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Phytonadione

  • Prescription medicine
  • Given by a clinician
  • 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 Phytonadione does in the body

Bleeding, or a risk of bleeding, because the body cannot finish building four of its clotting proteins — from warfarin, from a newborn gut that has not started making vitamin K yet, or from a condition that stops fat being absorbed

Four of your clotting proteins leave the liver unfinished. An enzyme has to add a chemical clip to them before they can grab calcium and stick to the surface of an injured blood vessel, and that enzyme cannot work without vitamin K. Give vitamin K and the liver starts finishing proteins again. It is not a clotting factor and it does not stop bleeding directly — it restarts a production line, which is why it takes hours rather than minutes.

What happened in people

A pooled relative risk of 0.02 (95% CI 0.00 to 0.10) for late vitamin K deficiency bleeding with intramuscular prophylaxis, from four surveillance studies

Source-linked record

Where this came from

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

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

The limit that matters most

That correcting a raised INR prevents bleeding — the randomised trial designed to show it found 15.8% against 16.3% over 90 days

Where it acts
Liver hepatocyte endoplasmic reticulum, where the clotting factors are assembled and carboxylated
Kind of result
The kind of result is not recorded
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

What the registries record it as

  • The substance registry classes this as mixture.

    FDA substance registry · A034SE7857 · read 2026-08-29

  • The supplement label database classes it as vitamin, under the name Vitamin K.

    NIH Dietary Supplement Label Database · 208 · read 2026-08-29

  • Its recorded molecular formula is C31H46O2, weighing 450.70.

    US prescribing information · d954e3d7-a4d5-4798-887d-7af916ff0181 · read 2026-08-30

Where each sentence above came from

No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.

Shown as the opening line on this page.

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

The four opening statements run to 148 words.

Words this page uses

Four words worth knowing first

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

Stand-in result

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

A picture of it, and where the picture fails

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

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

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

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

Randomisation

Randomisation means chance decides who gets which treatment.

A picture of it, and where the picture fails

It is like a coin toss deciding the groups.

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

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

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

Confidence interval

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

A picture of it, and where the picture fails

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

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

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

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

Pathway

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

A picture of it, and where the picture fails

A pathway is like a row of dominoes.

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

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

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

What happened in peopleRead from sources, not yet reviewed

What happened in people

Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.

Bleeding events over 90 days

The study did not show it

Who was studied
Crowther oral vitamin K versus placebo in over-anticoagulated warfarin patients
How many people
724
Study design
Multicentre randomised double-blind placebo-controlled trial, 14 clinics, 90 days
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
15.8% versus 16.3%, absolute difference -0.5 percentage points (95% CI -6.1 to 5.1). INR fell 2.8 versus 1.4 at 24 hours, p<0.001
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. Major bleeding was numerically higher on vitamin K, 2.5% against 1.1% (absolute difference 1.5 percentage points, 95% CI -0.8 to 3.7). Warfarin dosing after enrolment was neither mandated nor recorded.

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

Form and route. Injectable emulsion for subcutaneous, intramuscular or intravenous use, and oral tablets

Interval reported. 95% CI -6

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

Incidence of late vitamin K deficiency bleeding

The study showed what it set out to show

Who was studied
Pooled surveillance estimate of intramuscular vitamin K against late vitamin K deficiency bleeding
How many people
0
Study design
Four surveillance studies pooled within a systematic review — no randomised trial exists
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Pooled relative risk 0.02 (95% CI 0.00 to 0.10)
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. A sample size of zero is the accurate entry for the randomised evidence: the reviewers state that no randomised trial has evaluated the effect of vitamin K prophylaxis on late vitamin K deficiency bleeding. The estimate is observational and graded low quality.

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

Form and route. Injectable emulsion for subcutaneous, intramuscular or intravenous use, and oral tablets

Interval reported. 95% CI 0

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

Any bleeding, moderate-to-severe bleeding, and secondary bleeding after circumcision in the first week

The study showed what it set out to show

Who was studied
Randomised trials of intramuscular prophylaxis against classical vitamin K deficiency bleeding
How many people
0
Study design
Two randomised controlled trials identified in the systematic review
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Any bleeding RR 0.73 (95% CI 0.56-0.96); moderate-to-severe RR 0.19 (0.08-0.46), NNT 74; post-circumcision bleeding RR 0.18 (0.08-0.42), NNT 9
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. Participant counts for the two individual trials are not stated in the review abstract, so the sample size field is left at zero rather than guessed. These trials address classical, not late, vitamin K deficiency bleeding.

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

Form and route. Injectable emulsion for subcutaneous, intramuscular or intravenous use, and oral tablets

Interval reported. 95% CI 0

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

Odds of childhood cancer after intramuscular vitamin K compared with oral or none

The study showed what it set out to show

Who was studied
Golding Bristol case-control study of childhood cancer and intramuscular vitamin K
How many people
753
Study design
Hospital-based case-control study, cases diagnosed 1971-1991
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Odds ratio 1.97 (95% CI 1.3 to 3.0), p = 0.002
Repeated elsewhere
Failed to Replicate

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. This is the hypothesis-generating study. Pooled individual patient data from six studies (2,431 cases, 6,338 controls) did not confirm it, and excluding the Bristol data returned the leukaemia odds ratio to 1.06 (0.89-1.25).

