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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.

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.

How to Take It

Take Exforge HCT once a day. Your doctor may increase your dose after 2 weeks. The highest recommended dose is 10/320/25 mg. You can take Exforge HCT with other blood pressure medicines.

This is a plain-language summary of amlodipine/valsartan's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.

Pregnancy & Breastfeeding

Do not take Exforge HCT if you are pregnant. It can cause serious harm to your unborn baby, including death. Breastfeeding is not recommended while taking this medicine.

This is a plain-language summary of amlodipine/valsartan's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is close to your next dose, skip the missed dose and continue with your regular schedule.

This is a plain-language summary of amlodipine/valsartan's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.

Storage

Store Exforge HCT at room temperature, away from moisture.

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

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.

What to do: Do not take more than 20 mg of simvastatin per day if you are also taking this medication. Talk to your doctor about adjusting your dose to keep it at a safe level.

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.

What to do: Do not use this combination if you have diabetes or existing kidney problems. Your provider will monitor your blood pressure and kidney health very closely if these drugs are used.

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.

What to do: Your doctor should check your cyclosporine blood levels frequently and adjust your dose if necessary.

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.

What to do: Your doctor should monitor your lithium levels closely to prevent toxicity while you are taking these drugs together.

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.

What to do: Do not take these two medications together. Your doctor will need to choose one or adjust the dose to keep you safe.

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This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.

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 most commonly reported side effects of amlodipine/valsartan include Dizziness, Swelling in your arms, hands, legs, and feet, Headache, Heartburn, Tiredness. Based on 86 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does amlodipine/valsartan interact with other medications?
Yes, amlodipine/valsartan has 14 known drug interactions. Notable interactions include simvastatin, aliskiren, cyclosporine. Always inform your doctor about all medications you are taking.
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.
Is amlodipine/valsartan safe during pregnancy?
Do not take Exforge HCT if you are pregnant. It can cause serious harm to your unborn baby, including death. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

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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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.

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. Always consult a healthcare professional before making medication decisions.

Last updated: December 12, 2025

Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.

All federal data sources used on this page