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Atomoxetine

  • 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 Atomoxetine does in the body

Attention-Deficit/Hyperactivity Disorder

From the FDA-approved label: The precise mechanism by which atomoxetine produces its therapeutic effects in Attention-Deficit/Hyperactivity Disorder (ADHD) is unknown, but is thought to be related to selective inhibition of the pre-synaptic norepinephrine transporter, as determined in ex vivo uptake and neurotransmitter depletion studies.

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 · 57WVB6I2W0 · read 2026-08-29

  • Its recorded molecular formula is C17H21NO•HCL, weighing 291.82.

    US prescribing information · 92de0ca1-6a02-4925-aefc-b32573d349a7 · 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 61 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.

Biomarker

A biomarker is a number from a test that stands in for something about health.

A picture of it, and where the picture fails

A biomarker is like a fuel gauge.

Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.

What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.

A measurable indicator used as a substitute for a clinical outcome of interest.

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.

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
FocusNothing 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.
SleepNothing 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
Focus
brown attention deficit disorder scale; attention network effects; attention deficit hyperactivity disorder symptomatology
Sleep
sleep onset latency

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.
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.

Financial impact on the total cost of patient care resulting from implementation of a Pharmacogenetics testing program within a safety-net and Academic healthcare system

The study did not show it

Who was studied
NCT02297126
How many people
4465
Study design
Not applicable
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

Health-related quality of life

The study did not show it

Who was studied
NCT07679282
How many people
2400
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

Percentage of Participants Who Maintain a Satisfactory Response During the Double-Blind Maintenance/Randomized Withdrawal Period

The study did not show it

Who was studied
NCT00700427
How many people
2017
Study design
Phase 3
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

Categorical Changes in Vital Signs (Blood Pressure [BP], Pulse, Weight, Temperature) During the Study

The study did not show it

Who was studied
NCT00190684
How many people
1553
Study design
Phase 3
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

Observed and change from baseline measures for ADHD-RS total scores will be summarized by descriptive statistics and analyzed by repeated measures of analysis of covariance.

The study did not show it

Who was studied
NCT00866996
How many people
1323
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

Number of Participants With Adverse Events (AES) and Serious Adverse Events (SAEs)

The study did not show it

Who was studied
NCT06566820
How many people
1280
Study design
Phase 3
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
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 No evidence recorded. Death, a heart attack, a stroke, a hospital stay.No registered study measures this.
  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 Evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.2 registered measures of this kind.
  5. A number that stands in for health Evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.7 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 No evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
  8. Cells in a dish No evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
  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.

  • clinical global impression
  • adult adhd investigator symptom rating scale

Measured

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

  • increase in heart rate standing
  • level of catecholamines in blood from baseline
  • systolic blood pressure
  • diastolic blood pressure
  • heart rate
  • blood level concentrations of the drugs in use
  • maximum observed plasma concentration

Meaningful

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

No registered study measured anything of this kind.

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 (31)
  • global assessment of functioning
  • adhd rs total
  • sleep onset latency
  • safety
  • cardiovascular responses
  • adhd rating scale iv
  • adverse events leading to discontinuation
  • effects of adhd medication versus placebo on cotinine levels
  • brown attention deficit disorder scale
  • transient ischemic attack
  • executive function test
  • time to first response
  • chinese version of snap iv rating scale
  • attention network effects
  • receptor occupancy
  • rapid visual information processing
  • adhd rating scale
  • correct inhibition in assessed the go no go task
  • treatment retention
  • snap iv teacher and parent rating scale

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. 5 hours hours

    Read from the label, which states: “Atomoxetine has a half-life of about 5 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.

  • Atomoxetine hydrochloride is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). (1.1) 1.1 Attention-Deficit/Hyperactivity Disorder (ADHD) Atomoxetine capsules are indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).

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: “Anyone considering the use of atomoxetine hydrochloride in a child or adolescent must balance the potential risks with the clinical need [see Boxed Warning and Warnings and Precautions (5.1) ].”