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

Form and route. Injectable emulsion for subcutaneous, intramuscular or intravenous use, and oral tablets

Interval reported. 95% CI 1

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

Incidence of anaphylaxis per intravenous dose administered

The study showed what it set out to show

Who was studied
Riegert-Johnson and Volcheck retrospective review of intravenous phytonadione
How many people
6572
Study design
Single-centre retrospective review over 58 months
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
2 cases in 6,572 doses — 3 per 10,000 (95% CI 0.04 to 11 per 10,000)
Repeated elsewhere
Unreplicated

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

The limits of this study, and where it came from

Main limit. The sample size is doses, not patients. A defined administration protocol was in place throughout, so this is the incidence under controlled administration rather than under routine practice.

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

Form and route. Injectable emulsion for subcutaneous, intramuscular or intravenous use, and oral tablets

Interval reported. 95% CI 0

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

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 happened in peopleRead from sources, not yet reviewed

How close this is to real life

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

  1. Living longer, or avoiding a major event No evidence recorded. Death, a heart attack, a stroke, a hospital stay.No registered study measures this.
  2. What a body can do day to day No evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
  3. Measured performance No evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
  4. Symptoms and quality of life No evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.No registered study measures this.
  5. A number that stands in for health Evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.1 registered measure of this kind.
  6. A step measured inside a person Evidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
  7. Animals Evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Mouse, 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 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

    Phytonadione

    What a person takes: Injectable emulsion for subcutaneous, intramuscular or intravenous use, and oral tablets.

    The measurement behind this step

    The label restricts the intravenous and intramuscular routes to situations where the subcutaneous route is not feasible and the risk is judged justified. Newborn prophylaxis is a single intramuscular injection. Oral absorption requires bile, so the oral route fails in exactly the malabsorption states that cause the deficiency.

  2. Getting in

    An oily vitamin has to be forced into an injectable form

    Vitamin K1 does not dissolve in water at all. To inject it, it has to be emulsified with a detergent — and that detergent is where the serious allergic reactions come from.

    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 injectable emulsion contains phytonadione with a polyoxyethylated fatty acid derivative as solubiliser, hydrous dextrose and benzyl alcohol as preservative, at pH about 6.3. The substance is oxygen sensitive. Given by mouth, absorption requires bile salts and normal fat absorption, which is exactly what is missing in obstructive jaundice, biliary fistula and cystic fibrosis — three of the indications on the label.

  3. Reaching the cell

    It is taken up by liver cells and reduced

    The vitamin reaches the liver, where it is converted into a chemically reactive form. Only that reduced form can drive the reaction the clotting factors need.

    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

    Phylloquinone is reduced to vitamin K hydroquinone (KH2) in the hepatocyte endoplasmic reticulum. The reduction is carried out by VKOR and by NAD(P)H-dependent quinone reductases; the VKOR route is the one warfarin blocks, which is why warfarin causes a functional vitamin K deficiency in the presence of plenty of vitamin K.

  4. The change it makes

    The reactive vitamin powers a chemical clip onto four clotting factors

    The reduced vitamin is consumed to add a small chemical group to specific spots on the unfinished clotting proteins. That group is what lets them grip calcium.

    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

    Gamma-glutamyl carboxylase uses the oxidation of vitamin K hydroquinone to vitamin K 2,3-epoxide to abstract a proton from the gamma carbon of specific glutamate residues, allowing carbon dioxide to be added and producing gamma-carboxyglutamate. Factors II, VII, IX and X, along with proteins C, S and Z, each carry a cluster of these residues in their amino-terminal Gla domain.

  5. What it acts on

    The finished factors can now stick to a damaged vessel wall

    The new chemical group lets each factor hold a calcium ion, and the calcium bridges it onto the surface of injured cells. Clotting is a surface reaction, and this is the ticket to the surface.

    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

    Gamma-carboxyglutamate residues chelate calcium ions, which bridge the Gla domain to negatively charged phospholipid exposed on activated platelets and damaged endothelium. Colocalisation on that surface accelerates the tenase and prothrombinase reactions by orders of magnitude. Uncarboxylated factors circulate at normal concentration and are functionally inert, which is why the immunoassay for des-gamma-carboxy prothrombin detects deficiency that a factor level does not.

  6. What that does for a person

    The clotting time normalises — over hours, not minutes

    Because the vitamin restarts manufacturing rather than supplying the product, the effect appears as new factors accumulate. That is fine for a raised number on a blood test and much too slow for someone bleeding into their brain.

    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 INR falls as newly carboxylated factor VII, the shortest-lived of the four, enters the circulation, followed by the others. In the Crowther trial the INR fell by a mean of 2.8 in 24 hours on oral vitamin K against 1.4 on placebo. Over the following 90 days, bleeding events were 15.8% against 16.3% — the number moved and the outcome did not.

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

What we know
The record describes 5 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.

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

Felt, measured, or meaningful

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

Felt

Things a person could notice without a test.

