Medicine guide

Amlodipine Besylate

10 mg · Tablet

Prescription only
Calcium Channel Blocker

Active substance: Amlodipine Besylate
Used in: Heart, blood pressure and circulation
Made by: ST. MARY'S MEDICAL PARK PHARMACY
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2026-05-22

What it is

Calcium Channel Blocker

Used for

Hypertension ( 1.1 ) Amlodipine besylate tablets are indicated for the treatment of hypertension, to lower blood pressure.

The label’s usual adult dose

Adult recommended starting dose: 5 mg 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.

Adult recommended starting dose: 5 mg once daily with maximum dose 10 mg once daily.

Full directions ↓

Do not take it if

Known sensitivity to amlodipine ( 4 ) Amlodipine besylate tablets are contraindicated in patients with known sensitivity to amlodipine.

All warnings ↓

Good to know

Prescription only
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

120other products contain Amlodipine Besylate — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

Amlodipine besylate tablets are calcium channel blockers and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of:

Hypertension ( 1.1 ) Amlodipine besylate tablets are indicated for the treatment of hypertension, to lower blood pressure.
Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
Coronary Artery Disease ( 1.2 ) Chronic Stable Angina Vasospastic Angina (Prinzmetal's or Variant Angina) Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%
1.1 Hypertension Amlodipine besylate tablets are indicated for the treatment of hypertension, to lower blood pressure.
Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine besylate tablets.
Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake.
Many patients will require more than one drug to achieve blood pressure goals.
For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits.
The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.
Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mm Hg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit.
Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.
Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease).
These considerations may guide selection of therapy.
Amlodipine besylate tablets may be used alone or in combination with other antihypertensive agents.
1.2 Coronary Artery Disease (CAD) Chronic Stable Angina Amlodipine besylate tablets are indicated for the symptomatic treatment of chronic stable angina.
Amlodipine besylate tablets may be used alone or in combination with other antianginal agents.
Vasospastic Angina (Prinzmetal's or Variant Angina) Amlodipine besylate tablets are indicated for the treatment of confirmed or suspected vasospastic angina.
Amlodipine besylate tablets may be used as monotherapy or in combination with other antianginal agents.
Angiographically Documented CAD In patients with recently documented CAD by angiography and without heart failure or an ejection fraction <40%, amlodipine besylate tablets are indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure.

From the official label · 2026-05-22 · DailyMed

How it works

From this product’s own US prescribing label.

Amlodipine is a dihydropyridine calcium antagonist (calcium ion antagonist or slow-channel blocker) that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle.
Experimental data suggest that amlodipine binds to both dihydropyridine and nondihydropyridine binding sites.

Peak level after6–12 h

Half-life30–50 h

Mostly cleared after≈ 8 daysfive half-lives — our arithmetic

The shape is a standard model drawn from the two times above, not a measurement. How fast a medicine acts and wears off also depends on the dose, the form and the person.

How it leaves the body

Amlodipine is extensively (about 90%) converted to inactive metabolites via hepatic metabolism with 10% of the parent compound and 60% of the metabolites excreted in the urine.

With food

The bioavailability of amlodipine is not altered by the presence of food.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-05-22

Do not take it if

Known sensitivity to amlodipine ( 4 ) Amlodipine besylate tablets are contraindicated in patients with known sensitivity to amlodipine.

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

Adult recommended starting dose: 5 mg 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 )
2.1
Adults The usual initial antihypertensive oral dose of amlodipine besylate tablets are 5 mg 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 amlodipine besylate tablets to other antihypertensive therapy.
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 5–10 mg, with the lower dose suggested in the elderly and in patients with hepatic insufficiency.
Most patients will require 10 mg for adequate effect.
Coronary artery disease :
The recommended dose range for patients with coronary artery disease is 5–10 mg once daily.
In clinical studies, the majority of patients required 10 mg [see Clinical Studies ( 14.4 )].
2.2 Children The effective antihypertensive oral dose in pediatric patients ages 6–17 years is 2.5 mg to 5 mg once daily.
Doses in excess of 5 mg daily have not been studied in pediatric patients [see Clinical Pharmacology ( 12.4 ), Clinical Studies ( 14.1 )] .

