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Fluticasone Propionate

  • 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 Fluticasone Propionate does in the body

Preventing asthma, treating hay fever or reducing skin inflammation.

Fluticasone is breathed or sprayed onto an inflamed surface, crosses into the cells there, binds a receptor and carries it into the nucleus, where it switches off the genes making inflammatory signals. It is designed to be destroyed rapidly by the liver, so very little of what is swallowed reaches the bloodstream intact. Two things break that design: doses above the licensed range, and any medicine that blocks the liver enzyme doing the destroying — which is how an inhaler has repeatedly produced full-blown Cushing syndrome.

What happened in people

Adding salmeterol reduced severe asthma attacks by 21% without increasing serious asthma events.

Reviewed first-read answer

Where this came from

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

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

No source is stored against this line.

The limit that matters most

Laboratory claims that it binds especially strongly have unknown importance for patients.

Where it acts
Airway epithelium and submucosal inflammatory cells; nasal mucosa for the spray; epidermis and dermis for the cream
Kind of result
The kind of result is not recorded
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.

What the registries record it as

  • Its recorded molecular formula is C25H31F3O5S, weighing 500.6.

    US prescribing information · 549ff4f2-fa68-3dd8-e054-00144ff8d46c · 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.

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

The four opening statements run to 109 words.

Words this page uses

Four words worth knowing first

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

Stand-in result

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

A picture of it, and where the picture fails

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

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

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

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

Randomisation

Randomisation means chance decides who gets which treatment.

A picture of it, and where the picture fails

It is like a coin toss deciding the groups.

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

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

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

Confidence interval

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

A picture of it, and where the picture fails

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

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

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

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

Pathway

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

A picture of it, and where the picture fails

A pathway is like a row of dominoes.

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

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

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

What happened in peopleRead from sources, not yet reviewed

What 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.

Time to first serious asthma-related event — death, endotracheal intubation or hospitalisation

The study showed what it set out to show

Who was studied
AUSTRI (NCT01475721)
How many people
11679
Study design
Phase 4, randomised, double-blind, FDA-mandated safety trial, 26 weeks
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Hazard ratio 1.03 (95% CI 0.64 to 1.66), noninferiority achieved at P=0.003; severe exacerbations hazard ratio 0.79 (95% CI 0.70 to 0.89), P<0.001
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. 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. Pressurised HFA inhalation aerosol, Diskus dry-powder inhaler, aqueous nasal spray, and topical cream and ointment

Interval reported. 95% CI 0

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

Death from any cause, salmeterol-fluticasone combination against placebo, in chronic obstructive pulmonary disease

The study did not show it

Who was studied
TORCH (NCT00268216)
How many people
6112
Study design
Phase 3/4, randomised, double-blind, placebo-controlled, four-arm, three years
Compared against
A dummy treatment
Kind of result
Living longer, or avoiding a major event
What was found
Combination against placebo hazard ratio 0.825 (95% CI 0.681 to 1.002), P=0.052. All-cause mortality by arm: 12.6% combination, 13.5% salmeterol, 15.2% placebo, 16.0% fluticasone alone; monotherapy arms did not differ significantly from placebo.
Repeated elsewhere
Partially Replicated

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

The limits of this study, and where it came from

Main limit. The fluticasone-only arm had the numerically highest mortality of the four. Pneumonia was 18.3% on fluticasone alone and 19.6% on the combination against 12.3% on placebo, P<0.001.

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

Form and route. Pressurised HFA inhalation aerosol, Diskus dry-powder inhaler, aqueous nasal spray, and topical cream and ointment

Interval reported. 95% CI 0

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

Time to first serious asthma-related event in children aged 4 to 11 years

The study showed what it set out to show

Who was studied
VESTRI (NCT01462344)
How many people
6208
Study design
Phase 4, randomised, double-blind, FDA-mandated paediatric safety trial, 26 weeks
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Hazard ratio 1.28 (95% CI 0.73 to 2.27), noninferiority against an upper bound of 2.675 achieved, P=0.006; severe exacerbations hazard ratio 0.86 (95% CI 0.73 to 1.01)
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. Every serious asthma-related event in the trial was a hospitalisation. The noninferiority margin in children was wider than the adult one.

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

Form and route. Pressurised HFA inhalation aerosol, Diskus dry-powder inhaler, aqueous nasal spray, and topical cream and ointment

Interval reported. 95% CI 0

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

Confirmed cases of acute adrenal crisis associated with inhaled corticosteroids, and the drug involved

The study showed what it set out to show

Who was studied
Todd 2002 — United Kingdom national survey of adrenal crisis
How many people
33
Study design
National questionnaire survey with case confirmation by HPA-axis testing
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
33 confirmed cases from 2,912 questionnaires — 28 children and 5 adults; 30 (91%) on fluticasone, 1 on fluticasone and budesonide, 2 on beclometasone
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. A survey cannot give a rate, because the denominator of exposed patients is unknown. What it does establish is the distribution across drugs, and that distribution was strongly skewed toward the least-prescribed agent of the three at the time.

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

Form and route. Pressurised HFA inhalation aerosol, Diskus dry-powder inhaler, aqueous nasal spray, and topical cream and ointment

Interval reported. Not recorded in this summary

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

What we know
RNAWiki holds 4 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.0 registered measures of this kind. 1 written-up study measured this and did not show a benefit.
  2. What a body can do day to day 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.6 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.1 registered measure of this kind.
  6. A step measured inside a person Evidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
  7. Animals Evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Mouse. A result in animals says what to test next. It does not say what happens in people.
  8. Cells in a dish Evidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
  9. A guess from software No evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.

