it may lower your blood pressure too much.
Are there any foods I should avoid while taking Exforge HCT?
Talk to your doctor or pharmacist about any specific dietary restrictions.
What should I do if I experience swelling in my legs or ankles?
Swelling is a common side effect. Talk to your doctor if it becomes bothersome.
Can Exforge HCT cause any problems with my kidneys?
Your doctor will monitor your kidney function while you are taking Exforge HCT.
What are the common side effects of amlodipine/valsartan?
The registry lists Dizziness, Swelling in your arms, hands, legs, and feet, Headache, Heartburn, Tiredness among the most-reported FAERS reaction terms for amlodipine/valsartan. The compiled record contains 86 FDA adverse-event reports. These counts are not an individual symptom assessment.
Does amlodipine/valsartan interact with other medications?
The registry has 14 documented interaction rows for amlodipine/valsartan. Notable source-record pairings include simvastatin, aliskiren, cyclosporine. These rows are not a complete medication review.
What drug class is amlodipine/valsartan?
amlodipine/valsartan belongs to the CCB / ARB Combination drug class. It requires a prescription (Rx). Exforge HCT is used to treat high blood pressure.
What pregnancy or breastfeeding source fields are listed for amlodipine/valsartan?
The FDA label for amlodipine/valsartan contains product-specific pregnancy or breastfeeding language. PlainMeds does not apply that source text to an individual.

Related Medications in CCB / ARB Combination

Other drugs grouped near amlodipine/valsartan - same-class peers and common alternatives.

acebutolol

Sectral

Acebutolol is a medicine that helps lower blood pressure and control irregular heartbeats.

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aliskiren

Tekturna

Tekturna is a medicine used to treat high blood pressure.

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amiloride

Midamor

Amiloride is a water pill that helps your body hold onto potassium.

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amlodipine

Norvasc

Amlodipine (Norvasc) is a drug that lowers blood pressure and treats chest pain.

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amlodipine/benazepril

Lotrel

Lotrel is a combination medicine that contains amlodipine and benazepril.

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Medication Guides

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What the FDA Data Shows for amlodipine/valsartan

The FDA label for amlodipine/valsartan (sold under brand names such as Exforge) classifies it as a prescription-only medication in the CCB / ARB Combination class. Exforge HCT is used to treat high blood pressure. Official labeling lists 9 commonly reported side effects, including Dizziness, Swelling in your arms, hands, legs, and feet, Headache.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 86 voluntary reports. The database also lists 14 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS.

Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.

Last updated: December 12, 2025

PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.

Read our methodology - how this data is sourced, computed, and verified.

Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.

All federal data sources used on this page