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Oxymetazoline

  • 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 Oxymetazoline does in the body

Used briefly for a blocked nose and, in other products, facial redness or a drooping eyelid.

The lining of your nose contains large veins that swell up with blood when you have a cold or an allergy, and it is that swelling, not mucus, that blocks the airway. Oxymetazoline binds to receptors on the muscle wrapped around those veins and makes it squeeze. The veins empty, the lining shrinks back, and air moves through within a minute or two. The same squeeze is what the 1% cream does to the small vessels in facial skin that make rosacea look red, and what the eye drop does to a thin muscle in the upper eyelid that lifts it a fraction of a millimetre higher.

What happened in people

After one month of nasal use, healthy volunteers developed thicker, more reactive nasal linings.

Reviewed first-read answer

Where this came from

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

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

No source is stored against this line.

The limit that matters most

The three-day use limit is a safety margin, not a directly measured rebound threshold.

Where it acts
Capacitance venous sinusoids of the nasal turbinate mucosa; dermal arterioles of the face; Müller’s smooth muscle in the upper eyelid
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

  • The substance registry classes this as chemical.

    FDA substance registry · K89MJ0S5VY · read 2026-08-29

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 139 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.

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.

Absolute difference

An absolute difference is how many more people in a hundred were affected.

A picture of it, and where the picture fails

It is like counting heads in two rooms of a hundred.

Where that stops being true. Heads are easy to count. Study results carry a margin of error too.

What people get wrong. It is confused with a percentage change, which can look far larger.

The arithmetic difference in event rates between arms.

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.

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.

Composite ≥2-grade improvement on Clinician Erythema Assessment and Subject Self-Assessment at 3, 6, 9 and 12 hours on day 29

The study showed what it set out to show

Who was studied
REVEAL 1 (NCT02131636)
How many people
440
Study design
Phase 3, randomised, double-blind, vehicle-controlled
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
P<0.02 at each timepoint and P<0.001 overall against vehicle
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. Topical: 0.05% aqueous nasal spray (over the counter), 1.0% dermal cream (prescription), 0.1% ophthalmic solution in single-patient-use containers (prescription)

Interval reported. Not recorded in this summary

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

  • Graf P, Hallén H, Juto JE. Benzalkonium chloride in a decongestant nasal spray aggravates rhinitis medicamentosa in healthy volunteers. Clin Exp Allergy 1995… · a recorded source, not a stored snapshot
  • Graf P, Hallén H, Juto JE. The pathophysiology and treatment of rhinitis medicamentosa. Clin Otolaryngol Allied Sci 1995;20(3):224-229 (7554332) · a recorded source, not a stored snapshot
  • Graf P, Juto JE. Sustained use of xylometazoline nasal spray shortens the decongestive response and induces rebound swelling. Rhinology 1995;33(1):14-17 (754… · a recorded source, not a stored snapshot
  • Graf P, Enerdal J, Hallén H. Ten days' use of oxymetazoline nasal spray with or without benzalkonium chloride in patients with vasomotor rhinitis. Arch Otola… · a recorded source, not a stored snapshot

Composite ≥2-grade improvement on Clinician Erythema Assessment and Subject Self-Assessment on day 29

The study showed what it set out to show

Who was studied
REVEAL 2 (NCT02132117)
How many people
445
Study design
Phase 3, randomised, double-blind, vehicle-controlled
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Composite P=0.001; CEA P<0.001; SSA P=0.011
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. Post-treatment rebound erythema occurred in 2 patients (1.2%) on oxymetazoline against none on vehicle. The pooled analysis of both REVEAL trials submitted to J Am Acad Dermatol was subsequently withdrawn at author and editor request.

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

Form and route. Topical: 0.05% aqueous nasal spray (over the counter), 1.0% dermal cream (prescription), 0.1% ophthalmic solution in single-patient-use containers (prescription)

Interval reported. Not recorded in this summary

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

  • Graf P, Hallén H, Juto JE. Benzalkonium chloride in a decongestant nasal spray aggravates rhinitis medicamentosa in healthy volunteers. Clin Exp Allergy 1995… · a recorded source, not a stored snapshot
  • Graf P, Hallén H, Juto JE. The pathophysiology and treatment of rhinitis medicamentosa. Clin Otolaryngol Allied Sci 1995;20(3):224-229 (7554332) · a recorded source, not a stored snapshot
  • Graf P, Juto JE. Sustained use of xylometazoline nasal spray shortens the decongestive response and induces rebound swelling. Rhinology 1995;33(1):14-17 (754… · a recorded source, not a stored snapshot
  • Graf P, Enerdal J, Hallén H. Ten days' use of oxymetazoline nasal spray with or without benzalkonium chloride in patients with vasomotor rhinitis. Arch Otola… · a recorded source, not a stored snapshot

Mean change from baseline in the number of points seen on the Leicester Peripheral Field Test

The study showed what it set out to show

Who was studied
RVL-1201 blepharoptosis trial (NCT02436759)
How many people
140
Study design
Phase 3, randomised, double-masked, vehicle-controlled
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Pooled with NCT03565887: mean difference 4.07 points (95% CI 2.74 to 5.39) on day 1 and 4.74 (95% CI 3.43 to 6.04) on day 14, both 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. Topical: 0.05% aqueous nasal spray (over the counter), 1.0% dermal cream (prescription), 0.1% ophthalmic solution in single-patient-use containers (prescription)

