Skip to content

Fluoxetine

  • 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 Fluoxetine does in the body

Fluoxetine blocks that pump, so serotonin stays in the gap longer.

Nerve cells that use serotonin release it into the gap between cells and then pull most of it back in through a protein pump. What happens after that is not established: the pump is blocked within hours, and any mood effect takes weeks, so the block cannot be the whole explanation. The prescribing information says as much — that the exact mechanism is unknown and is presumed to be linked to serotonin reuptake inhibition.

Why people take it. Depression, obsessive-compulsive disorder, bulimia and panic attacks

What happened in people

Twelve-week response 60.6% on fluoxetine against 34.8% on placebo, and 71.0% for fluoxetine plus cognitive behavioural therapy, in 439 adolescents (TADS)

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 recorded finding that sits closest to something a person would notice. Written into the record, not signed off, and it carries no population or interval.

The limit that matters most

The only serotonin reuptake inhibitor with a United States paediatric major depressive disorder indication, from age eight

Where it acts
Serotonin transporter on presynaptic terminals of raphe-projecting neurons throughout the central nervous system
Kind of result
The kind of result is not recorded
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

  • Its recorded molecular formula is C17H18F3NO•HCl, weighing 345.79.

    US prescribing information · d1c768b5-64bb-4036-aa92-797b3a5f92eb · read 2026-08-30

Where each sentence above came from

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

The recorded use, written for a reader without medical training. Not signed off.

A limit recorded against this substance. Not signed off as a reviewed claim.

The four opening statements run to 115 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.

Placebo

A placebo is a dummy treatment given so the real one can be compared with it.

A picture of it, and where the picture fails

A placebo is like a blank control in an experiment.

Where that stops being true. A blank does nothing. People given a placebo often do get better.

What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.

An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.

Comparator

A comparator is whatever the treatment was measured against.

A picture of it, and where the picture fails

It is like the other runner in a race.

Where that stops being true. A race has one winner. A study can show both arms improved.

What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.

The control condition against which the experimental intervention is assessed.

Randomisation

Randomisation means chance decides who gets which treatment.

A picture of it, and where the picture fails

It is like a coin toss deciding the groups.

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

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

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

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.

Children’s Depression Rating Scale-Revised total score at 12 weeks, with a dichotomised Clinical Global Impressions improvement score for the responder analysis, in adolescents aged 12 to 17

The study showed what it set out to show

Who was studied
TADS — NCT00006286 (JAMA 2004;292:807-820)
How many people
439
Study design
Phase 3, randomised, four-arm; drug arms double-blind, therapy arms unblinded
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Response 71.0% combination, 60.6% fluoxetine alone, 43.2% cognitive behavioural therapy alone, 34.8% placebo; combination against placebo p=0.001, fluoxetine alone against therapy alone p=0.01
Repeated elsewhere
Partially Replicated

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

The limits of this study, and where it came from

Main limit. Seven of 439 patients (1.6%) attempted suicide, with no completed suicides. The two therapy-containing arms could not be blinded, so their comparison against placebo is not protected against expectancy in the way the fluoxetine-placebo comparison is.

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

Form and route. Oral capsule, tablet and oral solution at 10, 20, 40 and 60 mg, once daily; a 90 mg delayed-release capsule is licensed for once-weekly dosing in maintenance treatment of depression

Interval reported. Not recorded in this summary

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

Change from baseline in Children’s Depression Rating Scale-Revised total score over 8 to 9 weeks, ages 8 to 18

The study showed what it set out to show

Who was studied
Two paediatric major depressive disorder trials (NDA 018936, section 14.1)
How many people
315
Study design
Phase 3, randomised, double-blind, placebo-controlled
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
Both studies independently produced a statistically significantly greater mean change than placebo; subgroup analyses showed no differential responsiveness by age or gender
Repeated elsewhere
Replicated

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

The limits of this study, and where it came from

Main limit. Across the three paediatric studies (N=418 randomised), mania or hypomania occurred in 6 of 228 on fluoxetine (2.6%) against 0 of 190 on placebo. In the 19-week study, treated subjects gained 1.1 cm less in height and 1.1 kg less in weight than placebo.

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

Form and route. Oral capsule, tablet and oral solution at 10, 20, 40 and 60 mg, once daily; a 90 mg delayed-release capsule is licensed for once-weekly dosing in maintenance treatment of depression

Interval reported. Not recorded in this summary

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

Relapse over 38 weeks after randomisation, in outpatients who had responded to 12 weeks of open-label fluoxetine 20 mg/day

The study showed what it set out to show

Who was studied
Relapse-prevention randomised withdrawal trial (NDA 018936, section 14.1)
How many people
298
Study design
Phase 3, randomised withdrawal, double-blind, placebo-controlled
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
Statistically significantly lower relapse rate on continued fluoxetine than on placebo at 38 weeks (50 weeks total)
Repeated elsewhere
Replicated

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

The limits of this study, and where it came from

Main limit. A randomised-withdrawal design enriches for responders and cannot distinguish relapse prevention from withdrawal effects in the placebo arm. Fluoxetine’s long half-life blunts that confound relative to shorter-acting drugs but does not remove it.

