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Amlodipine

  • Prescription medicine
  • Prescription only
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Amlodipine does in the body

Amlodipine dissolves into the fatty part of the cell membrane, works its way sideways into those gates and blocks them.

The muscle around your small arteries needs calcium flowing in through tiny gates to stay contracted. The muscle relaxes, the arteries widen, and pressure falls. It binds and releases very slowly, which is why it lasts a full day and why the pressure does not swing.

Why people take it. Used for high blood pressure and chest pain from narrowed heart arteries.

What happened in people

An amlodipine-based plan caused fewer strokes, total heart-related problems and deaths than an older treatment plan.

Reviewed first-read answer

Where this came from

A person wrote this and a reviewer approved it against this exact record. It carries no effect size.

A reviewer approved this against this record. The reviewed-claim record carrying the exact population and effect size does not exist yet.

No source is stored against this line.

The limit that matters most

The study’s main prechosen heart result did not clearly differ.

Where it acts
Arterial smooth muscle cell membrane (systemic resistance arterioles)
Kind of result
The kind of result is not recorded
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.

What the registries record it as

  • Its recorded molecular formula is C20H25CIN2O5•C6H6O3S, weighing 567.1.

    US prescribing information · 1a24433f-4464-4c6d-9456-ed1ce38e8ec4 · read 2026-08-30

Where each sentence above came from

A person wrote this explanation into the record, with the studies named in the path below.

A reviewer approved this sentence against this exact record and its sources.

The limit a reviewer approved as the one that matters most here.

The four opening statements run to 94 words.

Words this page uses

Four words worth knowing first

Chosen from what this page shows, with each one explained before the word it depends on.

Stand-in result

A stand-in result is a number measured because the real result takes too long.

A picture of it, and where the picture fails

It is like judging a journey by the speedometer rather than by arriving.

Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.

What people get wrong. A stand-in result is often reported as the result itself.

A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.

Randomisation

Randomisation means chance decides who gets which treatment.

A picture of it, and where the picture fails

It is like a coin toss deciding the groups.

Where that stops being true. A coin toss is fair once. Fairness here comes from doing it for everyone.

What people get wrong. It is thought to make groups identical. It makes them similar on average, including on things nobody measured.

Allocation of participants to arms by a chance process, so that unmeasured factors are balanced in expectation.

Confidence interval

A confidence interval is the range the true answer is likely to sit in.

A picture of it, and where the picture fails

It is like a weather forecast giving a range rather than one number.

Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.

What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.

An interval estimate that would contain the true parameter in a stated proportion of repeated studies.

Formulation

A formulation is the exact made-up form a substance comes in.

A picture of it, and where the picture fails

It is like the difference between a whole bean and instant coffee.

Where that stops being true. Coffee tastes different. A formulation can change how much reaches the blood.

What people get wrong. Two products with the same name are assumed to behave the same. They often do not.

The specific composition and physical form of a product, including salt, excipients and release profile.

What happened in peopleRead from sources, not yet reviewed

What was measured, goal by goal

One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.

Registered studies list 40 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.

There is no single score. A strong test result and a weak life result are different facts.

Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
GoalLife outcomeWhat a body can doHow a person feelsA test resultA step in the bodyHarmsHow longWho was studied
Blood sugarNothing in the sources checkedNo registered study lists a life outcome for this goal.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Nothing in the sources checkedNo registered study lists a symptom measure for this goal.Only a number moved2 registered test measure.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
Healthy ageingWaiting for a reviewer1 registered study measure of this kind. No reviewed result yet.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Nothing in the sources checkedNo registered study lists a symptom measure for this goal.Nothing in the sources checkedNo registered study lists a test result for this goal.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
CholesterolNothing in the sources checkedNo registered study lists a life outcome for this goal.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Nothing in the sources checkedNo registered study lists a symptom measure for this goal.Only a number moved1 registered test measure.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Blood sugar
metabolic profiles including lipid profile and blood glucose; glycated hemoglobin a1c
Healthy ageing
all cause mortality
Cholesterol
metabolic profiles including lipid profile and blood glucose

Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.

What each mark on this table means
Nothing in the sources checked
No registered study lists a life outcome for this goal.
Only a number moved
2 registered test measure.
Not recorded
Harms were not a registered measure for this goal.
Waiting for a reviewer
Who was studied is listed further down the page.

What happened in peopleRead from sources, not yet reviewed

What happened in people

Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.

Non-fatal myocardial infarction including silent infarction, plus fatal coronary heart disease

The study did not show it

Who was studied
ASCOT-BPLA
How many people
19257
Study design
Randomised open, blinded-endpoint trial, stopped early at median 5.5 years
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
HR 0.90 (95% CI 0.79-1.02), P = 0.1052 — not statistically significant
Repeated elsewhere
Partially Replicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. Stroke, total cardiovascular events, all-cause mortality and new-onset diabetes all favoured the amlodipine-based regimen with p-values from 0.025 to below 0.0001. The trial is remembered for those and not for the endpoint it was designed around.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet, and oral suspensions for children; also sold in many fixed-dose combinations

Interval reported. 95% CI 0

Written into the record, not signed off as a reviewed claim.

Death from any cause plus hospitalisation for major cardiovascular events in severe heart failure

The study did not show it

Who was studied
PRAISE
How many people
1153
Study design
Randomised double-blind placebo-controlled trial, 6 to 33 months
Compared against
A dummy treatment
Kind of result
Living longer, or avoiding a major event
What was found
9% reduction (95% CI 24% reduction to 10% increase), P = 0.31
Repeated elsewhere
Failed to Replicate

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. The 46% mortality reduction in the non-ischaemic subgroup (p<0.001) was a subgroup of a trial that missed its own primary endpoint.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet, and oral suspensions for children; also sold in many fixed-dose combinations

Interval reported. 95% CI 24% reduction to 10% increase), P = 0

Written into the record, not signed off as a reviewed claim.

All-cause mortality in severe heart failure due to non-ischaemic cardiomyopathy

The study did not show it

Who was studied
PRAISE-2
How many people
1654
Study design
Randomised double-blind placebo-controlled confirmatory trial
Compared against
A dummy treatment
Kind of result
Living longer, or avoiding a major event
What was found
HR 1.09 (95% CI 0.92-1.29), P = 0.33
Repeated elsewhere
Failed to Replicate

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. Both PRAISE trials recorded higher frequencies of peripheral oedema and pulmonary oedema on amlodipine.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet, and oral suspensions for children; also sold in many fixed-dose combinations

Interval reported. 95% CI 0

Written into the record, not signed off as a reviewed claim.

Combined fatal coronary heart disease or non-fatal myocardial infarction, amlodipine versus chlorthalidone

The study did not show it

Who was studied
ALLHAT amlodipine arm (NCT00000542)
How many people
24303
Study design
Randomised double-blind active-controlled trial, mean 4.9 years
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
RR 0.98 (95% CI 0.90-1.07) — no difference
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. Six-year heart failure rate 10.2% against 7.7% on chlorthalidone, RR 1.38 (1.25-1.52).