    US prescribing information · 92de0ca1-6a02-4925-aefc-b32573d349a7 · read 2026-08-30

  • On older people, the label states: “The safety, efficacy and pharmacokinetics of atomoxetine hydrochloride in geriatric patients have not been evaluated.”

    US prescribing information · 92de0ca1-6a02-4925-aefc-b32573d349a7 · read 2026-08-30

  • On people who are pregnant, the label states: “Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including atomoxetine hydrochloride, during pregnancy.”

    US prescribing information · 92de0ca1-6a02-4925-aefc-b32573d349a7 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of atomoxetine or its metabolite in human milk, the effects on the breastfed child, or the effects on milk production.”

    US prescribing information · 92de0ca1-6a02-4925-aefc-b32573d349a7 · 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: S6.

No source is stored against this line.

What is in the pack

Sold as capsule, solution, 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.

Atomoxetine appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 2386 reaction mentions were counted. One report can name several reactions.

The recorded terms (10)
  • suicidal ideation — 461 reaction mentions
  • aggression — 318 reaction mentions
  • abnormal behaviour — 222 reaction mentions
  • anxiety — 217 reaction mentions
  • depression — 211 reaction mentions
  • somnolence — 204 reaction mentions
  • insomnia — 198 reaction mentions
  • tachycardia — 190 reaction mentions
  • agitation — 187 reaction mentions
  • tic — 178 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

  • 170 products list this as an active ingredient in the United States drug directory. 170 of them contain it and nothing else.

    FDA National Drug Code directory · 65862-239 · read 2026-08-29

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

    FDA National Drug Code directory · 65862-239 · read 2026-08-29

  • The regulator's established pharmacologic class for it is norepinephrine reuptake inhibitor [epc] and norepinephrine uptake inhibitors [moa].

    FDA National Drug Code directory · 65862-239 · read 2026-08-29

  • 51 published labels name it as an active ingredient. 51 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 92de0ca1-6a02-4925-aefc-b32573d349a7 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 92de0ca1-6a02-4925-aefc-b32573d349a7 · read 2026-08-29

  • Atomoxetine is oral at 3 DOSAGE FORMS AND STRENGTHS Each capsule contains atomoxetine HCl equivalent to 10 mg (Opaque white, opaque white), 18 mg (Opaque dark gold, opaque white), 25 mg (Opaque dark blue, opaque white), 40 mg (Opaque dark blu…, recorded as fda label in effect 2023-10-20 in the United States.

    US prescribing information · 92de0ca1-6a02-4925-aefc-b32573d349a7 · read 2026-08-30

  • Recorded price in US: 0.31707–0.53999 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 73 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 Atomoxetine 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 Atomoxetine 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.

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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

  • 50 documents were read for this substance.

    RNAWiki source record

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

    RNAWiki source record

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

    RNAWiki source record

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

    RNAWiki source record

  • 5 of them state the same proteinBinding, and they agree.

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
57WVB6I2W0
RxNorm concept
349595

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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

  • 13 approved applications cover products containing this substance. The earliest was NDA021411, approved 20021126 to LILLY.

    Drugs@FDA application register · NDA021411 · read 2026-08-29

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

    Drugs@FDA application register · NDA021411 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20021126.

    FDA National Drug Code directory · 65862-239 · read 2026-08-29

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5 questions this page could not answer

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Recorded evidence blocks (11)

What did Atomoxetine's largest trial (430000 people) and its longest (33 years) measure?


430000 people in Atomoxetine's largest registered study, 33 years in its longest registered window, measuring Blood level concentrations of the drugs in use;. ClinicalTrials.gov · 2026-09-01

58 phase4, 46 phase2, 35 phase3, 18 phase1, 14 na, 14 na or unstated, 3 early phase1; NCT00262470; 2029-12; no ageing endpoint recorded. Last human test completed 2025, NCT02879136.