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

Form and route. Oral capsule, tablet and oral solution at 10, 20, 40 and 60 mg, once daily; a 90 mg delayed-release capsule is licensed for once-weekly dosing in maintenance treatment of depression

Interval reported. Not recorded in this summary

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

What we know
RNAWiki holds 3 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 it changes in the bodyRead from sources, not yet reviewed

The path through the body

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

Where a source records it acting

  • Brain: Presumed to be linked to inhibition of CNS neuronal uptake of serotonin, as recorded

    US prescribing information · 02283de9-6087-45f7-a9ce-3b082ce860de · read 2026-08-27

  1. Start

    Fluoxetine

    What a person takes: Oral capsule, tablet and oral solution at 10, 20, 40 and 60 mg, once daily; a 90 mg delayed-release capsule is licensed for once-weekly dosing in maintenance treatment of depression.

    The measurement behind this step

    Absorbed with or without food; peak plasma concentrations of 15 to 55 ng/mL at 6 to 8 hours after a single 40 mg dose. About 94.5% protein-bound. Metabolism is not proportional to dose, so plasma concentrations on chronic dosing run higher than single-dose studies predict; norfluoxetine, by contrast, is linear. Because the parent has a 4- to 6-day half-life on chronic dosing and norfluoxetine 4 to 16 days, dose changes are not fully reflected in plasma for weeks in either direction.

  2. Getting in

    Swallowed, absorbed, and slow to leave

    A capsule taken with or without food. What is unusual about this drug is how long it stays: weeks after the last one, active drug is still circulating.

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

    The measurement behind this step

    Peak plasma concentrations of 15 to 55 ng/mL at 6 to 8 hours after a single 40 mg dose. Food does not affect systemic bioavailability and may delay absorption by 1 to 2 hours. Elimination half-life is 1 to 3 days after acute administration and 4 to 6 days on chronic dosing; the active metabolite norfluoxetine runs 4 to 16 days. Steady state is not reached for four to five weeks.

  3. Reaching the cell

    Into the brain, and demethylated into a second active drug

    The liver converts part of it into a second compound that blocks the same pump and lasts even longer. A person on fluoxetine is carrying two active molecules, not one.

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

    The measurement behind this step

    Extensive hepatic metabolism to norfluoxetine and other metabolites. In animal models S-norfluoxetine is a potent and selective serotonin uptake inhibitor of essentially equivalent activity to the parent, while R-norfluoxetine is significantly less potent. About 7% of the population has reduced CYP2D6 activity and reaches higher S-fluoxetine concentrations; the label notes that because the parent and metabolite are both active, the clinical consequence is smaller than the exposure difference suggests.

  4. What it acts on

    The serotonin pump is blocked

    Serotonin released between nerve cells is normally vacuumed back up. Fluoxetine plugs the vacuum, so more serotonin stays in the gap.

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

    The measurement behind this step

    Competitive inhibition of SLC6A4, the sodium-dependent serotonin transporter, on the presynaptic terminal. Studies at clinically relevant doses in man demonstrate blockade of serotonin uptake into human platelets, which share the transporter. Fluoxetine is a much more potent inhibitor of serotonin than of noradrenaline uptake in animals, and binds muscarinic, histaminergic and alpha-1 receptors far more weakly than the tricyclics do.

  5. The change it makes

    And then nothing happens for several weeks

    The pump is blocked almost immediately. Any change in mood takes four to six weeks. Whatever produces the clinical effect, it is not the block itself.

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

    The measurement behind this step

    The gap between near-complete transporter occupancy within days and clinical separation from placebo at four to six weeks is the central unexplained fact of this drug class. Proposed bridges — presynaptic 5-HT1A autoreceptor desensitisation, downstream changes in neuroplasticity and BDNF signalling — are hypotheses, and section 12.1 of the label declines to endorse any of them, stating only that the exact mechanism is unknown.

  6. What that does for a person

    A rating scale moves

    What the trials measured was a score. In the adolescent trial six in ten responded on the drug and three and a half in ten responded on placebo.

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

    The measurement behind this step

    Licensing was on the Hamilton Depression Rating Scale in 5- and 6-week placebo-controlled adult trials and on the Children’s Depression Rating Scale-Revised in two 8- to 9-week paediatric trials (N=315 randomised). A 12-week open-label responder cohort randomised to continue fluoxetine 20 mg or switch to placebo (N=298) showed a significantly lower relapse rate on drug at 38 further weeks.

  7. What that does for a person

    What has never been measured

    No trial of this drug has measured deaths, and paediatric safety has not been systematically studied beyond several months.

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

    The measurement behind this step

    The label states that the safety of fluoxetine in paediatric patients has not been systematically assessed for chronic treatment longer than several months, and that no study directly evaluates longer-term effects on growth, development and maturation. The pooled short-term trials could not resolve an effect on completed suicide in adults because there were too few events. Mortality is not an endpoint anywhere in the registration programme.

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

What we know
The record describes 6 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.

What 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.

  • Adults and, for depression from age eight and for obsessive compulsive disorder from age seven, children and adolescents. Fluoxetine is the only serotonin reuptake inhibitor with a United States paediatric depression indication. Not people taking a monoamine oxidase inhibitor, pimozide or thioridazine.