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet, and oral suspensions for children; also sold in many fixed-dose combinations

Interval reported. 95% CI 0

Written into the record, not signed off as a reviewed claim.

Incidence of a composite of cardiovascular events, amlodipine versus placebo, in coronary disease with normal blood pressure

The study showed what it set out to show

Who was studied
CAMELOT
How many people
1991
Study design
Randomised double-blind placebo-controlled trial, 24 months
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
HR 0.69 (95% CI 0.54-0.88), P = 0.003
Repeated elsewhere
Unreplicated

What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.

The limits of this study, and where it came from

Main limit. The intravascular ultrasound substudy comparison against placebo was p=0.12 and is widely quoted as though it were positive.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral tablet, and oral suspensions for children; also sold in many fixed-dose combinations

Interval reported. 95% CI 0

Written into the record, not signed off as a reviewed claim.

What we know
RNAWiki holds 5 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.

What happened in peopleRead from sources, not yet reviewed

How close this is to real life

The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.

  1. Living longer, or avoiding a major event Evidence recorded. Death, a heart attack, a stroke, a hospital stay.2 registered measures of this kind. 1 written-up study measured this and did not show a benefit.
  2. What a body can do day to day Evidence recorded. Walking, dressing, breathing, recovering.1 registered measure of this kind.
  3. Measured performance Evidence recorded. How much was lifted, how far was run, how fast.1 registered measure of this kind.
  4. Symptoms and quality of life No evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
  5. A number that stands in for health Evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.19 registered measures of this kind.
  6. A step measured inside a person Evidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
  7. Animals Evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Mouse, Rat, Dog. A result in animals says what to test next. It does not say what happens in people.
  8. Cells in a dish Evidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
  9. A guess from software No evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.

Higher on these steps means closer to something a person would feel. It does not mean better done.

What it changes in the bodyRead from sources, not yet reviewed

The path through the body

From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.

Where a source records it acting

  • Blood and vessels: Peripheral arterial vasodilator that acts directly on vascular smooth muscle to reduce peripheral vascular resistance and blood pressure

    US prescribing information · 003dd1ec-16f8-4f96-b6a8-c4689d35892a · read 2026-08-27

  • Heart: In exertional angina, reduces the total peripheral resistance (afterload) against which the heart works and thus myocardial oxygen demand

    US prescribing information · 003dd1ec-16f8-4f96-b6a8-c4689d35892a · read 2026-08-27

  1. Start

    Amlodipine

    What a person takes: Oral tablet, and oral suspensions for children; also sold in many fixed-dose combinations.

    The measurement behind this step

    Once daily, with or without food. Absorption is slow and the elimination half-life is 30 to 50 hours, so the effect builds over about a week and a missed dose does not produce a rebound. That slow onset is also why it does not cause the reflex tachycardia and flushing of the short-acting dihydropyridines.

  2. Getting in

    Absorbed slowly and completely, and eliminated over days

    The tablet is absorbed over hours and cleared over days. It takes about a week of daily doses for the effect to reach its full size, and it fades just as slowly if a dose is missed.

    Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.

    The measurement behind this step

    Oral bioavailability is 64 to 90%, unaffected by food, with peak plasma concentration at 6 to 12 hours. Elimination half-life is 30 to 50 hours and steady state is reached after 7 to 8 days. Clearance is hepatic, largely by CYP3A4, to inactive pyridine metabolites.

  3. Reaching the cell

    It dissolves into the cell membrane rather than entering the cell

    The molecule is greasy and settles inside the fatty double layer that forms the cell surface. From there it moves sideways to reach its target, instead of floating up to it through water.

    Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.

    The measurement behind this step

    Amlodipine partitions strongly into the phospholipid bilayer and, being partly ionised at physiological pH, anchors near the membrane surface. Access to the dihydropyridine site is lateral, from within the lipid phase, which is why the on- and off-rates are slow and why the pharmacodynamic half-life exceeds the plasma half-life.

  4. What it acts on

    It locks the calcium gate preferentially where the gate is already tired

    The gates it blocks have three states: closed, open, and a spent state after opening. The drug grips the spent state hardest, and artery muscle spends far more time in that state than heart muscle does.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    The dihydropyridine site on the alpha-1C subunit is state-dependent, with much higher affinity for the inactivated channel. Vascular smooth muscle sits at a more depolarised resting potential than cardiac myocytes, so a larger fraction of its L-type channels is inactivated at rest. That single biophysical fact is the basis for vascular selectivity and for the absence of the negative inotropy that condemned the earlier calcium blockers in heart failure.

  5. The change it makes

    Less calcium enters, so the contraction machinery stands down

    Without calcium coming in, the enzyme that keeps the muscle fibres pulling is not switched on, and the artery wall relaxes.

    Described, with no measurement named. No measurement is named for this step, so it is drawn as an unconfirmed link.

    The measurement behind this step

    Reduced calcium influx lowers cytosolic calcium, so less binds calmodulin, so myosin light chain kinase activity falls and myosin light chain phosphorylation declines. Actin-myosin cross-bridge cycling slows and the vessel dilates. Because the drug acts on arterioles far more than on venules, capillary hydrostatic pressure rises — which is the mechanism of the ankle oedema, and the reason a diuretic treats that oedema badly.

  6. What that does for a person

    Resistance falls, pressure falls, and in ASCOT there were fewer strokes

    Widened arteries mean the heart pushes against less resistance. Over years, in the trials that counted them, that produced fewer strokes and fewer deaths than the older regimen it was compared with.

    Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.

    The measurement behind this step

    Reduced systemic vascular resistance lowers arterial pressure without reflex tachycardia at steady state, because the onset is too slow to trigger a baroreflex surge. In ASCOT-BPLA the amlodipine-based regimen produced 327 strokes against 422 (HR 0.77, p=0.0003) and 738 deaths against 820 (HR 0.89, p=0.025) across 19,257 patients.

No suggested links are held for this record, so nothing is hidden from this path.

What we know
The record describes 5 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.

What it would be like to takeRead from sources, not yet reviewed

Felt, measured, or meaningful

Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.

Felt

Things a person could notice without a test.

No registered study measured anything of this kind.

Measured

Things only a test, a scale or a device shows.

  • blood pressure
  • systolic blood pressure from the start of the study
  • trough seated diastolic blood pressure
  • blood pressure less than 140/90 after 14 weeks
  • sitting systolic blood pressure to week 12
  • mean sitting diastolic blood pressure at trough
  • sitting systolic blood pressure from baseline to week 8
  • metabolic profiles including lipid profile and blood glucose
  • achieving blood pressure goals
  • sitting systolic blood pressure

and 10 more.

Meaningful

Things that change how a life goes, not only a number.

  • all cause mortality
  • any adverse events serious adverse events and death

A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.

Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.

Measured, but not felt. A number moves. The person notices nothing. Both can be true.

Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.

Matters, but takes years. The result that counts may take longer than anyone would keep watching.

