Amlodipine Benzoate: uses, dosing, side effects & brands
Amlodipine Benzoate is a medicine sold in the U.S. under one brand, for variant angina pectoris, coronary artery disease and hypertension. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Variant Angina Pectoris, Coronary Artery Disease and Hypertension
- Available as
- Suspension
- Sold as
- Katerzia
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Half-life
- about 30 to 50 hours
Get treated for Amlodipine Benzoate conditions online
Licensed online providers — consult & get prescribed if eligible.
Advertising disclosure: We may earn a commission, at no extra cost to you. This never affects our ratings. Details
How amlodipine benzoate is dosed
From the FDA label for Katerzia (application NDA211340). Other amlodipine benzoate products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Adult recommended starting dose: 5 mg orally once daily with maximum dose 10 mg once daily. ( 2.1 ) Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily. ( 2.1 ) Pediatric starting dose: 2.5 mg to 5 mg once daily. ( 2.2 ) Important Limitation : Doses in excess of 5 mg daily have not been studied in pediatric patients. ( 2.2 ) SHAKE BEFORE USING 2.1 Adults The usual initial antihypertensive oral dose of KATERZIA is 5 mg orally once daily, and the maximum dose is 10 mg once daily. Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily and this dose may be used when adding KATERZIA to other antihypertensive therapy [see Use in Specific Populations ( 8.6 )] . Adjust dosage according to blood pressure goals. In general, wait 7 to 14 days between titration steps. Titrate more rapidly, however, if clinically warranted, provided the patient is assessed frequently. Angina : The recommended dose for chronic stable or vasospastic angina is 5 to 10 mg once daily, with the lower dose suggested in the elderly and in patients with hepatic insufficiency. Most patients will require 10 mg once daily for adequate effect. Coronary artery disease : The recommended dose range for patients with coronary artery disease is 5 to 10 mg once daily. In clinical studies, the majority of…
Amlodipine Benzoate side effects
Most common adverse reaction to amlodipine is edema which occurred in a dose related manner. Other adverse experiences not dose related but reported with an incidence >1.0% are fatigue, nausea, abdominal pain, and somnolence. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc., at 1-800-461-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Amlodipine has been evaluated for safety in more than 11,000 patients in U.S. and foreign clinical trials. In general, treatment with amlodipine was well-tolerated at doses up to 10 mg daily. Most adverse reactions reported during therapy with amlodipine were of mild or moderate severity. In controlled clinical trials directly comparing amlodipine (N=1730) at doses up to 10 mg to placebo (N=1250), discontinuation of amlodipine because of adverse reactions was required in about 1.5% of patients and was not different from placebo (about 1%). The most commonly reported adverse reactions more frequent than placebo are reflected in the table below. The incidence (%) of adverse reactions that occurred in a dose related…
Who shouldn’t take amlodipine benzoate
KATERZIA is contraindicated in patients with known sensitivity to amlodipine. Known sensitivity to amlodipine. ( 4 )
Amlodipine Benzoate drug interactions
Do not exceed doses greater than 20 mg daily of simvastatin. ( 7.2 ) 7.1 Impact of Other Drugs on Amlodipine CYP3A Inhibitors Co-administration 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 co-administered 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. Blood pressure should be closely monitored when amlodipine is co-administered with CYP3A inducers. 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 )] . Immunosuppressants Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when co‑administered. Frequent monitoring of trough blood levels of cyclosporine and tacrolimus is recommended and adjust the dose when appropriate [see Clinical Pharmacology ( 12.3 )] .
Every amlodipine benzoate product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Katerzia.
What people report to the FDA about amlodipine benzoate
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 54 reports naming amlodipine benzoate, and the FDA flagged 52% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- asthenia4 reports
- diarrhoea4 reports
- illness4 reports
- arthralgia3 reports
- delusion3 reports
- fatigue3 reports
- hallucination3 reports
- hypotension3 reports
Read these as a signal, not a rate. A report does not mean amlodipine benzoate caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
How long amlodipine benzoate stays in your system
The elimination half-life of amlodipine benzoate is about 30 to 50 hours. This is the parent drug's terminal elimination half-life in adults with normal liver function; it is longer (about 56 hours) in people with impaired liver function, and elderly patients and those with liver problems or heart failure clear the drug more slowly (roughly 40 to 60% higher blood levels). Amlodipine's metabolites are inactive, so no active-metabolite caveat applies.
NORVASC (amlodipine besylate) tablets — FDA prescribing information, DailyMed ↗Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.
Is amlodipine benzoate safe during pregnancy?