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: “Fluoxetine pharmacokinetics were evaluated in 21 pediatric patients (ages 6 to ≤18) with Major Depressive Disorder or OCD [see Clinical Pharmacology (12.3) ] .”

    US prescribing information · d1c768b5-64bb-4036-aa92-797b3a5f92eb · read 2026-08-30

  • On older people, the label states: “U.S. fluoxetine clinical trials included 687 patients ≥65 years of age and 93 patients ≥75 years of age.”

    US prescribing information · d1c768b5-64bb-4036-aa92-797b3a5f92eb · read 2026-08-30

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

    US prescribing information · d1c768b5-64bb-4036-aa92-797b3a5f92eb · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary Data from published literature report the presence of fluoxetine and norfluoxetine in human milk (see Data).”

    US prescribing information · d1c768b5-64bb-4036-aa92-797b3a5f92eb · read 2026-08-30

  • On people with reduced liver function, the label states: “In subjects with cirrhosis of the liver, the clearances of fluoxetine and its active metabolite, norfluoxetine, were decreased, thus increasing the elimination half-lives of these substances.”

    US prescribing information · d1c768b5-64bb-4036-aa92-797b3a5f92eb · read 2026-08-30

Where the result stopped carrying

  • Twenty-three of 74 FDA-registered antidepressant trials, covering 3,449 participants, were never published; fluoxetine is among the 12 agents in that audit
  • A boxed warning for suicidal thinking and behaviour in under-25s was added only after the regulator compelled disclosure of unpublished paediatric data
  • In head-to-head comparisons in the 2018 network meta-analysis, fluoxetine sat in the least efficacious group of the 21 drugs assessed
  • Paediatric safety has never been systematically assessed beyond several months, and no study evaluates longer-term effects on growth and maturation
  • 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 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 (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
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 capsule, tablet and oral solution at 10, 20, 40 and 60 mg, once daily; a 90 mg delayed-release capsule is licensed for once-weekly dosing in maintenance treatment of depression

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

Absorbed with or without food; peak plasma concentrations of 15 to 55 ng/mL at 6 to 8 hours after a single 40 mg dose. 5% protein-bound. Metabolism is not proportional to dose, so plasma concentrations on chronic dosing run higher than single-dose studies predict; norfluoxetine, by contrast, is linear.

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. The rest of the recorded wording: Because the parent has a 4- to 6-day half-life on chronic dosing and norfluoxetine 4 to 16 days, dose changes are not fully reflected in plasma for weeks in either direction.

No source is stored against this line.

Where it is registered

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

Counted from records

Where this came from

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

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

No source is stored against this line.

Why people stop

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

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

No source is stored against this line.

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

What can go wrong

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

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

Boxed warning for increased suicidal thinking and behaviour in children, adolescents and young adults; not approved below age seven. Contraindicated with monoamine oxidase inhibitors, pimozide and thioridazine, and the long half-life makes the required washout run in weeks. Serotonin syndrome risk rises with triptans, tricyclics, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines and St John’s Wort. Also labelled for allergic reactions and rash, activation of mania or hypomania, seizures, significant weight loss, abnormal bleeding with NSAIDs, aspirin or anticoagulants, angle-closure glaucoma, hyponatremia with SIADH, anxiety and insomnia, and QT prolongation with reports of torsades de pointes.

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

Where this came from

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 capsule, tablet and oral solution at 10, 20, 40 and 60 mg, once daily; a 90 mg delayed-release capsule is licensed for once-weekly dosing in maintenance treatment of depression

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

5% protein-bound. Metabolism is not proportional to dose, so plasma concentrations on chronic dosing run higher than single-dose studies predict; norfluoxetine, by contrast, is linear.

Source-linked record

Where this came from

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

Recorded notes on which forms are sold. The rest of the recorded wording: Because the parent has a 4- to 6-day half-life on chronic dosing and norfluoxetine 4 to 16 days, dose changes are not fully reflected in plasma for weeks in either direction.

No source is stored against this line.

What is recorded as being sold

  • 280 products list this as an active ingredient in the United States drug directory. 265 of them contain it and nothing else.

    FDA National Drug Code directory · 72162-1495 · read 2026-08-29

  • They are sold as capsule, capsule, delayed release pellets, for solution, liquid, powder and solution, taken oral.

    FDA National Drug Code directory · 72162-1495 · read 2026-08-29

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

    FDA National Drug Code directory · 72162-1495 · read 2026-08-29

  • 174 published labels name it as an active ingredient. 171 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 3c28cf18-01a3-468a-ab3e-8aa82f918251 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 3c28cf18-01a3-468a-ab3e-8aa82f918251 · read 2026-08-29

  • 6 marketed supplement labels list this ingredient, classed as other combinations and vitamin.

    NIH Dietary Supplement Label Database · 174230 · read 2026-08-29

  • Those labels carry all other and nutrient claims. A claim of that kind is written by the manufacturer and is not assessed by any regulator, so its presence says nothing about whether it is true.