Names that fit none of the three (18)
  • heart failure
  • renal dysfunction
  • normalization of microalbuminuria
  • 50 reduction in uae from the baseline
  • at 8 weeks in seated trough cuff mean dbp
  • seated trough cuff mean dbp
  • overall percentage of adverse events
  • peripheral edema from baseline to week 8
  • lateral mitral annular myocardial relaxation velocity
  • bioequivalence
  • plasminogen activator inhibitor 1
  • basal metabolic rate
  • rate and extend of absorption
  • flow mediated dilatation
  • average changes from baseline in sitdbp
  • bioequivalence based on cmax and auc parameters
  • c terminal propeptide of procollagen type i
  • coronary flow reserve

These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.

What it would be like to takeRead from sources, not yet reviewed

How long anything takes

Nine different lengths of time that get confused with each other. None of them is worked out from another.

  1. Before anything is noticed. RNAWiki does not store this separately, and never works it out from another figure on this page.

  2. Before a test result moves. RNAWiki does not store this separately, and never works it out from another figure on this page.

  3. Before performance moves. RNAWiki does not store this separately, and never works it out from another figure on this page.

  4. How long the result was watched. No finished study window is recorded for a study that tested this substance.

  5. How long people took it. How long people actually took it is not stored. The study window is not the same thing.

  6. How long people were followed. Follow-up length is not stored separately. It is never read off the study window, which would be a different thing.

  7. How fast the body clears it. about 30 to 50 hours

    Read from the label, which states: “Elimination from the plasma is biphasic with a terminal elimination half-life of about 30 to 50 hours. Steady-state plasma levels of amlodipine are reached after 7 to 8 days of consecutive daily dosing.”

  8. How long effects linger. RNAWiki does not store this separately, and never works it out from another figure on this page.

  9. Beyond the studies. Nothing is recorded about the long term.

    The longest finished study sets the edge of what anyone measured.

A study window is not how long people took it, and neither is how long they were followed. Where RNAWiki holds only one of the three, it shows one.

What is missing or unclearRead from sources, not yet reviewed

Were people like you studied?

RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.

Who was studied

People similar to this profile were included.

  • Among the most-dispensed drugs in the world for hypertension, alone or in fixed combinations. Also used for chronic stable angina and for coronary spasm. It is on the WHO Model List of Essential Medicines.

Who is missing from the studies

  • Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What the label states about particular groups

  • On pediatric, the label states: “Amlodipine besylate tablets (2.5 to 5 mg daily) are effective in lowering blood pressure in patients 6 to 17 years [see Clinical Studies ( 14.1 )] .”

    US prescribing information · 1a24433f-4464-4c6d-9456-ed1ce38e8ec4 · read 2026-08-30

  • On older people, the label states: “Clinical studies of amlodipine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.”

    US prescribing information · 1a24433f-4464-4c6d-9456-ed1ce38e8ec4 · read 2026-08-30

  • On people who are pregnant, the label states: “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.”

    US prescribing information · 1a24433f-4464-4c6d-9456-ed1ce38e8ec4 · read 2026-08-30

  • On people who are breastfeeding, the label states: “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%.”

    US prescribing information · 1a24433f-4464-4c6d-9456-ed1ce38e8ec4 · read 2026-08-30

Where the result stopped carrying

  • ASCOT-BPLA did not reach significance on its designated primary endpoint and was stopped early
  • PRAISE missed its own primary endpoint (p=0.31) before producing the subgroup that PRAISE-2 then failed to confirm
  • ALLHAT found 38% more heart failure on amlodipine than on a diuretic costing about the same
  • This is a scope explorer, not a diagnosis engine.
  • It shows who was studied so you can see whether people similar to you were included.

RNAWiki cannot tell whether a study fits you. It can show who was in it.

What it would be like to takeRead from sources, not yet reviewed

Why it might seem to do nothing

A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.

It was studied for a different goal

The studies measured something else entirely.

On this record: Some registered studies measured things that match no goal on this page.

It was studied in different people

The people in the studies were not much like the reader.

On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

A different form was studied

The studied form is not the form on the shelf.

On this record: This record is linked to 1 related forms. Evidence does not carry across all of them.

The evidence may simply be wrong

Small early studies often do not hold up.

On this record: RNAWiki has not yet published a reviewed conclusion for this use.

Other reasons RNAWiki checked and found nothing for (9)
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.

None of these is a reason to take more. Taking more is not a step this page ever suggests.

What it would be like to takeRead from sources, not yet reviewed

What taking it involves

The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.

How it is supplied

Prescription only

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Read from the recorded approval status.

No source is stored against this line.

Form and route

Oral tablet, and oral suspensions for children; also sold in many fixed-dose combinations

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form and route recorded on this substance.

No source is stored against this line.

Who oversees it

RNAWiki has not recorded a supervision or regulatory status for this substance.

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

No register row and no identity class settled the question.

No source is stored against this line.

What is in the pack

Once daily, with or without food. Absorption is slow and the elimination half-life is 30 to 50 hours, so the effect builds over about a week and a missed dose does not produce a rebound. That slow onset is also why it does not cause the reflex tachycardia and flushing of the short-acting dihydropyridines.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on how this is sold and what that means for what is in the pack.

No source is stored against this line.

Where it is registered

Regulatory records are listed in the technical disclosure at the foot of this page.

Counted from records

Where this came from

A count of rows RNAWiki holds. It describes our records, not your body.

Register entries are stored per jurisdiction and shown with their dates.

No source is stored against this line.

Why people stop

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No record of why people stopped taking it is stored for this substance.

No source is stored against this line.

What it would be like to takeRead from sources, not yet reviewed

What can go wrong

Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.

Worth asking a clinician aboutWritten into the record from the studies named on this page

Dose-dependent peripheral oedema is the characteristic effect and was more frequent than placebo in both PRAISE trials. Flushing, headache and palpitations occur early and usually settle. It does not depress cardiac contractility at usual exposures, which is the design intent behind its vascular selectivity. Clearance is by CYP3A4, so strong inhibitors including grapefruit furanocoumarins raise exposure.

Nobody counted how many people took this and were fine, so this cannot be turned into a rate.

Where this came from

Reports sent to a regulator

  • These are reports people sent to a regulator. They do not show the medicine caused the reaction.
  • Nobody counted how many people took the medicine and reported nothing.
  • The same event can be reported more than once, and many reports are incomplete.
  • News coverage, lawsuits and new warnings change how often people report.
  • A count is not a rate and not a risk.

Amlodipine appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 14961 reaction mentions were counted. One report can name several reactions.

The recorded terms (10)
  • hypotension — 3365 reaction mentions
  • drug hypersensitivity — 1828 reaction mentions
  • fall — 1549 reaction mentions
  • toxicity to various agents — 1463 reaction mentions
  • oedema peripheral — 1403 reaction mentions
  • hypertension — 1293 reaction mentions
  • acute kidney injury — 1257 reaction mentions
  • blood pressure increased — 983 reaction mentions
  • bradycardia — 913 reaction mentions
  • suicide attempt — 907 reaction mentions
  • open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot

Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.

Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What is missing or unclearRead from sources, not yet reviewed

Does the exact form matter?

Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.

The form that was studied

Oral tablet, and oral suspensions for children; also sold in many fixed-dose combinations

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form used in the studies cited on this page.

No source is stored against this line.

What is sold

Absorption is slow and the elimination half-life is 30 to 50 hours, so the effect builds over about a week and a missed dose does not produce a rebound. That slow onset is also why it does not cause the reflex tachycardia and flushing of the short-acting dihydropyridines.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on which forms are sold and how they compare.

No source is stored against this line.

What is recorded as being sold

  • 610 products list this as an active ingredient in the United States drug directory. 233 of them contain it and nothing else.

    FDA National Drug Code directory · 71335-2924 · read 2026-08-29

  • They are sold as capsule, powder, solution, tablet, tablet, coated and tablet, film coated, taken oral.

    FDA National Drug Code directory · 71335-2924 · read 2026-08-29

  • The regulator's established pharmacologic class for it is calcium channel antagonists [moa], calcium channel blocker [epc] and cytochrome p450 3a inhibitors [moa].

    FDA National Drug Code directory · 71335-2924 · read 2026-08-29

  • 248 published labels name it as an active ingredient. 132 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 9fb71df8-f70f-47dc-9465-8d8748261caf · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 9fb71df8-f70f-47dc-9465-8d8748261caf · read 2026-08-29

  • Amlodipine Besylate is tablets at 2.5 mg, 5 mg, and 10 mg, recorded as prescription product; fda label in effect 2026-04-20 in the United States.

    US prescribing information · 003dd1ec-16f8-4f96-b6a8-c4689d35892a · read 2026-08-27

  • Recorded price in US: 0.01012–0.01503 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 94 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..

    Recorded source · 2026-08-26 · read 2026-08-28

Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.

Names and forms linked to this record

  • Stereoisomer of

    Levamlodipine

    Evidence on this page does not automatically apply to this one.

What it would be like to takeRead from sources, not yet reviewed

What you could measure

This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.

RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.

Questions worth asking

  • Which of the trials of Amlodipine studied people like me?
  • What was measured, and for how long?
  • Was the result a laboratory value or a health outcome?
  • What would we watch for, and when would we stop?

Tracking can show whether something changed for you. It cannot show what caused it.

RNAWiki records evidence. It does not say whether this substance is right for you.

What is missing or unclearRead from sources, not yet reviewed

Claims that go past the evidence

Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.

Goes past the evidence

That ASCOT-BPLA showed amlodipine-based therapy prevents coronary events — the coronary primary endpoint gave p=0.1052

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That amlodipine slows coronary atherosclerosis — the CAMELOT ultrasound comparison against placebo was p=0.12

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That amlodipine prolongs survival in non-ischaemic dilated cardiomyopathy — the hypothesis PRAISE raised and PRAISE-2 refuted

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

Goes past the evidence

That the ASCOT-BPLA advantage cannot be explained by blood pressure — the paper itself flags this as an open question addressed in a companion analysis

Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.

The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.

What would change this

A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.

RNAWiki has not yet published a reviewed conclusion for this use.

What is missing or unclearRead from sources, not yet reviewed

What nobody knows yet

Open questions, each with why it is open and what would close it.

Missing populations

Which groups were under-represented in the studies has not been recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing long-term data

No completed tested study window is recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

No reviewed conclusion

RNAWiki has not yet published a reviewed conclusion for this use.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing interaction studies

No interaction was found in the registers checked. Not finding one is not the same as showing there is none.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Formulation uncertainty

Several salts, forms or products of Amlodipine are recorded. Results from one form may not transfer to another.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Mechanism not reviewed

No reviewed mechanism story exists for this substance.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

What happened in peopleRead from sources, not yet reviewed

Check any of this yourself

Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.

Every line above can be traced to the study named beside it. Follow the link and read it.