The label says the data are limited
The label's §8.1 risk summary says the limited available data from post-marketing reports in pregnant women are not sufficient to inform a drug-associated risk for major birth defects or miscarriage. It notes that poorly controlled hypertension in pregnancy carries its own risks to mother and fetus (pre-eclampsia, growth restriction, premature delivery). Animal studies showed no teratogenicity but, in rats at high doses, decreased litter size, more intrauterine deaths, and prolonged gestation/labor. The label does not declare the drug safe or unsafe; a pregnant person should discuss use with their prescriber.
This is what amlodipine benzoate’s FDA label says — not a recommendation to take or stop it. In pregnancy, that decision is your prescriber’s; do not start or stop a medicine on your own.
Amlodipine Besylate — DailyMed FDA Label ↗Does amlodipine benzoate cause weight gain?
The label reports no established weight effect
The label does not establish a weight effect. Weight is mentioned only in the adverse-reactions list of infrequent events reported where a causal relationship is uncertain, where both 'weight gain' and 'weight decrease' appear (no rates given). It is not presented as a systematic or expected effect of the drug.
Only what the FDA label reports — many drugs blamed for weight change online have no weight effect in their label, and we say so rather than repeat the folklore.
Amlodipine Besylate — DailyMed FDA Label ↗Related guides
Related calculators
Frequently asked questions
What is amlodipine benzoate?
Katerzia (Amlodipine Benzoate) is a medication used to treat Variant Angina Pectoris, Coronary Artery Disease, Hypertension.
Is amlodipine benzoate safe during pregnancy?
The label's §8.1 risk summary says the limited available data from post-marketing reports in pregnant women are not sufficient to inform a drug-associated risk for major birth defects or miscarriage. It notes that poorly controlled hypertension in pregnancy carries its own risks to mother and fetus (pre-eclampsia, growth restriction, premature delivery). Animal studies showed no teratogenicity but, in rats at high doses, decreased litter size, more intrauterine deaths, and prolonged gestation/labor. The label does not declare the drug safe or unsafe; a pregnant person should discuss use with their prescriber. This is what amlodipine benzoate's FDA label says; whether to use it in pregnancy is your prescriber's decision.
Does amlodipine benzoate cause weight gain?
The label does not establish a weight effect. Weight is mentioned only in the adverse-reactions list of infrequent events reported where a causal relationship is uncertain, where both 'weight gain' and 'weight decrease' appear (no rates given). It is not presented as a systematic or expected effect of the drug.
How long does amlodipine benzoate stay in your system?
The elimination half-life of amlodipine benzoate is about 30 to 50 hours — that is how long the body takes to clear half of a dose. This is the parent drug's terminal elimination half-life in adults with normal liver function; it is longer (about 56 hours) in people with impaired liver function, and elderly patients and those with liver problems or heart failure clear the drug more slowly (roughly 40 to 60% higher blood levels). Amlodipine's metabolites are inactive, so no active-metabolite caveat applies. Half-life is not the same as how long a drug test can detect the drug, and it varies with age, kidney and liver function.
Can you take amlodipine benzoate with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run amlodipine benzoate against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does amlodipine benzoate come in?
Across the brands we track, amlodipine benzoate is currently marketed as suspension, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic amlodipine benzoate?
We do not currently list a generic-labelled amlodipine benzoate product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
How long does it take for amlodipine benzoate to work?
Amlodipine lowers blood pressure gradually because it builds up slowly in the body — most of the effect appears over the first 1 to 2 weeks, reaching steady levels after about a week or more of daily dosing. You will not feel it; it is tracked by blood-pressure readings.
What are the common side effects of amlodipine?
The most common and characteristic side effect is swelling of the ankles, feet, and lower legs (peripheral edema). MedlinePlus also lists nausea, stomach pain, dizziness or lightheadedness, drowsiness, excessive tiredness, flushing (a warm, red face or neck), and muscle stiffness or tremors. The NHS adds headache, palpitations (a faster or more noticeable heartbeat), constipation or diarrhea, and fatigue. Most of these are mild. The NHS notes that several 'should ease after a week or so as your body gets used to the medicine' — but the ankle swelling is different and often persists (see below). Tell your prescriber if any common effect is severe or does not go away.
What are the serious side effects of amlodipine, and when should I call a doctor?
Per MedlinePlus, call your doctor immediately or get emergency medical treatment if you have: 'more frequent or more severe chest pain,' a 'rapid, pounding, or irregular heartbeat,' or fainting. Chest pain that gets worse can rarely happen when you first start amlodipine or increase the dose. The NHS also flags urgent, rare reactions: a serious allergic reaction with 'a swollen throat or tongue, a raised, itchy rash and difficulty breathing' (call emergency services); 'sudden and severe tummy pain that does not go away' (possible pancreas inflammation); and skin blistering, painful sores, or peeling (a Stevens-Johnson-type reaction). If someone has collapsed, had a seizure, can't breathe, or can't be woken, MedlinePlus says call 911. This is not a complete list — report any severe or unusual symptom.
