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Phentolamine

  • 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 Phentolamine does in the body

And pediatric patients ages 3 years and older for the reversal of soft-tissue anesthesia, i

From the FDA-approved label: RYZUMVI is a relatively non-selective alpha-1 and alpha-2 adrenergic antagonist. Dilation of the pupil is primarily controlled by the radial iris dilator muscles surrounding the pupil; these muscles are activated by the alpha-1 adrenergic receptors. Phentolamine reversibly binds to these receptors on the iris dilator muscle, thereby reducing pupil diameter. Phentolamine directly antagonizes the mydriatic effect of an α-1 adrenergic agonist, and indirectly reverses mydriasis induced by muscarinic antagonist effects on the iris sphincter muscle.

What happened in people

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

A fixed RNAWiki sentence

Where this came from

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

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

No source is stored against this line.

The limit that matters most

Not recorded.

Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
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 · Z468598HBV · 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.

No statement of the main limit is recorded.

The four opening statements run to 107 words.

Words this page uses

Four words worth knowing first

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

Stand-in result

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

A picture of it, and where the picture fails

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

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

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

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

Enzyme

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

A picture of it, and where the picture fails

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

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

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

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

Receptor

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

A picture of it, and where the picture fails

A receptor is like a lock waiting for one key.

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

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

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

Pathway

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

A picture of it, and where the picture fails

A pathway is like a row of dominoes.

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

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

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

What happened in peopleRead from sources, not yet reviewed

What was measured, goal by goal

One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.

Registered studies list 32 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.

There is no single score. A strong test result and a weak life result are different facts.

Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
GoalLife outcomeWhat a body can doHow a person feelsA test resultA step in the bodyHarmsHow longWho was studied
PainNothing in the sources checkedNo registered study lists a life outcome for this goal.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Waiting for a reviewer1 registered symptom measure.Nothing in the sources checkedNo registered study lists a test result for this goal.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Pain
analgesics required for intraoral pain

Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.

What each mark on this table means
Nothing in the sources checked
No registered study lists a life outcome for this goal.
Waiting for a reviewer
1 registered symptom measure.
Not recorded
Harms were not a registered measure for this goal.

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.

Combined death and disability

The study did not show it

Who was studied
NCT01422616
How many people
4587
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Ophthalmic

Interval reported. Not recorded in this summary

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

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

A Composite of Death or Dependency, With Dependency Being Defined by a Score of 3 to 5 on the Modified Rankin Scale (mRS)

The study did not show it

Who was studied
NCT00716079
How many people
2839
Study design
Not applicable
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Ophthalmic

Interval reported. Not recorded in this summary

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

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

Percentage of Subjects With ≥ 15 Letters of Improvement in Binocular DCNVA and With < 5 Letters of Loss in Binocular BCDVA From Baseline Comparing POS-treated Participants to Placebo-treated Participants at 12 Hours Post-dose at Visit 4 (Day 8)

The study did not show it

Who was studied
NCT06542497
How many people
569
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Ophthalmic

Interval reported. Not recorded in this summary

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

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

Change in Limb Blood Flow

The study did not show it

Who was studied
NCT02966665
How many people
420
Study design
Phase 1
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Ophthalmic

Interval reported. Not recorded in this summary

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

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

Combination death and dependency, according to a 3-6 scores on the modified Rankin Score.

The study did not show it

Who was studied
NCT00226096
How many people
404
Study design
Not applicable
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Ophthalmic

Interval reported. Not recorded in this summary

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

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

Percent of Subjects' Study Eyes With Pupil Diameter Returning to Baseline

The study did not show it

Who was studied
NCT05134974
How many people
368
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

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

Form and route. Ophthalmic

Interval reported. Not recorded in this summary

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

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.

What happened in peopleRead from sources, not yet reviewed

How close this is to real life

The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.