ASCOT-BPLA missed the primary endpoint it was designed to test
In plain words
The trial everyone cites as showing amlodipine beat the older regimen did not, on the measure it was built around. Heart attacks and coronary deaths came out 429 against 474, a difference that could have been chance.
What was measured
Non-fatal myocardial infarction and fatal coronary heart disease
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
ASCOT-BPLA randomised 19,257 hypertensive patients aged 40 to 79 with at least three other cardiovascular risk factors to an amlodipine-based regimen adding perindopril as required (n=9,639) or an atenolol-based regimen adding bendroflumethiazide as required (n=9,618). The trial was stopped prematurely after a median 5.5 years, accumulating 106,153 patient-years. The prespecified primary endpoint, non-fatal myocardial infarction including silent infarction plus fatal coronary heart disease, occurred in 429 on the amlodipine-based regimen against 474 on the atenolol-based regimen: unadjusted hazard ratio 0.90 (95% CI 0.79 to 1.02), p=0.1052. The paper states the direction "though not significant" in its first sentence of findings. Early stopping reduces the power to detect the primary effect, which is an explanation, not a result.
Source
Dahlöf B et al., ASCOT-BPLA, Lancet 2005;366:895-906
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
The same trial did reach significance on stroke, death and new diabetes
In plain words
On four other outcomes, the amlodipine-based regimen clearly won: a quarter fewer strokes, fewer total cardiovascular events, fewer deaths from any cause, and 30% fewer new diabetes diagnoses.
What was measured
Fatal and non-fatal stroke, total cardiovascular events, all-cause mortality and new-onset diabetes over a median 5.5 years
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Against the atenolol-based regimen, the amlodipine-based regimen produced fewer fatal and non-fatal strokes (327 against 422; HR 0.77, 95% CI 0.66 to 0.89, p=0.0003), fewer total cardiovascular events and procedures (1,362 against 1,602; HR 0.84, 0.78 to 0.90, p<0.0001), lower all-cause mortality (738 against 820; HR 0.89, 0.81 to 0.99, p=0.025) and a lower incidence of new-onset diabetes (567 against 799; HR 0.70, 0.63 to 0.78, p<0.0001). These are secondary endpoints in a trial that missed its primary one, which is exactly why they should be read as a strong and internally consistent set of measured differences rather than as confirmation of the primary hypothesis.
Source
Dahlöf B et al., ASCOT-BPLA, Lancet 2005;366:895-906
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
PRAISE promised a 46% mortality reduction; PRAISE-2 delivered a hazard ratio of 1.09
In plain words
In a heart failure trial, a subgroup of patients whose disease was not caused by blocked arteries appeared to have their risk of death nearly halved. A second trial was run in exactly that subgroup. It found nothing at all.
What was measured
All-cause mortality in severe non-ischaemic cardiomyopathy, confirmatory trial versus originating subgroup
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
PRAISE randomised 1,153 patients with severe heart failure and ejection fraction under 30% to amlodipine (n=571) or placebo (n=582) for 6 to 33 months. The primary combined endpoint of death or hospitalisation for major cardiovascular events was reached in 42% on placebo and 39% on amlodipine, a 9% reduction whose interval ran from 24% reduction to 10% increase, p=0.31. Death occurred in 38% against 33%, a 16% reduction, p=0.07. In the prespecified non-ischaemic subgroup, amlodipine reduced the combined endpoint by 31% (p=0.04) and death by 46% (p<0.001). PRAISE-2 then randomised 1,654 patients with severe non-ischaemic cardiomyopathy: 278 deaths on amlodipine against 262 on placebo, hazard ratio 1.09 (95% CI 0.92 to 1.29), p=0.33. Pooling both trials in non-ischaemic patients gave a hazard ratio of 0.97 (0.83 to 1.13), p=0.66. The authors close by naming the lesson: great caution is needed when striking benefits appear in subgroups or in trials not designed to test them.
Source
Packer M et al., PRAISE, N Engl J Med 1996;335:1107-1114; Packer M et al., PRAISE-2, JACC Heart Fail 2013;1:308-314
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
ALLHAT: 38% more heart failure than on a thiazide-type diuretic
In plain words
In the largest hypertension trial ever run, amlodipine matched the diuretic on heart attacks and on death, but produced substantially more heart failure over six years.
What was measured
Six-year rate of heart failure, amlodipine versus chlorthalidone
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
ALLHAT randomised 9,048 participants to amlodipine 2.5-10 mg against 15,255 to chlorthalidone 12.5-25 mg, mean follow-up 4.9 years. The primary endpoint of fatal coronary heart disease plus non-fatal myocardial infarction did not differ: 6-year rates 11.3% against 11.5%, relative risk 0.98 (95% CI 0.90 to 1.07). All-cause mortality did not differ. Secondary outcomes were similar except for heart failure, where the 6-year rate was 10.2% on amlodipine against 7.7% on chlorthalidone: relative risk 1.38 (1.25 to 1.52). Five-year systolic blood pressure was 0.8 mm Hg higher on amlodipine (p=0.03), a difference far too small to account for the heart failure gap.
Source
ALLHAT Officers and Coordinators, JAMA 2002;288:2981-2997 (NCT00000542)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
CAMELOT: fewer events in coronary disease at a blood pressure already called normal
In plain words
Two thousand people with narrowed coronary arteries and blood pressure in the normal range were given amlodipine, an ACE inhibitor or placebo for two years. Amlodipine reduced cardiovascular events. The ACE inhibitor did not, significantly.
What was measured
Incidence of a composite of cardiovascular events over 24 months, amlodipine versus placebo
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
CAMELOT randomised 1,991 patients with angiographically documented coronary artery disease and diastolic pressure below 100 mm Hg to amlodipine 10 mg, enalapril 20 mg or placebo for 24 months. Baseline pressure averaged 129/78 mm Hg. Pressure rose 0.7/0.6 mm Hg on placebo and fell 4.8/2.5 on amlodipine and 4.9/2.4 on enalapril (p<0.001 for both against placebo). Cardiovascular events occurred in 151 placebo patients (23.1%), 110 amlodipine patients (16.6%; HR 0.69, 95% CI 0.54 to 0.88, p=0.003) and 136 enalapril patients (20.2%; HR 0.85, 0.67 to 1.07, p=0.16). The direct enalapril versus amlodipine comparison was not significant (HR 0.81, 0.63 to 1.04, p=0.10).
Source
Nissen SE et al., CAMELOT, JAMA 2004;292:2217-2225
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
The "slows atherosclerosis" claim comes from a substudy that was not significant
In plain words
CAMELOT included an ultrasound look inside the coronary arteries. Amlodipine appeared to slow plaque growth. The comparison against placebo did not reach statistical significance, and only one subgroup did.
What was measured
That amlodipine slows the progression of coronary atherosclerosis — a substudy trend of p=0.12, with significance only in an above-mean-pressure subgroup
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The intravascular ultrasound substudy of CAMELOT measured change in percent atheroma volume between baseline and study completion. The amlodipine versus placebo comparison showed a trend, p=0.12. Significance was reached only in the subgroup whose systolic pressure was above the study mean, p=0.02. Within-group changes showed progression on placebo (p<0.001), a trend toward progression on enalapril (p=0.08) and no progression on amlodipine (p=0.31); an absence of within-group significance is not a between-group difference. The correlation between blood pressure reduction and atheroma progression in the amlodipine group was r=0.19, p=0.07. The paper describes this as evidence of slowing; the number attached to the headline comparison is 0.12.
Source
Nissen SE et al., CAMELOT, JAMA 2004;292:2217-2225
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
contested
Review state
Written into the record, not signed off as a reviewed claim

How many documents were read

  • 131 documents were read for this substance.

    RNAWiki source record

  • 2 of them state the same tMax, and they agree.

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
864V2Q084H
CAS registry number
88150-42-9
PubChem compound
2162
RxNorm concept
104416

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

    The opening statement carries the origin: Written into the record, not signed off.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Not passed

    Safety mode resolved

    No register row and no identity class settled the question.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.

What the approval register records

  • 117 approved applications cover products containing this substance. The earliest was NDA019787, approved 19920731 to VIATRIS.

    Drugs@FDA application register · NDA019787 · read 2026-08-29

  • Marketing status on the register: discontinued, none (tentative approval) and prescription.

    Drugs@FDA application register · NDA019787 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 19920731.

    FDA National Drug Code directory · 71335-2924 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

This order is fixed in code and does not count clicks or time on the page.

What is not here

3 questions this page could not answer

These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.

  • What it may clash with — found nothing in the sources checked.
  • Other ways to the same goal — found nothing in the sources checked.
  • What changed on this page — found nothing in the sources checked.

The record as stored

The full record, for auditing

Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.

The older medicine-wide conclusion held in this record

Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.

A long-acting vascular-selective calcium channel blocker whose flagship trial, ASCOT-BPLA, did not reach statistical significance on the primary endpoint it was designed around (429 versus 474 events, p=0.1052) while reaching it convincingly on stroke, all-cause mortality and new-onset diabetes — and whose most striking subgroup result, a 46% mortality reduction in non-ischaemic cardiomyopathy, evaporated completely in the trial run to confirm it.

Recorded evidence blocks (14)

What did Amlodipine's largest trial (68500 people) and its longest (14 years) measure?


68500 people in Amlodipine's largest registered study, 14 years in its longest registered window, measuring All cause mortality. ClinicalTrials.gov · 2026-09-01

98 phase4, 80 phase3, 51 phase1, 38 phase2, 31 na, 18 na or unstated, 3 early phase1; NCT00382421; 2006-04. Last human test completed 2024, NCT04434664.

Interpretation These counts include studies where Amlodipine was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.

Show the evidence
  • phase4
    98
  • phase3
    80
  • phase1
    51
  • phase2
    38
  • na
    31
  • na or unstated
    18
2 more recorded rows
  • early phase1
    3
  • Last recorded human test NCT04434664
    2024-12-20

recorded 2026-09-01 · last checked 2026-09-04

From mouse to human: where has Amlodipine shown lifespan?


mouse: lifespan, rat: lifespan, dog: lifespan and human: lifespan (308): the rungs where Amlodipine has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Interpretation All cause mortality — the recorded outcome words.

Yeast C. elegans Drosophila Mouse lifespanRat lifespanDog lifespanNon-human primate Human lifespan
Show the evidence
  • mouse
    lifespan
  • rat
    lifespan
  • dog
    lifespan
  • human NCT00134160
    lifespan; All cause mortality; 308

recorded 2026-09-01 · last checked 2026-09-04

26 of Amlodipine's trials stopped: safety, futility/efficacy, accrual/recruitment, funding/business, sponsor decision unspecified, other?


safety (1), futility/efficacy (3), accrual/recruitment (7), funding/business (5), sponsor decision unspecified (1) and other (9): Amlodipine's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"Early termination resulted from interim analysis of the ALTITUDE trial"; 26 of 308 registered studies

Show the evidence

Trial

  • NCT00498433
    terminated; "Early termination resulted from interim analysis of the ALTITUDE trial"
  • NCT00542269
    terminated; "Early termination of the study due to slow recruitment."
  • NCT00825188
    terminated; "funding to complete was inadequate"
  • NCT00987662
    withdrawn; "no funding"
  • NCT01080768
    terminated; "Publication of data from a similar study made the current study redundant."
  • NCT01252238
    terminated; "Study sponsor terminated study due to AE's reported with valsartan and aliskiren"
14 further recorded trials
  • NCT01259297
    terminated; "Terminated early in agreement with Health Authorities for feasibility reasons"
  • NCT01368536
    terminated; "Based on results from an ALTITUDE study interim analysis, testing aliskiren concomitantly with an ACE inhibitor or ARB, in diabetics with renal impairment"
  • NCT01409408
    withdrawn; "Due to preliminary results of Altitude Trial."
  • NCT01425242
    terminated; "Insufficient number of participants"
  • NCT01549496
    withdrawn; "Investigator left this hospital"
  • NCT02058823
    terminated; "budget constraints"
  • NCT02642146
    terminated; "We decided to terminate recruit earlier because patient recruiting was not active as expected at the beginning of the study."
  • NCT02940548
    terminated; "The patient recruitment and follow-ups were influenced with the pandemic of COVID-19"
  • NCT02969265
    withdrawn; "Business reasons unrelated to product safety"
  • NCT03082014
    terminated; "completed for the primary study group of sporadic SVD patients, halted prematurely for the additional study group due to slow recruitment at 26 of 30 CADASIL patients in December 2022"
  • NCT03106597
    terminated; "Difficulty in enrolling subjects"
  • NCT03722381
    withdrawn; "Study activities were not initiated, and we do not plan to initiate them in the future."
  • NCT03978884
    withdrawn; "Unable to effective arrange trial logistics"
  • NCT04121299
    withdrawn; "lack of funding"

recorded 2026-09-01 · last checked 2026-09-04

Human studies of Amlodipine used Amlodipine 10 mg — over how long?


Human studies of Amlodipine used "Amlodipine 10 mg". ClinicalTrials.gov · 2026-09-01

20 recorded entries; human; capsule, tablet; also "Amlodipine 5 mg", "Amlodipine 2.5 mg", "Valsartan/amlodipine 80/5 mg"

Show the evidence

human

  • NCT00171054
    Amlodipine 10 mg
  • NCT00281580
    Amlodipine 5 mg
  • NCT00281580
    Amlodipine 2.5 mg
  • NCT00413049
    Valsartan/amlodipine 80/5 mg
  • NCT00421863
    Norvasc 10 mg
  • NCT00425373
    Valsartan + amlodipine 40/2.5 mg
14 more recorded rows
  • human NCT00425373
    Valsartan + amlodipine 40/5 mg
  • human NCT00425373
    Valsartan + amlodipine 80/2.5 mg
  • human NCT00425373
    Valsartan + amlodipine 80/5 mg
  • human NCT00426478
    Amlodipine (5mg)
  • human NCT00437645
    Amlodipine 5 mg capsules
  • human NCT00627952
    amlodipine 10 mg
  • human NCT00627952
    amlodipine 5 mg + delapril 30 mg
  • human NCT00687973
    Valsartan/amlodipine 80/5 mg tablets
  • human NCT00687973
    Amlodipine 10 mg capsules
  • human NCT00739973
    capsule; Amlodipine 5 mg capsule
  • human NCT00739973
    capsule; Amlodipine 10 mg capsule
  • human NCT00739973
    tablet; Aliskiren/amlodipine 150/5 mg tablet
  • human NCT00739973
    tablet; Aliskiren/amlodipine 150/10 mg tablet
  • human NCT00739973
    tablet; Aliskiren/amlodipine 300/5 mg tablet

recorded 2026-09-01 · last checked 2026-09-04

Amlodipine's half-life is about 30 to 50 hours — which schedules were studied?


about 30 to 50 hours, the half-life Amlodipine's label states. openfda-label · 5866d1ee-631d-d09e-e063-6294a90abe01 · 2026-08-27

bioavailability between 64 and 90%.

Show the evidence
  • half life
    about 30 to 50 hours; Elimination from the plasma is biphasic with a terminal elimination half-life of about 30 to 50 hours. Steady-state plasma levels of amlodipine are reached after 7 to 8 days of consecutive daily dosing.
  • bioavailability
    between 64 and 90%; Absolute bioavailability has been estimated to be between 64 and 90%. The bioavailability of amlodipine is not altered by the presence of food.
  • metabolism
    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.

recorded 2026-08-27 · last checked 2026-09-04

Could one person measure Amlodipine's effect on blood pressure?


Blood pressure: measured in Amlodipine's trials.

Interpretation blood pressure is the recorded endpoint.

Show the evidence

biomarkers

  • blood pressure; 2026-09-01
  • heart failure; 2026-09-01
  • renal dysfunction; 2026-09-01
  • all cause mortality; 2026-09-01
  • systolic blood pressure from the start of the study; 2026-09-01
  • normalization of microalbuminuria; 2026-09-01
14 more recorded rows
  • biomarkers
    50 reduction in uae from the baseline; 2026-09-01
  • biomarkers
    trough seated diastolic blood pressure; 2026-09-01
  • biomarkers
    at 8 weeks in seated trough cuff mean dbp; 2026-09-01
  • biomarkers
    seated trough cuff mean dbp; 2026-09-01
  • biomarkers
    blood pressure less than 140/90 after 14 weeks; 2026-09-01
  • biomarkers
    sitting systolic blood pressure to week 12; 2026-09-01
  • biomarkers
    overall percentage of adverse events; 2026-09-01
  • biomarkers
    mean sitting diastolic blood pressure at trough; 2026-09-01
  • biomarkers
    sitting systolic blood pressure from baseline to week 8; 2026-09-01
  • biomarkers
    peripheral edema from baseline to week 8; 2026-09-01
  • biomarkers
    lateral mitral annular myocardial relaxation velocity; 2026-09-01
  • biomarkers
    metabolic profiles including lipid profile and blood glucose; 2026-09-01
  • biomarkers
    bioequivalence; 2026-09-01
  • biomarkers
    achieving blood pressure goals; 2026-09-01
  • half life
    2026-09-04; halfLife; about 30 to 50 hours; 2026-08-27
  • human trials at or under30
    54
  • smallest human trial
    0; NCT00987662; PHASE4; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; WITHDRAWN

Which of 50 reduction in uae from the baseline, achieving blood pressure goals and all cause mortality did Amlodipine's trials measure?