Interval reported. 95% CI 2

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

  • Graf P, Hallén H, Juto JE. Benzalkonium chloride in a decongestant nasal spray aggravates rhinitis medicamentosa in healthy volunteers. Clin Exp Allergy 1995… · a recorded source, not a stored snapshot
  • Graf P, Hallén H, Juto JE. The pathophysiology and treatment of rhinitis medicamentosa. Clin Otolaryngol Allied Sci 1995;20(3):224-229 (7554332) · a recorded source, not a stored snapshot
  • Graf P, Juto JE. Sustained use of xylometazoline nasal spray shortens the decongestive response and induces rebound swelling. Rhinology 1995;33(1):14-17 (754… · a recorded source, not a stored snapshot
  • Graf P, Enerdal J, Hallén H. Ten days' use of oxymetazoline nasal spray with or without benzalkonium chloride in patients with vasomotor rhinitis. Arch Otola… · a recorded source, not a stored snapshot

Mean change from baseline in the number of points seen on the Leicester Peripheral Field Test

The study showed what it set out to show

Who was studied
RVL-1201 blepharoptosis trial (NCT03565887)
How many people
164
Study design
Phase 3, randomised, double-masked, vehicle-controlled
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Reported only in the 304-patient pooled analysis, both timepoints 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. The endpoint is a visual field point count on a peripheral test, not visual acuity, and the marginal reflex distance gain was 0.47 to 0.67 mm. Neither trial reports what proportion of participants noticed the change without measurement.

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

Form and route. Topical: 0.05% aqueous nasal spray (over the counter), 1.0% dermal cream (prescription), 0.1% ophthalmic solution in single-patient-use containers (prescription)

Interval reported. Not recorded in this summary

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

  • Graf P, Hallén H, Juto JE. Benzalkonium chloride in a decongestant nasal spray aggravates rhinitis medicamentosa in healthy volunteers. Clin Exp Allergy 1995… · a recorded source, not a stored snapshot
  • Graf P, Hallén H, Juto JE. The pathophysiology and treatment of rhinitis medicamentosa. Clin Otolaryngol Allied Sci 1995;20(3):224-229 (7554332) · a recorded source, not a stored snapshot
  • Graf P, Juto JE. Sustained use of xylometazoline nasal spray shortens the decongestive response and induces rebound swelling. Rhinology 1995;33(1):14-17 (754… · a recorded source, not a stored snapshot
  • Graf P, Enerdal J, Hallén H. Ten days' use of oxymetazoline nasal spray with or without benzalkonium chloride in patients with vasomotor rhinitis. Arch Otola… · a recorded source, not a stored snapshot

Rebound nasal mucosal swelling by rhinostereometry and evening symptom score after 30 days of thrice-daily dosing

The study showed what it set out to show

Who was studied
Graf, Hallén & Juto 1995 rebound study (PMID 7553241) — pre-dates ClinicalTrials.gov, no registry entry
How many people
20
Study design
Randomised, double-blind, 30-day mechanistic study in healthy volunteers
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Rebound swelling 1.1 mm with benzalkonium chloride against 0.5 mm without (P<0.05); evening symptom score 43 against 25 (P<0.05)
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. Twenty healthy volunteers, no untreated control arm, and the comparison is preservative against no preservative rather than drug against placebo. It measures how much worse benzalkonium chloride makes rebound, not the absolute size of rebound against no spray at all.

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

Form and route. Topical: 0.05% aqueous nasal spray (over the counter), 1.0% dermal cream (prescription), 0.1% ophthalmic solution in single-patient-use containers (prescription)

Interval reported. Not recorded in this summary

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

  • Graf P, Hallén H, Juto JE. Benzalkonium chloride in a decongestant nasal spray aggravates rhinitis medicamentosa in healthy volunteers. Clin Exp Allergy 1995… · a recorded source, not a stored snapshot
  • Graf P, Hallén H, Juto JE. The pathophysiology and treatment of rhinitis medicamentosa. Clin Otolaryngol Allied Sci 1995;20(3):224-229 (7554332) · a recorded source, not a stored snapshot
  • Graf P, Juto JE. Sustained use of xylometazoline nasal spray shortens the decongestive response and induces rebound swelling. Rhinology 1995;33(1):14-17 (754… · a recorded source, not a stored snapshot
  • Graf P, Enerdal J, Hallén H. Ten days' use of oxymetazoline nasal spray with or without benzalkonium chloride in patients with vasomotor rhinitis. Arch Otola… · a recorded source, not a stored snapshot
What we know
RNAWiki holds 5 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.

What 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

    Oxymetazoline

    What a person takes: Topical: 0.05% aqueous nasal spray (over the counter), 1.0% dermal cream (prescription), 0.1% ophthalmic solution in single-patient-use containers (prescription).

    The measurement behind this step

    All three routes put the drug directly on the tissue it acts on and rely on local receptor occupancy rather than systemic exposure. The ophthalmic product is supplied preservative-free in single-use containers, and its label instructs patients not to touch the container tip to the eye or any surface.

  2. Getting in

    Sprayed onto the lining, not swallowed

    Two sprays put the drug directly on the swollen tissue. Almost none of it needs to reach the bloodstream to work, which is why it acts in a minute or two rather than in an hour.

    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 over-the-counter nasal formulation is oxymetazoline hydrochloride 0.05% in buffered aqueous vehicle, typically preserved with benzalkonium chloride. The cream is 1.0% in an oil-in-water emulsion under NDA 208552 and the ophthalmic solution is 0.1% in single-patient-use containers under NDA 212520.