    NIH Dietary Supplement Label Database · 174230 · read 2026-08-29

  • Fluoxetine is capsules at 10 mg, 20 mg, and 40 mg, recorded as prescription product; fda label in effect 2019-02-01 in the United States.

    US prescribing information · 02283de9-6087-45f7-a9ce-3b082ce860de · read 2026-08-27

  • Recorded price in US: 0.02885–0.18699 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 144 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

  • Recorded price in US: 0.1962 USD per one millilitre, across 6 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 Fluoxetine studied people like me?
  • What was measured, and for how long?
  • Was the result a laboratory value or a health outcome?
  • What would we watch for, and when would we stop?

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

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

What is missing or unclearRead from sources, not yet reviewed

Claims that go past the evidence

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

Goes past the evidence

That depression is caused by a serotonin deficiency and this drug corrects it — a claim absent from every version of the label, whose section 12.1 says the mechanism is unknown

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

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

What would change this

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

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

Goes past the evidence

That blocking the transporter is what produces the clinical effect, when the block is complete in days and the effect takes weeks

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

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

What would change this

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

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

Goes past the evidence

That the average benefit seen in licensing trials is clinically meaningful across the whole severity range, which the FDA-data meta-analysis found only at the upper end of very severe depression

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

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

What would change this

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

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

Goes past the evidence

That the class-level paediatric suicidality signal applies equally to every drug in it, when the label states there was considerable variation among drugs

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

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

What would change this

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

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

What is missing or unclearRead from sources, not yet reviewed

What nobody knows yet

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

Missing populations

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

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

What would answer it

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

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

Missing long-term data

No completed tested study window is recorded.

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

What would answer it

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

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

No reviewed conclusion

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

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

What would answer it

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

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

Missing interaction studies

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

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

What would answer it

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

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

Formulation uncertainty

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

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

What would answer it

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

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

Mechanism not reviewed

No reviewed mechanism story exists for this substance.