No registered study measured anything of this kind.

Measured

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

  • 0 12 hr urinary dextromethorphan/dextrorphan

Meaningful

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

No registered study measured anything of this kind.

A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.

Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.

Measured, but not felt. A number moves. The person notices nothing. Both can be true.

Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.

Matters, but takes years. The result that counts may take longer than anyone would keep watching.

Names that fit none of the three (5)
  • recruitment rate
  • dropout rate
  • auc0 inf
  • beat calci wound assessment scale baseline to week 12
  • rebleeding

These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.

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.

  • Almost every baby born in a country with a functioning maternity system receives it once at birth. Adults receive it to reverse warfarin, and long-term where fat absorption is impaired.

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 effectiveness of phytonadione injectable emulsion for prophylaxis and treatment of vitamin K deficiency have been established in neonates.”

    US prescribing information · d954e3d7-a4d5-4798-887d-7af916ff0181 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary If phytonadione is needed during pregnancy, consider using a preservative-free formulation.”

    US prescribing information · d954e3d7-a4d5-4798-887d-7af916ff0181 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary If available, preservative-free phytonadione is recommended when phytonadione is needed during lactation [see USE IN SPECIFIC POPULATIONS ( 8.4 )] .”

    US prescribing information · d954e3d7-a4d5-4798-887d-7af916ff0181 · read 2026-08-30

Where the result stopped carrying

  • The Golding case-control study reported an odds ratio of 1.97 for childhood cancer after intramuscular vitamin K and recommended switching to oral prophylaxis; the pooled reanalysis a decade later found no convincing association
  • Crowther's randomised trial found no reduction in bleeding despite halving the INR, with major bleeding numerically higher on vitamin K
  • The injectable formulation carries a boxed warning for fatal anaphylactoid reactions attributed to its solubilising vehicle rather than to the vitamin
  • Both originator applications — Mephyton tablets from 1955 and AquaMEPHYTON injection from 1960 — are listed as discontinued
  • 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

Given by a clinician

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

Injectable emulsion for subcutaneous, intramuscular or intravenous use, and oral tablets

Source-linked record

Where this came from

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

The form and route recorded on this substance.

No source is stored against this line.

Who oversees it

Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

Quoted from a source

Where this came from

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

Suppression classes recorded: S6.

No source is stored against this line.

What is in the pack

The label restricts the intravenous and intramuscular routes to situations where the subcutaneous route is not feasible and the risk is judged justified. Newborn prophylaxis is a single intramuscular injection. Oral absorption requires bile, so the oral route fails in exactly the malabsorption states that cause the deficiency.

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

A boxed warning for severe reactions including fatalities during and immediately after intravenous injection, and also after intramuscular administration, typically resembling hypersensitivity or anaphylaxis with shock and cardiac or respiratory arrest, sometimes on first exposure. Measured incidence under a defined protocol was 3 per 10,000 intravenous doses. The reactions are attributed to the polyoxyethylated solubiliser. The formulation contains benzyl alcohol. In patients on a vitamin K antagonist, correction can be excessive and leave them resistant to re-anticoagulation for a period.

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

Where this came from

Reports sent to a regulator

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

Phytonadione appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 190 reaction mentions were counted. One report can name several reactions.

The recorded terms (10)
  • injury associated with device — 41 reaction mentions
  • hypotension — 22 reaction mentions
  • premature baby — 20 reaction mentions
  • anaphylactic reaction — 18 reaction mentions
  • erythema — 17 reaction mentions
  • infusion related reaction — 15 reaction mentions
  • international normalised ratio increased — 15 reaction mentions
  • deep vein thrombosis — 14 reaction mentions
  • pancreatitis acute — 14 reaction mentions
  • toxic epidermal necrolysis — 14 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

Injectable emulsion for subcutaneous, intramuscular or intravenous use, and oral tablets

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

Newborn prophylaxis is a single intramuscular injection. Oral absorption requires bile, so the oral route fails in exactly the malabsorption states that cause the deficiency.

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

  • 54 products list this as an active ingredient in the United States drug directory. 48 of them contain it and nothing else.

    FDA National Drug Code directory · 51927-5292 · read 2026-08-29

  • They are sold as emulsion, injection, emulsion, injection, solution, liquid, oil and powder, taken intramuscular, intravenous, oral and parenteral.

    FDA National Drug Code directory · 51927-5292 · read 2026-08-29

  • The regulator's established pharmacologic class for it is increased prothrombin activity [pe], reversed anticoagulation activity [pe] and vitamin k [cs].

    FDA National Drug Code directory · 51927-5292 · read 2026-08-29

  • 38 published labels name it as an active ingredient. 34 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 5429b58b-ec2b-4a18-95d9-a9d804321192 · read 2026-08-29

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

    US prescribing information · 5429b58b-ec2b-4a18-95d9-a9d804321192 · read 2026-08-29

  • PHYTONADIONE is intramuscular at 3 DOSAGE FORMS AND STRENGTHS Injection: 1 mg/0.5 mL single-dose prefilled syringe., recorded as fda label in effect 2026-03-24 in the United States.