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

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

The path through the body

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

  1. Start

    Fluticasone Propionate

    What a person takes: Pressurised HFA inhalation aerosol, Diskus dry-powder inhaler, aqueous nasal spray, and topical cream and ointment.

    The measurement behind this step

    Inhaled twice daily for asthma maintenance and never for acute symptoms. A large fraction of every inhaled dose is deposited in the mouth and swallowed, which is why rinsing and spitting after each dose is part of the instructions and why hepatic first-pass metabolism carries the systemic safety of the whole product.

  2. Getting in

    Inhaled or sprayed onto the inflamed surface

    A measured dose lands on the airway or nasal lining. A large part of every inhaled dose lands in the mouth instead and is swallowed, which is where the systemic story begins.

    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

    Fluticasone propionate as a pressurised HFA aerosol, a Diskus dry powder, an aqueous nasal suspension or a topical cream. Micronised particle size distribution determines the fraction reaching the small airways rather than the oropharynx and is a specification, not an accident.

  3. Reaching the cell

    The liver destroys almost everything that is swallowed

    What goes down the throat is absorbed from the gut and passes through the liver, which breaks it down before it can circulate. That first pass is what makes an inhaled steroid different from a tablet.

    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

    Fluticasone propionate is a CYP3A4 substrate hydrolysed to an inactive 17-beta carboxylic acid metabolite, with negligible oral bioavailability. The systemic safety of the drug is a pharmacokinetic property rather than a pharmacodynamic one, which is why strong CYP3A4 inhibitors abolish it.

  4. What it acts on

    It binds the glucocorticoid receptor very tightly

    Inside a lining cell it binds a receptor waiting in the cytoplasm — more tightly than most other steroids, though the label declines to say what that means for a patient.

    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

    In-vitro glucocorticoid receptor binding affinity 18 times dexamethasone, almost twice beclomethasone-17-monopropionate and over 3 times budesonide, with the McKenzie vasoconstrictor assay in man consistent and clinical significance stated as unknown.

  5. The change it makes

    The pair enters the nucleus and rewrites which genes are read

    The receptor carries the drug into the nucleus and switches off the inflammatory programme. It is a change in gene transcription, which is why it takes days and does nothing during an attack.

    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

    Activated receptor represses pro-inflammatory transcription factors and transactivates anti-inflammatory genes, with effects across mast cells, eosinophils, neutrophils, macrophages and lymphocytes and across histamine, eicosanoids, leukotrienes and cytokines. The label states that corticosteroids do not affect asthma symptoms immediately and that maximum benefit takes time.

  6. What that does for a person

    Inflammation subsides and exacerbations become less frequent

    The lining becomes less swollen and less twitchy. Adding a long-acting bronchodilator on top cut severe attacks by a further fifth in nearly twelve thousand people.

    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

    In AUSTRI, severe exacerbations occurred in 480 of 5,834 (8%) on fluticasone-salmeterol against 597 of 5,845 (10%) on fluticasone alone, hazard ratio 0.79 (95% CI 0.70 to 0.89, P<0.001), with a serious-asthma-event hazard ratio of 1.03 (95% CI 0.64 to 1.66).

  7. What that does for a person

    Where the design fails, it fails completely

    Above the licensed dose, or alongside a medicine that blocks the liver enzyme, the same inhaler behaves like an oral steroid — adrenal collapse, low blood sugar, seizures, Cushing syndrome.

    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

    Thirty of 33 confirmed adrenal crises in a United Kingdom national survey were on fluticasone at 500 to 2,000 micrograms per day, including nine children with coma and convulsions and one death. Postmarketing reports of ritonavir coadministration record Cushing syndrome and adrenal suppression, and a formal interaction study showed significantly raised plasma fluticasone and significantly reduced serum cortisol.

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 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.

  • total nasal symptom over 2 week randomized treatment period
  • exacerbations of copd condition specific quality of life
  • total combined symptom over the entire grass pollen season
  • 12 hour reflective total nasal symptom
  • 4 nasal symptom after 2 weeks
  • nasal symptom scores

Measured

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

  • nasal inflammatory markers

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 (33)
  • at least 1 adverse event
  • treatment failure
  • inhaled corticosteroid prescriptions refilled
  • morning peak expiratory flow
  • pc20 amp
  • pre dose fev1
  • fev1
  • who experience at least one adverse event
  • who discontinue study drug due to an ae
  • ocular itching
  • asthma exacerbation
  • endoscopy polyp grading
  • methacholine pc20
  • feno
  • acoustic rhinometry
  • proxy asthma control
  • sputum eosinophils
  • sputum neutrophil
  • cmax
  • tmax

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. 7.8 hours hours

    Read from the label, which states: “Elimination Following intravenous dosing, fluticasone propionate showed polyexponential kinetics and had a terminal elimination half-life of approximately 7.8 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.

  • Anyone with persistent asthma from age 4 upward, on its own or inside a combination inhaler with salmeterol or vilanterol; people with allergic rhinitis, using the nasal spray; and people with inflammatory skin disease.

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: “Six hundred fifty (650) subjects aged 4 to 11 years and 440 subjects aged 12 to 17 years were studied in US clinical trials with fluticasone propionate nasal spray.”