  1. Living longer, or avoiding a major event Evidence recorded. Death, a heart attack, a stroke, a hospital stay.2 registered measures of this kind. 3 written-up studies measured this and did not show a benefit.
  2. What a body can do day to day No evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
  3. Measured performance No evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
  4. Symptoms and quality of life Evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.1 registered measure of this kind.
  5. A number that stands in for health Evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.7 registered measures of this kind.
  6. A step measured inside a person Evidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
  7. Animals Evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Mouse, Rat. A result in animals says what to test next. It does not say what happens in people.
  8. Cells in a dish Evidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
  9. A guess from software No evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.

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

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

Felt, measured, or meaningful

Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.

Felt

Things a person could notice without a test.

  • analgesics required for intraoral pain

Measured

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

  • heart rate
  • peripheral blood pressure
  • central blood pressure
  • systolic diastolic and mean arterial blood pressure
  • arterial blood pressure
  • circulating sex hormone concentrations
  • circulating sympathetic neurotransmitter concentrations

Meaningful

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

  • combined death and disability
  • stroke volume

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 (22)
  • potency rate at 2 years after surgery
  • clinically significant changes in vital signs
  • clinically significant changes in oral cavity assessments
  • incidence and severity of adverse events
  • time to return of normal soft tissue sensation and function
  • limb blood flow
  • c peptide suppression during hyperinsulinemia euglycemia
  • glucagon activation during hyperinsulinemia hypoglycemia
  • cardiac output
  • ecg/cardiac monitor
  • contrast enhanced ultrasonography
  • forearm vascular conductance intra arterial drug infusion
  • arterial blood flow
  • vascular conductance
  • cold pressor test
  • propranolol
  • forearm blood flow
  • forearm vascular resistance
  • forearm vascular conductance
  • muscle sympathetic nerve activity

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. 2-3 hours hours

    Read from the label, which states: “The terminal elimination half-life of phentolamine in the blood was approximately 2-3 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.

  • INDICATONS AND USAGE OraVerse an alpha adrenergic blocker, is indicated for adult and pediatric patients ages 3 years and older for the reversal of soft-tissue anesthesia, i.e., anesthesia of the lip and tongue, and the associated functional deficits resulting from an intraoral submucosal injection of a local anesthetic containing a vasoconstrictor.

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: “The safety and efficacy of OraVerse has not been established in patients younger than 3 years.”

    US prescribing information · 4025cf98-ea87-4531-b0fc-6283c84f63f3 · read 2026-08-30

  • On older people, the label states: “Of the total number of patients in clinical studies of OraVerse, 55 were 65 and over, while 21 were 75 and over.”

    US prescribing information · 4025cf98-ea87-4531-b0fc-6283c84f63f3 · read 2026-08-30

  • On people who are pregnant, the label states: “Category C Risk summary There are no available data with OraVerse in pregnant women to inform a drug-associated risk for major birth defects and miscarriage.”

    US prescribing information · 4025cf98-ea87-4531-b0fc-6283c84f63f3 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary There is no information regarding the presence of phentolamine in human milk, the effects on the breastfed infant or the effects on milk production.”

    US prescribing information · 4025cf98-ea87-4531-b0fc-6283c84f63f3 · read 2026-08-30

Where the result stopped carrying

  • This is a scope explorer, not a diagnosis engine.
  • It shows who was studied so you can see whether people similar to you were included.

RNAWiki cannot tell whether a study fits you. It can show who was in it.

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

Why it might seem to do nothing

A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.

It was studied for a different goal

The studies measured something else entirely.

On this record: Some registered studies measured things that match no goal on this page.

It was studied in different people

The people in the studies were not much like the reader.

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

The evidence may simply be wrong

Small early studies often do not hold up.

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

Other reasons RNAWiki checked and found nothing for (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.

None of these is a reason to take more. Taking more is not a step this page ever suggests.

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

What taking it involves

The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.

How it is supplied

Prescription only

Quoted from a source

Where this came from

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

Read from the recorded approval status.

No source is stored against this line.