    US prescribing information · d954e3d7-a4d5-4798-887d-7af916ff0181 · read 2026-08-30

  • Recorded price in US: 8.83139 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 10 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..

    Recorded source · 2026-08-26 · read 2026-08-28

Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.

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

What you could measure

This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.

Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.

Questions worth asking

  • Which of the trials of Phytonadione 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 correcting a raised INR prevents bleeding — the randomised trial designed to show it found 15.8% against 16.3% over 90 days

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

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

What would change this

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

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

Goes past the evidence

That the newborn prophylaxis benefit has been demonstrated in a randomised trial — for late vitamin K deficiency bleeding, the outcome the practice exists to prevent, none has ever been run

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 vitamin K reverses warfarin — it restores the ability to make factors, and does nothing about the uncarboxylated factors already circulating

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 intramuscular vitamin K causes childhood leukaemia — a 1992 case-control finding that pooled individual patient data from six studies did not support

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

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

What would change this

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

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

What is missing or unclearRead from sources, not yet reviewed

What nobody knows yet

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

How fast does the body clear it?

The sources RNAWiki checked hold nothing for this field.

Why it matters. Without this, nothing on this page can say how long anything lasts.

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 Phytonadione 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.

Surveillance shows a fiftyfold reduction in late newborn bleeding — from no trial
In plain words
Countries that give the injection at birth report roughly one fiftieth the rate of late vitamin K deficiency bleeding of those that do not. That comparison comes from surveillance programmes, not from a randomised trial, and no randomised trial of it has ever been done.
What was measured
Incidence of late vitamin K deficiency bleeding per 100,000 live births, with and without prophylaxis
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Sankar and colleagues systematically reviewed the burden of late vitamin K deficiency bleeding and the effect of prophylaxis. The median burden without prophylaxis was 35 per 100,000 live births (interquartile range 10.5 to 80), rising to 80 per 100,000 in low- and middle-income countries against 8.8 per 100,000 in high-income countries. Two randomised trials evaluated intramuscular prophylaxis, but only against classical vitamin K deficiency bleeding: one found a reduction in any bleeding (RR 0.73, 95% CI 0.56 to 0.96) and in moderate-to-severe bleeding (RR 0.19, 95% CI 0.08 to 0.46, number needed to treat 74), and the other a reduction in secondary bleeding after circumcision (RR 0.18, 95% CI 0.08 to 0.42, NNT 9). The reviewers state plainly that no randomised trial has evaluated the effect of vitamin K prophylaxis on late vitamin K deficiency bleeding, which is the outcome the whole practice exists to prevent. The estimate for that outcome comes from four surveillance studies pooled: relative risk 0.02 (95% CI 0.00 to 0.10). They grade the evidence as low quality from observational studies, and still recommend universal intramuscular prophylaxis, because the outcome being prevented is intracranial haemorrhage in a healthy infant.
Source
Sankar MJ, Chandrasekaran A, Kumar P, Thukral A, Agarwal R, Paul VK. Vitamin K prophylaxis for prevention of vitamin K deficiency bleeding: a systematic review. J Perinatol 2016;36(Suppl 1):S29-S35
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 1992 childhood cancer scare was real, published, and did not survive pooling
In plain words
A study in 1992 reported that babies given the vitamin K injection were about twice as likely to develop cancer, and recommended switching to oral dosing. A pooled analysis of six studies and nearly nine thousand children found no convincing association.
What was measured
That intramuscular vitamin K causes childhood leukaemia — an association from a single hypothesis-generating case-control study that the pooled individual patient data did not support
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Golding and colleagues compared 195 children diagnosed with cancer between 1971 and 1991 with 558 controls, all born in two Bristol maternity hospitals. They reported an odds ratio of 1.97 (95% CI 1.3 to 3.0, p=0.002) for intramuscular vitamin K against oral or none, with no increased risk for oral vitamin K (OR 1.15, 95% CI 0.5 to 2.7), and concluded that "the prophylactic benefits against haemorrhagic disease are unlikely to exceed the potential adverse effects from intramuscular vitamin K". Roman and colleagues then pooled individual patient data from six case-control studies in Great Britain and Germany, 2,431 children with cancer and 6,338 controls. Where no written record of vitamin K was found and absence was assumed, adjusted odds ratios were 1.09 (95% CI 0.92 to 1.28) for leukaemia and 1.05 (0.92 to 1.20) for other cancers. Where administration was imputed from hospital policy, the leukaemia estimate rose to 1.21 (1.02 to 1.44) — but the shift did not occur in all studies, and excluding the hypothesis-generating Bristol data returned it to 1.06 (0.89 to 1.25) and 1.16 (0.97 to 1.39) under the two analyses. Their conclusion is that small effects cannot be entirely ruled out but there is no convincing evidence of an association.
Source
Golding J, Greenwood R, Birmingham K, Mott M. Childhood cancer, intramuscular vitamin K, and pethidine given during labour. BMJ 1992;305(6849):341-346; Roman E et al. Vitamin K and childhood cancer: analysis of individual patient data from six case-control studies. Br J Cancer 2002;86(1):63-69
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
Vitamin K corrects the INR twice as fast as placebo and does not reduce bleeding at all
In plain words
In 724 patients on warfarin whose blood was too thin but who were not bleeding, low-dose oral vitamin K halved the raised clotting number in a day. Bleeding over the next three months was identical to placebo — and major bleeding was numerically more common on vitamin K.
What was measured
Bleeding events over 90 days (primary outcome), and change in INR at 24 hours