    US prescribing information · 549ff4f2-fa68-3dd8-e054-00144ff8d46c · read 2026-08-30

  • On older people, the label states: “A limited number of subjects aged 65 years and older (n = 129) or 75 years and older (n = 11) have been treated with Fluticasone Propionate Nasal Spray in clinical trials.”

    US prescribing information · 549ff4f2-fa68-3dd8-e054-00144ff8d46c · read 2026-08-30

  • On people who are pregnant, the label states: “Teratogenic Effects Pregnancy Category C.”

    US prescribing information · 549ff4f2-fa68-3dd8-e054-00144ff8d46c · read 2026-08-30

  • On people who are breastfeeding, the label states: “It is not known whether fluticasone propionate is excreted in human breast milk.”

    US prescribing information · 549ff4f2-fa68-3dd8-e054-00144ff8d46c · read 2026-08-30

  • On people with reduced liver function, the label states: “Formal pharmacokinetic trials using Fluticasone Propionate Nasal Spray have not been conducted in subjects with hepatic impairment.”

    US prescribing information · 549ff4f2-fa68-3dd8-e054-00144ff8d46c · read 2026-08-30

  • On people with reduced kidney function, the label states: “Formal pharmacokinetic trials using Fluticasone Propionate Nasal Spray have not been conducted in subjects with renal impairment.”

    US prescribing information · 549ff4f2-fa68-3dd8-e054-00144ff8d46c · read 2026-08-30

Where the result stopped carrying

  • The fluticasone-only arm of TORCH had the highest three-year mortality of the four arms and 50% more pneumonia than placebo
  • A national survey found 91% of confirmed inhaled-steroid adrenal crises on this one drug, at doses within contemporary guideline ranges
  • Coadministration with ritonavir has produced Cushing syndrome and adrenal suppression in postmarketing use
  • The label requires bone density assessment, paediatric growth monitoring and ophthalmological referral — three surveillance obligations a drug with no systemic effect would not need
  • 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

Pressurised HFA inhalation aerosol, Diskus dry-powder inhaler, aqueous nasal spray, and topical cream and ointment

Source-linked record

Where this came from

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

The form and route recorded on this substance.

No source is stored against this line.

Who oversees it

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

Quoted from a source

Where this came from

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

No register row and no identity class settled the question.

No source is stored against this line.

What is in the pack

Inhaled twice daily for asthma maintenance and never for acute symptoms.

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: A large fraction of every inhaled dose is deposited in the mouth and swallowed, which is why rinsing and spitting after each dose is part of the instructions and why hepatic first-pass metabolism carries the systemic safety of the whole product.

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

Candida albicans infection of the mouth and pharynx, with periodic monitoring and rinsing without swallowing after inhalation. Potential worsening of existing tuberculosis and of fungal, bacterial, viral, parasitic and ocular herpes simplex infections, with a more serious or fatal course of chickenpox or measles possible in susceptible patients. Risk of impaired adrenal function when transferring from systemic corticosteroids, requiring slow tapering. Hypercorticism and adrenal suppression may occur at very high dosages or at regular dosage in susceptible individuals. Assessment for decreased bone mineral density initially and periodically. Monitoring of growth in paediatric patients. Glaucoma and cataracts with long-term use, with ophthalmologist referral to be considered. Strong CYP3A4 inhibitors including ritonavir and ketoconazole are not recommended, with postmarketing reports of Cushing syndrome and adrenal suppression.

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

Where this came from

Reports sent to a regulator

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

Fluticasone Propionate appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 13516 reaction mentions were counted. One report can name several reactions.

The recorded terms (10)
  • dyspnoea — 3120 reaction mentions
  • asthma — 3080 reaction mentions
  • cough — 1501 reaction mentions
  • wheezing — 1328 reaction mentions
  • therapeutic product effect incomplete — 925 reaction mentions
  • pneumonia — 847 reaction mentions
  • chronic obstructive pulmonary disease — 756 reaction mentions
  • chest discomfort — 686 reaction mentions
  • obstructive airways disorder — 668 reaction mentions
  • blood count abnormal — 605 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 unclearNothing found in the sources checked

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

Pressurised HFA inhalation aerosol, Diskus dry-powder inhaler, aqueous nasal spray, and topical cream and ointment

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

A recorded note compares this form with the others that are sold. It is kept below, word for word.

A fixed RNAWiki sentence

Where this came from

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

The recorded note, unchanged: A large fraction of every inhaled dose is deposited in the mouth and swallowed, which is why rinsing and spitting after each dose is part of the instructions and why hepatic first-pass metabolism carries the systemic safety of the whole product.

No source is stored against this line.

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.

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

Questions worth asking

  • Which of the trials of Fluticasone Propionate 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 an 18-fold in-vitro receptor affinity over dexamethasone establishes a clinical potency ranking — the label states the significance 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 the negligible oral bioavailability makes systemic effects impossible, when a CYP3A4 inhibitor removes exactly that protection

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 a national survey of 33 cases gives a rate, when the number of exposed patients 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 inhaled corticosteroid monotherapy benefits chronic obstructive pulmonary disease, which TORCH’s four-arm design does not support

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 Fluticasone Propionate 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.