Interpretation These counts include studies where Atomoxetine 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
    58
  • phase2
    46
  • phase3
    35
  • phase1
    18
  • na
    14
  • na or unstated
    14
2 more recorded rows
  • early phase1
    3
  • Last recorded human test NCT02879136
    2025-12-12

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

Atomoxetine was tested only in human — what did it show?


human: biomarker (176): the rungs where Atomoxetine has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Interpretation Blood level concentrations of the drugs in use; — the recorded outcome words.

Yeast C. elegans Drosophila Mouse Rat Dog Non-human primate Human biomarker
Show the evidence
  • human NCT01057329
    biomarker; Blood level concentrations of the drugs in use;; 176

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

11 of Atomoxetine's trials stopped: accrual/recruitment, funding/business, other?


accrual/recruitment (5), funding/business (3) and other (3): Atomoxetine's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"Insufficient number of interested potentital subjects"; 11 of 176 registered studies

Show the evidence

Trial

  • NCT00299234
    terminated; "Insufficient number of interested potentital subjects"
  • NCT00548327
    terminated; "The scientific director decided to terminate: low priority study with slow accrual"
  • NCT00562055
    withdrawn; "This study was withdrawn due to business reasons."
  • NCT00687609
    terminated; "The study was discontinued early, owing to difficulties in recruiting the target sample after seven patients had been recruited."
  • NCT01019707
    terminated; "End in funding"
  • NCT01127646
    terminated; "Due to lack of availability of study participants to accommodate the study design"
5 further recorded trials
  • NCT01207622
    withdrawn; "Poor enrollment"
  • NCT01802515
    terminated; "No funding stopped recruitment march 2014 with only 14 enrolled"
  • NCT02046551
    withdrawn; "funding lost"
  • NCT03808740
    terminated; "Due to COVID-19 pandemic, recruitment was stopped. All the weight loss surgeries were stopped.. Weight Loss clinic (VWL) was closed for IN person visits. We could not recruit any participant for Non surgical weight loss category."
  • NCT04354103
    terminated; "experimental treatment (Atomoxetine) not available"

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

Human studies of Atomoxetine used atomoxetine 0.5 mg/kg/day — over how long?


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

5 recorded entries; human; also "atomoxetine 0.5 mg/kg/day", "atomoxetine 1.2 mg/kg/day", "atomoxetine 1.2-1.4 mg/kg/day"

Show the evidence

human

  • NCT00192023
    atomoxetine 0.5 mg/kg/day
  • NCT00192023
    atomoxetine 1.2 mg/kg/day
  • NCT00192023
    atomoxetine 1.2-1.4 mg/kg/day
  • NCT02287038
    Atomoxetine 80 MG
  • NCT05944965
    Atomoxetine 80 mg plus Oxybutynin 5 mg

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

Atomoxetine's half-life is 5 hours — which schedules were studied?


5 hours, the half-life Atomoxetine's label states. openfda-label · 132852a6-5bff-15dd-255c-98309dd83630 · 2026-08-30

bioavailability 63% %.

Show the evidence
  • half life
    5 hours hours; Atomoxetine has a half-life of about 5 hours.
  • bioavailability
    63% %; Absorption and distribution - Atomoxetine is rapidly absorbed after oral administration, with absolute bioavailability of about 63% in Ems and 94% in PMs.

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

Which of adhd rating scale, adhd rating scale iv and adhd rs total did Atomoxetine's trials measure?


adhd rating scale, adhd rating scale iv and adhd rs total lead 40 outcome terms across Atomoxetine's trials. ClinicalTrials.gov · 2026-09-01

Interpretation clinical global impression, increase in heart rate standing, safety, cardiovascular responses, adhd rating scale iv and adverse events leading to discontinuation follow.