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

What would answer it

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

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

What happened in peopleRead from sources, not yet reviewed

Check any of this yourself

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

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

The label has never said serotonin deficiency causes depression
In plain words
Fluoxetine is the drug that put the phrase "chemical imbalance" into everyday speech. Its prescribing information says the exact mechanism is unknown and only presumed to be linked to serotonin reuptake — and a 2022 review of all the evidence for a serotonin abnormality in depression found no consistent support for one.
What was measured
That depression is caused by a serotonin deficiency which this drug corrects — an account that appears in no version of the label and that the umbrella review of the underlying evidence does not support
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Section 12.1 of the fluoxetine United States prescribing information reads in full: "Although the exact mechanism of fluoxetine is unknown, it is presumed to be linked to its inhibition of CNS neuronal uptake of serotonin." Section 12.2 adds only that fluoxetine blocks serotonin uptake into human platelets at clinically relevant doses and is a more potent uptake inhibitor of serotonin than of noradrenaline in animals. Nothing on the document asserts a serotonin deficit in depressed people. The 2022 umbrella review by Moncrieff and colleagues synthesised 17 reviews and large data-set analyses across serotonin and 5-HIAA concentrations, 5-HT1A receptor binding, transporter binding, tryptophan depletion and transporter gene associations, and reported no consistent evidence of an association between serotonin and depression, together with evidence that lowered plasma serotonin was associated with antidepressant use rather than with depression. There is also a timing problem the label does not resolve: transporter occupancy is essentially complete within days and clinical separation from placebo takes weeks.
Source
Fluoxetine United States prescribing information, sections 12.1 and 12.2 (NDA 018936); Moncrieff J et al., Mol Psychiatry 2023;28:3243-3256
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
contested
Review state
Written into the record, not signed off as a reviewed claim
TADS: 60.6% against 34.8% in adolescents, with therapy measured alongside
In plain words
The largest independent adolescent trial randomised 439 twelve-to-seventeen-year-olds to fluoxetine, cognitive behavioural therapy, both, or placebo. Response was 60.6% on the drug, 43.2% on therapy alone, 71.0% on both, and 34.8% on placebo.
What was measured
Twelve-week response rate on the Clinical Global Impressions improvement score, four arms, 439 adolescents
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The Treatment for Adolescents With Depression Study (TADS, NCT00006286) randomised 439 patients aged 12 to 17 with DSM-IV major depressive disorder across 13 United States academic and community clinics to twelve weeks of fluoxetine 10 to 40 mg/day, cognitive behavioural therapy, both, or placebo. Placebo and fluoxetine alone were double-blind; the therapy arms could not be blinded. Response rates on the dichotomised Clinical Global Impressions improvement score were 71.0% (95% CI 62 to 80) for fluoxetine with therapy, 60.6% (95% CI 51 to 70) for fluoxetine alone, 43.2% (95% CI 34 to 52) for therapy alone and 34.8% (95% CI 26 to 44) for placebo. Fluoxetine alone was superior to therapy alone (p=0.01); the combination was superior to both (p=0.02 against fluoxetine, p=0.01 against therapy). Clinically significant suicidal thinking was present in 29% of the sample at baseline and improved in all four groups, with the greatest reduction in the combination arm (p=0.02). Seven of 439 patients (1.6%) attempted suicide; there were no completed suicides. This is a publicly funded trial with a placebo arm and an active psychological comparator in the same randomisation, which is rare in this field.
Source
March J, Silva S, Petrycki S, et al. Treatment for Adolescents With Depression Study (TADS) randomized controlled trial. JAMA 2004;292:807-820
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
A third of the trials were never published, and the ones that were looked better
In plain words
When researchers compared what the FDA held on 12 antidepressants against what had appeared in journals, 31% of the registered trials had never been published. The published literature made 94% of trials look positive. The FDA’s own analysis put it at 51%.
What was measured
Proportion of FDA-registered antidepressant trials published, and effect-size difference between the FDA and journal data sets
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Turner and colleagues obtained FDA reviews for 74 registered studies of 12 antidepressant agents involving 12,564 patients and searched systematically for matching publications. Twenty-three of the 74 studies, accounting for 3,449 participants, were never published. Of the studies the FDA viewed as positive, 37 of 38 were published. Of those the FDA viewed as negative or questionable, 22 were not published and 11 were published in a way the authors judged conveyed a positive outcome, leaving 3 exceptions. Separate meta-analyses of the FDA and journal data sets showed effect-size inflation of 11% to 69% for individual drugs and 32% overall. Fluoxetine is one of the 12 agents in that data set. This is not a claim that fluoxetine does not work — it does separate from placebo — but a measurement of how much of the apparent size of the effect came from which trials reached print.
Source
Turner EH, Matthews AM, Linardatos E, Tell RA, Rosenthal R. N Engl J Med 2008;358:252-260
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
The drug-placebo gap depends on how depressed you were to start with
In plain words
A meta-analysis of the complete FDA data sets for four newer antidepressants, fluoxetine among them, found the difference from placebo grew with baseline severity — and reached conventional criteria for clinical significance only at the very top of the very severe range.
What was measured
That the average rating-scale improvement seen in the licensing trials represents a clinically meaningful benefit across the whole range of depression severity
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Kirsch and colleagues obtained the full data submitted to the FDA for licensing of the four new-generation antidepressants for which complete data sets were available, and modelled linear and quadratic effects of initial severity on improvement in drug and placebo groups. Drug-placebo differences rose with baseline severity, from virtually none at moderate levels to a relatively small difference at very severe levels, reaching conventional criteria for clinical significance only at the upper end of the very severely depressed category. The mechanism the meta-regression identified was not increasing drug response with severity but decreasing placebo response: the relationship was attributable to reduced responsiveness to placebo among the most severely depressed, not to increased responsiveness to medication. The analysis has been contested on its choice of the NICE three-point threshold and on the statistical handling of the severity gradient, and the contest is itself part of the record; what is not contested is the underlying FDA data set it used.
Source
Kirsch I, Deacon BJ, Huedo-Medina TB, Scoboria A, Moore TJ, Johnson BT. PLoS Med 2008;5:e45
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
contested
Review state
Written into the record, not signed off as a reviewed claim
14 additional cases of suicidality per 1,000 under-eighteens, from pooled FDA data
In plain words
The boxed warning at the top of the label exists because the FDA pooled 24 short-term trials in over 4,400 children and adolescents and found 14 additional cases of suicidal thinking or behaviour per 1,000 treated. In adults over 24 the same pooling found no increase, and over 65 it found a reduction.
What was measured
Drug-placebo difference in cases of suicidal thinking and behaviour per 1,000 patients treated, by age stratum
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
The pooled paediatric analysis covered 24 short-term trials of 9 antidepressants in over 4,400 patients with major depressive disorder, obsessive compulsive disorder or other psychiatric disorders; the adult analysis covered 295 short-term trials of 11 drugs in over 77,000 patients. The drug-placebo differences in cases of suicidality per 1,000 treated were 14 additional under 18, 5 additional at 18 to 24, 1 fewer at 25 to 64 and 6 fewer at 65 and over. No suicides occurred in any of the paediatric trials, and the number in the adult trials was insufficient to reach a conclusion about drug effect on completed suicide. The finding is a class-level signal rather than a fluoxetine-specific one, and the label states there was considerable variation among drugs. It became visible only when the regulator compelled disclosure of the unpublished paediatric data set, which connects it directly to the selective-publication audit above.
Source
Fluoxetine United States prescribing information, Boxed Warning and section 5.1, Table 2 (NDA 018936)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
Children on it grew 1.1 cm less and gained 1.1 kg less over nineteen weeks
In plain words
In the longer paediatric trial, children and adolescents on fluoxetine grew about a centimetre less in height and gained about a kilogram less in weight than those on placebo over nineteen weeks. Nobody has studied what happens over years.
What was measured
Difference in height and weight gain against placebo over 19 weeks in paediatric patients
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Section 8.4 of the label records that after 19 weeks of treatment in a clinical trial, paediatric subjects treated with fluoxetine gained an average of 1.1 cm less in height and 1.1 kg less in weight than subjects on placebo, and that fluoxetine treatment was associated with a decrease in alkaline phosphatase levels. The same section states that the safety of fluoxetine in paediatric patients has not been systematically assessed for chronic treatment longer than several months, and that there are no studies directly evaluating longer-term effects on growth, development and maturation. It also records mania or hypomania in 6 of 228 fluoxetine-treated patients (2.6%) against 0 of 190 on placebo across the three paediatric studies. A measured growth difference over nineteen weeks with no data past that point is a specific gap, not a general reassurance.
Source
Fluoxetine United States prescribing information, section 8.4 Pediatric Use (NDA 018936)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
Least efficacious group, most tolerable group, in the same analysis
In plain words
The biggest comparison ever run — 522 trials, 116,477 patients, 21 drugs — put fluoxetine among the least effective when drugs were compared directly against each other, and among only two that people were less likely to quit than placebo.
What was measured
Efficacy and acceptability odds ratios across 21 antidepressants, 522 trials, 116,477 participants
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The 2018 network meta-analysis found all 21 antidepressants more effective than placebo, with odds ratios from 2.13 (95% CrI 1.89 to 2.41) for amitriptyline down to 1.37 (1.16 to 1.63) for reboxetine. In the head-to-head studies, fluoxetine, fluvoxamine, reboxetine and trazodone were the least efficacious drugs (range of odds ratios 0.51 to 0.84), while agomelatine, amitriptyline, escitalopram, mirtazapine, paroxetine, venlafaxine and vortioxetine were more effective than the others (1.19 to 1.96). On acceptability, only agomelatine (OR 0.84, 95% CrI 0.72 to 0.97) and fluoxetine (0.88, 0.80 to 0.96) had fewer dropouts than placebo. The authors rated 46 of 522 trials (9%) at high risk of bias and 380 (73%) at moderate, and the certainty of evidence as moderate to very low. The two findings are both real and they point in opposite directions, which is the honest summary of what is known about choosing between these drugs.
Source
Cipriani A, Furukawa TA, Salanti G, et al. Lancet 2018;391:1357-1366
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim

How many documents were read

  • 171 documents were read for this substance.

    RNAWiki source record

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

    RNAWiki source record

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

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
I9W7N6B1KJ
CAS registry number
54910-89-3
PubChem compound
3386
RxNorm concept
227224

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

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

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Passed

    Safety mode resolved

    Suppression classes recorded: S6.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

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

What the approval register records

  • 80 approved applications cover products containing this substance. The earliest was NDA018936, approved 19871229 to ELI LILLY AND CO.

    Drugs@FDA application register · NDA018936 · read 2026-08-29

  • Marketing status on the register: discontinued and prescription.

    Drugs@FDA application register · NDA018936 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 19880201.

    FDA National Drug Code directory · 72162-1495 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

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

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

What is not here

7 questions this page could not answer

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

  • What was measured, goal by goal — found nothing in the sources checked.
  • How close this is to real life — found nothing in the sources checked.
  • Felt, measured, or meaningful — found nothing in the sources checked.
  • How long anything takes — found nothing in the sources checked.
  • What it may clash with — found nothing in the sources checked.
  • Other ways to the same goal — found nothing in the sources checked.
  • What changed on this page — found nothing in the sources checked.

The record as stored

The full record, for auditing

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

The older medicine-wide conclusion held in this record

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

A serotonin reuptake inhibitor whose own label states the exact mechanism is unknown and only presumed, whose best adolescent trial put twelve-week response at 60.6% against 34.8% on placebo in 439 patients, and whose FDA-pooled paediatric safety data show 14 additional cases of suicidal thinking or behaviour per 1,000 under-eighteens treated.

Recorded evidence blocks (10)

On the Fluoxetine label: indicated for what?


"Fluoxetine is indicated for the treatment of: Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1) ] . Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2) ] .": indications and usage on Fluoxetine's label. DailyMed label · 23899405-007b-48d9-82a9-a530b8e90784 · 2026-08-20

224 registered trials of Fluoxetine — at which phases?


Registered studies posting no result
154 of 224

224 registered studies of Fluoxetine: 57 na, 52 phase4, 50 phase2, 41 phase3, 23 phase1, 9 na or unstated, 5 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01

1724 with a PubMed record

Show the evidence
  • na
    57
  • phase4
    52
  • phase2
    50
  • phase3
    41
  • phase1
    23
  • na or unstated
    9
8 more recorded rows
  • early phase1
    5
  • completed
    147
  • unknown
    27
  • terminated
    18
  • recruiting
    17
  • withdrawn
    9
  • not yet recruiting
    4
  • active not recruiting
    2

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

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


futility/efficacy (1), accrual/recruitment (11), funding/business (2) and other (7): Fluoxetine's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Study PI resigned"; 21 of 224 registered studies