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Crowther and colleagues randomised non-bleeding patients with INR values of 4.5 to 10.0 at 14 anticoagulant clinics in Canada, the United States and Italy to low-dose oral vitamin K (355 assigned, 347 analysed) or matching placebo (369 assigned, 365 analysed). The day after treatment the INR had fallen by a mean of 2.8 on vitamin K against 1.4 on placebo (p<0.001). Over 90 days, at least one bleeding complication occurred in 56 patients (15.8%) on vitamin K and 60 (16.3%) on placebo, absolute difference -0.5 percentage points (95% CI -6.1 to 5.1). Major bleeding occurred in 9 (2.5%) against 4 (1.1%), absolute difference 1.5 percentage points (95% CI -0.8 to 3.7). Thromboembolism occurred in 4 (1.1%) against 3 (0.8%). The authors' conclusion is one sentence long: low-dose oral vitamin K did not reduce bleeding in warfarin recipients with INRs of 4.5 to 10.0. This is the cleanest demonstration in this entire file that correcting a laboratory number is not the same as preventing the event the number predicts.
Source
Crowther MA et al. Oral vitamin K versus placebo to correct excessive anticoagulation in patients receiving warfarin: a randomized trial. Ann Intern Med 2009;150(5):293-300
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 boxed warning is about the solubiliser, not the vitamin
In plain words
Vitamin K injection carries the FDA's strongest warning because people have died of anaphylactic-type reactions during and just after intravenous injection. The reactions are attributed to the detergent used to make an oily vitamin injectable, not to the vitamin itself.
What was measured
Cases of anaphylaxis per intravenous dose administered
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
The phytonadione injectable emulsion label carries a boxed warning stating that severe reactions including fatalities have occurred during and immediately after intravenous injection, even when the product has been diluted and infused slowly, and following intramuscular administration; that these reactions have typically resembled hypersensitivity or anaphylaxis including shock and cardiac or respiratory arrest; and that some patients reacted on first exposure. The formulation contains a polyoxyethylated fatty acid derivative as solubiliser, with dextrose and benzyl alcohol, at a pH of about 6.3. Riegert-Johnson and Volcheck reviewed 6,572 intravenous doses given over 58 months at a large academic centre under a defined administration protocol and identified two cases of anaphylaxis, an incidence of 3 per 10,000 doses (95% CI 0.04 to 11 per 10,000). They attribute the reaction to the polyethoxylated castor oil vehicle, note that the incidence is comparable to or slightly less than other drugs known to cause anaphylaxis, and recommend against routine pretreatment with antihistamines or corticosteroids.
Source
Phytonadione injectable emulsion USP, FDA-approved prescribing information, boxed warning and description; Riegert-Johnson DL, Volcheck GW. The incidence of anaphylaxis following intravenous phytonadione (vitamin K1): a 5-year retrospective review. Ann Allergy Asthma Immunol 2002;89(4):400-406
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
It is not a reversal agent, and treating it as one wastes the hours that matter
In plain words
Vitamin K does not neutralise warfarin and it does not supply clotting factors. It restarts a manufacturing process in the liver, and manufacturing takes hours. For someone bleeding into their head right now, that is the wrong timescale.
What was measured
That vitamin K reverses warfarin — it restores the capacity to make factors, which is a different claim on a different timescale
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Phytonadione acts as the cofactor for gamma-glutamyl carboxylase, so its effect requires new synthesis and carboxylation of factors II, VII, IX and X. The uncarboxylated factors already in circulation are unaffected. The label's own clinical pharmacology section frames the indications around "faulty formation" of those four factors rather than around neutralising an anticoagulant. This is why guideline reversal of vitamin K antagonists in major bleeding pairs vitamin K with a source of finished factors — four-factor prothrombin complex concentrate or plasma — rather than using vitamin K alone: the concentrate supplies the factors immediately and is consumed within hours, and the vitamin keeps the liver making them once the concentrate is gone. Neither on its own is sufficient, and the commonest error is to give one and consider the problem solved.
Source
Phytonadione injectable emulsion USP, FDA-approved prescribing information, clinical pharmacology and indications
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
A single oral dose is 24 times worse than the injection in surveillance data
In plain words
Parents who decline the injection are sometimes offered drops instead. Pooled surveillance data show one oral dose carries about twenty-four times the risk of vitamin K deficiency bleeding compared with the injection. Repeated oral doses did much better, but the estimate is imprecise.
What was measured
Relative risk of vitamin K deficiency bleeding, oral versus intramuscular prophylaxis
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
In the same systematic review, a single oral dose of vitamin K carried a relative risk of vitamin K deficiency bleeding of 24.5 (95% CI 7.4 to 81.0) compared with intramuscular prophylaxis. Multiple oral doses did not show a statistically significant increase (RR 3.64, 95% CI 0.82 to 16.3) — but the point estimate is above 3 and the interval reaches 16, so this is a failure to demonstrate a difference rather than a demonstration of equivalence. The mechanism is straightforward: an intramuscular depot releases over weeks, an oral dose is absorbed once and depends on bile for absorption, and a multiple-dose oral schedule depends on the schedule being completed at home.
Source
Sankar MJ et al. Vitamin K prophylaxis for prevention of vitamin K deficiency bleeding: a systematic review. J Perinatol 2016;36(Suppl 1):S29-S35
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
Both original brands are discontinued; only generics remain
In plain words
Mephyton tablets, approved in 1955, and AquaMEPHYTON injection, approved in 1960, are both listed as discontinued. The drug is entirely generic now, which is why no brand holder has any reason to run the randomised trial that has never been run.
What was measured
Marketing status of the two originator applications
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Drugs@FDA lists MEPHYTON (phytonadione tablets) under NDA 010104, originally approved 30 September 1955, with the product marked discontinued, and AQUAMEPHYTON (phytonadione injectable) under NDA 012223, originally approved 28 June 1960, with all products marked discontinued. Supply is from abbreviated new drug applications. This is a structural observation rather than a clinical one, and it belongs on the page: the evidence gap identified in the 2016 systematic review — no randomised trial against late vitamin K deficiency bleeding — sits on a molecule with no patent, no brand sponsor and no commercial party with a reason to close it.
Source
openFDA Drugs@FDA records for NDA 010104 (MEPHYTON) and NDA 012223 (AQUAMEPHYTON), marketing status as of the August 2026 dataset
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
verified
Review state
Written into the record, not signed off as a reviewed claim