Thirty of 33 adrenal crises in a national survey were on this drug, and a child died
In plain words
A survey of nearly three thousand United Kingdom specialists found 33 patients who had suffered acute adrenal collapse while on an inhaled steroid. Thirty of them were on fluticasone. Twenty-three children arrived with dangerously low blood sugar, nine of them in coma with seizures, and one of those children died.
What was measured
Cases of confirmed acute adrenal crisis on inhaled corticosteroids, by drug, from a national specialist survey
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Questionnaires were sent to all consultant paediatricians and adult endocrinologists in a United Kingdom medical directory. From 2,912 initial questionnaires, 33 patients met the diagnostic criteria for acute adrenal crisis associated with inhaled corticosteroids — 28 children and 5 adults — confirmed by symptoms and abnormal hypothalamic-pituitary-adrenal axis testing. Twenty-three children had acute hypoglycaemia: 13 with decreased consciousness or coma, nine with coma and convulsions, and one with coma, convulsions and death. Five children and four adults had insidious onset. All 33 were on 500 to 2,000 micrograms per day of inhaled corticosteroid; 30 (91%) had received fluticasone, one fluticasone and budesonide, and two beclometasone. The authors note that fluticasone was at the time the least prescribed and most recently introduced of the inhaled steroids and was associated with 94% of cases, and advise that the licensed paediatric dose of 400 micrograms per day should not be exceeded without specialist supervision.
Source
Todd GRG, Acerini CL, Ross-Russell R, et al. Arch Dis Child 2002;87:457-461
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
TORCH: the fluticasone-only arm had the highest mortality of the four
In plain words
In the three-year survival trial in six thousand people with chronic obstructive pulmonary disease, four groups were compared. The group on fluticasone alone had the most deaths of any of them — more than placebo — and got pneumonia half again as often.
What was measured
Three-year all-cause mortality and pneumonia incidence by treatment arm in chronic obstructive pulmonary disease
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
TORCH randomised 6,112 patients in the efficacy population to salmeterol plus fluticasone propionate, salmeterol alone, fluticasone propionate alone, or placebo for three years. Three-year all-cause mortality was 12.6% on the combination, 13.5% on salmeterol, 15.2% on placebo and 16.0% on fluticasone alone. The paper states that mortality for salmeterol alone or fluticasone propionate alone did not differ significantly from placebo, so the fluticasone figure is a numerical rather than a statistical excess — but it is the highest of the four and it is the arm that was supposed to be treating the inflammation. Pneumonia reported as an adverse event was 18.3% on fluticasone alone and 19.6% on the combination, against 12.3% on placebo, P<0.001 for both comparisons against placebo. Inhaled corticosteroid monotherapy is no longer a treatment for chronic obstructive pulmonary disease.
Source
Calverley PMA, Anderson JA, Celli B, et al. N Engl J Med 2007;356:775-789 (TORCH, NCT00268216)
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
AUSTRI: 11,679 patients, and adding salmeterol cut severe exacerbations by 21%
In plain words
The largest trial of this drug asked whether adding a long-acting bronchodilator to it was dangerous. It was not, and it prevented attacks: 480 people had a severe exacerbation on the combination against 597 on fluticasone alone.
What was measured
First serious asthma-related event and first severe exacerbation, fluticasone-salmeterol against fluticasone alone
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
AUSTRI randomised 11,679 patients aged 12 and over with persistent asthma and a severe exacerbation in the preceding year to fluticasone plus salmeterol or fluticasone alone for 26 weeks. Serious asthma-related events were 36 events in 34 patients on the combination against 38 events in 33 patients on fluticasone alone, hazard ratio 1.03 (95% CI 0.64 to 1.66), meeting noninferiority at P=0.003. There were no asthma-related deaths, and the two asthma-related intubations that occurred were both in the fluticasone-only group. Severe exacerbations occurred in 480 of 5,834 (8%) against 597 of 5,845 (10%), hazard ratio 0.79 (95% CI 0.70 to 0.89), P<0.001.
Source
Stempel DA, Raphiou IH, Kral KM, et al. N Engl J Med 2016;374:1822-1830 (AUSTRI, NCT01475721)
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
An HIV drug or an antifungal turns the inhaler into an oral steroid
In plain words
Fluticasone is safe systemically because the liver destroys almost all of what gets absorbed. Several common medicines block the enzyme that does the destroying, and when that happens people on an ordinary inhaler have developed full Cushing syndrome and adrenal failure.
What was measured
Plasma fluticasone exposure and serum cortisol with and without ritonavir, and postmarketing reports of Cushing syndrome
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
The label states that fluticasone propionate is a CYP3A4 substrate and that use of strong CYP3A4 inhibitors — ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin — is not recommended because increased systemic corticosteroid adverse effects may occur. A drug interaction trial with fluticasone propionate aqueous nasal spray in healthy subjects showed that ritonavir significantly increased plasma fluticasone exposure and significantly reduced serum cortisol. During postmarketing use there have been reports of clinically significant interactions in patients receiving fluticasone propionate and ritonavir resulting in systemic corticosteroid effects including Cushing syndrome and adrenal suppression. This is not a rare idiosyncrasy: it is the drug behaving exactly as its pharmacology predicts once first-pass metabolism is removed.
Source
FLOVENT HFA (fluticasone propionate) United States prescribing information, Drug Interactions 7.1 and Clinical Pharmacology 12.3
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 18-fold affinity number is a potency claim the label refuses to interpret
In plain words
Fluticasone is described everywhere as the most potent of the older inhaled steroids, on the basis that it binds the receptor eighteen times as tightly as dexamethasone. The label gives that number and then says nobody knows what it means clinically.
What was measured
That an 18-fold in-vitro receptor affinity over dexamethasone establishes a clinical potency ranking — a translation the label explicitly declines, and one that the adrenal-crisis data complicate rather than support
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The Mechanism of Action section reports in-vitro glucocorticoid receptor binding affinity 18 times that of dexamethasone, almost twice that of beclomethasone-17-monopropionate and over 3 times that of budesonide, adds that the McKenzie vasoconstrictor assay in man is consistent, and then states that the clinical significance of these findings is unknown. Receptor affinity is a statement about potency at the surface where the drug lands. It does not by itself predict clinical efficacy, which also depends on how much drug is deposited there, nor systemic risk, which depends on absorbed fraction and hepatic clearance. The adrenal-crisis survey is the clearest illustration: the drug with the highest affinity accounted for 91% of cases while being, at the time, the least prescribed of the three.
Source
FLOVENT HFA United States prescribing information, Clinical Pharmacology 12.1; Todd GRG et al., Arch Dis Child 2002;87:457-461
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 label asks for four separate long-term surveillance measures
In plain words
The prescribing information does not treat this as a drug with no systemic effect. It asks for children’s growth to be monitored, for bone density to be assessed initially and periodically, for referral to an eye specialist if vision changes, and for slow withdrawal if signs of steroid excess appear.
What was measured
Labelled long-term monitoring requirements for an inhaled corticosteroid
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The FLOVENT HFA Warnings and Precautions require: monitoring for Candida albicans infection of the mouth and pharynx with rinsing after inhalation; caution in existing tuberculosis and fungal, bacterial, viral, parasitic and ocular herpes simplex infections, with a more serious or fatal course of chickenpox or measles possible in susceptible patients; slow tapering when transferring from systemic corticosteroids because of impaired adrenal function; recognition that hypercorticism and adrenal suppression may occur at very high dosages or at regular dosage in susceptible individuals, with slow discontinuation if they do; assessment for decreased bone mineral density initially and periodically; monitoring of growth in paediatric patients; and consideration of ophthalmologist referral for glaucoma and cataracts with long-term use. That list is what a well-characterised systemic risk profile looks like written into a label.
Source
FLOVENT HFA (fluticasone propionate) United States prescribing information, Warnings and Precautions 5.1 to 5.9
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

