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amlodipine

Verify with FDA → · CMS NADAC pricing →

Brand names: Norvasc

Calcium Channel Blocker Rx

Amlodipine (Norvasc) is a drug that lowers blood pressure and treats chest pain. It belongs to a class of drugs called calcium channel blockers.

Drug Shortage Alert

amlodipine is currently listed as to be discontinued by the FDA. Affected manufacturer: Novartis Pharmaceuticals Corporation.

View all drug shortages →

Drug Pricing (NADAC)

Brand Price

$11.12/unit

Generic Price

$0.02/unit

Generic Savings

100%

Generic Available

Yes (40 manufacturers)

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

What it does

This medicine treats high blood pressure (hypertension).

Common side effects

Swelling in your ankles or feet, Dizziness, Flushing (redness of the face)

Key warnings

Amlodipine may cause low blood pressure, especially if you have severe aortic stenosis.

How It Works

Amlodipine blocks calcium from entering heart and blood vessel cells. This relaxes and widens blood vessels, making it easier for blood to flow. As a result, the heart does not have to work as hard, which lowers blood pressure and reduces chest pain.

How to Take It

Take amlodipine once a day, with or without food. The usual starting dose for adults is 5 mg daily. Your doctor may increase the dose to a maximum of 10 mg daily. If you are small, elderly, fragile, or have liver problems, your doctor may start you on a lower dose of 2.5 mg daily.

Pregnancy & Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant. High blood pressure during pregnancy can harm both the mother and the baby. Amlodipine passes into breast milk, but no harmful effects on the breastfed infant have been seen.

Missed Dose

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

Storage

Store amlodipine tablets at room temperature (68° to 77°F) in a tightly closed, light-resistant container.

Side Effects (from patient reports)

Based on 118,800 FDA adverse event reports.

Feeling tired
15,696
Diarrhea
14,038
Feeling sick to your stomach
13,425
Shortness of breath
13,222
Medication not working
12,075
Using the medicine for something it's not approved for
11,242
Feeling lightheaded or unsteady
10,671
Head pain
9,887
Sudden damage to the kidneys
9,369
Discomfort
9,175

FDA Adverse Event Report Analysis

Detailed analysis of 257,862 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2003–2025.

Total Reports

257,862

Death-Related Reports

28,135

Hospitalization Reports

104,040

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 125,206 (53%)
Male 111,135 (47%)

Age Distribution

0–17 4,095
18–44 12,639
45–64 59,928
65–74 54,749
75+ 57,161

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 FATIGUE 15,697
2 DIARRHOEA 14,039
3 NAUSEA 13,425
4 DYSPNOEA 13,218
5 DRUG INEFFECTIVE 12,077
6 OFF LABEL USE 11,242
7 DIZZINESS 10,671
8 HEADACHE 9,889
9 ACUTE KIDNEY INJURY 9,369
10 PAIN 9,173
11 VOMITING 8,736
12 FALL 8,493
13 ASTHENIA 8,485
14 HYPOTENSION 8,369
15 MALAISE 7,952

Reactions in Death Reports

DEATH 7,743
COMPLETED SUICIDE 5,086
TOXICITY TO VARIOUS AGENTS 2,638
PNEUMONIA 1,371
ACUTE KIDNEY INJURY 1,341
CARDIAC ARREST 1,235
DYSPNOEA 1,166
HYPOTENSION 1,065
OFF LABEL USE 1,022
RENAL FAILURE 988

Reactions in Hospitalization Reports

DYSPNOEA 7,038
ACUTE KIDNEY INJURY 6,232
HYPOTENSION 6,099
DIARRHOEA 5,849
PNEUMONIA 5,830
FALL 5,823
NAUSEA 5,689
FATIGUE 5,147
VOMITING 5,039
ASTHENIA 4,309

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Amlodipine may cause low blood pressure, especially if you have severe aortic stenosis. Some people with severe heart disease may experience worsening chest pain or a heart attack when starting or increasing the dose of amlodipine. If you have severe liver problems, your doctor will increase your dose slowly.

Known Drug Interactions

7 DRUG INTERACTIONS Do not exceed doses greater than 20 mg daily of simvastatin. 7.2 Impact of Amlodipine on Other Drugs Simvastatin Co-administration 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 )] .

Mechanism: Amlodipine makes it harder for your body to clear simvastatin, which raises the level of the cholesterol medicine in your blood.

What to do: If you take both medicines, do not take more than 20 mg of simvastatin each day.

7 DRUG INTERACTIONS • Potassium supplements/potassium-sparing diuretics: hyperkalemia ( 7.1 ) • Lithium: Increased serum lithium levels; toxicity symptoms ( 7.1 ) • Injectable gold: facial flushing, nausea, vomiting, hypotension ( 7.1 ) • Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): Risk of renal dysfunction, loss of antihypertensive effect ( 7.1 ) • Do not exceed doses greater than 20 mg daily of simvastatin ( 7.1 ) • mTOR inhibitors: increased risk of angioedema ( 7.1 ) • Dual inhibition of the RAS: Increased risk of renal impairment, hypotension, and hyperkalemia ( 7.1 ) • Neprilysin i...

Mechanism: This combination pill already contains amlodipine, so taking extra amlodipine separately can lead to an overdose and dangerously low blood pressure.

What to do: Check with your doctor or pharmacist to ensure you are not accidentally taking the same medicine in two different pills.

For patients taking amiodarone, amlodipine, or ranolazine, do not exceed ezetimibe and simvastatin 10 mg/20 mg daily [see Dosage and Administration ( 2.3 )].