Where else this substance is registered

FDA substance identifier (UNII)
A034SE7857
RxNorm concept
198102

Checks this page had to pass

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  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

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    enforced by the copy-contract test over the rendered page

  • Passed

    Safety mode resolved

    Suppression classes recorded: S6.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

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

What the approval register records

  • 29 approved applications cover products containing this substance. The earliest was NDA010104, approved 19550930 to BAUSCH.

    Drugs@FDA application register · NDA010104 · read 2026-08-29

  • Marketing status on the register: discontinued and prescription.

    Drugs@FDA application register · NDA010104 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20030418.

    FDA National Drug Code directory · 51927-5292 · 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

5 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.

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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.

The cofactor four clotting factors cannot be finished without, given once to virtually every newborn on the strength of surveillance data showing a fiftyfold reduction in late haemorrhagic disease — a benefit no randomised trial has ever measured, attached to an injection whose boxed warning describes fatal anaphylactoid reactions that come from the solubiliser rather than the vitamin.

Recorded evidence blocks (13)

What did Phytonadione's largest trial (690 people) and its longest (8.3 years) measure?


690 people in Phytonadione's largest registered study, 8.3 years in its longest registered window, measuring Number and percent of mortality. ClinicalTrials.gov · 2026-09-01

8 phase3, 6 phase2, 5 na, 4 phase1, 2 phase4, 1 na or unstated; NCT05018221; 2029-12; no ageing endpoint recorded. Last human test completed 2024, NCT06839352.

Interpretation These counts include studies where Phytonadione was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.

Show the evidence
  • phase3
    8
  • phase2
    6
  • na
    5
  • phase1
    4
  • phase4
    2
  • na or unstated
    1
1 more recorded row
  • Last recorded human test NCT06839352
    2024-12-30

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

From mouse to human: where has Phytonadione shown lifespan?


mouse: mechanism-only, rat: lifespan and human: lifespan (23): the rungs where Phytonadione has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Interpretation Number and percent of mortality — the recorded outcome words.

Yeast C. elegans Drosophila Mouse mechanism-onlyRat lifespanDog Non-human primate Human lifespan
Show the evidence
  • mouse
    mechanism-only
  • rat
    lifespan
  • human NCT06839352
    lifespan; Number and percent of mortality; 23

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

2 of Phytonadione's trials stopped: accrual/recruitment?


accrual/recruitment (2): Phytonadione's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"Enrollment problems"; 2 of 23 registered studies

Show the evidence

Trial

  • NCT00905229
    withdrawn; "Enrollment problems"
  • NCT01742273
    terminated; "Termination stopped due to low recruitment rates"

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

Human studies of Phytonadione used Vitamin K1 500 µg — over how long?


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

1 recorded entry; human; also "Vitamin K1 500 µg"

Show the evidence
  • human NCT06385275
    Vitamin K1 500 µg

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

More Phytonadione was worse in human: at what point?