Where else this substance is registered

FDA substance identifier (UNII)
O2GMZ0LF5W
CAS registry number
80474-14-2
PubChem compound
444036
RxNorm concept
41126

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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.

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A trifluorinated corticosteroid the label reports as binding the human glucocorticoid receptor 18 times as tightly as dexamethasone and more than 3 times as tightly as budesonide — while stating the clinical significance is unknown; it cut severe asthma exacerbations by 21% when salmeterol was added in 11,679 patients, produced the only arm of TORCH with higher three-year mortality than placebo (16.0% against 15.2%), and accounted for 30 of the 33 cases of adrenal crisis found by a United Kingdom national survey, one of them fatal.

Recorded evidence blocks (14)

What did Fluticasone Propionate's largest trial (815377 people) and its longest (11 years) measure?


815377 people in Fluticasone Propionate's largest registered study, 11 years in its longest registered window, measuring Hour 24 Fold Change From Period Baseline in Interleukin-5 (IL-5) Protein Concentration (pg/mL). ClinicalTrials.gov · 2026-09-01

82 phase3, 79 phase4, 57 phase2, 31 phase1, 27 na, 16 na or unstated, 1 early phase1; NCT02476825; 2026-10-31; no ageing endpoint recorded. Last human test completed 2025, NCT07380178.

Interpretation These counts include studies where Fluticasone Propionate 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
  • phase3
    82
  • phase4
    79
  • phase2
    57
  • phase1
    31
  • na
    27
  • na or unstated
    16
2 more recorded rows
  • early phase1
    1
  • Last recorded human test NCT07380178
    2025-07-05

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

From mouse to human: where has Fluticasone Propionate shown biomarker?


mouse: mechanism-only and human: biomarker (288): the rungs where Fluticasone Propionate has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Hour 24 Fold Change From Period Baseline in Interleukin-5 (IL-5) Protein Concentration (pg/mL) — the recorded outcome words.

Yeast C. elegans Drosophila Mouse mechanism-onlyRat Dog Non-human primate Human biomarker
Show the evidence
  • mouse
    mechanism-only
  • human NCT00623714
    biomarker; Hour 24 Fold Change From Period Baseline in Interleukin-5 (IL-5) Protein Concentration (pg/mL); 288

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

25 of Fluticasone Propionate's trials stopped: accrual/recruitment, funding/business, other?


accrual/recruitment (6), funding/business (4) and other (15): Fluticasone Propionate's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"Difficulty in recruitment"; 25 of 288 registered studies

Show the evidence

Trial

  • NCT00119015
    terminated; "Difficulty in recruitment"
  • NCT00387036
    terminated; "Termininated for business reasons"
  • NCT00409630
    withdrawn; "Sponsor decided against going forward with the study."
  • NCT00503009
    terminated; "lack of data"
  • NCT00509197
    terminated; "Inability to complete the recruitment."
  • NCT00524095
    terminated; "we decided not to go on treatment phase"
14 further recorded trials
  • NCT00540839
    withdrawn; "Based on input from regulatory agencies, it is not necessary to conduct this study. An ongoing study was sufficient for regulatory purposes."
  • NCT00567463
    terminated; "Completed"
  • NCT00656916
    terminated; "Terminated due to slow accrual."
  • NCT00695604
    withdrawn; "Study was not able to be completed, no results analyzed."
  • NCT00706446
    terminated; "Funding was terminated"
  • NCT00845598
    withdrawn; "Could not get IMP"
  • NCT01013701
    terminated; "Terminated based on mutual agreement between PI and sponsor (Glaxo Smith Kline)"
  • NCT01772056
    terminated; "Patient recruitment is very slow, economic grant has ended and the number of patients is enough according to sample size (22 children/ arm)."
  • NCT01845025
    terminated; "Due to the action to withdraw the Foradil Aerolizer NDA in US; study was discontinued. This was a commercial reason and not due to any change in benefit-risk."
  • NCT01881412
    terminated; "Funding complete"
  • NCT02246920
    terminated; "Development Halted"
  • NCT02491970
    terminated; "Difficulty of patients enrollments"
  • NCT02569437
    terminated; "A high percentage of patients were dropping out of the study and were not able to complete the protocol."
  • NCT02883439
    withdrawn; "no available patients"