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis.
However, acute hypotension is unlikely.
( 5.1 ) Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine, particularly in patients with severe obstructive coronary artery disease.
( 5.2 ) Titrate slowly in patients with severe hepatic impairment ( 5.3 )
5.1 Hypotension Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis.
Because of the gradual onset of action, acute hypotension is unlikely.
5.2 Increased Angina or Myocardial Infarction Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine, particularly in patients with severe obstructive coronary artery disease.
5.3 Patients with Hepatic Failure Because amlodipine is extensively metabolized by the liver and the plasma elimination half-life (t 1/2 ) is 56 hours in patients with impaired hepatic function, titrate slowly when administering amlodipine to patients with severe hepatic impairment.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Risk Summary The limited available data based on post-marketing reports with amlodipine use in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage.
There are risks to the mother and fetus associated with poorly controlled hypertension in pregnancy [see Clinical Considerations] .
In animal reproduction studies, there was no evidence of adverse developmental effects when pregnant rats and rabbits were treated orally with amlodipine maleate during organogenesis at doses approximately 10 and 20-times the maximum recommended human dose (MRHD), respectively.
However for rats, litter size was significantly decreased (by about 50%) and the number of intrauterine deaths was significantly increased (about 5-fold).
Amlodipine has been shown to prolong both the gestation period and the duration of labor in rats at this dose [see Data].
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively.
Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section and post-partum hemorrhage).
Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death.
Pregnant women with hypertension should be carefully monitored and managed accordingly.
Data Animal Data No evidence of teratogenicity or other embryo/fetal toxicity was found when pregnant rats and rabbits were treated orally with amlodipine maleate at doses up to 10 mg amlodipine/kg/day (approximately 10 and 20 times the MRHD based on body surface area, respectively) during their respective periods of major organogenesis.
However for rats, litter size was significantly decreased (by about 50%) and the number of intrauterine deaths was significantly increased (about 5-fold)in rats receiving amlodipine maleate at a dose equivalent to 10 mg amlodipine/kg/day for 14 days before mating and throughout mating and gestation.
Amlodipine maleate has been shown to prolong both the gestation period and the duration of labor in rats at this dose.
IN SPECIFIC POPULATIONS Pediatric: Effect on patients less than 6 years old is not known.
( 8.4 ) Geriatric: Start dosing at the low end of the dose range.
( 8.5 )
8.1 Pregnancy Risk Summary The limited available data based on post-marketing reports with amlodipine use in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage.
There are risks to the mother and fetus associated with poorly controlled hypertension in pregnancy [see Clinical Considerations] .
In animal reproduction studies, there was no evidence of adverse developmental effects when pregnant rats and rabbits were treated orally with amlodipine maleate during organogenesis at doses approximately 10 and 20-times the maximum recommended human dose (MRHD), respectively.
However for rats, litter size was significantly decreased (by about 50%) and the number of intrauterine deaths was significantly increased (about 5-fold).
Amlodipine has been shown to prolong both the gestation period and the duration of labor in rats at this dose [see Data].
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively.
Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section and post-partum hemorrhage).
Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death.
Pregnant women with hypertension should be carefully monitored and managed accordingly.
Data Animal Data No evidence of teratogenicity or other embryo/fetal toxicity was found when pregnant rats and rabbits were treated orally with amlodipine maleate at doses up to 10 mg amlodipine/kg/day (approximately 10 and 20 times the MRHD based on body surface area, respectively) during their respective periods of major organogenesis.
However for rats, litter size was significantly decreased (by about 50%) and the number of intrauterine deaths was significantly increased (about 5-fold)in rats receiving amlodipine maleate at a dose equivalent to 10 mg amlodipine/kg/day for 14 days before mating and throughout mating and gestation.
Amlodipine maleate has been shown to prolong both the gestation period and the duration of labor in rats at this dose.
8.2 Lactation Risk Summary Limited available data from a published clinical lactation study reports that amlodipine is present in human milk at an estimated median relative infant dose of 4.2%.
No adverse effects of amlodipine on the breastfed infant have been observed.
There is no available information on the effects of amlodipine on milk production.
8.4 Pediatric Use Amlodipine (2.5 to 5 mg daily) is effective in lowering blood pressure in patients 6 to 17 years [see Clinical Studies ( 14.1 )] .
Effect of amlodipine on blood pressure in patients less than 6 years of age is not known.
8.5 Geriatric Use Clinical studies of amlodipine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Elderly patients have decreased clearance of amlodipine with a resulting increase of AUC of approximately 40–60%, and a lower initial dose may be required [see Dosage and Administration ( 2.1 )] .

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

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.
Sildenafil Monitor for hypotension when sildenafil is co-administered with amlodipine [see Clinical Pharmacology ( 12.2 )] .
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 )] .