U-shaped in human: "We observed a U-shaped association between fracture risk and vitamin K intake at recommended dietary allowance (RDA) levels." Europe PMC · dose-response search · 2025-10-28

5 recorded sentences naming Phytonadione; U-shaped, dose-response

Show the evidence

U-shaped

  • PMID 40947710
    "We observed a U-shaped association between fracture risk and vitamin K intake at recommended dietary allowance (RDA) levels."
  • PMID 41164270
    "Further RCS analysis showed an inverse U-shaped relationship between vitamin K intake and the incidence of cancer cachexia."
  • PMID 41164270
    "In particular, there is an inverse U-shaped relationship between vitamin K intake and the incidence of cancer cachexia, and high vitamin K intake may reduce the risk of all-cause and cardiac mortality in cancer cachexia survivors."

dose-response

  • PMID 40947710
    "This meta-analysis aimed to comprehensively evaluate the association between dietary vitamin K intake and the risk of fractures, including a dose-response analysis to explore potential non-linear relationships."
  • PMID 39346641
    "A non-linear negative dose-response association is found between dietary vitamin K intake and serum NfL levels (<i>P</i> for non-linearity = 0.008); this association reaches a plateau when the dietary vitamin K intake is higher than 200 μg/d."

recorded 2025-10-28 · last checked 2026-09-04

Which of 0 12 hr urinary dextromethorphan/dextrorphan, auc0 inf and beat calci wound assessment scale baseline to week 12 did Phytonadione's trials measure?


0 12 hr urinary dextromethorphan/dextrorphan, auc0 inf and beat calci wound assessment scale baseline to week 12 lead 6 outcome terms across Phytonadione's trials. ClinicalTrials.gov · 2026-09-01

0 12 hr urinary dextromethorphan/dextrorphan, beat calci wound assessment scale baseline to week 12 and rebleeding follow.

Show the evidence
  • recruitment rate
    1
  • dropout rate
    1
  • auc0 inf
    1
  • 0 12 hr urinary dextromethorphan/dextrorphan
    1
  • beat calci wound assessment scale baseline to week 12
    1
  • rebleeding
    1

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

Which of Phytonadione's 3 ongoing trials reports first?


3 registered trials of Phytonadione are open; earliest completion 2026-12. ClinicalTrials.gov · 2026-09-01

Efficacy will be assessed by subject progression free survival; BEAT-Calci Wound Assessment Scale (BCWAS) - Baseline to Week 12; latest 2030-08-26

Show the evidence

Trial

  • NCT04752813
    "A Study of BPM31510 With Vitamin K1 in Subjects With Newly Diagnosed Glioblastoma (GB)"; n 50; "Efficacy will be assessed by subject progression free survival"; 2030-08-26
  • NCT05018221
    "Better Evidence and Translation for Calciphylaxis"; n 350; "BEAT-Calci Wound Assessment Scale (BCWAS) - Baseline to Week 12"; 2029-12
  • NCT06385275
    "The Role of Vitamin K on Knee Osteoarthritis Outcomes"; n 49; "Change in uncarboxylated matrix Gla protein (ucMGP) levels"; 2026-12

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

Which running trial of Phytonadione could settle lifespan?


NCT04752813 measures Efficacy will be assessed by subject progression free survival, reading out 2030-08-26.

1 open trial; n 50; "A Study of BPM31510 With Vitamin K1 in Subjects With Newly Diagnosed Glioblastoma (GB)"

Show the evidence
  • Trial NCT04752813
    "A Study of BPM31510 With Vitamin K1 in Subjects With Newly Diagnosed Glioblastoma (GB)"; n 50; "Efficacy will be assessed by subject progression free survival"; 2030-08-26

Which 14 trials of Phytonadione posted no result?


Posted no result
14 of 14 completed trials
Registrations
NCT00143715, NCT01034124, NCT00794755, NCT01194778, NCT01638182 and NCT00990158, and 8 more
Completion dates
oldest 2007-01; newest 2023-01-20
Show the evidence

Trial

  • NCT00143715
    2007-01
  • NCT01034124
    2008-06
  • NCT00794755
    2010-04
  • NCT01194778
    2010-08
  • NCT01638182
    2011-09
  • NCT00990158
    2014-04
8 further recorded trials
  • NCT01474460
    2015-11
  • NCT02324686
    2017-12-18
  • NCT01528800
    2019-12
  • NCT05060809
    2020-01-01
  • NCT04477811
    2021-01-01
  • NCT05273775
    2022-06-23
  • NCT05392127
    2022-08-18
  • NCT05713045
    2023-01-20

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


Median enrolment
80
Largest enrolment
690
Registered trials counted
23

What do 190 spontaneous reports say about Phytonadione — 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.

Phytonadione appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 190 reaction mentions were counted: injury associated with device 41; hypotension 22; premature baby 20; anaphylactic reaction 18. open-targets-adr · CHEMBL1201519 · 2026-06-24

Show the evidence
  • injury associated with device
    41
  • hypotension
    22
  • premature baby
    20
  • anaphylactic reaction
    18
  • erythema
    17
  • infusion related reaction
    15
4 more recorded rows
  • international normalised ratio increased
    15
  • deep vein thrombosis
    14
  • pancreatitis acute
    14
  • toxic epidermal necrolysis
    14

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

Was Phytonadione studied with fasting?


fasting is named in Phytonadione's label sentences: "There is, however, scant evidence to support this promising potential in a clinical setting. <b>Aim:</b> The aim of this study was to confirm the effects of vitamin K supplementation on glycaemic parameters such as fasting blood glucose (FBG), fasting insulin (FI), glycated haemoglobin (HbA1c),…" openfda-label+europepmc · 2026-01-14

1 recorded statement; fasting

Show the evidence
  • fasting
    There is, however, scant evidence to support this promising potential in a clinical setting. <b>Aim:</b> The aim of this study was to confirm the effects of vitamin K supplementation on glycaemic parameters such as fasting blood glucose (FBG), fasting insulin (FI), glycated haemoglobin (HbA1c), insulin resistance (HOMA-IR), and homeostatic model of beta cell function (HOMA-β) across randomised…

recorded 2026-01-14 · last checked 2026-09-04

What is recorded about Phytonadione and NAD+?


"We detail the multifaceted molecular mechanisms through which FSP1 inhibits ferroptosis, including the canonical FSP1-CoQ<sub>10</sub>-NAD(P)H axis, the non-canonical vitamin K cycle, ESCRT-III-mediated membrane repair, and the newly characterized vitamin B2-dependent metabolic stability pathway." — where Phytonadione and NAD+ appear together. Europe PMC · pathway abstract search · 2026-08-07

NAD+, senolytic, mTOR, autophagy; PMID 42630571, 41745778, 40440064, 38103582

Show the evidence
  • NAD+ PMID 42630571
    "We detail the multifaceted molecular mechanisms through which FSP1 inhibits ferroptosis, including the canonical FSP1-CoQ<sub>10</sub>-NAD(P)H axis, the non-canonical vitamin K cycle, ESCRT-III-mediated membrane repair, and the newly characterized vitamin B2-dependent metabolic stability pathway."
  • senolytic PMID 41745778
    "Emerging therapies-including tissue-nonspecific alkaline phosphatase inhibition, ectonucleotide pyrophosphatase/phosphodiesterase 1 enzyme replacement, vitamin K<sub>2</sub> activation, senolytic agents, and SNF472 crystal-growth blockade-are mapped to their optimal phenotypic contexts."
  • NAD+ PMID 40440064
    "FSP1 is an FAD-dependent oxidoreductase that uses NAD(P)H to regenerate the reduced forms of lipophilic quinone antioxidants, such as coenzyme Q10 and vitamin K. These quinone antioxidants function as radical scavenging agents that prevent the propagation of lipid peroxidation and the induction of ferroptosis."
  • mTOR PMID 38103582
    "In BRL-3A cells, 1.0 mM DHA-S increased the expression levels of mTOR, p-mTOR and p-ERK and decreased the levels of VKORC1, VKORC1L1 and Vitamin K. Rapamycin significantly decreased the expression levels of p-mTOR and p-ERK, while FR180204 (p-ERK Inhibition) lead to a decrease in p-ERK level."
  • autophagy PMID 36028390
    "Newly discovered functions of vitamin K in cancer cells include activation of the steroid and xenobiotic receptor (SXR) and regulation of oxidative stress, apoptosis, and autophagy."
  • NAD+ PMID 35922516
    "Ferroptosis suppressor protein 1 (FSP1), a NAD(P)H-ubiquinone reductase and the second mainstay of ferroptosis control after glutathione peroxidase-4<sup>4,5</sup>, was found to efficiently reduce vitamin K to its hydroquinone, a potent radical-trapping antioxidant and inhibitor of (phospho)lipid peroxidation."
2 more recorded rows
  • autophagy PMID 38342807
    "After the tilt test, we observed an increase in the level of vimentin, vitamin K-dependent protein C, Wnt signaling pathway proteins, proteins involved in autophagy and adaptive immune response, focal adhesion proteins, vascular damage marker S100A8, PEDF regulator, and some proteins of the heart: cardiac actin ACTC1 and transcription factor GATA4."
  • mTOR PMID 33334200
    "We further validated the cell signaling details of the compound-induced expression of dentin sialophosphoprotein (DSPP), which is known as a marker of odontoblastic differentiation.<b>Results</b>: We investigated shikonin, which is one of the derivatives of naphthoquinone, the skeleton of vitamin K. Shikonin-induced expression of DSPP was inhibited by PI3K, AKT, and mTOR inhibitors."

recorded 2026-08-07 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1201519
CAS number
81818-54-4
RxCUI
11258
Also called
Phytonadione (Vitamin K1)
Also called
VITAMIN K, konakion, phytomenadione, vitamin k1, 2-METHYL-3-PHYTYL-1,4-NAPHTHOQUINONE, 3-PHYTYLMENADIONE, MIXTURE OF THE TRANS (E) AND CIS (Z) ISOMERS CONTAINING NOT LESS THAN 75% OF TRANS-PHYTOMENADIONE, PHYTOMENADIONE [EP IMPURITY], PHYTOMENADIONE [MART.], PHYTOMENADIONE [WHO-IP]
Trade name
Aquamephyton, Mephyton, Vitamin K1 Phytonadione, Infuvite Adult, M.v.i. Adult, PHYTONADIONE PHYTONADIONE, Mephyton / AquaMEPHYTON / Konakion, MONO-KAY
Salt form
Multiple Vitamins Injection Adult, Multiple Vitamins Injection Pediatric (Pharmacy Bulk Package)
Component
Phytonadione (Vitamin K1)
Sources (10)

Sources

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

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: 10 source rows
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