amlodipine
Brand names: Norvasc
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.
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
Age Distribution
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
Reactions in Hospitalization Reports
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.
Common Questions
Can I take amlodipine with other blood pressure medications?
How long does it take for amlodipine to start working?
Can amlodipine cause dizziness?
What should I do if I experience swelling in my ankles or feet?
Can I drink alcohol while taking amlodipine?
Are there any foods I should avoid while taking amlodipine?
Can amlodipine affect my kidneys?
Will amlodipine cure my high blood pressure?
Can I stop taking amlodipine if my blood pressure is normal?
Does amlodipine interact with any other medications?
What are the common side effects of amlodipine?
Does amlodipine interact with other medications?
What drug class is amlodipine?
Is there a generic version of amlodipine?
Is amlodipine safe during pregnancy?
Has amlodipine been recalled?
Is amlodipine currently in shortage?
Active Recalls
Failed Dissolution Specifications: low dissolution results
Ascend Laboratories, LLC
Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
Lupin Pharmaceuticals Inc.
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.
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.
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)
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Teva Pharmaceuticals USA
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Teva Pharmaceuticals USA
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Teva Pharmaceuticals USA
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Mylan Pharmaceuticals Inc.
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Mylan Pharmaceuticals Inc.
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
Mylan Pharmaceuticals Inc.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Torrent Pharma Inc.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Torrent Pharma Inc.
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
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages