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Irbesartan

  • 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 Irbesartan does in the body

Hypertension, to lower blood pressure

From the FDA-approved label: Angiotensin II is a potent vasoconstrictor formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE, kininase II). Angiotensin II is the primary vasoactive hormone of the renin-angiotensin system, and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. , vascular smooth muscle, adrenal gland). There is also an AT 2 receptor in many tissues, but it is not involved in cardiovascular homeostasis.

What happened in people

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

A fixed RNAWiki sentence

Where this came from

Wording RNAWiki always uses, not a finding about this substance.

No reviewed claim names a result for any goal on this record.

No source is stored against this line.

The limit that matters most

Not recorded.

Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

What the registries record it as

  • The substance registry classes this as chemical.

    FDA substance registry · J0E2756Z7N · read 2026-08-29

  • Its recorded molecular formula is C25H28N6O, weighing 428.53.

    US prescribing information · 868bd0a7-38ff-4722-8063-a697af3be527 · read 2026-08-30

Where each sentence above came from

No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.

Shown as the opening line on this page.

No statement of the main limit is recorded.

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.

Enzyme

An enzyme is a protein that speeds up one chemical change.

A picture of it, and where the picture fails

An enzyme is like a machine on a production line doing one cut.

Where that stops being true. A machine is switched on and off by a person. Enzymes are controlled by the cell.

What people get wrong. Enzymes are thought to be used up. They are not; they work again and again.

A catalytic protein that lowers the activation energy of a specific reaction.

Receptor

A receptor is a part of a cell that a signal fits into.

A picture of it, and where the picture fails

A receptor is like a lock waiting for one key.

Where that stops being true. A lock either opens or does not. A receptor can be half-triggered, or worn out.

What people get wrong. Fitting a receptor is read as causing a benefit. It causes a step, and nothing more.

A protein that binds a specific ligand and converts that binding into a cellular response.

Pathway

A pathway is a chain of steps inside a cell, each one setting off the next.

A picture of it, and where the picture fails

A pathway is like a row of dominoes.

Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.

What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.

An ordered series of molecular interactions producing a defined cellular change.

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
Healthy ageingWaiting for a reviewer3 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.
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 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.
Fertility and sexual healthNothing 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.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.
Which registered measures put each goal on this table
Healthy ageing
mortality; all cause mortality; all cause hospitalization or all cause mortality
Blood sugar
insulin resistance week16
Fertility and sexual health
female sexual function index

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
Waiting for a reviewer
3 registered study measure of this kind. No reviewed result yet.
Nothing in the sources checked
No registered study lists a performance measure for this goal.
Not recorded
Harms were not a registered measure for this goal.
Only a number moved
1 registered test measure.

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.

To evaluate the impact of circadian time of treatment in cardiovascular, cerebrovascular, metabolic, and renal risk assessment.

The study did not show it

Who was studied
NCT00741585
How many people
21983
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
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. No limitation is recorded for this study.

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

Form and route. Oral

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

All-cause mortality

The study did not show it

Who was studied
NCT02735707
How many people
20000
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
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. No limitation is recorded for this study.

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

Form and route. Oral

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke or Vascular Death as Per Adjudication

The study did not show it

Who was studied
NCT00249795
How many people
9016
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
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. No limitation is recorded for this study.

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

Form and route. Oral

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

First Occurence of Any Component of the Composite of Stroke, Non-Central Nervous System (Non-CNS) Systemic Embolism, Myocardial Infarction or Vascular Death as Per Adjudication

The study did not show it

Who was studied
NCT00249873
How many people
7554
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
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. No limitation is recorded for this study.

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

Form and route. Oral

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Primary outcome:time to the first occurrence of stroke, non-CNS systemic embolism, myocardial infarction or vascular death

The study did not show it

Who was studied
NCT00243178
How many people
6706
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
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. No limitation is recorded for this study.

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

Form and route. Oral

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Percentage of Participants With First Occurrence of the Composite Outcome of Death (All Cause) or Protocol-Specified Cardiovascular (CV) Hospitalization at Given Timepoints

The study did not show it

Who was studied
NCT00095238
How many people
4128
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
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. No limitation is recorded for this study.

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

Form and route. Oral

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 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.5 registered measures of this kind. 4 written-up studies measured this and did not show a benefit.
  2. What a body can do day to day No evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
  3. Measured performance No evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
  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.9 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. 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 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.

  • insulin resistance week16
  • systolic blood pressure after 4 weeks
  • urinary albumin excretion rate
  • home systolic blood pressure
  • blood pressure
  • heart rate
  • urinary sodium excretion rate
  • urine protein/creatinine at week 36
  • effect of arni on blood pressure in ckd who are on dialysis

Meaningful

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

  • remission of proteinuria
  • mortality
  • all cause mortality
  • all cause hospitalization or all cause mortality
  • composite events of death or heart failure hospitalization

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 (26)
  • left ventricular function
  • vascular responses after treatment
  • tolerability
  • forearm vascular resistance
  • adverse events
  • left atrial volume
  • diastolic function
  • functional recruitment of capillaries in the skin
  • progression of if/ta from month 6 to month 24
  • female sexual function index
  • international index of erectile function
  • microneurography
  • vascular function
  • bioequivalence determined by statistical comparison cmax
  • cmax ss
  • auc ss
  • low density lipoprotein
  • days alive and not receiving organ support in icu
  • flow mediated dilatation
  • 7 national institute of health clinical health

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. 11 to 15 hours hours

    Read from the label, which states: “The terminal elimination half-life of irbesartan averages 11 to 15 hours.”

  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.

  • Irbesartan tablets are an angiotensin II receptor blocker (ARB) indicated for: • Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) • Treatment of diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria.

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: “Irbesartan, in a study at a dose of up to 4.5 mg/kg/day, once daily, did not appear to lower blood pressure effectively in pediatric patients ages 6 to 16 years.”

    US prescribing information · 868bd0a7-38ff-4722-8063-a697af3be527 · read 2026-08-30

  • On older people, the label states: “Of 4925 subjects receiving irbesartan in controlled clinical studies of hypertension, 911 (18.5%) were 65 years and over, while 150 (3.0%) were 75 years and over.”

    US prescribing information · 868bd0a7-38ff-4722-8063-a697af3be527 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Irbesartan can cause fetal harm when administered to a pregnant woman.”

    US prescribing information · 868bd0a7-38ff-4722-8063-a697af3be527 · read 2026-08-30

  • On people who are breastfeeding, the label states: “There are no available data on the presence of irbesartan in human milk, effects on milk production, or the breastfed infant.”

    US prescribing information · 868bd0a7-38ff-4722-8063-a697af3be527 · read 2026-08-30

Where the result stopped carrying

  • 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.

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 (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
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

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

Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

Quoted from a source

Where this came from

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

Suppression classes recorded: S3, S6.

No source is stored against this line.

What is in the pack

Sold as tablet, tablet, film coated, given by the oral route.

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 takeNothing found in the sources checked

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.

Nothing found in the sources checked

No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.

The sources listed were searched and held nothing. That is not the same as nothing existing.

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.

Irbesartan appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 2920 reaction mentions were counted. One report can name several reactions.

The recorded terms (10)
  • acute kidney injury — 622 reaction mentions
  • hypotension — 469 reaction mentions
  • hyponatraemia — 401 reaction mentions
  • fall — 349 reaction mentions
  • hyperkalaemia — 295 reaction mentions
  • renal failure acute — 189 reaction mentions
  • bradycardia — 159 reaction mentions
  • syncope — 149 reaction mentions
  • lactic acidosis — 145 reaction mentions
  • renal failure — 142 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

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

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

Nothing further is recorded about which forms are sold.

No source is stored against this line.

What is recorded as being sold

  • 142 products list this as an active ingredient in the United States drug directory. 106 of them contain it and nothing else.

    FDA National Drug Code directory · 72162-2354 · read 2026-08-29

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

    FDA National Drug Code directory · 72162-2354 · read 2026-08-29

  • The regulator's established pharmacologic class for it is angiotensin 2 receptor antagonists [moa] and angiotensin 2 receptor blocker [epc].

    FDA National Drug Code directory · 72162-2354 · read 2026-08-29

  • 64 published labels name it as an active ingredient. 45 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 1898f438-4571-4aab-ae06-9bf1aabf0486 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 1898f438-4571-4aab-ae06-9bf1aabf0486 · read 2026-08-29

  • Irbesartan is oral at 3 DOSAGE FORMS AND STRENGTHS Irbesartan Tablets USP, 75 mg are white to off white, capsule shaped, biconvex tablets, debossed with '158' on one side and 'H' on the other side., recorded as fda label in effect 2023-12-21 in the United States.

    US prescribing information · 868bd0a7-38ff-4722-8063-a697af3be527 · read 2026-08-30

  • Recorded price in US: 0.08267–0.15554 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 56 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.

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.

Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.

Questions worth asking

  • Which of the trials of Irbesartan 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

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 Irbesartan 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.

How many documents were read

  • 45 documents were read for this substance.

    RNAWiki source record

  • 45 of them state the same bioavailability, and they agree.

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
J0E2756Z7N
RxNorm concept
200095

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    Trial roles classified for highlighted evidence

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    Suppression classes recorded: S3, S6.

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    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

  • 42 approved applications cover products containing this substance. The earliest was NDA020758, approved 19970930 to SANOFI AVENTIS US.

    Drugs@FDA application register · NDA020758 · read 2026-08-29

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

    Drugs@FDA application register · NDA020758 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 19970930.

    FDA National Drug Code directory · 72162-2354 · 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.

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What is not here

5 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.

  • The path through the body — found nothing in the sources checked.
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  • Other ways to the same goal — found nothing in the sources checked.
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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.

Recorded evidence blocks (15)

What did Irbesartan's largest trial (40000 people) and its longest (14 years) measure?


40000 people in Irbesartan's largest registered study, 14 years in its longest registered window, measuring mortality. ClinicalTrials.gov · 2026-09-01

34 phase4, 30 phase3, 10 na, 9 phase2, 6 phase1, 3 na or unstated, 1 early phase1; NCT00535925; 2019-05. Last human test completed 2026, NCT03493685.

Interpretation These counts include studies where Irbesartan 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
    34
  • phase3
    30
  • na
    10
  • phase2
    9
  • phase1
    6
  • na or unstated
    3
2 more recorded rows
  • early phase1
    1
  • Last recorded human test NCT03493685
    2026-03-19

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

From mouse to human: where has Irbesartan shown lifespan?


mouse: mechanism-only, rat: mechanism-only and human: lifespan (90): the rungs where Irbesartan has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Interpretation mortality — the recorded outcome words.

Yeast C. elegans Drosophila Mouse mechanism-onlyRat mechanism-onlyDog Non-human primate Human lifespan
Show the evidence
  • mouse
    mechanism-only
  • rat
    mechanism-only
  • human NCT01992796
    lifespan; mortality; 90

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

6 of Irbesartan's trials stopped: futility/efficacy, accrual/recruitment, funding/business, other?


futility/efficacy (1), accrual/recruitment (2), funding/business (2) and other (1): Irbesartan's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"Study was never active"; 6 of 90 registered studies

Show the evidence

Trial

  • NCT00152698
    withdrawn; "Study was never active"
  • NCT00987662
    withdrawn; "no funding"
  • NCT01519297
    suspended; "Pending funding"
  • NCT02644486
    terminated; "difficulty in enrollment"
  • NCT04606563
    terminated; "DSMC recommendation due to futility"
  • NCT05056727
    terminated; "The study started enrollment in Sep 2021 and despite huge efforts the rate of patient enrollment continued to be below target such that the completion of the study within a reasonable timeframe was deemed very unlikely."

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

Human studies of Irbesartan used Placebo matching irbesartan 150 mg — over how long?


studies of Irbesartan used the recorded amount. ClinicalTrials.gov · 2026-09-01

4 recorded entries; human; tablet; also "Placebo matching irbesartan 150 mg", "Irbesartan 150mg / Hydrochlorothiazide 12.5mg", "Irbesartan 150mg"

Show the evidence

human

  • NCT00791830
    Placebo matching irbesartan 150 mg
  • NCT00847834
    Irbesartan 150mg / Hydrochlorothiazide 12.5mg
  • NCT00847834
    Irbesartan 150mg
  • NCT05272878
    tablet; IRBESARTAN, tablet, 150 mg

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

More Irbesartan was worse in human: at what point?


U-shaped in human: "We recently demonstrated that inhibition of Ang II-mediated facilitation in the pithed rat by irbesartan resulted in a U-shaped dose response curve, which was not observed when PD 123319, at a concentration that selectively blocks the AT(2)-receptor, was co-administered." Europe PMC · dose-response search · 2019-09-18

5 recorded sentences naming Irbesartan; U-shaped, dose-response

Show the evidence

U-shaped

  • PMID 12806592
    "We recently demonstrated that inhibition of Ang II-mediated facilitation in the pithed rat by irbesartan resulted in a U-shaped dose response curve, which was not observed when PD 123319, at a concentration that selectively blocks the AT(2)-receptor, was co-administered."
  • PMID 12806592
    "Irbesartan dose-dependently attenuate Ang II-augmented transmitter release (pIC50 7.99+0.03), whereas no U-shaped concentration-response relationship for irbesartan was observed."
  • PMID 12563569
    "The U-shaped dose-response relationship observed with irbesartan, which is illustrative for other ARBs in this model, was not observed when PD 123319 was co-administered with irbesartan, nor with the non-selective AT(1)/AT(2)-blocker, saralasin."

dose-response

  • PMID 31607648
    "In vitro SerpinB3 effect on mesenteric microvessels of 5 Wistar-Kyoto rats was analyzed measuring its direct action on: (a) preconstricted arteries, (b) dose-response curves to phenylephrine, before and after inhibition of angiotensin II type 1 receptors with irbesartan."
  • PMID 7589203
    "SR 47436 (0.3-10 mg/kg i.v.), EXP 3174 (0.03-1 mg/kg i.v.) and [Sar1,Val5,Ala8]angiotensin II (0.03-1 mg/kg i.v.) induced, at least at high doses, a non-parallel shift to the right of the angiotensin II dose-response curve and this was associated with a reduction of the maximal response."

recorded 2019-09-18 · last checked 2026-09-04

Irbesartan's half-life is 11 to 15 hours — which schedules were studied?


11 to 15 hours, the half-life Irbesartan's label states. openfda-label · e8635a1c-ae06-4e23-99f7-e704f91d6f43 · 2026-08-30

bioavailability 60% %.

Show the evidence
  • half life
    11 to 15 hours hours; The terminal elimination half-life of irbesartan averages 11 to 15 hours.
  • bioavailability
    60% %; 12.3 Pharmacokinetics Absorption The oral absorption of irbesartan is rapid and complete with an average absolute bioavailability of 60% to 80%.
  • metabolism
    Metabolism Irbesartan is an orally active agent that does not require biotransformation into an active form.

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

Which of 7 national institute of health clinical health, adverse events and all cause hospitalization or all cause mortality did Irbesartan's trials measure?


7 national institute of health clinical health, adverse events and all cause hospitalization or all cause mortality lead 40 outcome terms across Irbesartan's trials. ClinicalTrials.gov · 2026-09-01

systolic blood pressure after 4 weeks, tolerability, urinary albumin excretion rate, forearm vascular resistance, adverse events and left atrial volume follow.

Show the evidence
  • insulin resistance week16
    1
  • left ventricular function
    1
  • vascular responses after treatment
    1
  • systolic blood pressure after 4 weeks
    1
  • tolerability
    1
  • urinary albumin excretion rate
    1
14 more recorded rows
  • forearm vascular resistance
    1
  • adverse events
    1
  • left atrial volume
    1
  • diastolic function
    1
  • remission of proteinuria
    1
  • functional recruitment of capillaries in the skin
    1
  • progression of if/ta from month 6 to month 24
    1
  • home systolic blood pressure
    1
  • female sexual function index
    1
  • international index of erectile function
    1
  • microneurography
    1
  • vascular function
    1
  • bioequivalence determined by statistical comparison cmax
    1
  • cmax ss
    1

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

Which of Irbesartan's 9 ongoing trials reports first?


9 registered trials of Irbesartan are open; earliest completion 2026-04-30. ClinicalTrials.gov · 2026-09-01

All-cause mortality; Irbesartan concentration in blood serum (area under curve (AUC)); latest 2029-03-31

Show the evidence

Trial

  • NCT02735707
    "Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia"; n 20000; "All-cause mortality"; 2028-02
  • NCT03476603
    "Bariatric Surgery and Pharmacokinetics of Irbesartan"; n 12; "Irbesartan concentration in blood serum (area under curve (AUC))"; 2026-10
  • NCT03762850
    "A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy"; n 406; "Percent Change From Baseline in the Urine Protein/Creatinine (UP/C) at Week 36"; 2026-07
  • NCT05272878
    "Impact of a Treatment With Angiotensin Receptor Blocker on Outcome After Acute Kidney Injury in Patients Discharged From the ICU."; n 508; "Time to MACE (major adverse cardiovascular events)"; 2026-06-27
  • NCT06635772
    "A Study of the Effect and Safety of HS-10390 in the Treatment of Patients with Primary IgA Nephropathy"; n 90; "Change from baseline in 24-hour urine protein at Week 12"; 2026-04-30
  • NCT06660940
    "Clinical Trial of Keluoxin Capsules in the Treatment of Diabetic Kidney Disease with Diabetic Retinopathy"; n 460; "The 24-hour urinary protein quantitation (24h UTP) level and changes from baseline at 52 weeks."; 2027-10
3 further recorded trials
  • NCT07360002
    "The Randomized Controlled Study of Shenqi Yishen Granules in the Treatment of IgA Nephropathy"; n 102; "24-hour urinary protein quantification"; 2026-12
  • NCT07547878
    "Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)"; n 64; "On-study retention rate at 6 months"; 2029-03-31
  • NCT07555054
    "A Study of the Effect and Safety of HS-10390 in the Treatment of Participants With Chronic Kidney Disease"; n 182; "Change in Urinary Albumin to Creatinine Ratio (UACR) From Baseline to Week 12"; 2028-12-31

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

Which running trial of Irbesartan could settle lifespan?


NCT02735707 measures All-cause mortality, reading out 2028-02.

1 open trial; n 20000; "Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia"

Show the evidence
  • Trial NCT02735707
    "Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia"; n 20000; "All-cause mortality"; 2028-02

Which 47 trials of Irbesartan posted no result?


Posted no result
47 of 47 completed trials
Registrations
NCT00005010, NCT00562809, NCT00106561, NCT00320879, NCT00564187 and NCT00529750, and 41 more
Completion dates
oldest 2004-03; newest 2023-06-13
Show the evidence

Trial

  • NCT00005010
    2004-03
  • NCT00562809
    2004-08
  • NCT00106561
    2004-09
  • NCT00320879
    2004-11
  • NCT00564187
    2004-12
  • NCT00529750
    2005-01
14 further recorded trials
  • NCT00185055
    2005-02
  • NCT00549133
    2005-04
  • NCT00095394
    2005-05
  • NCT00095550
    2005-06
  • NCT00561964
    2005-07
  • NCT00180024
    2005-09
  • NCT00095290
    2005-11
  • NCT00171080
    2006-03
  • NCT00154024
    2006-10
  • NCT00335673
    2006-11
  • NCT00110422
    2007-02
  • NCT00347087
    2007-06
  • NCT00352560
    2007-06
  • NCT00350038
    2007-08

At the median, Irbesartan's trials enrolled 151 people — anything larger?


Median enrolment
151
Largest enrolment
40000
Registered trials counted
87

What do 2920 spontaneous reports say about Irbesartan — 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.

Irbesartan appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 2920 reaction mentions were counted: acute kidney injury 622; hypotension 469; hyponatraemia 401; fall 349. open-targets-adr · CHEMBL1513 · 2026-06-24

Show the evidence
  • acute kidney injury
    622
  • hypotension
    469
  • hyponatraemia
    401
  • fall
    349
  • hyperkalaemia
    295
  • renal failure acute
    189
4 more recorded rows
  • bradycardia
    159
  • syncope
    149
  • lactic acidosis
    145
  • renal failure
    142

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

Irbesartan and CYP2C9 and CYP3A4: shared by which compounds?


CYP2C9 and CYP3A4 appear in Irbesartan's recorded interaction sentences, 3 in all. openfda-label+europepmc · 2026-08-30

Interpretation pharmacokinetics

Show the evidence

CYP2C9

  • pharmacokinetics
    In vitro studies indicate irbesartan is oxidized primarily by CYP2C9; metabolism by CYP3A4 is negligible.
  • pharmacokinetics
    Drug-Drug Interactions In vitro studies show significant inhibition of the formation of oxidized irbesartan metabolites with the known cytochrome CYP 2C9 substrates/inhibitors sulphenazole, tolbutamide and nifedipine.
  • CYP3A4 pharmacokinetics
    In vitro studies indicate irbesartan is oxidized primarily by CYP2C9; metabolism by CYP3A4 is negligible.

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

Was Irbesartan studied with fasting?


fasting is named in Irbesartan's label sentences: "Twenty- four 10-week-old diabetic db/db mice were equally randomized into irbesartan treatment (50 mg/kg per day) group and model group, using 12 nondiabetic littermates (db/+) as the controls, The mice were treated with irbesartan or saline vehicle for 16 consecutive weeks, after which the heart…" openfda-label+europepmc · 2026-08-30

1 recorded statement; fasting

Show the evidence
  • fasting
    Twenty- four 10-week-old diabetic db/db mice were equally randomized into irbesartan treatment (50 mg/kg per day) group and model group, using 12 nondiabetic littermates (db/+) as the controls, The mice were treated with irbesartan or saline vehicle for 16 consecutive weeks, after which the heart pathology was observed and the heart weight, body weight, and serum levels of fasting blood glucose…

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

What is recorded about Irbesartan and autophagy?


"The present work explored the potential modulation of inflammatory, apoptotic, and autophagic events by irbesartan for the attenuation of ethanol-evoked gastric mucosal injury." — where Irbesartan and autophagy appear together. Europe PMC · pathway abstract search · 2022-09-14

autophagy, AMPK, IGF-1, mTOR; PMID 36115582, 31191364, 34147903, 29155324

Show the evidence

autophagy

  • PMID 36115582
    "The present work explored the potential modulation of inflammatory, apoptotic, and autophagic events by irbesartan for the attenuation of ethanol-evoked gastric mucosal injury."
  • PMID 31191364
    "In addition, irbesartan also increased the autophagy flux, in terms of increased numbers of autolysosomes and autophagosomes, and the upregulation and mitochondrial localization of the autophagic proteins Atg5 and LC3BII/I. Activation of protein kinase C (PKC) and inhibition of the autophagic flux exacerbated mitochondrial dysfunction in the steatotic hepatocytes."
  • AMPK PMID 31191364
    "Furthermore, AngII upregulated PKC which inhibited AMPK phosphorylation via direct interaction with the AngII receptor AT1-R. Irbesartan inhibited PKC and activated AMPK and its downstream effector ULK1, thereby inducing autophagy, decreasing lipid deposition, and restoring mitochondrial function."
  • autophagy PMID 31191364
    "Furthermore, AngII upregulated PKC which inhibited AMPK phosphorylation via direct interaction with the AngII receptor AT1-R. Irbesartan inhibited PKC and activated AMPK and its downstream effector ULK1, thereby inducing autophagy, decreasing lipid deposition, and restoring mitochondrial function."
  • AMPK PMID 31191364
    "Taken together, irbesartan triggers autophagy via the PKC/AMPK/ULK1 axis to ameliorate the pathological changes in the steatotic hepatocytes."
  • IGF-1 PMID 34147903
    "Irbesartan also inhibited the expression levels of IGF-1, Profilin1 and Col1a1 to relieve pulmonary artery pressure and improve lung function by inhibiting vascular remodeling."
  • mTOR PMID 29155324
    "Administration of irbesartan inhibited activation of stress-induced AT1 pathway to reduce intestinal ROS accumulation and inflammation, restored expression of ACE2/B<sup>0</sup>AT-1, activity of mTOR and p70S6K, dysbiosis and tryptophan metabolism."

recorded 2022-09-14 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1513
PubChem CID
3749
CAS number
138402-11-6
RxCUI
83818
InChIKey
YOSHYTLCDANDAN-UHFFFAOYSA-N
Trade name
Aprovel, Avapro, Ifirmasta, Irbesartan component of avalide, Irbesartan component of coaprovel, Irbesartan component of ibersartan/hydrochlorothiazide ibersartan, Irbesartan component of ibersartan/hydrochlorothiazide teva ibersartan, Irbesartan component of ibersartan/hydrochlorothiazide zentiva ibersartan, Irbesartan component of ifirmacombi, Karvea, Sabervel, Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop)
Development code
BMS-186295, NSC-758696, SR 47436
Also called
Irbesartan bms, Irbesartan teva, Irbesartan zentiva, Sarbevel, angiotensin receptor blocker, irb, sr47436, IRBESARTAN HYDROCHLORIDE, IRBESARTAN HCL, IRBESARTAN HYDROCHLORIDE [EMA EPAR], Irbesartan hydrochloride [WHO-DD]
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

ChEMBL ATC CC BY-SA · 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
  • no raw internal fields: enforced by the copy-contract test over the rendered page

This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.