    • Graf P, Hallén H, Juto JE. Benzalkonium chloride in a decongestant nasal spray aggravates rhinitis medicamentosa in healthy volunteers. Clin Exp Allergy 1995… · a recorded source, not a stored snapshot
    • Graf P, Hallén H, Juto JE. The pathophysiology and treatment of rhinitis medicamentosa. Clin Otolaryngol Allied Sci 1995;20(3):224-229 (7554332) · a recorded source, not a stored snapshot
    • Graf P, Juto JE. Sustained use of xylometazoline nasal spray shortens the decongestive response and induces rebound swelling. Rhinology 1995;33(1):14-17 (754… · a recorded source, not a stored snapshot
  3. Reaching the cell

    It reaches receptors on the outside of the muscle cells

    The molecule never has to get inside a cell. It docks onto a protein that sits on the outer surface of the muscle cells wrapped around the blood vessels in the lining.

    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

    Oxymetazoline diffuses through the mucus layer to reach adrenoceptors on vascular smooth muscle of the capacitance sinusoids. These are G-protein-coupled receptors with an extracellular binding pocket; no cellular uptake or metabolic activation is required, which is the structural reason the onset is measured in minutes.

    • Graf P, Hallén H, Juto JE. Benzalkonium chloride in a decongestant nasal spray aggravates rhinitis medicamentosa in healthy volunteers. Clin Exp Allergy 1995… · a recorded source, not a stored snapshot
    • Graf P, Hallén H, Juto JE. The pathophysiology and treatment of rhinitis medicamentosa. Clin Otolaryngol Allied Sci 1995;20(3):224-229 (7554332) · a recorded source, not a stored snapshot
    • Graf P, Juto JE. Sustained use of xylometazoline nasal spray shortens the decongestive response and induces rebound swelling. Rhinology 1995;33(1):14-17 (754… · a recorded source, not a stored snapshot
  4. What it acts on

    It docks onto an adrenaline receptor

    The receptor it binds is the one your own adrenaline uses to tighten blood vessels. The drug is a synthetic stand-in for that signal, applied locally and continuously.

    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 Rhofade label describes oxymetazoline as an alpha-1A adrenoceptor agonist; it also has substantial alpha-2 adrenoceptor activity, and the balance between the two differs by vascular bed. The imidazoline ring is the shared pharmacophore of oxymetazoline, xylometazoline, tetrahydrozoline and naphazoline.

    • Graf P, Hallén H, Juto JE. Benzalkonium chloride in a decongestant nasal spray aggravates rhinitis medicamentosa in healthy volunteers. Clin Exp Allergy 1995… · a recorded source, not a stored snapshot
    • Graf P, Hallén H, Juto JE. The pathophysiology and treatment of rhinitis medicamentosa. Clin Otolaryngol Allied Sci 1995;20(3):224-229 (7554332) · a recorded source, not a stored snapshot
    • Graf P, Juto JE. Sustained use of xylometazoline nasal spray shortens the decongestive response and induces rebound swelling. Rhinology 1995;33(1):14-17 (754… · a recorded source, not a stored snapshot
  5. The change it makes

    The muscle around the vein contracts

    The muscle squeezes. Blood is pushed out of the spongy veins in the nasal lining, the tissue shrinks back against the wall, and the airway opens.

    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

    Alpha-1A activation couples through Gq to phospholipase C, generating inositol trisphosphate and diacylglycerol, releasing intracellular calcium and activating myosin light-chain kinase. Alpha-2 activation couples through Gi. The net result in the nasal mucosa is emptying of the venous sinusoids rather than arteriolar constriction, which is why decongestion does not cause ischaemia at labelled doses.

    • Graf P, Hallén H, Juto JE. Benzalkonium chloride in a decongestant nasal spray aggravates rhinitis medicamentosa in healthy volunteers. Clin Exp Allergy 1995… · a recorded source, not a stored snapshot
    • Graf P, Hallén H, Juto JE. The pathophysiology and treatment of rhinitis medicamentosa. Clin Otolaryngol Allied Sci 1995;20(3):224-229 (7554332) · a recorded source, not a stored snapshot
    • Graf P, Juto JE. Sustained use of xylometazoline nasal spray shortens the decongestive response and induces rebound swelling. Rhinology 1995;33(1):14-17 (754… · a recorded source, not a stored snapshot
  6. What that does for a person

    Air moves, for up to twelve hours

    This is the whole therapeutic effect: a physically wider airway for as long as the drug is on the tissue. Nothing about the cold or the allergy has changed.

    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 same contraction in facial dermal arterioles is what produced composite success on the Clinician Erythema Assessment out to 12 hours post-dose in REVEAL, and contraction of Müller’s muscle is what produced a 0.47 to 0.67 mm gain in marginal reflex distance in the blepharoptosis trials.

    • Graf P, Hallén H, Juto JE. Benzalkonium chloride in a decongestant nasal spray aggravates rhinitis medicamentosa in healthy volunteers. Clin Exp Allergy 1995… · a recorded source, not a stored snapshot
    • Graf P, Hallén H, Juto JE. The pathophysiology and treatment of rhinitis medicamentosa. Clin Otolaryngol Allied Sci 1995;20(3):224-229 (7554332) · a recorded source, not a stored snapshot
    • Graf P, Juto JE. Sustained use of xylometazoline nasal spray shortens the decongestive response and induces rebound swelling. Rhinology 1995;33(1):14-17 (754… · a recorded source, not a stored snapshot
  7. What that does for a person

    And with sustained use, the tissue answers back

    Keep signalling the same receptor every day and the response gets shorter, and the swelling between doses gets worse than it was to begin with. That is the rebound, and it is the best-measured thing about this drug.