50 reduction in uae from the baseline, achieving blood pressure goals and all cause mortality lead 40 outcome terms across Amlodipine's trials. ClinicalTrials.gov · 2026-09-01

all cause mortality, systolic blood pressure from the start of the study, normalization of microalbuminuria, 50 reduction in uae from the baseline, trough seated diastolic blood pressure and at 8 weeks in seated trough cuff mean dbp follow.

Show the evidence
  • blood pressure
    1
  • heart failure
    1
  • renal dysfunction
    1
  • all cause mortality
    1
  • systolic blood pressure from the start of the study
    1
  • normalization of microalbuminuria
    1
14 more recorded rows
  • 50 reduction in uae from the baseline
    1
  • trough seated diastolic blood pressure
    1
  • at 8 weeks in seated trough cuff mean dbp
    1
  • seated trough cuff mean dbp
    1
  • blood pressure less than 140/90 after 14 weeks
    1
  • sitting systolic blood pressure to week 12
    1
  • overall percentage of adverse events
    1
  • mean sitting diastolic blood pressure at trough
    1
  • sitting systolic blood pressure from baseline to week 8
    1
  • peripheral edema from baseline to week 8
    1
  • lateral mitral annular myocardial relaxation velocity
    1
  • metabolic profiles including lipid profile and blood glucose
    1
  • bioequivalence
    1
  • achieving blood pressure goals
    1

recorded 2026-09-01 · last checked 2026-09-04

Which of Amlodipine's 18 ongoing trials reports first?


18 registered trials of Amlodipine are open; earliest completion 2025-09. ClinicalTrials.gov · 2026-09-01

Amlodipine concentration in blood serum (area under curve (AUC)); Composite of Major Adverse Cardiovascular and Cerebrovascular Events; latest 2030-12-31

Show the evidence

Trial

  • NCT02904291
    "Bariatric Surgery and Pharmacokinetics of Amlodipine"; n 12; "Amlodipine concentration in blood serum (area under curve (AUC))"; 2026-05
  • NCT03264352
    "Intervention for High-normal Blood Pressure in Adults With Type 2 Diabetes"; n 11414; "Composite of Major Adverse Cardiovascular and Cerebrovascular Events"; 2025-09
  • NCT04840342
    "MR Antagonist and LSD1"; n 300; "24-hour systolic ambulatory blood pressure"; 2026-06
  • NCT04974138
    "China Stroke Primary Prevention Trial 2 for Participants With H-type Hypertension and MTHFR 677 CC/CT Genotype (CSPPT2-CC/CT)"; n 32000; "First ischemic stroke"; 2030-06-30
  • NCT04974151
    "China Stroke Primary Prevention Trial 2 for Participants With Hypertension and MTHFR 677 TT Genotype"; n 24000; "First ischemic stroke"; 2029-06-30
  • NCT05312892
    "Sympathetic Mechanisms in Obesity-Crossover Design"; n 12; "Endogenous glucose production"; 2030-12-31
12 further recorded trials
  • NCT05416840
    "Effects and Safety of Clonidine Patch on Young and Middle-aged Smokers With Mild Hypertension"; n 92; "Change in clinic sitting systolic BP from baseline at 8-week"; 2026-12
  • NCT05786417
    "LIVEBETTER: A Trial Comparing Medications in Older Adults With Stable Angina and Multiple Chronic Conditions"; n 741; "Change in Quality of Life assessed using EQ-5D-5L"; 2027-05-30
  • NCT06150560
    "A Study of Angiotensin-II Receptor Blocker on Cardiovascular Remodeling (VALUE Trial)"; n 120; "Change in Left Ventricular (LV) Fibrosis"; 2028-07-01
  • NCT06424834
    "Efficacy of Targeted Medical Therapy in Angina and Nonobstructive Coronary Arteries"; n 150; "Seattle Angina Questionnaire summary score"; 2026-12
  • NCT06942377
    "Calcium Channel Blocker Amlodipine for Endometrial Cancer Therapy"; n 140; "Pathological cumulative complete response rate after 6 months treatment"; 2027-12-01
  • NCT07075965
    "Calcium Channel Blocker in Myotonic Dystrophy Type 1"; n 20; "Number of Subjects Who Provided Informed Consent"; 2030-10-01
  • NCT07099677
    "Short-Term Effects of Antihypertensive Drugs on Postural Balance and Fall Risk"; n 186; "Fall Risk Score (Biodex Balance System)"; 2026-06-30
  • NCT07241338
    "Sacubitril/Allisartan for Hypertensive Patients With Overweight or Obesity"; n 104; "The change in the mean sitting systolic blood pressure (msSBP) from baseline to week 8, assessed for sacubitril/allisartan as compared to amlodipine"; 2027-06
  • NCT07262710
    "Association of Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers With Post-Stroke Pneumonia: A Real-World Retrospective Cohort Study"; n 13656; "Occurrence of post-stroke pneumonia"; 2026-08-19
  • NCT07291375
    "Role of Amlodipine in Reduction of CIN"; n 40; "measuring serum creatinine level"; 2026-07-01
  • NCT07618806
    "A Clinical Study Comparing Ankle Swelling Caused by Two Different Blood Pressure Medications, Levamlodipine and Amlodipine, in Post-menopausal Women With Mild High Blood Pressure."; n 344; "Ankle Foot Volume (AFV) change as measured by water displacement volumetry."; 2028-05-31
  • NCT07687160
    "SPIRO-First: A Pragmatic Primary Care-Embedded Pilot Trial of Renin-Guided First-Line Antihypertensive Therapy"; n 30; "PRIMARY OUTCOME: Recruitment Rate of Randomized Participants per Month"; 2028-02

recorded 2026-09-01 · last checked 2026-09-04

Which 131 trials of Amlodipine posted no result?


Posted no result
131 of 131 completed trials
Registrations
NCT00000522, NCT00000542, NCT01131936, NCT01131923, NCT06395194 and NCT00039975, and 125 more
Completion dates
oldest 1994-05; newest 2024-02-13
Show the evidence

Trial

  • NCT00000522
    1994-05
  • NCT00000542
    2002-03
  • NCT01131936
    2002-11
  • NCT01131923
    2002-12
  • NCT06395194
    2003-12-05
  • NCT00039975
    2004-04
14 further recorded trials
  • NCT03276598
    2004-04-01
  • NCT00601302
    2004-05
  • NCT00602017
    2004-05
  • NCT00409643
    2004-07
  • NCT00143195
    2005-01
  • NCT01518855
    2005-04
  • NCT00870142
    2005-05
  • NCT00870571
    2005-05
  • NCT00006294
    2005-08
  • NCT00159692
    2005-08
  • NCT00775905
    2005-10
  • NCT00775151
    2005-11
  • NCT00156403
    2005-12
  • NCT00174330
    2006-02

At the median, Amlodipine's trials enrolled 128 people — anything larger?