Show the evidence

Trial

  • NCT00108316
    withdrawn; "Study PI resigned"
  • NCT00449007
    terminated; "recruitment of this population was not feasible"
  • NCT00557427
    terminated; "Lack of enrollment"
  • NCT00573547
    withdrawn; "Principal Investigator decided not to initiate the study."
  • NCT00592852
    terminated; "Slow subject recruitment."
  • NCT00758966
    terminated; "Sponsor Decision- Financial Considerations"
14 further recorded trials
  • NCT00873834
    withdrawn; "Withdrawn for problem of logistics with the associated laboratories"
  • NCT01436643
    terminated; "Due to slow enrollment the study was terminated early"
  • NCT01615055
    withdrawn; "Study withdrawn. No participants enrolled."
  • NCT01674868
    withdrawn; "unable to find patients meeting inclusion/exclusion criteria"
  • NCT01687478
    terminated; "Interim assessment: Lack of efficacy"
  • NCT01737541
    terminated; "Study recruitment was suspended due to lack of funding"
  • NCT01740726
    terminated; "Lack of success with recruitment"
  • NCT01963832
    withdrawn; "not funded"
  • NCT02063425
    terminated; "Not enough recruitment"
  • NCT02238977
    terminated; "Study stopped due to difficulty recruiting"
  • NCT02389712
    terminated; "Difficulties with recruitment"
  • NCT02737930
    terminated; "Slow recruitment and lack of funding to expand to other sites."
  • NCT02893371
    terminated; "Per PI, this study is not a clinical trial and was inadvertently entered in the system"
  • NCT04570449
    withdrawn; "Study timeline is not feasible"

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

Human studies of Fluoxetine used Fluoxetine Capsules 40 mg — over how long?


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

18 recorded entries; human; also "Fluoxetine Capsules 40 mg", "Prozac Pulvules 40 mg", "Fluoxetine 60 mg"

Show the evidence

human

  • NCT00649636
    Fluoxetine Capsules 40 mg
  • NCT00649636
    Prozac Pulvules 40 mg
  • NCT00758966
    Fluoxetine 60 mg
  • NCT00758966
    Naltrexone 32 mg and fluoxetine 60 mg
  • NCT00778024
    fluoxetine HCL 40 mg capsules
  • NCT00913718
    Fluoxetine Hydrochloride 20 mg Capsules (Geneva Pharmaceutical, Inc.)
12 more recorded rows
  • human NCT00913718
    Prozac Fluoxetine Hydrochloride 20 mg Capsules (Dista)
  • human NCT00947076
    Fluoxetine Hydrochloride Capsules, 40 mg (Geneva Pharmaceutical, Inc)
  • human NCT00947076
    Fluoxetine Hydrochloride Capsules, 40 mg (Prozac) (Eli Lilly)
  • human NCT01166087
    Prozac ® weekly 90 mg Delayed Release Capsules
  • human NCT01166100
    Prozac ® weekly 90 mg Delayed-Release Capsules
  • human NCT02569970
    fluoxetine 20 mg
  • human NCT03728153
    Fluoxetine 20 MG Oral Tablet
  • human NCT03728153
    Prozac 20 MG Oral Tablet
  • human NCT04727424
    Fluoxetine 20 MG
  • human NCT05532332
    Fluoxetine 10 mg capsules
  • human NCT05532332
    Prozac® 10 mg capsules
  • human NCT05792540
    Fluoxetine 20 mg

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

Fluoxetine's half-life is 1 to 3 days — which schedules were studied?


1 to 3 days, the half-life Fluoxetine's label states: "Accumulation and Slow Elimination — The relatively slow elimination of fluoxetine (elimination half-life of 1 to 3 days after acute administration and 4 to 6 days after chronic administration) and its active metabolite, norfluoxetine (elimination half-life of 4 to 16 days after acute and chronic administration), leads…" DailyMed label · 23899405-007b-48d9-82a9-a530b8e90784 · 2026-08-20

tmax 6 to 8 hours.

Show the evidence
  • half life pharmacokinetics
    1 to 3 days; Accumulation and Slow Elimination — The relatively slow elimination of fluoxetine (elimination half-life of 1 to 3 days after acute administration and 4 to 6 days after chronic administration) and its active metabolite, norfluoxetine (elimination half-life of 4 to 16 days after acute and chronic administration), leads to significant accumulation of these active species in chronic use and delayed…
  • tmax pharmacokinetics
    6 to 8 hours; Systemic Bioavailability — In man, following a single oral 40 mg dose, peak plasma concentrations of fluoxetine from 15 ng/mL to 55 ng/mL are observed after 6 to 8 hours.
  • metabolism pharmacokinetics
    Metabolism — Fluoxetine is extensively metabolized in the liver to norfluoxetine and a number of other unidentified metabolites.

recorded 2026-08-20 · last checked 2026-09-04

Which 78 trials of Fluoxetine posted no result?


Posted no result
78 of 78 completed trials
Registrations
NCT00000213, NCT00913718, NCT01360190, NCT00227981, NCT00947076 and NCT00009178, and 72 more
Completion dates
oldest 1991-04; newest 2023-02-28
Show the evidence

Trial

  • NCT00000213
    1991-04
  • NCT00913718
    1996-07
  • NCT01360190
    1996-08
  • NCT00227981
    2001-03
  • NCT00947076
    2001-04
  • NCT00009178
    2001-12
14 further recorded trials
  • NCT00113737
    2002-01
  • NCT00004486
    2002-12
  • NCT00427128
    2003-03
  • NCT00000381
    2003-05
  • NCT00005850
    2003-09
  • NCT00000379
    2003-12
  • NCT00778024
    2003-12
  • NCT00006286
    2004-03
  • NCT00018200
    2004-03
  • NCT00714779
    2004-12
  • NCT00018174
    2005-01
  • NCT00485771
    2005-01
  • NCT00035321
    2005-07
  • NCT00027404
    2005-08

At the median, Fluoxetine's trials enrolled 80 people — anything larger?