    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

    Sustained use shortens the decongestive response — in a 30-day xylometazoline study the effect at 1 hour matched baseline while the effect at 5 hours was significantly reduced (p<0.005) and rebound swelling appeared in 8 of 9 subjects. The rebound is interstitial oedema rather than vasodilation, which is why a topical corticosteroid resolves it and a stronger vasoconstrictor does not.

    • Graf P, Hallén H, Juto JE. Benzalkonium chloride in a decongestant nasal spray aggravates rhinitis medicamentosa in healthy volunteers. Clin Exp Allergy 1995… · a recorded source, not a stored snapshot
    • Graf P, Hallén H, Juto JE. The pathophysiology and treatment of rhinitis medicamentosa. Clin Otolaryngol Allied Sci 1995;20(3):224-229 (7554332) · a recorded source, not a stored snapshot
    • Graf P, Juto JE. Sustained use of xylometazoline nasal spray shortens the decongestive response and induces rebound swelling. Rhinology 1995;33(1):14-17 (754… · a recorded source, not a stored snapshot

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 children aged 6 and over for the nasal spray, under the labelled three-day limit. Adults only for the cream and the eye drop, both of which are prescription products.

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: “Safety and effectiveness of oxymetazoline hydrochloride have not been established in pediatric patients below the age of 18 years.”

    US prescribing information · 8a7f2400-5e18-4215-8d2c-f55881706107 · read 2026-08-30

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

    US prescribing information · 8a7f2400-5e18-4215-8d2c-f55881706107 · read 2026-08-30

  • On people who are pregnant, the label states: “Animal Data Effects on embryo-fetal development were evaluated in rats and rabbits following oral administration of oxymetazoline hydrochloride during the period of organogenesis.”

    US prescribing information · 8a7f2400-5e18-4215-8d2c-f55881706107 · read 2026-08-30

  • On people who are breastfeeding, the label states: “No clinical data are available to assess the effects of oxymetazoline on the quantity or rate of breastmilk production, or to establish the level of oxymetazoline present in human breastmilk post-dose.”

    US prescribing information · 8a7f2400-5e18-4215-8d2c-f55881706107 · read 2026-08-30

Where the result stopped carrying

  • Cochrane could draw no conclusion at all about a single dose of a nasal decongestant, and called the multiple-dose effect of unknown clinical relevance
  • Sustained dosing shortens the drug’s own duration: at 30 days the 5-hour effect was significantly below baseline while the 1-hour effect was unchanged (p<0.005)
  • The pooled REVEAL publication in J Am Acad Dermatol was withdrawn at author and editor request; only the two separate trial reports stand
  • Rebound erythema after stopping the cream was reported in 1.2% to 2.2% of treated patients — the same phenomenon as nasal rebound, in skin
  • 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

Topical: 0.05% aqueous nasal spray (over the counter), 1.0% dermal cream (prescription), 0.1% ophthalmic solution in single-patient-use containers (prescription)

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

All three routes put the drug directly on the tissue it acts on and rely on local receptor occupancy rather than systemic exposure. The ophthalmic product is supplied preservative-free in single-use containers, and its label instructs patients not to touch the container tip to the eye or any surface.

Source-linked record

Where this came from

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

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

No source is stored against this line.

Where it is registered

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

Counted from records

Where this came from

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

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

No source is stored against this line.

Why people stop

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

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

No source is stored against this line.

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

What can go wrong

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

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

The nasal label limits use to 3 days and warns that frequent or prolonged use may cause congestion to recur or worsen; it directs users to a poison control centre if the product is swallowed and to keep it out of reach of children. The cream label warns about blood-pressure effects of alpha-adrenergic agonists and advises caution in cerebral or coronary insufficiency, Raynaud’s phenomenon, thromboangiitis obliterans, scleroderma, Sjögren’s syndrome and angle-closure glaucoma risk; commonest adverse events were application-site dermatitis, worsening inflammatory rosacea lesions, pruritus, erythema and pain, each about 1 to 2%. The eyelid drop label warns that ptosis may indicate stroke, intracranial aneurysm, Horner syndrome or myasthenia gravis, and lists punctate keratitis, conjunctival hyperaemia, dry eye, blurred vision, instillation-site pain, eye irritation and headache at 1 to 5%.

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

Where this came from
  • Graf P, Hallén H, Juto JE. Benzalkonium chloride in a decongestant nasal spray aggravates rhinitis medicamentosa in healthy volunteers. Clin Exp Allergy 1995… · a recorded source, not a stored snapshot
  • Graf P, Hallén H, Juto JE. The pathophysiology and treatment of rhinitis medicamentosa. Clin Otolaryngol Allied Sci 1995;20(3):224-229 (7554332) · a recorded source, not a stored snapshot
  • Graf P, Juto JE. Sustained use of xylometazoline nasal spray shortens the decongestive response and induces rebound swelling. Rhinology 1995;33(1):14-17 (754… · a recorded source, not a stored snapshot

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

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

What is missing or unclearRead from sources, not yet reviewed

Does the exact form matter?

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

The form that was studied

Topical: 0.05% aqueous nasal spray (over the counter), 1.0% dermal cream (prescription), 0.1% ophthalmic solution in single-patient-use containers (prescription)

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

The ophthalmic product is supplied preservative-free in single-use containers, and its label instructs patients not to touch the container tip to the eye or any surface.