Mechanism: Amlodipine can increase the levels of the cholesterol medicine in your blood, which may lead to side effects.

What to do: Your doctor should limit your dose of the combination medicine to 10 mg/20 mg daily.

For patients taking amiodarone, amlodipine, or ranolazine, do not exceed VYTORIN 10/20 mg daily [see Dosage and Administration (2.3) ] .

Mechanism: Amlodipine can cause the cholesterol medication to stay in your system longer, which increases the chance of muscle pain or weakness.

What to do: Your daily dose of ezetimibe and simvastatin should be limited to 10 mg/20 mg to prevent muscle problems.

Calcium channel blockers amlodipine, diltiazem, felodipine, nicardipine, nifedipine, verapamil ↑ calcium channel blocker Caution is warranted and clinical monitoring of patients is recommended.

Mechanism: This medication slows down how fast your body processes amlodipine. This can cause the blood pressure medicine to build up to high levels in your blood.

What to do: Use caution if you must take both drugs. Your doctor should monitor you closely for side effects like dizziness or low blood pressure.

Check all your medications →

Common Questions

Can I take amlodipine with other blood pressure medications?
Yes, amlodipine can be used alone or with other blood pressure medications.
How long does it take for amlodipine to start working?
Amlodipine starts to work gradually to lower blood pressure.
Can amlodipine cause dizziness?
Yes, dizziness is a common side effect of amlodipine.
What should I do if I experience swelling in my ankles or feet?
Talk to your doctor if you experience swelling in your ankles or feet, as this is a common side effect.
Can I drink alcohol while taking amlodipine?
Talk to your doctor about drinking alcohol while taking amlodipine, as it may lower your blood pressure further.
Are there any foods I should avoid while taking amlodipine?
There are no specific foods to avoid while taking amlodipine.
Can amlodipine affect my kidneys?
Amlodipine is not known to cause kidney problems.
Will amlodipine cure my high blood pressure?
Amlodipine helps to control high blood pressure, but it is usually a long-term treatment.
Can I stop taking amlodipine if my blood pressure is normal?
Do not stop taking amlodipine without talking to your doctor first.
Does amlodipine interact with any other medications?
Yes, amlodipine can interact with some medications. Tell your doctor about all the medicines you take.
What are the common side effects of amlodipine?
The most commonly reported side effects of amlodipine include Swelling in your ankles or feet, Dizziness, Flushing (redness of the face), Palpitations (feeling your heart beat rapidly or irregularly), Fatigue (feeling tired). Based on 118,800 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does amlodipine interact with other medications?
Yes, amlodipine has 15 known drug interactions. Notable interactions include simvastatin, amlodipine/benazepril, ezetimibe. Always inform your doctor about all medications you are taking.
What drug class is amlodipine?
amlodipine belongs to the Calcium Channel Blocker drug class. It requires a prescription (Rx). This medicine treats high blood pressure (hypertension).
Is there a generic version of amlodipine?
Yes, generic amlodipine is available from 40 manufacturers. The generic costs $0.02 per unit compared to $11.12 for the brand version, saving approximately 100%. Pricing is based on NADAC (National Average Drug Acquisition Cost) data from CMS.
Is amlodipine safe during pregnancy?
Tell your doctor if you are pregnant or plan to become pregnant. High blood pressure during pregnancy can harm both the mother and the baby. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.
Has amlodipine been recalled?
There are 14 recalls associated with amlodipine products. Failed Dissolution Specifications: low dissolution results. Check the recalls section below for full details and affected products.
Is amlodipine currently in shortage?
Yes, amlodipine is currently listed as to be discontinued by the FDA. Affected manufacturer: Novartis Pharmaceuticals Corporation. Visit the FDA Drug Shortages database for the latest updates.

Active Recalls

Class II July 21, 2025

Failed Dissolution Specifications: low dissolution results

Ascend Laboratories, LLC

Class II July 2, 2025

Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027

Lupin Pharmaceuticals Inc.

Class II December 31, 2018

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Aurobindo Pharma USA Inc.

Class II December 31, 2018

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Aurobindo Pharma USA Inc.

Class II December 4, 2018

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Mylan Laboratories Limited, (Nashik FDF)

Class II November 27, 2018

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

Teva Pharmaceuticals USA

Class II November 27, 2018

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

Teva Pharmaceuticals USA

Class II November 27, 2018

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

Teva Pharmaceuticals USA

Class II November 20, 2018

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

Mylan Pharmaceuticals Inc.

Class II November 20, 2018

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

Mylan Pharmaceuticals Inc.

Class II November 20, 2018

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

Mylan Pharmaceuticals Inc.

Class II August 17, 2018

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Torrent Pharma Inc.

Class II August 17, 2018

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Torrent Pharma Inc.

Class II August 17, 2018

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Torrent Pharma Inc.

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What the FDA Data Shows for amlodipine

The FDA label for amlodipine (sold under brand names such as Norvasc) classifies it as a prescription-only medication in the Calcium Channel Blocker class. This medicine treats high blood pressure (hypertension). Official labeling lists 8 commonly reported side effects, including Swelling in your ankles or feet, Dizziness, Flushing (redness of the face).

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 118,800 voluntary reports. The database also lists 15 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $0.02 versus $11.12 for the brand — a 100% generic savings.

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 (currently 14 recall records on file), 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). Shortage status: FDA Drug Shortages Database.

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: October 14, 2025

All federal data sources used on this page