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

Human studies of Fluticasone Propionate used fluticasone 500 mcg — over how long?


Human studies of Fluticasone Propionate used "fluticasone 500 mcg". ClinicalTrials.gov · 2026-09-01

20 recorded entries; human; also "fluticasone 500 mcg + salmeterol 50 mcg", "Fluticasone Propionate/Salmeterol 500/50mcg combination", "Fluticasone Propionate 500mcg"

Show the evidence

human

  • NCT00158847
    fluticasone 500 mcg
  • NCT00158847
    fluticasone 500 mcg + salmeterol 50 mcg
  • NCT00358358
    Fluticasone Propionate/Salmeterol 500/50mcg combination
  • NCT00358358
    Fluticasone Propionate 500mcg
  • NCT00549146
    fluticasone propionate DISKUS 500mcg
  • NCT00550550
    Fluticasone 44 mcg Rescue Treatment
14 more recorded rows
  • human NCT00562159
    Fluticasone propionate 44 mcg
  • human NCT00716963
    Fluticasone propionate (Flovent Diskus) 250 mcg
  • human NCT01192178
    FLOVENT™ DISKUS™ 100 mcg BID
  • human NCT01213849
    Fluticasone furoate 50 mcg (4 inhalations)
  • human NCT01213849
    Fluticasone furoate 100 mcg (4 inhalations)
  • human NCT01213849
    Fluticasone furoate 200 mcg (4 inhalations)
  • human NCT01246921
    Fluticasone proprionate 0.05% cream
  • human NCT01436071
    Fluticasone furoate 50mcg
  • human NCT01436110
    Fluticasone propionate 100mcg
  • human NCT01462344
    FLOVENT 100mcg
  • human NCT01462344
    FLOVENT 250mcg
  • human NCT01475721
    FLOVENT 500mcg
  • human NCT01485445
    Fluticasone Furoate (200mcg unit strength)
  • human NCT01485445
    Fluticasone Furoate/Vilanterol (200/25mcg unit strength)

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

Fluticasone Propionate's half-life is 7.8 hours — which schedules were studied?


7.8 hours, the half-life Fluticasone Propionate's label states. openfda-label · 549ff4f2-fa68-3dd8-e054-00144ff8d46c · 2026-08-30

bioavailability 2% %.

Show the evidence
  • half life
    7.8 hours hours; Elimination Following intravenous dosing, fluticasone propionate showed polyexponential kinetics and had a terminal elimination half-life of approximately 7.8 hours.
  • bioavailability
    2% %; Absorption Indirect calculations indicate that fluticasone propionate delivered by the intranasal route has an absolute bioavailability averaging less than 2%.
  • metabolism
    Trials using oral dosing of labeled and unlabeled drug have demonstrated that the oral systemic bioavailability of fluticasone propionate is negligible (<1%), primarily due to incomplete absorption and presystemic metabolism in the gut and liver.

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

Could one person measure Fluticasone Propionate's effect on at least 1 adverse event?


At least 1 adverse event: measured in Fluticasone Propionate's trials.

at least 1 adverse event is the recorded endpoint.

Show the evidence

biomarkers

  • at least 1 adverse event; 2026-09-01
  • total nasal symptom over 2 week randomized treatment period; 2026-09-01
  • treatment failure; 2026-09-01
  • exacerbations of copd condition specific quality of life; 2026-09-01
  • inhaled corticosteroid prescriptions refilled; 2026-09-01
  • morning peak expiratory flow; 2026-09-01
14 more recorded rows
  • biomarkers
    pc20 amp; 2026-09-01
  • biomarkers
    pre dose fev1; 2026-09-01
  • biomarkers
    fev1; 2026-09-01
  • biomarkers
    who experience at least one adverse event; 2026-09-01
  • biomarkers
    who discontinue study drug due to an ae; 2026-09-01
  • biomarkers
    total combined symptom over the entire grass pollen season; 2026-09-01
  • biomarkers
    12 hour reflective total nasal symptom; 2026-09-01
  • biomarkers
    ocular itching; 2026-09-01
  • biomarkers
    asthma exacerbation; 2026-09-01
  • biomarkers
    4 nasal symptom after 2 weeks; 2026-09-01
  • biomarkers
    endoscopy polyp grading; 2026-09-01
  • biomarkers
    methacholine pc20; 2026-09-01
  • biomarkers
    feno; 2026-09-01
  • biomarkers
    nasal inflammatory markers; 2026-09-01
  • half life
    2026-09-04; halfLife; hours; 7.8 hours; 2026-08-30
  • human trials at or under30
    72
  • smallest human trial
    0; NCT00409630; NA; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; WITHDRAWN

Which of 12 hour reflective total nasal symptom, 4 nasal symptom after 2 weeks and acoustic rhinometry did Fluticasone Propionate's trials measure?