Source-linked record

Where this came from

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

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

No source is stored against this line.

What is recorded as being sold

  • 226 products list this as an active ingredient in the United States drug directory. 226 of them contain it and nothing else.

    FDA National Drug Code directory · 72288-859 · read 2026-08-29

  • They are sold as aerosol, spray, cream, liquid, powder, solution and solution/ drops, taken nasal, ophthalmic and topical.

    FDA National Drug Code directory · 72288-859 · read 2026-08-29

  • The regulator's established pharmacologic class for it is imidazolines [cs], increased sympathetic activity [pe] and vasoconstriction [pe].

    FDA National Drug Code directory · 72288-859 · read 2026-08-29

  • 215 published labels name it as an active ingredient. 214 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 464534ee-15f8-3af8-e063-6394a90a3f18 · read 2026-08-29

  • Those labels are classed as human otc drug and human prescription drug.

    US prescribing information · 464534ee-15f8-3af8-e063-6394a90a3f18 · read 2026-08-29

  • Oxymetazoline Hydrochloride is topical at 3 DOSAGE FORMS AND STRENGTHS Oxymetazoline hydrochloride cream, 1% is a white to off-white cream., recorded as fda label in effect 2026-05-08 in the United States.

    US prescribing information · 8a7f2400-5e18-4215-8d2c-f55881706107 · read 2026-08-30

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 Oxymetazoline 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 three days is a measured threshold for rebound — no randomised comparison establishes it, and a 10-day study in 35 patients found no rebound at all

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 benzalkonium chloride causes rhinitis medicamentosa, when removing it halved rather than abolished rebound

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 relieving congestion shortens a cold or prevents sinusitis — no trial on this page measured either

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 measured half-millimetre eyelid lift is a change a patient notices; the trials report the measurement, not the noticing

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 Oxymetazoline 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 days of daily use produced measurable rebound swelling in a randomised trial
In plain words
Twenty healthy volunteers with no nasal disease used the spray three times a day for a month. Their nasal linings ended up thicker than when they started, and more reactive to an irritant. The version containing the preservative benzalkonium chloride was about twice as bad.
What was measured
Rebound nasal mucosal swelling in millimetres by rhinostereometry, and histamine sensitivity, after 30 days of dosing in healthy volunteers
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Graf, Hallén and Juto randomised 20 healthy volunteers, double-blind, to oxymetazoline nasal spray with or without benzalkonium chloride, three times daily for 30 days. Mean rebound mucosal swelling was 1.1 mm in the benzalkonium chloride group against 0.5 mm without it (P<0.05), and the mean evening symptom score was 43 against 25 (P<0.05). Both groups showed increased histamine sensitivity, indicating nasal hyperreactivity — that is, the rebound was not solely a preservative effect. Rebound was measured by rhinostereometry against each subject’s own baseline.
Source
Graf P, Hallén H, Juto JE. Benzalkonium chloride in a decongestant nasal spray aggravates rhinitis medicamentosa in healthy volunteers. Clin Exp Allergy 1995;25(5):395-400
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
REVEAL: 885 patients across two identical phase 3 trials of the 1% rosacea cream
In plain words
Two trials asked whether a cream version made fixed facial redness measurably better for a day at a time. Both hit their target: a two-grade improvement judged by both the doctor and the patient, held out to twelve hours after the morning application.
What was measured
Composite ≥2-grade improvement on Clinician Erythema Assessment and Subject Self-Assessment at 3, 6, 9 and 12 hours on day 29
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
REVEAL 1 (NCT02131636) randomised 440 adults and REVEAL 2 (NCT02132117) randomised 445 adults with moderate to severe persistent facial erythema of rosacea to oxymetazoline cream 1.0% or vehicle once daily for 29 days. The primary endpoint in both was composite success — at least a 2-grade improvement from baseline on both the Clinician Erythema Assessment and the Subject Self-Assessment — at 3, 6, 9 and 12 hours post-dose on day 29. REVEAL 1 reported significance at each individual timepoint (P<0.02) and overall (P<0.001). REVEAL 2 reported composite success P=0.001, CEA P<0.001, SSA P=0.011, with digital image analysis also favouring oxymetazoline (P<0.001). Discontinuation for treatment-emergent adverse events was 1.8% against 0.5% in REVEAL 1 and 2.7% against 0.5% in REVEAL 2.
Source
Kircik LH et al., J Drugs Dermatol 2018;17(1):97-105 (REVEAL 1, PMID 29320594); Baumann L et al., J Drugs Dermatol 2018;17(3):290-298 (REVEAL 2, PMID 29537447)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
The eyelid drop widened the visual field by about five points on a 46-point test
In plain words
In 304 people whose upper eyelids had dropped far enough to cut into their field of vision, one drop a day let them see a few more points on a peripheral vision test than a placebo drop did — on the first day and still at two weeks.
What was measured
Change from baseline in points seen on the Leicester Peripheral Field Test, and marginal reflex distance in millimetres
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Slonim and colleagues pooled two phase 3, randomised, double-masked, vehicle-controlled trials (NCT02436759, n=140; NCT03565887, n=164) of oxymetazoline hydrochloride 0.1% ophthalmic solution once daily for 42 days in 304 adults with acquired ptosis and superior visual field deficit, randomised 2:1. Mean difference from vehicle in points seen on the Leicester Peripheral Field Test was 4.07 (95% CI 2.74 to 5.39; P<0.001) on day 1 and 4.74 (95% CI 3.43 to 6.04; P<0.001) on day 14. Marginal reflex distance improved by 0.47 mm (day 1) and 0.67 mm (day 14) more than vehicle, both P<0.001. Treatment-emergent adverse events were 31.0% (63 of 203) on drug against 35.6% (36 of 101) on vehicle.
Source
Slonim CB, Foster S, Jaros M, et al. Association of Oxymetazoline Hydrochloride, 0.1%, Solution Administration With Visual Field in Acquired Ptosis: A Pooled Analysis of 2 Randomized Clinical Trials. JAMA Ophthalmol 2020;138(11):1168-1175
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
Cochrane: fifteen trials, 1,838 people, and a decongestant effect of uncertain clinical relevance
In plain words
The systematic review of decongestants used on their own for a cold found a small benefit after several doses and could not reach any conclusion at all about a single dose. The reviewers described the evidence as low quality and said they did not know whether the effect mattered to patients.
What was measured
Standardised mean difference in subjective nasal congestion against placebo after multiple doses
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Deckx and colleagues reviewed 15 trials in 1,838 participants of nasal decongestants in monotherapy for the common cold. For multiple doses, subjective congestion was better than placebo approximately three hours after the last dose (SMD 0.49, 95% CI 0.07 to 0.92; P=0.02; GRADE low-quality evidence). The odds ratio for adverse events was 0.98 (95% CI 0.68 to 1.40; P=0.90; low-quality evidence). The authors were unable to draw conclusions on single-dose effectiveness, described the multiple-dose result as "a small positive effect" whose "clinical relevance of this small effect is unknown", and noted no apparent short-term increase in adverse events in adults.
Source
Deckx L, De Sutter AI, Guo L, Mir NA, van Driel ML. Nasal decongestants in monotherapy for the common cold. Cochrane Database Syst Rev 2016;10:CD009612
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 three-day rule on the label was never the output of a three-day trial
In plain words
The label says not to use it for more than three days. Nothing was measured at three days. The rebound studies ran for thirty days, and a separate ten-day study in patients found no rebound at all. Three days is a margin of safety, not a measured threshold.
What was measured
That three days is the measured safe limit — the number is a regulatory precaution sitting between a ten-day study that found nothing and a thirty-day study that found rebound, with nothing tested in between
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The over-the-counter monograph label states "Do not use for more than 3 days" and "Frequent or prolonged use may cause nasal congestion to recur or worsen". The human data bracket that limit rather than establish it. At 30 days, rebound swelling and hyperreactivity are reproducible. At 10 days, Graf and colleagues gave oxymetazoline with or without benzalkonium chloride to 35 patients with vasomotor rhinitis and found no rebound swelling in either group by objective measure or symptom score, concluding it was safe to use for 10 days in that population — while noting the benzalkonium chloride group showed significantly reduced histamine sensitivity after treatment (P<0.001). No published randomised comparison establishes three days as the point at which rebound begins.
Source
AFRIN over-the-counter drug facts label (FDA monograph application M012); Graf P, Enerdal J, Hallén H. Ten days' use of oxymetazoline nasal spray with or without benzalkonium chloride in patients with vasomotor rhinitis. Arch Otolaryngol Head Neck Surg 1999;125(10):1128-1132
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
Benzalkonium chloride was blamed for rebound; the controlled data made it a modifier
In plain words
For years the preservative was widely held to be the cause of rebound congestion, and preservative-free sprays were sold on that basis. The randomised work showed something narrower: removing the preservative halved the rebound but did not abolish it, and both groups still became more sensitive to irritants.
What was measured
That benzalkonium chloride is the cause of rhinitis medicamentosa — the randomised comparison makes it an aggravating factor of roughly twofold, not the mechanism
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
In the 30-day randomised volunteer study, rebound swelling was 1.1 mm with benzalkonium chloride and 0.5 mm without (P<0.05) — a difference, but not the difference between presence and absence — and increased histamine sensitivity appeared in both arms. Graf’s own review concluded that modern imidazoline vasoconstrictors carry minimal rhinitis medicamentosa risk on their own while overuse produces rebound congestion, hyperreactivity, tolerance and histologic change, and that benzalkonium chloride amplifies severity. A separate review notes that sustained benzalkonium chloride alone induces nasal mucosal swelling. The conclusion moved from "the preservative causes it" to "sustained alpha-agonism causes it and the preservative makes it worse".
Source
Graf P, Hallén H, Juto JE, Clin Exp Allergy 1995;25(5):395-400 (PMID 7553241); Graf P, Allergy 1997;52(40 Suppl):28-34 (PMID 9353558); Graf P, Clin Ther 1999;21(10):1749-1755 (PMID 10566570)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim
The pooled REVEAL paper in the Journal of the American Academy of Dermatology was withdrawn
In plain words
A paper combining the two rosacea trials was published online and then withdrawn at the request of the authors and the editor. The two individual trial reports remain in the literature and are what this page cites.
What was measured
Not recorded
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Stein-Gold L, Kircik LH, Draelos ZD, et al. "Efficacy and safety of topical oxymetazoline cream 1.0% for treatment of persistent facial erythema associated with rosacea: findings from the 2 phase 3, 29-day, randomized, controlled REVEAL trials", J Am Acad Dermatol, posted online 31 January 2018, carries the PubMed title prefix WITHDRAWN and the note that the article "has been withdrawn at the request of the author(s) and/or editor". The record supplies no abstract. The underlying trial data are reported separately in J Drugs Dermatol for REVEAL 1 (PMID 29320594) and REVEAL 2 (PMID 29537447), and those two papers, not the withdrawn pooled analysis, are the basis of every REVEAL number quoted here.
Source
PubMed record PMID 29409915, J Am Acad Dermatol 2018 Jan 31, marked WITHDRAWN
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
retracted
Review state
Written into the record, not signed off as a reviewed claim
A drooping eyelid can be a symptom, and the drop treats the droop rather than the cause
In plain words
A newly drooping eyelid is sometimes the first sign of a stroke, an aneurysm or myasthenia gravis. A drop that lifts the lid by half a millimetre makes the sign less visible without touching any of those.
What was measured
That lifting the eyelid addresses the problem — for involutional ptosis it does, and for the neurologic causes on the label it removes the sign while the cause continues
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The Upneeq label warns that ptosis may be an indication of a serious neurologic condition, listing stroke, intracranial aneurysm, Horner syndrome and myasthenia gravis, and that alpha-adrenergic agonists may impact blood pressure, with caution advised in cardiovascular disease, in cerebral or coronary insufficiency, and in narrow-angle glaucoma where angle-closure risk may be increased. Across four pooled randomised trials in 568 participants, treatment-emergent adverse events were 31.2% on drug against 30.6% on vehicle, with serious events in four participants on drug and one on vehicle; no ocular adverse event exceeded 3.5% incidence.
Source
UPNEEQ United States prescribing information (NDA 212520, label effective 19 September 2025); Wirta DL et al., Clin Ophthalmol 2021;15:4035-4048
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