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly a reflex tachycardia.
In humans, experience with intentional overdosage of amlodipine is limited.
Single oral doses of amlodipine maleate equivalent to 40 mg amlodipine/kg and 100 mg amlodipine/kg in mice and rats, respectively, caused deaths.
Single oral amlodipine maleate doses equivalent to 4 or more mg amlodipine/kg or higher in dogs (11 or more times the maximum recommended human dose on a mg/m 2 basis) caused a marked peripheral vasodilation and hypotension.
If massive overdose should occur, initiate active cardiac and respiratory monitoring.
Frequent blood pressure measurements are essential.
Should hypotension occur, provide cardiovascular support including elevation of the extremities and the judicious administration of fluids.
If hypotension remains unresponsive to these conservative measures, consider administration of vasopressors (such as phenylephrine) with attention to circulating volume and urine output.
As amlodipine is highly protein bound, hemodialysis is not likely to be of benefit.

Quoted from the official label, section “Overdosage”.

Use in children

Amlodipine (2.5 to 5 mg daily) is effective in lowering blood pressure in patients 6 to 17 years [see Clinical Studies ( 14.1 )] . Effect of amlodipine on blood pressure in patients less than 6 years of age is not known.

Quoted from the official label, section “Pediatric Use”.

Use in older people

Clinical studies of amlodipine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Elderly patients have decreased clearance of amlodipine with a resulting increase of AUC of approximately 40–60%, and a lower initial dose may be required [see Dosage and Administration ( 2.1 )] .

Quoted from the official label, section “Geriatric Use”.

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 Unichem Pharmaceuticals (USA), Inc., at 1 866-562-4616 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 only about 1.5% of patients and was not significantly different from placebo (about 1%).
The most commonly reported side effects more frequent than placebo are reflected in the table below.
The incidence (%) of side effects that occurred in a dose related manner are as follows:
Amlodipine Placebo 2.5 mg N=275 5 mg N=296 10 mg N=268 N=520 Edema 1.8 3.0 10.8
0.6 Dizziness 1.1 3.4 3.4
1.5 Flushing 0.7 1.4 2.6
0.0 Palpitation 0.7 1.4 4.5
0.6 Other adverse reactions that were not clearly dose related but were reported with an incidence greater than 1.0% in placebo-controlled clinical trials include the following:
Amlodipine (%) (N=1730) Placebo (%) (N=1250) Fatigue 4.5
2.8 Nausea 2.9
1.9 Abdominal Pain 1.6
0.3 Somnolence 1.4
0.6 For several adverse experiences that appear to be drug and dose related, there was a greater incidence in women than men associated with amlodipine treatment as shown in the following table:
Amlodipine Placebo Male = % (N=1218) Female=% (N=512) Male=% (N=914) Female=% (N=336) Edema 5.6 14.6 1.4
5.1 Flushing 1.5 4.5 0.3
0.9 Palpitations 1.4 3.3 0.9
0.9 Somnolence 1.3 1.6 0.8
0.3 The following events occurred in <1% but >0.1% of patients in controlled clinical trials or under conditions of open trials or marketing experience where a causal relationship is uncertain; they are listed to alert the physician to a possible relationship:
Cardiovascular:
arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, peripheral ischemia, syncope, tachycardia, vasculitis.
Central and Peripheral Nervous System:
hypoesthesia, neuropathy peripheral, paresthesia, tremor, vertigo.
Gastrointestinal:
anorexia, constipation, dysphagia, diarrhea, flatulence, pancreatitis, vomiting, gingival hyperplasia.
General:
allergic reaction, asthenia, 1 back pain, hot flushes, malaise, pain, rigors, weight gain, weight decrease.
Musculoskeletal System: arthralgia, arthrosis, muscle cramps, 1 myalgia.
Psychiatric:
sexual dysfunction (male 1 and female), insomnia, nervousness, depression, abnormal dreams, anxiety, depersonalization.
Respiratory System: dyspnea, 1 epistaxis.
Skin and Appendages:
angioedema, erythema multiforme, pruritus, 1 rash, 1 rash erythematous, rash maculopapular.
Special Senses: abnormal vision, conjunctivitis, diplopia, eye pain, tinnitus.
Urinary System: micturition frequency, micturition disorder, nocturia.
Autonomic Nervous System: dry mouth, sweating increased.
Metabolic and Nutritional: hyperglycemia, thirst.
Hemopoietic:
leukopenia, purpura, thrombocytopenia. 1 These events occurred in less than 1% in placebo-controlled trials, but the incidence of these side effects was between 1% and 2% in all multiple dose studies.
Amlodipine therapy has not been associated with clinically significant changes in routine laboratory tests.
No clinically relevant changes were noted in serum potassium, serum glucose, total triglycerides, total cholesterol, HDL cholesterol, uric acid, blood urea nitrogen, or creatinine.
In the CAMELOT and PREVENT studies [see Clinical Studies ( 14.4 )] , the adverse event profile was similar to that reported previously (see above), with the most common adverse event being peripheral edema.
6.2 Postmarketing Experience Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following postmarketing event has been reported infrequently where a causal relationship is uncertain:
gynecomastia.
In postmarketing experience, jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis), in some cases severe enough to require hospitalization, have been reported in association with use of amlodipine.
Postmarketing reporting has also revealed a possible association between extrapyramidal disorder and amlodipine.
Amlodipine has been used safely in patients with chronic obstructive pulmonary disease, well-compensated congestive heart failure, coronary artery disease, peripheral vascular disease, diabetes mellitus, and abnormal lipid profiles.