12 hour reflective total nasal symptom, 4 nasal symptom after 2 weeks and acoustic rhinometry lead 40 outcome terms across Fluticasone Propionate's trials. ClinicalTrials.gov · 2026-09-01

exacerbations of copd condition specific quality of life, inhaled corticosteroid prescriptions refilled, morning peak expiratory flow, pc20 amp, pre dose fev1 and fev1 follow.

Show the evidence
  • at least 1 adverse event
    1
  • total nasal symptom over 2 week randomized treatment period
    1
  • treatment failure
    1
  • exacerbations of copd condition specific quality of life
    1
  • inhaled corticosteroid prescriptions refilled
    1
  • morning peak expiratory flow
    1
14 more recorded rows
  • pc20 amp
    1
  • pre dose fev1
    1
  • fev1
    1
  • who experience at least one adverse event
    1
  • who discontinue study drug due to an ae
    1
  • total combined symptom over the entire grass pollen season
    1
  • 12 hour reflective total nasal symptom
    1
  • ocular itching
    1
  • asthma exacerbation
    1
  • 4 nasal symptom after 2 weeks
    1
  • endoscopy polyp grading
    1
  • methacholine pc20
    1
  • feno
    1
  • nasal inflammatory markers
    1

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

Which of Fluticasone Propionate's 11 ongoing trials reports first?


11 registered trials of Fluticasone Propionate are open; earliest completion 2026-09-19. ClinicalTrials.gov · 2026-09-01

Relative change from baseline in airway tissue gene expression following 4-weeks of inhaled fluticasone propionate treatment; Changes in the hyper polarized MRI xenon-129 MRI (HXe MRI) assessment pre-post 30-day treatment of umeclidinium+vilanterol or Flovent; latest 2028-01-31

Show the evidence

Trial

  • NCT02476825
    "A Bronchoscopy Study to Assess the Effects of Inhaled Corticosteroids on Adult Healthy Volunteers"; n 30; "Relative change from baseline in airway tissue gene expression following 4-weeks of inhaled fluticasone propionate treatment"; 2026-10-31
  • NCT03002389
    "Hyperpolarized Xenon-129 MRI: a New Multi-dimensional Biomarker to Determine Pulmonary Physiologic Responses to COPD Therapeutics"; n 95; "Changes in the hyper polarized MRI xenon-129 MRI (HXe MRI) assessment pre-post 30-day treatment of umeclidinium+vilanterol or Flovent"; 2028-01-31
  • NCT04171167
    "The Causal Relation of Nasal Nitric Oxide Levels to the Severity of Chronic Rhinosinusitis and Its Inflammatory Phenotype"; n 88; "Nasal nitric oxide levels"; 2026-12
  • NCT04278404
    "Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)"; n 5000; "Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling"; 2026-12
  • NCT05535738
    "Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation"; n 45; "To collect and evaluate single-cell multiomics data (RNAseq, CITEseq, TCRseq)"; 2027-12-31
  • NCT05922761
    "BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP)"; n 45; "24-week Overall Response Rate (ORR) [Cohort A]"; 2027-12-31
5 further recorded trials
  • NCT06572228
    "Efficacy of Dupilumab Added to Medium Dose Inhaled Corticosteroid/Long-acting Beta-agonist (ICS/LABA) in Comparison to ICS Dose Escalation to High Dose ICS/LABA in Adolescent and Adult Patients With Uncontrolled Asthma"; n 120; "Annualized severe asthma exacerbation rate"; 2027-04-24
  • NCT06664619
    "A Randomized, Double-Blind, Placebo-Controlled Trial on Efficacy and Safety of Fluticasone Propionate/Albuterol Sulfate Combination in Participants 12 Years and Older With Asthma"; n 724; "Change from Baseline forced expiratory volume in one second (FEV1) area under the effect curve over 4 weeks"; 2026-09-19
  • NCT06705387
    "Dupilumab Versus Topical Corticosteroid Effectiveness - Comparison in the Treatment of Stenotic EoE"; n 72; "Esophageal Lumen Distensibility"; 2027-03
  • NCT07537439
    "Evaluation of the Adjunctive Effects of Moxibustion in the Treatment of Cold-Syndrome Allergic Rhinitis"; n 60; "Change in Total Nasal Symptom Score (TNSS)"; 2026-10-01
  • NCT07664527
    "Novel Method for Removal of Orally Deposited Inhaled Fluticasone Propionate"; n 20; "FP concentration in mouthwashes (ng/mL)"; 2027-07

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

Which 98 trials of Fluticasone Propionate posted no result?


Posted no result
98 of 98 completed trials
Registrations
NCT00184977, NCT00641680, NCT00115622, NCT00830102, NCT00763529 and NCT00783458, and 92 more
Completion dates
oldest 2003-01; newest 2022-10-24
Show the evidence

Trial

  • NCT00184977
    2003-01
  • NCT00641680
    2003-07
  • NCT00115622
    2005-01
  • NCT00830102
    2005-01
  • NCT00763529
    2005-01-01
  • NCT00783458
    2005-01-01
14 further recorded trials
  • NCT00817050
    2005-01-01
  • NCT00400855
    2005-08
  • NCT00169546
    2005-12
  • NCT00280358
    2005-12
  • NCT00407264
    2005-12
  • NCT00549146
    2006-04
  • NCT00400998
    2006-11
  • NCT00123656
    2006-12
  • NCT00404586
    2007-01-16
  • NCT00358358
    2007-02
  • NCT00315744
    2007-04-12
  • NCT00370097
    2007-04-12
  • NCT00403286
    2007-05
  • NCT00296530
    2007-07

At the median, Fluticasone Propionate's trials enrolled 81 people — anything larger?