Form and route

Ophthalmic

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

Sold as solution, injectable, injection, solution, injection, given by the ophthalmic, injection, submucosal route.

Source-linked record

Where this came from

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

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

No source is stored against this line.

Where it is registered

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

Counted from records

Where this came from

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

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

No source is stored against this line.

Why people stop

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

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

No source is stored against this line.

What it would be like to takeNothing found in the sources checked

What can go wrong

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

Nothing found in the sources checked

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

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

Reports sent to a regulator

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

Phentolamine appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 34 reaction mentions were counted. One report can name several reactions.

The recorded terms (10)
  • abdominal sepsis — 6 reaction mentions
  • hypertension — 6 reaction mentions
  • oedema — 6 reaction mentions
  • blood phosphorus decreased — 3 reaction mentions
  • facial pain — 3 reaction mentions
  • priapism — 3 reaction mentions
  • ventricular extrasystoles — 3 reaction mentions
  • post procedural swelling — 2 reaction mentions
  • compulsive cheek biting — 1 reaction mentions
  • phaeochromocytoma excision — 1 reaction mentions
  • open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot

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

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

What is missing or unclearRead from sources, not yet reviewed

Does the exact form matter?

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

The form that was studied

Ophthalmic

Source-linked record

Where this came from

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

The form used in the studies cited on this page.

No source is stored against this line.

What is sold

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

Nothing further is recorded about which forms are sold.

No source is stored against this line.

What is recorded as being sold

  • 26 products list this as an active ingredient in the United States drug directory. 26 of them contain it and nothing else.

    FDA National Drug Code directory · 42973-389 · read 2026-08-29

  • They are sold as injection, injection, powder, for solution, injection, solution, powder and solution/ drops, taken intramuscular, intravenous, ophthalmic and submucosal.

    FDA National Drug Code directory · 42973-389 · read 2026-08-29

  • The regulator's established pharmacologic class for it is adrenergic alpha-antagonists [moa] and alpha-adrenergic blocker [epc].

    FDA National Drug Code directory · 42973-389 · read 2026-08-29

  • 4 published labels name it as an active ingredient. 4 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · e146c7ee-d2fa-433c-8768-0945e4ff0990 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · e146c7ee-d2fa-433c-8768-0945e4ff0990 · read 2026-08-29

  • Oraverse is submucosal at 3., recorded as fda label in effect 2018-12-05 in the United States.

    US prescribing information · 4025cf98-ea87-4531-b0fc-6283c84f63f3 · 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 Phentolamine studied people like me?
  • What was measured, and for how long?
  • Was the result a laboratory value or a health outcome?
  • What would we watch for, and when would we stop?

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

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

What is missing or unclearRead from sources, not yet reviewed

What nobody knows yet

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

How much did people take in the studies?

The sources RNAWiki checked hold nothing for this field.

Why it matters. A result belongs to an amount. Without the amount the result floats free.

What would answer it

A stored source that records 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 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 Phentolamine 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.

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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.

Where else this substance is registered

FDA substance identifier (UNII)
Z468598HBV
CAS registry number
50-60-2
PubChem compound
5775
ChEMBL
CHEMBL597
ChEBI
8081
WHO international nonproprietary name list entry
22
RxNorm concept
8153
EMA substance identifier
100000082263
European Chemicals Agency number
200-053-1
DrugBank
DB00692

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    Canonical metadata present

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What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

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

What the approval register records

  • 5 approved applications cover products containing this substance. The earliest was NDA008278, approved 19520130 to NOVARTIS.

    Drugs@FDA application register · NDA008278 · read 2026-08-29

  • Marketing status on the register: discontinued and prescription.

    Drugs@FDA application register · NDA008278 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 19961211.

    FDA National Drug Code directory · 42973-389 · read 2026-08-29

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5 questions this page could not answer

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Recorded evidence blocks (12)

What did Phentolamine's largest trial (4587 people) and its longest (18 years) measure?


4587 people in Phentolamine's largest registered study, 18 years in its longest registered window, measuring Circulating sex hormone concentrations. ClinicalTrials.gov · 2026-09-01

8 na, 5 phase3, 4 early phase1, 4 phase2, 3 phase1, 3 phase4; NCT02966665; 2026-08; no ageing endpoint recorded. Last human test completed 2025, NCT03079921.

Interpretation These counts include studies where Phentolamine 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
  • na
    8
  • phase3
    5
  • early phase1
    4
  • phase2
    4
  • phase1
    3
  • phase4
    3
1 more recorded row
  • Last recorded human test NCT03079921
    2025-12-31

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

From mouse to human: where has Phentolamine shown lifespan?


mouse: lifespan, rat: mechanism-only and human: biomarker (26): the rungs where Phentolamine has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Interpretation Circulating sex hormone concentrations — the recorded outcome words.

Yeast C. elegans Drosophila Mouse lifespanRat mechanism-onlyDog Non-human primate Human biomarker
Show the evidence
  • mouse
    lifespan
  • rat
    mechanism-only
  • human NCT05997732
    biomarker; Circulating sex hormone concentrations; 26

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

Why did Phentolamine's trial NCT03098680 stop?


1 recorded trial of Phentolamine stopped. ClinicalTrials.gov · 2026-09-01

"Unable to recruit in time before end of PhD studentship"; 1 of 26 registered studies

Show the evidence
  • Trial NCT03098680
    terminated; "Unable to recruit in time before end of PhD studentship"

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

Phentolamine's half-life is 2-3 hours — which schedules were studied?


2-3 hours, the half-life Phentolamine's label states. openfda-label · 96bb1e53-c2cc-4e60-a21a-db0269c371bf · 2026-08-30

Show the evidence
  • half life
    2-3 hours hours; The terminal elimination half-life of phentolamine in the blood was approximately 2-3 hours.

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

Could one person measure Phentolamine's effect on potency rate at 2 years after surgery?


Potency rate at 2 years after surgery: measured in Phentolamine's trials.

potency rate at 2 years after surgery is the recorded endpoint.

Show the evidence

biomarkers

  • potency rate at 2 years after surgery; 2026-09-01
  • clinically significant changes in vital signs; 2026-09-01
  • clinically significant changes in oral cavity assessments; 2026-09-01
  • analgesics required for intraoral pain; 2026-09-01
  • combined death and disability; 2026-09-01
  • incidence and severity of adverse events; 2026-09-01
14 more recorded rows
  • biomarkers
    time to return of normal soft tissue sensation and function; 2026-09-01
  • biomarkers
    limb blood flow; 2026-09-01
  • biomarkers
    c peptide suppression during hyperinsulinemia euglycemia; 2026-09-01
  • biomarkers
    glucagon activation during hyperinsulinemia hypoglycemia; 2026-09-01
  • biomarkers
    heart rate; 2026-09-01
  • biomarkers
    peripheral blood pressure; 2026-09-01
  • biomarkers
    central blood pressure; 2026-09-01
  • biomarkers
    cardiac output; 2026-09-01
  • biomarkers
    stroke volume; 2026-09-01
  • biomarkers
    ecg/cardiac monitor; 2026-09-01
  • biomarkers
    contrast enhanced ultrasonography; 2026-09-01
  • biomarkers
    forearm vascular conductance intra arterial drug infusion; 2026-09-01
  • biomarkers
    systolic diastolic and mean arterial blood pressure; 2026-09-01
  • biomarkers
    arterial blood flow; 2026-09-01
  • half life
    2026-09-04; halfLife; hours; 2-3 hours; 2026-08-30
  • human trials at or under30
    5
  • smallest human trial
    9; NCT03079921; EARLY_PHASE1; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; COMPLETED

Which of analgesics required for intraoral pain, arterial blood flow and arterial blood pressure did Phentolamine's trials measure?


analgesics required for intraoral pain, arterial blood flow and arterial blood pressure lead 32 outcome terms across Phentolamine's trials. ClinicalTrials.gov · 2026-09-01

Interpretation analgesics required for intraoral pain, combined death and disability, incidence and severity of adverse events, time to return of normal soft tissue sensation and function, limb blood flow and c peptide suppression during hyperinsulinemia euglycemia follow.