Median enrolment
128
Largest enrolment
68500
Registered trials counted
303

What do 14961 spontaneous reports say about Amlodipine — and not say?


These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.

Amlodipine appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 14961 reaction mentions were counted: hypotension 3365; drug hypersensitivity 1828; fall 1549; toxicity to various agents 1463. open-targets-adr · CHEMBL1200402 · 2026-06-24

Show the evidence
  • hypotension
    3365
  • drug hypersensitivity
    1828
  • fall
    1549
  • toxicity to various agents
    1463
  • oedema peripheral
    1403
  • hypertension
    1293
4 more recorded rows
  • acute kidney injury
    1257
  • blood pressure increased
    983
  • bradycardia
    913
  • suicide attempt
    907

recorded 2026-06-24 · last checked 2026-09-04

Amlodipine and CYP3A5: shared by which compounds?


CYP3A5 appear in Amlodipine's recorded interaction sentences, 5 in all. openfda-label+europepmc · 2026-08-30

Interpretation pharmacokinetics, clinical_pharmacology

Show the evidence

CYP3A5

  • pharmacokinetics
    Tacrolimus : A prospective study in healthy Chinese volunteers (N=9) with CYP3A5 expressers showed a 2.5-to 4-fold increase in tacrolimus exposure when concomitantly administered with amlodipine compared to tacrolimus alone.
  • pharmacokinetics
    This finding was not observed in CYP3A5 non-expressers (N= 6).
  • pharmacokinetics
    However, a 3-fold increase in plasma exposure to tacrolimus in a renal transplant patient (CYP3A5 non-expresser) upon initiation of amlodipine for the treatment of post-transplant hypertension resulting in reduction of tacrolimus dose has been reported.
  • pharmacokinetics
    Irrespective of the CYP3A5 genotype status, the possibility of an interaction cannot be excluded with these drugs [see Drug Interactions ( 7.2 )].
  • clinical_pharmacology
    Irrespective of the CYP3A5 genotype status, the possibility of an interaction cannot be excluded with these drugs [see Drug Interactions ( 7.2 )]. 12.4 Pediatric Patients Sixty-two hypertensive patients aged 6 to 17 years received doses of amlodipine besylate tablets between 1.25 mg and 20 mg.

recorded 2026-08-30 · last checked 2026-09-04

Was Amlodipine studied with fasting?


fasting is named in Amlodipine's label sentences: "The trial demonstrated that the test and the reference drug of fixed-dose combinations of lisinopril /amlodipine besylate were bioequivalent and well tolerated under fasting and fed condition". openfda-label+europepmc · 2026-08-30

1 recorded statement; fasting

Show the evidence
  • fasting
    The trial demonstrated that the test and the reference drug of fixed-dose combinations of lisinopril /amlodipine besylate were bioequivalent and well tolerated under fasting and fed condition

recorded 2026-08-30 · last checked 2026-09-04

What is recorded about Amlodipine and autophagy?


"The combination of amlodipine with the ER stress inhibitor 4-phenylbutyric acid further confirmed the role of the ER stress response in amlodipine-induced apoptosis, EMT, and autophagy." — where Amlodipine and autophagy appear together. Europe PMC · pathway abstract search · 2024-01-01

autophagy, NAD+, IGF-1; PMID 38313237, 22072110, 21538457, 20015035

Show the evidence

autophagy

  • PMID 38313237
    "The combination of amlodipine with the ER stress inhibitor 4-phenylbutyric acid further confirmed the role of the ER stress response in amlodipine-induced apoptosis, EMT, and autophagy."
  • PMID 38313237
    "Collectively, we demonstrate for the first time that amlodipine promotes apoptosis, induces autophagy, and inhibits migration through ER stress, thereby exerting anti-tumor effects in EC."
  • NAD+ PMID 22072110
    "In contrast, treatment with amlodipine failed to modulate renal NAD(P)H oxidase, SOD and Nrf2."
  • autophagy PMID 21538457
    "The rats were pretreated with vehicle, amlodipine, atorvastatin, or amlodipine plus atorvastatin for 28 days, and 24 hr after transient MCAO the infarct size was assessed via hematoxylin and eosin staining, and terminal deoxynucleotidyl transferase-mediated dUTP-biotin in situ nick end labeling (TUNEL) and microtubule-associated protein 1 light chain 3 (LC3) expression were examined by…"
  • IGF-1 PMID 20015035
    "No single specific therapeutic agent can treat diabetic cardiomyopathy because once the disease is overt, the management may require a variety of approaches such as risk factors and lifestyle modification, glucose control (insulin, alpha glucosidase inhibitors, sulfonylureas, biguanides, meglitinides, thiazolidinediones and dipeptidyl peptidase 4 (DPP-4) inhibitors); hormones (IGF-1); ACE…"

recorded 2024-01-01 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1200402
PubChem CID
11365087
CAS number
150566-71-5
RxCUI
2184116
InChIKey
HTIQEAQVCYTUBX-UHFFFAOYSA-N

Relations

Also called
AMLODIPINE BESYLATE, Amlodipine benzenesulfonate, Amlor, Antacal, Lodipressin, Monopina, Norliqva, aml, amlodin, amlodipine odt, AMLODIPINE MALEATE, Amlodipino
Japanese name
Amlodipine besilate
Salt form
Amlodipine besylate component of amlessa, Amlodipine besylate component of amturnide, Amlodipine besylate component of azor, Amlodipine besylate component of caduet, Amlodipine besylate component of consensi, Amlodipine besylate component of copalia, Amlodipine besylate component of dafiro amlodipine besilate, Amlodipine besylate component of dafiro-hct amlodipine besilate, Amlodipine besylate component of exforge, Amlodipine besylate component of exforge amlodipine besilate, Amlodipine besylate component of exforge hct, Amlodipine besylate component of exforge-hct amlodipine besilate
Trade name
Norvasc, Amvaz, Astudal 5, Istin, Norvas
Development code
NSC-758922, UK-48,340-26, UK-48340-26, UK-48,340-11, UK-48340-11, AMLODIPINE COMPONENT OF CKD-330, HGP-0904, HGP0904
Sources (11)

Sources

  • ClinicalTrials.gov clinicaltrials.gov ·
  • ClinicalTrials.gov ClinicalTrials.gov API v2 snapshot 2026-09-01T09:00:05 ·
  • this record's own fields 2,3,5 ·
  • Europe PMC dose-response search ·
  • Europe PMC pathway abstract search ·
  • Europe PMC search ·
5 more sources

ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 5 required field(s) not terminal: Why people use it, Best-supported result, Most important common problem, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 11 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
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