Where else this substance is registered

FDA substance identifier (UNII)
K89MJ0S5VY
RxNorm concept
1000990

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: Reviewed first-read answer.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Not passed

    Safety mode resolved

    No register row and no identity class settled the question.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

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

What the approval register records

  • 7 approved applications cover products containing this substance. The earliest was NDA018471, approved 19860530 to BAYER HEALTHCARE LLC.

    Drugs@FDA application register · NDA018471 · read 2026-08-29

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

    Drugs@FDA application register · NDA018471 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 19750714.

    FDA National Drug Code directory · 72288-859 · 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.

An alpha-adrenergic agonist that clamps the veins in the nose shut and unblocks it within minutes — and whose best-measured property is the opposite one: in a randomised 30-day study in 20 healthy volunteers, daily use produced rebound mucosal swelling of 0.5 mm without a preservative and 1.1 mm with benzalkonium chloride, alongside increased histamine sensitivity in both groups.

Recorded evidence blocks (9)

On the Oxymetazoline label: indicated for what?


"Oxymetazoline Hydrochloride Cream, 1% is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults. Oxymetazoline Hydrochloride Cream is an alpha 1A adrenoceptor agonist indicated for the topical treatment of persistent facial erythema associated with rosacea in adults.": indications and usage on Oxymetazoline's label. DailyMed label · 34298db6-647d-480d-88a8-dc53258a5164 · 2026-07-13

48 registered trials of Oxymetazoline — at which phases?


Registered studies posting no result
32 of 48

48 registered studies of Oxymetazoline: 14 na, 11 phase1, 9 phase4, 7 phase3, 5 phase2, 3 na or unstated. CLINICALTRIALS_SNAPSHOT · 2026-09-01

133 with a PubMed record

Show the evidence
  • na
    14
  • phase1
    11
  • phase4
    9
  • phase3
    7
  • phase2
    5
  • na or unstated
    3
6 more recorded rows
  • completed
    36
  • terminated
    3
  • unknown
    3
  • withdrawn
    3
  • recruiting
    2
  • not yet recruiting
    1

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

5 of Oxymetazoline's trials stopped: accrual/recruitment, other?


accrual/recruitment (1) and other (4): Oxymetazoline's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"The suppliers were unable to provide the investigational medicinal product (IMP)"; 5 of 48 registered studies

Show the evidence

Trial

  • NCT00846326
    withdrawn; "The suppliers were unable to provide the investigational medicinal product (IMP)"
  • NCT02062996
    withdrawn; "Could not receive FDA approval for IND"
  • NCT04610801
    withdrawn; "Study Period Ended/ Not Completed"
  • NCT05109611
    terminated; "Recruitment challenges, i.e., not able to meet sample size targeted; secondary to the changing landscape of COVID-19 infection pathology."
  • NCT05290987
    terminated; "Number of participants needed not reached (13/80)"

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

Human studies of Oxymetazoline used Oxymetazoline 0.05% nasal solution — over how long?


Human studies of Oxymetazoline used "Oxymetazoline 0.05% nasal solution". ClinicalTrials.gov · 2026-09-01

10 recorded entries; human; nasal, ophthalmic; also "Oxymetazoline 0.05%", "Oxymetazoline HCL 1.0% Cream", "Rhofade Cream, 1%"

Show the evidence

human

  • NCT00223691
    nasal; Oxymetazoline 0.05% nasal solution
  • NCT02285634
    Oxymetazoline 0.05%
  • NCT03380390
    Oxymetazoline HCL 1.0% Cream
  • NCT03954444
    Rhofade Cream, 1%
  • NCT04153188
    Oxymetazoline HCL 1% Cream
  • NCT04831047
    ophthalmic; Oxymetazoline hydrochloride 0.1% ophthalmic solution
4 more recorded rows
  • human NCT05148689
    Oxymetazoline hydrochloride Cream, 1%
  • human NCT05148689
    Rhofade™ (oxymetazoline) cream, 1%
  • human NCT05639959
    Mometasone Nasal 50 Mcg/Inh Nasal Spray
  • human NCT05945615
    Oxymetazoline 0.1% (Pf) Oph Soln Ud

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

Which 18 trials of Oxymetazoline posted no result?