Median enrolment
80
Largest enrolment
3255526
Registered trials counted
219

What do 6056 spontaneous reports say about Fluoxetine — 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.

Fluoxetine appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 6056 reaction mentions were counted: drug interaction 1034; serotonin syndrome 706; suicide attempt 686; toxicity to various agents 612. FAERS via Open Targets · CHEMBL1201082 · 2026-06-24

Show the evidence
  • drug interaction
    1034
  • serotonin syndrome
    706
  • suicide attempt
    686
  • toxicity to various agents
    612
  • suicidal ideation
    550
  • depression
    535
4 more recorded rows
  • anxiety
    527
  • confusional state
    481
  • somnolence
    481
  • agitation
    444

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

Which 10 reactions does Fluoxetine's label not list?


agitation, anxiety and confusional state and 7 more reported for Fluoxetine, absent from its label. FAERS via Open Targets · CHEMBL1201082 · 2026-06-24

2 label terms; 10 reported and unlisted; 23899405-007b-48d9-82a9-a530b8e90784

Show the evidence
  • agitation
    count not stated
  • anxiety
    count not stated
  • confusional state
    count not stated
  • depression
    count not stated
  • drug interaction
    count not stated
  • serotonin syndrome
    count not stated
4 more recorded rows
  • somnolence
    count not stated
  • suicidal ideation
    count not stated
  • suicide attempt
    count not stated
  • toxicity to various agents
    count not stated

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

Fluoxetine and CYP2D6: shared by which compounds?


CYP2D6 appear in Fluoxetine's recorded interaction sentences, 8 in all. DailyMed label · 23899405-007b-48d9-82a9-a530b8e90784 · 2026-08-20

CYP2D6, CYP2D6, CYP2D6; 3 shared nodes; drug_interactions

Show the evidence

Interaction statement

  • drug_interactions
    Monoamine Oxidase Inhibitors (MAOIs): ( 2.9 , 2.10 , 4.1 , 5.2 ) Drugs Metabolized by CYP2D6: Fluoxetine is a potent inhibitor of CYP2D6 enzyme pathway ( 7.7 ) Tricyclic Antidepressants (TCAs): Monitor TCA levels during coadministration with fluoxetine or when fluoxetine has been recently discontinued ( 5.2 , 7.7 ) CNS Acting Drugs: Caution should be used when taken in combination with other…
  • drug_interactions
    Fluoxetine can increase the level of pimozide through inhibition of CYP2D6.
  • drug_interactions
    The rate of debrisoquin hydroxylation is felt to depend on the level of CYP2D6 isozyme activity.
  • drug_interactions
    Thus, this study suggests that drugs which inhibit CYP2D6, such as certain SSRIs, including fluoxetine, will produce elevated plasma levels of thioridazine.
  • drug_interactions
    Drugs Metabolized by CYP2D6 — Fluoxetine inhibits the activity of CYP2D6, and may make individuals with normal CYP2D6 metabolic activity resemble a poor metabolizer.
  • drug_interactions
    Coadministration of fluoxetine with other drugs that are metabolized by CYP2D6, including certain antidepressants (e.g., TCAs), antipsychotics (e.g., phenothiazines and most atypicals), and antiarrhythmics (e.g., propafenone, flecainide, and others) should be approached with caution.
2 more recorded rows
  • Interaction statement drug_interactions
    Therapy with medications that are predominantly metabolized by the CYP2D6 system and that have a relatively narrow therapeutic index (see list below) should be initiated at the low end of the dose range if a patient is receiving fluoxetine concurrently or has taken it in the previous 5 weeks.
  • Interaction statement drug_interactions
    If fluoxetine is added to the treatment regimen of a patient already receiving a drug metabolized by CYP2D6, the need for decreased dose of the original medication should be considered.

CYP2D6

  • FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Sofpironium, Bupropion
  • FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Sofpironium, Bupropion
  • FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Sofpironium, Bupropion

recorded 2026-08-20 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1201082
PubChem CID
9884593
CAS number
114247-06-2
RxCUI
227224
InChIKey
RTHCYVBBDHJXIQ-UHFFFAOYSA-N
Trade name
Ranflutin, Felicium, Olena, Oxactin, Prozac, Prozac 60, Prozac weekly, Prozep, Prozit, Sarafem, Selfemra, Prozac / Prozac Weekly / Sarafem / Selfemra
Also called
Reconcile, FLUOXETINE HYDROCHLORIDE, Adofen, Fluctin, Fluneurin, Fluoxeren, Fluox-puren, Flusol, Fluxet, Fontex, Foxetin, Lovan
Salt form
Fluoxetine hydrochloride component of symbyax, FLUOXETINE HCL
Development code
LY-110140, LY110140, NSC-283480, NSC-758685
Sources (6)

Sources

ChEMBL 37 — CC BY-SA 3.0 Unported · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · 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: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 6 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.