Why does amlodipine cause ankle and leg swelling, and will a water pill fix it?
Amlodipine is a calcium channel blocker, and its signature side effect is dose-related peripheral edema: it widens small arteries, which raises pressure in the leg capillaries and pushes fluid into the tissue. Per the Norvasc FDA label (via Wikipedia), edema occurred in about 10.8% of people on the 10 mg dose versus 0.6% on placebo, and it is roughly three times more common in women than men. Importantly, this is not the kind of fluid overload a diuretic ('water pill') treats well — because the fluid is trapped locally, not from too much whole-body volume, diuretics often don't relieve it. The FDA-label-cited approach is to lower the dose or, under a prescriber, add an ACE inhibitor or angiotensin-receptor blocker, which the source says can reduce the swelling. Do not adjust or stop amlodipine yourself — this is prescriber-managed.
When do amlodipine side effects start, and how long do they last?
Early effects like flushing, headache, dizziness, and palpitations tend to show up in the first days after starting or increasing the dose. The NHS notes many of these 'should ease after a week or so as your body gets used to the medicine, but others can last longer.' Ankle and leg swelling is the main exception: because it is driven by how the drug works (and is dose-related per the FDA label), it often persists for as long as you keep taking that dose rather than fading in a week. MedlinePlus does not give exact day-by-day timing, so treat any specific 'it lasts X days' claim skeptically. If a side effect is worsening or not settling after a couple of weeks, contact your prescriber.
What are the long-term side effects of taking amlodipine every day?
Amlodipine is designed for daily, long-term blood-pressure control, and MedlinePlus does not list a distinct set of cumulative organ toxicities that appear only with years of use. The most relevant long-term issue is the dose-related ankle and leg swelling described above, which can continue for as long as you take the drug and is more common at the 10 mg dose and in women (Norvasc FDA label, via Wikipedia). The rare serious reactions — worsening chest pain, irregular heartbeat, severe allergic reaction, pancreas inflammation, or serious skin reactions — can occur at any point, not just early on, so the red-flag list above still applies over time. Because untreated high blood pressure carries its own serious long-term risks, never stop amlodipine on your own; any change in dose or drug should be decided with your prescriber.
What is Norvasc (amlodipine) used for?
Amlodipine is a calcium channel blocker with two main FDA-approved uses. First, it treats high blood pressure (hypertension) — MedlinePlus notes it "lowers blood pressure by relaxing the blood vessels so the heart does not have to pump as hard." Second, it treats angina (chest pain), including chronic stable angina and vasospastic (Prinzmetal) angina, and is approved in documented coronary artery disease to reduce the risk of hospitalization and revascularization procedures. Beyond these approvals, amlodipine is also used off-label (not FDA-approved for this) for Raynaud phenomenon — the cold-triggered constriction of blood vessels in the fingers and toes; StatPearls calls it "an effective short-term treatment" because it relaxes vascular smooth muscle. This isn't a complete list, and off-label prescribing is legal and often evidence-based — your prescriber decides based on your situation.
Is Norvasc (amlodipine) a blood thinner?
No — this is a common mix-up. Amlodipine is a calcium channel blocker: it lowers blood pressure and eases chest pain by relaxing (widening) blood vessels, not by thinning the blood or preventing clots. Blood thinners are a different category — anticoagulants like warfarin or apixaban, and antiplatelets like aspirin or clopidogrel. If you've been told you need a blood thinner, amlodipine does not fill that role. Keep taking any medication exactly as prescribed and don't add or stop one on your own — ask your prescriber or pharmacist how each of your medicines works.
Does Norvasc (amlodipine) lower your heart rate?
Generally no — and this is a useful distinction. Amlodipine belongs to the dihydropyridine class of calcium channel blockers, which mainly relax blood vessels and typically do not slow the heart rate the way beta-blockers or the non-dihydropyridine calcium channel blockers (diltiazem, verapamil) do. In some people amlodipine can cause a mild reflex increase in heart rate as blood pressure drops. If you're specifically looking to lower a fast heart rate, amlodipine is not the right tool and a different medication is usually needed — a decision only your prescriber can make.
Cite this page
- APA
- pharmaranks. (2026, July 24). Amlodipine Benzoate: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/amlodipine-benzoate
- MLA
- “Amlodipine Benzoate: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/amlodipine-benzoate.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for amlodipine benzoate on DailyMed (NIH) ↗.