Posted no result
18 of 18 completed trials
Registrations
NCT01363089, NCT01850511, NCT01986582, NCT02154334, NCT02299557 and NCT00223691, and 12 more
Completion dates
oldest 2008-02; newest 2023-08-14
Show the evidence

Trial

  • NCT01363089
    2008-02
  • NCT01850511
    2013-10
  • NCT01986582
    2014-02
  • NCT02154334
    2014-10
  • NCT02299557
    2015-07
  • NCT00223691
    2017-01
12 further recorded trials
  • NCT01925729
    2019-03-22
  • NCT02601235
    2019-04-03
  • NCT05148689
    2019-05-31
  • NCT05006898
    2020-07-01
  • NCT04531358
    2020-12-31
  • NCT04532762
    2020-12-31
  • NCT04681001
    2021-08-30
  • NCT05599919
    2022-02-02
  • NCT01785342
    2022-02-28
  • NCT04703673
    2022-04-30
  • NCT05639959
    2022-11-06
  • NCT05443945
    2023-08-14

At the median, Oxymetazoline's trials enrolled 46.5 people — anything larger?


Median enrolment
46.5
Largest enrolment
1389
Registered trials counted
48

What do 282 spontaneous reports say about Oxymetazoline — 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.

Oxymetazoline appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 282 reaction mentions were counted: vision blurred 47; eye irritation 42; mydriasis 39; headache 38. FAERS via Open Targets · CHEMBL1200791 · 2026-06-24

Show the evidence
  • vision blurred
    47
  • eye irritation
    42
  • mydriasis
    39
  • headache
    38
  • ocular hyperaemia
    36
  • dry eye
    20
4 more recorded rows
  • swelling of eyelid
    18
  • lacrimation increased
    16
  • eye pain
    14
  • prescription drug used without a prescription
    12

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

Which 10 reactions does Oxymetazoline's label not list?


dry eye, eye irritation and eye pain and 7 more reported for Oxymetazoline, absent from its label. FAERS via Open Targets · CHEMBL1200791 · 2026-06-24

2 label terms; 10 reported and unlisted; 34298db6-647d-480d-88a8-dc53258a5164

Show the evidence
  • dry eye
    count not stated
  • eye irritation
    count not stated
  • eye pain
    count not stated
  • headache
    count not stated
  • lacrimation increased
    count not stated
  • mydriasis
    count not stated
4 more recorded rows
  • ocular hyperaemia
    count not stated
  • prescription drug used without a prescription
    count not stated
  • swelling of eyelid
    count not stated
  • vision blurred
    count not stated

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

Oxymetazoline and CYP1A2, CYP2B6 and CYP3A4: shared by which compounds?


CYP1A2, CYP2B6 and CYP3A4 appear in Oxymetazoline's recorded interaction sentences, 4 in all. DailyMed label · 34298db6-647d-480d-88a8-dc53258a5164 · 2026-07-13

CYP1A2, CYP2B6, CYP3A4; 3 shared nodes; pharmacokinetics, clinical_pharmacology

Show the evidence

Interaction statement

  • pharmacokinetics
    Drug Interaction In vitro studies using human liver microsomes demonstrated that oxymetazoline up to the tested concentration of 100 nM had no inhibition on the activities of the cytochrome P450 (CYP) isoenzymes 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, and 3A4/5.
  • pharmacokinetics
    Treatment of cultured human hepatocytes with up to 100 nM oxymetazoline did not induce CYP1A2, CYP2B6, or CYP3A4.
  • clinical_pharmacology
    Drug Interaction In vitro studies using human liver microsomes demonstrated that oxymetazoline up to the tested concentration of 100 nM had no inhibition on the activities of the cytochrome P450 (CYP) isoenzymes 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, and 3A4/5.
  • clinical_pharmacology
    Treatment of cultured human hepatocytes with up to 100 nM oxymetazoline did not induce CYP1A2, CYP2B6, or CYP3A4.
  • CYP1A2
    FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Sofpironium, Golodirsen, Tinidazole
  • CYP2B6
    FINGOLIMOD LAURYL SULFATE, TAFAMIDIS MEGLUMINE, Arimoclomol, Sofpironium, Bupropion, Golodirsen, Tinidazole, Naldemedine
  • CYP3A4
    FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Beclometasone, Rasagiline, Sofpironium

recorded 2026-07-13 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1200791
PubChem CID
66259
CAS number
2315-02-8
RxCUI
106101
InChIKey
WYWIFABBXFUGLM-UHFFFAOYSA-N
Also called
OXYMETAZOLINE HYDROCHLORIDE, Agn-199201, kovacaine mist, Nasacon, Operil, Oximetazolina, oxy
Trade name
Afrazine, Ocuclear, Rhofade, Upneeq, Visine l.r., Afrin, Nasal, No Drip Nasal Mist, Major Nasal Decongestant, Good Sense Nasal, Equate, Nostrilla
Development code
NSC-757254, SCH 9384
Salt form
Oximetazoline hydrochloride, Oxymetazoline hcl, Oxymetazoline hydrochloride component of kovanaze, Oxymethazoline HCL
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.