Quoted from the official label, section “Adverse Reactions”.

Strengths and forms

FORMS AND STRENGTHS Tablets:
2.5 mg, 5 mg, and 10 mg ( 3 ) Tablets:
2.5 mg Light yellow round flat faced beveled edge tablets debossed with 'U' on one side and '2' on the other side.
Tablets:
5 mg White to off-white round flat faced beveled edge tablets debossed with 'U' on one side and '5' on the other side.
Tablets:
10 mg White to off-white round flat faced beveled edge tablets debossed with 'U' on one side and '10' on the other side.

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

16.1 How Supplied Amlodipine Besylate Tablets, USP 10mg White to off-white round flat faced beveled edge tablets debossed with 'U' on one side and '10' on the other side BOTTLE OF 30 (60760-445-30) 05/2026
Storage
Store at 20° to 25°C (68° to 77° F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] and dispense in tight, light-resistant containers.
Additional Summary of Information About leaflets can be obtained by calling Unichem at 1-866-562-4616.

Quoted from the official label, section “How Supplied”.

What is in it

Amlodipine besylate, USP is the besylate salt of amlodipine, a long-acting calcium channel blocker. Amlodipine besylate, USP is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl] 4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C 20 H 25 ClN 2 O 5
C 6 H 6 O 3 S and its structural formula is:
Amlodipine besylate, USP is a white crystalline powder with a molecular weight of 567.1. It is slightly soluble in water and sparingly soluble in ethanol. Amlohowdipinebesylate Tablets, USP are formulated as yellow tablets equivalent to 2.5 mg or white tablets equivalent to 5 and 10 mg of amlodipine for oral administration. In addition to the active ingredient, amlodipine besylate, USP, each tablet contains the following inactive ingredients:
colloidal silicon dioxide,magnesium stearate,microcrystalline cellulose and sodium starch glycolate. The 2.5 mg strength additionally contains ferric oxide yellow as coloring agent. structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

This label’s list of inactive ingredients names none of: lactose, wheat or gluten, colour dyes, sugars, sugar alcohols, alcohol (ethanol), aspartame (phenylalanine), gelatin, peanut oil, soy, parabens, sulfites, titanium dioxide.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (45)

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Same active substance, strength and form in other countries

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Canada1 matching products

NB-AMLODIPINE 10 mg · tablet

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Netherlands1 matching products

Amlodipine (als besilaat) 10 mg PCH 10 mg · tablet

Every strength and form (2)

Details

Made by	ST. MARY'S MEDICAL PARK PHARMACY
Active substance	Amlodipine Besylate
Used in	Heart, blood pressure and circulation
Strength	10 mg
Form	Tablet
Route	Oral
Packs	30 TABLET in 1 BOTTLE, PLASTIC
NDC	60760-445

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

101 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Amlodipine Besylate2.5 mgPrescription onlyTablet Teva Pharmaceuticals, Inc. · Amlodipine Besylate Amlodipine Besylate5 mgPrescription onlyTablet Teva Pharmaceuticals, Inc. · Amlodipine Besylate Amlodipine Besylate10 mgPrescription onlyTablet Teva Pharmaceuticals, Inc. · Amlodipine Besylate Amlodipine Besylate2.5 mgPrescription onlyTablet NCS HealthCare of KY, LLC dba Vangard Labs · Amlodipine Besylate Amlodipine Besylate5 mgPrescription onlyTablet NCS HealthCare of KY, LLC dba Vangard Labs · Amlodipine Besylate Amlodipine Besylate10 mgPrescription onlyTablet NCS HealthCare of KY, LLC dba Vangard Labs · Amlodipine Besylate

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