Show the evidence
  • global assessment of functioning
    1
  • adhd rs total
    1
  • sleep onset latency
    1
  • clinical global impression
    1
  • increase in heart rate standing
    1
  • safety
    1
14 more recorded rows
  • cardiovascular responses
    1
  • adhd rating scale iv
    1
  • adverse events leading to discontinuation
    1
  • effects of adhd medication versus placebo on cotinine levels
    1
  • brown attention deficit disorder scale
    1
  • transient ischemic attack
    1
  • level of catecholamines in blood from baseline
    1
  • adult adhd investigator symptom rating scale
    1
  • systolic blood pressure
    1
  • diastolic blood pressure
    1
  • heart rate
    1
  • blood level concentrations of the drugs in use
    1
  • executive function test
    1
  • time to first response
    1

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

Which of Atomoxetine's 10 ongoing trials reports first?


10 registered trials of Atomoxetine are open; earliest completion 2025-09-05. ClinicalTrials.gov · 2026-09-01

Increase in heart rate with standing; Number of patients with improved CONNERS scale; latest 2031-03

Show the evidence

Trial

  • NCT00262470
    "Treatment of Orthostatic Intolerance"; n 150; "Increase in heart rate with standing"; 2029-12
  • NCT04216186
    "Role of Coenzyme Q in ADHD in Children"; n 40; "Number of patients with improved CONNERS scale"; 2030-12-01
  • NCT05159687
    "Study of Atomoxetine in the Prevention of Vasovagal Syncope"; n 180; "The primary outcome measure will be the proportion of patients having at least one syncope recurrence."; 2027-09
  • NCT06573970
    "Atomoxetine and Executive Function in PTSD"; n 160; "Behavior Rating Inventory of Executive Function-Adult (BRIEF-A)"; 2029-09-28
  • NCT06841666
    "Evaluating the Efficacy of Atomoxetine in Reducing Primary Nocturnal Enuresis in Children With ADHD: A Randomized, Placebo-Controlled Study"; n 100; "Frequency of nocturnal enuresis episodes, recorded by parents in a nightly log."; 2025-09-05
  • NCT06899178
    "Atomoxetine in Melanocortin Obesity Syndrome"; n 20; "Body Mass Index (BMI)"; 2028-06
4 further recorded trials
  • NCT07239791
    "Role of the Noradrenergic System in the Regulation of Learning Dynamics: Evaluation of the Effect of a Low-dose Selective Noradrenaline Reuptake Inhibitor (NOISYXETINE)"; n 160; "Apparent Learning rate"; 2027-12
  • NCT07316296
    "Pharmacologically Modulating the Noradrenergic Arousal System to Reduce Freezing of Gait in Parkinson's Disease: a Multi-centre and Multi-modal Approach"; n 60; "The percentage of time frozen in the dopaminergic OFF-state"; 2027-12-31
  • NCT07724132
    "An Evaluation of Treatments for Sustained Clinical Response (18 Months) in Symptomatic Alzheimer's Disease"; n 1200; "Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) score"; 2031-03
  • NCT07771595
    "Study of the Effects of Atomoxetine on Motivation"; n 40; "Effort-based choice behaviour during the Apple Gathering Task"; 2027-10

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

Which 69 trials of Atomoxetine posted no result?


Posted no result
69 of 69 completed trials
Registrations
NCT00485628, NCT00486122, NCT00506727, NCT00485849, NCT00486083 and NCT00557960, and 63 more
Completion dates
oldest 2003-10; newest 2023-05-31
Show the evidence

Trial

  • NCT00485628
    2003-10
  • NCT00486122
    2004-06
  • NCT00506727
    2004-07-02
  • NCT00485849
    2004-10
  • NCT00486083
    2004-10
  • NCT00557960
    2004-10-25
14 further recorded trials
  • NCT00485459
    2004-11
  • NCT00485862
    2005-01
  • NCT00485875
    2005-01
  • NCT00386581
    2005-02
  • NCT00485550
    2005-03
  • NCT00485407
    2005-06
  • NCT00167297
    2005-07
  • NCT00181740
    2005-07
  • NCT00190931
    2005-07
  • NCT00174226
    2006-01
  • NCT00190957
    2006-01
  • NCT00191009
    2006-01
  • NCT00191516
    2006-02
  • NCT00191737
    2006-02

At the median, Atomoxetine's trials enrolled 61 people — anything larger?