Median enrolment
81
Largest enrolment
815377
Registered trials counted
287

What do 13516 spontaneous reports say about Fluticasone Propionate — 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.

Fluticasone Propionate appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 13516 reaction mentions were counted: dyspnoea 3120; asthma 3080; cough 1501; wheezing 1328. open-targets-adr · CHEMBL1473 · 2026-06-24

Show the evidence
  • dyspnoea
    3120
  • asthma
    3080
  • cough
    1501
  • wheezing
    1328
  • therapeutic product effect incomplete
    925
  • pneumonia
    847
4 more recorded rows
  • chronic obstructive pulmonary disease
    756
  • chest discomfort
    686
  • obstructive airways disorder
    668
  • blood count abnormal
    605

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

Fluticasone Propionate and CYP3A4: shared by which compounds?


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

Interpretation pharmacokinetics

Show the evidence

CYP3A4

  • pharmacokinetics
    Metabolism: The only circulating metabolite detected in man is the 17β-carboxylic acid derivative of fluticasone propionate, which is formed through the CYP3A4 pathway.
  • pharmacokinetics
    Drug Interactions Inhibitors of Cytochrome P450 3A4: Ritonavir: Fluticasone propionate is a substrate of CYP3A4.
  • pharmacokinetics
    Coadministration of fluticasone propionate and the strong CYP3A4 inhibitor, ritonavir, is not recommended based upon a multiple-dose, crossover drug interaction trial in 18 healthy subjects.

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

Was Fluticasone Propionate studied with fasting and exercise?


fasting and exercise are named in Fluticasone Propionate's label sentences: "To establish bioequivalence between the test and reference products of fluticasone propionate nasal spray, an open-label, randomized, single-dose, and 2-sequence crossover study was conducted on 84 healthy Chinese subjects under fasting conditions to determine the pharmacokinetic bioequivalence of…" openfda-label+europepmc · 2026-08-30

2 recorded statements; fasting, exercise

Show the evidence
  • fasting
    To establish bioequivalence between the test and reference products of fluticasone propionate nasal spray, an open-label, randomized, single-dose, and 2-sequence crossover study was conducted on 84 healthy Chinese subjects under fasting conditions to determine the pharmacokinetic bioequivalence of the 2 products.
  • exercise
    <i>Objective</i>: To investigate whether once-daily (OD) fluticasone furoate (FF)/vilanterol (VI) provides greater long-term protection from postexercise fall in forced expiratory volume in 1 s (FEV<sub>1</sub>) than twice-daily (BD) fluticasone propionate (FP) in patients with asthma and exercise-induced bronchoconstriction. <i>Methods</i>: A randomized, double-blind, crossover study was…

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

What is recorded about Fluticasone Propionate and sirtuin?


"Transcriptome analysis showed that the compounds inhibited the LPS-mediated induction of pro-inflammatory genes (InhbA, Ifit1) and suggested potential inhibition of regulators such as toll-like receptor 4 (TLR4), MyD88, and interferon regulatory factor 3 (IRF3), whereas anti-inflammatory genes (SerpinB2) and potential regulators IL-10,…" — where Fluticasone Propionate and sirtuin appear together. Europe PMC · pathway abstract search · 2021-02-19

sirtuin; PMID 33610761

Show the evidence
  • sirtuin PMID 33610761
    "Transcriptome analysis showed that the compounds inhibited the LPS-mediated induction of pro-inflammatory genes (InhbA, Ifit1) and suggested potential inhibition of regulators such as toll-like receptor 4 (TLR4), MyD88, and interferon regulatory factor 3 (IRF3), whereas anti-inflammatory genes (SerpinB2) and potential regulators IL-10, sirtuin 1 (Sirt-1), fluticasone propionate were induced."

recorded 2021-02-19 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1473
PubChem CID
444036
CAS number
80474-14-2
RxCUI
50121
InChIKey
WMWTYOKRWGGJOA-CENSZEJFSA-N
Also called
Fluticasone
Trade name
Aerivio spiromax, Airflusal forspiro, Armonair digihaler, Armonair respiclick, Cutivate, Flixonase, Flixotide, Flonase, Flonase allergy relief, Flovent diskus 100, Flovent diskus 250, Flovent diskus 50
Development code
CCI 18781, CCI18781, FLOVENT, NSC-759889, PF-00241939, R01AD08
Also called
Fluticaps, Fluticasone-17-propionate, Opn-375, Optinose, advair diskus, advair diskus 100/50 mcg, advair diskus 250 mcg, advair diskus 250/50 mcg inhalation powder/gsk, advair diskus 500/50 mcg inhalation powder/gsk, apt-1011, eds-flu, ep-104iar
Salt form
fluticasone nasal spray, fluticasone propionate 100 mcg/blister oral inhalation powder/respirent pharmaceuticals, fluticasone propionate 250 mcg and salmeterol xinafoate 50 mcg inhalation powder/respirent pharmaceuticals, fluticasone propionate 500 mcg and salmeterol xinafoate 50 mcg inhalation powder/respirent pharmaceuticals
Component
Fluticasone
Sources (11)

Sources

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

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

How these records are assembled · Which registers were checked

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

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