Show the evidence
  • potency rate at 2 years after surgery
    1
  • clinically significant changes in vital signs
    1
  • clinically significant changes in oral cavity assessments
    1
  • analgesics required for intraoral pain
    1
  • combined death and disability
    1
  • incidence and severity of adverse events
    1
14 more recorded rows
  • time to return of normal soft tissue sensation and function
    1
  • limb blood flow
    1
  • c peptide suppression during hyperinsulinemia euglycemia
    1
  • glucagon activation during hyperinsulinemia hypoglycemia
    1
  • heart rate
    1
  • peripheral blood pressure
    1
  • central blood pressure
    1
  • cardiac output
    1
  • stroke volume
    1
  • ecg/cardiac monitor
    1
  • contrast enhanced ultrasonography
    1
  • forearm vascular conductance intra arterial drug infusion
    1
  • systolic diastolic and mean arterial blood pressure
    1
  • arterial blood flow
    1

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

Which of Phentolamine's 7 ongoing trials reports first?


7 registered trials of Phentolamine are open; earliest completion 2025-04-01. ClinicalTrials.gov · 2026-09-01

Change in Limb Blood Flow; Contrast Enhanced-Ultrasonography (CEU); latest 2027-12-01

Show the evidence

Trial

  • NCT02966665
    ": Vascular Function in Health and Disease"; n 420; "Change in Limb Blood Flow"; 2026-08
  • NCT03318094
    "Role of Sympathetic Vasoconstriction on Insulin-Mediated Microvascular Recruitment and Glucose Uptake in Obesity"; n 36; "Contrast Enhanced-Ultrasonography (CEU)"; 2027-11-30
  • NCT05219799
    "Sex Disparities in Hypoxic Vasodilation and Impact of Obesity"; n 72; "Change in forearm vascular conductance with intra-arterial drug infusion"; 2027-07-30
  • NCT05448807
    "Effectiveness of Phentolamine Mesylate as a Reversing Agent for Local Anesthesia in Children"; n 100; "Time to return to normal function"; 2026-06
  • NCT05997732
    "Sympathetic Neurovascular Transduction: Role of Adrenergic Receptors and Sex Differences"; n 30; "Forearm blood flow"; 2027-12-01
  • NCT06620991
    "Pre-operative Phentolamine Vs Intraoperative Esmolol Efficacy for Hypotensive Anesthesia in Functional Endoscopic Sinus Surgery"; n 60; "Mean arterial pressure"; 2025-04-01
  • 1 further recorded trial NCT06787066
    "Sympathetic Vascular Transduction Across the Menopause Transition: Contributing Mechanisms"; n 75; "Sympathetic transduction"; 2026-12

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

Which 11 trials of Phentolamine posted no result?


Posted no result
11 of 11 completed trials
Registrations
NCT00154167, NCT00309335, NCT00309361, NCT00309322, NCT00226096 and NCT00080808, and 5 more
Completion dates
oldest 2003-06; newest 2023-02-05
Show the evidence

Trial

  • NCT00154167
    2003-06
  • NCT00309335
    2006-07
  • NCT00309361
    2006-07
  • NCT00309322
    2006-08
  • NCT00226096
    2007-09
  • NCT00080808
    2009-07
5 further recorded trials
  • NCT01474382
    2014-08
  • NCT02861378
    2016-04
  • NCT01422616
    2018-08
  • NCT02995291
    2019-09-15
  • NCT05525416
    2023-02-05

At the median, Phentolamine's trials enrolled 100 people — anything larger?


Median enrolment
100
Largest enrolment
4587
Registered trials counted
25

What do 34 spontaneous reports say about Phentolamine — 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.

Phentolamine appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 34 reaction mentions were counted: abdominal sepsis 6; hypertension 6; oedema 6; blood phosphorus decreased 3. open-targets-adr · CHEMBL1200873 · 2026-06-24

Show the evidence
  • abdominal sepsis
    6
  • hypertension
    6
  • oedema
    6
  • blood phosphorus decreased
    3
  • facial pain
    3
  • priapism
    3
4 more recorded rows
  • ventricular extrasystoles
    3
  • post procedural swelling
    2
  • compulsive cheek biting
    1
  • phaeochromocytoma excision
    1

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

Was Phentolamine studied with exercise?


exercise is named in Phentolamine's label sentences: "Recovery of FBF and FVC (steady state inflation plus exercise value - nadir)/[steady state exercise (control) value - nadir] with phentolamine was enhanced compared with the respective control (no drug) trial (FBF = 97 ± 5% vs. 81 ± 6%, P < 0.05; FVC = 126 ± 9% vs. 91 ± 5%, P < 0.01)." openfda-label+europepmc · 2012-07-18

1 recorded statement; exercise

Show the evidence
  • exercise
    Recovery of FBF and FVC (steady state inflation plus exercise value - nadir)/[steady state exercise (control) value - nadir] with phentolamine was enhanced compared with the respective control (no drug) trial (FBF = 97 ± 5% vs. 81 ± 6%, P < 0.05; FVC = 126 ± 9% vs. 91 ± 5%, P < 0.01).

recorded 2012-07-18 · last checked 2026-09-04

What is recorded about Phentolamine and AMPK?


"Phentolamine, an alpha-adrenoceptor antagonist, which prevents adenosine-induced activation of glycolysis in stressed hearts, prevented AMPK phosphorylation." — where Phentolamine and AMPK appear together. Europe PMC · pathway abstract search · 2006-04-28

AMPK, autophagy; PMID 16648181, 12112433

Show the evidence
  • AMPK PMID 16648181
    "Phentolamine, an alpha-adrenoceptor antagonist, which prevents adenosine-induced activation of glycolysis in stressed hearts, prevented AMPK phosphorylation."
  • autophagy PMID 12112433
    "Phentolamine, an alpha-adrenergic blocking agent which interferes with the generation of phosphoinositides and may activate the lysosomal calcium uptake pump, increased the total volume of autophagic vacuoles and the activity of lysosomal glycogen-hydrolyzing acid glucosidase and decreased the fractional volume of undigested glycogen inside the autophagic vacuoles."

recorded 2006-04-28 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1200873
PubChem CID
91430
CAS number
65-28-1
RxCUI
227240
InChIKey
MRBDMNSDAVCSSF-UHFFFAOYSA-N
Also called
PHENTOLAMINE MESYLATE, Phentolamine mesilate, Phentolamine methanesulfonate, Ryzumvi, nyxol, Fentolamina, Phentolamin, pos, Mesilate phentolamine, PHENOL, 3-(((4,5-DIHYDRO-1H-IMIDAZOL-2-YL)METHYL)(4-METHYLPHENYL)AMINO)-, MONOMETHANESULFONATE (SALT), PHENOL, 3-(((4,5-DIHYDRO-1H-IMIDAZOL-2-YL)METHYL)(4-METHYLPHENYL)AMINO)-, MONOMETHANESULPHONATE (SALT), PHENTOLAMINE MESILATE [EP MONOGRAPH]
Salt form
Mesylate phentolamine
Development code
NV-101
Trade name
Oraverse, Regitine, Rogitine, Ryzumvi / Oraverse / Regitine
Sources (9)

Sources

3 more sources
  • openfda-label 96bb1e53-c2cc-4e60-a21a-db0269c371bf ·
  • openfda-label+europepmc K1:Z468598HBV ·
  • national registers US, CA ·

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

How these records are assembled · Which registers were checked

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  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 9 source rows
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  • canonical metadata passed: slug and display name present
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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.