Median enrolment
61
Largest enrolment
430000
Registered trials counted
174

What do 2386 spontaneous reports say about Atomoxetine — 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.

Atomoxetine appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 2386 reaction mentions were counted: suicidal ideation 461; aggression 318; abnormal behaviour 222; anxiety 217. open-targets-adr · CHEMBL1702 · 2026-06-24

Show the evidence
  • suicidal ideation
    461
  • aggression
    318
  • abnormal behaviour
    222
  • anxiety
    217
  • depression
    211
  • somnolence
    204
4 more recorded rows
  • insomnia
    198
  • tachycardia
    190
  • agitation
    187
  • tic
    178

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

Atomoxetine and CYP2D6 and CYP2C19: shared by which compounds?


CYP2D6 and CYP2C19 appear in Atomoxetine's recorded interaction sentences, 9 in all. openfda-label+europepmc · 2026-08-30

Interpretation pharmacokinetics, clinical_pharmacology

Show the evidence
  • CYP2C19 pharmacokinetics
    N-Desmethylatomoxetine is formed by CYP2C19 and other cytochrome P450 enzymes, but has substantially less pharmacological activity compared with atomoxetine and circulates in plasma at lower concentrations (5% of atomoxetine concentration in Ems and 45% of atomoxetine concentration in PMs).

CYP2D6

  • pharmacokinetics
    It is eliminated primarily by oxidative metabolism through the cytochrome P450 2D6 (CYP2D6) enzymatic pathway and subsequent glucuronidation.
  • pharmacokinetics
    A fraction of the population (about 7% of Caucasians and 2% of African Americans) are poor metabolizers (PMs) of CYP2D6 metabolized drugs.
  • pharmacokinetics
    Metabolism and elimination - Atomoxetine is metabolized primarily through the CYP2D6 enzymatic pathway.
  • pharmacokinetics
    Laboratory tests are available to identify CYP2D6 PMs.
  • pharmacokinetics
    Atomoxetine did not inhibit or induce the CYP2D6 pathway.
  • clinical_pharmacology
    Cardiac Electrophysiology — The effect of atomoxetine hydrochloride on QTc prolongation was evaluated in a randomized, double-blinded, positive-(moxifloxacin 400 mg) and placebo-controlled, cross-over study in healthy male CYP2D6 poor metabolizers.
2 more recorded rows
  • CYP2D6 pharmacokinetics
    Drugs that inhibit CYP2D6, such as fluoxetine, paroxetine, and quinidine, cause similar increases in exposure.
  • CYP2D6 pharmacokinetics
    Coadministration of atomoxetine hydrochloride with potent inhibitors of CYP2D6, such as fluoxetine, paroxetine, or quinidine, results in a substantial increase in atomoxetine plasma exposure, and dosing adjustment may be necessary [see Warnings and Precautions (5.13) ].

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

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1702
PubChem CID
54840
CAS number
82248-59-7
RxCUI
353103
InChIKey
VHGCDTVCOLNTBX-QGZVFWFLSA-N
Also called
Tomoxetine
Also called
ATOMOXETINE HYDROCHLORIDE, atx, Atomoxetina, atm, atmx, ato, atooxy, ly139603, snri, Atomoxetine HCL [VANDF], Atomoxetine hydrochloride [EP MONOGRAPH], Atomoxetine hydrochloride [JAN]
Salt form
Atomoxetine (as hydrochloride), Atomoxetine hcl, (r)-(-)-tomoxetine hydrochloride, Atomoxetine Hydrochloride / Strattera / Atoncy
Development code
LY-139603, NSC-759104
Trade name
Strattera, Atomoxetine component of ad-109, Atomoxetine component of ad109, Atomoxetine component of ad-313, Atomoxetine component of ad313, Atoncy
Component
Tomoxetine
Sources (9)

Sources

3 more sources
  • openfda-label 132852a6-5bff-15dd-255c-98309dd83630 ·
  • openfda-label+europepmc K1:ASW034S0B8 ·
  • national registers US, CA ·

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: 9 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.