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Fosphenytoin

  • 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 Fosphenytoin does in the body

Generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery

From the FDA-approved label: Fosphenytoin is a prodrug of phenytoin and accordingly, its anticonvulsant effects are attributable to phenytoin. The precise mechanism by which phenytoin exerts its therapeutic effect has not been established but is thought to involve the voltage-dependent blockade of membrane sodium channels resulting in a reduction in sustained high-frequency neuronal discharges.

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
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 chemical.

    FDA substance registry · B4SF212641 · 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 80 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.

Biomarker

A biomarker is a number from a test that stands in for something about health.

A picture of it, and where the picture fails

A biomarker is like a fuel gauge.

Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.

What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.

A measurable indicator used as a substitute for a clinical outcome of interest.

Placebo

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

A picture of it, and where the picture fails

A placebo is like a blank control in an experiment.

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

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

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

Comparator

A comparator is whatever the treatment was measured against.

A picture of it, and where the picture fails

It is like the other runner in a race.

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

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

The control condition against which the experimental intervention is assessed.

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.

Number of Participants With Clinical Cessation of Status Epilepticus - Intention to Treat

The study did not show it

Who was studied
NCT01960075
How many people
478
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. Injection

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 patient with a cessation of seizures and absence of recurrence

The study did not show it

Who was studied
NCT01870024
How many people
434
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. Injection

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

Graft-versus-host disease-free, relapse-free survival (GRFS)

The study did not show it

Who was studied
NCT06859424
How many people
358
Study design
Phase 2
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. Injection

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

Number of Participants Who Experienced a Recurrent Seizure After Treatment.

The study did not show it

Who was studied
NCT00510783
How many people
158
Study design
Phase 4
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. Injection

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 Who Experience no Nonconvulsive Seizures (NCS) for 24 Hours Following Treatment With LCM vs. fPHT, as Measured by Continuous Electroencephalography (cEEG) Monitoring.

The study did not show it

Who was studied
NCT01458522
How many people
74
Study design
Phase 2
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. Injection

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

Seizure burden

The study did not show it

Who was studied
NCT01027715
How many people
69
Study design
Not applicable
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. Injection

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 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.

  • Fosphenytoin Sodium Injection, USP is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. Fosphenytoin Sodium Injection, USP can also be substituted, short-term, for oral phenytoin.

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: “CEREBYX is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery in all pediatric age groups [see Indications and Usage (1) and Dosage and Administration (2.3 , 2.4) ].”

    US prescribing information · d4c36fad-0ba2-4cd4-9c5e-dcf843f38a5a · read 2026-08-30

  • On older people, the label states: “No systematic studies in geriatric patients have been conducted.”

    US prescribing information · d4c36fad-0ba2-4cd4-9c5e-dcf843f38a5a · read 2026-08-30

  • On people who are pregnant, the label states: “Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as CEREBYX, during pregnancy.”

    US prescribing information · d4c36fad-0ba2-4cd4-9c5e-dcf843f38a5a · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary It is not known whether fosphenytoin is secreted in human milk.”

    US prescribing information · d4c36fad-0ba2-4cd4-9c5e-dcf843f38a5a · 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 in different people

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

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

The evidence may simply be wrong

Small early studies often do not hold up.

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

Other reasons RNAWiki checked and found nothing for (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.

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

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

What taking it involves

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

How it is supplied

Prescription only

Quoted from a source

Where this came from

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

Read from the recorded approval status.

No source is stored against this line.

Form and route

Injection

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: S3.

No source is stored against this line.

What is in the pack

Sold as injectable, solution, injection, injection, solution, given by the injection, intravenous, intramuscular 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.

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

Injection

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

  • 20 products list this as an active ingredient in the United States drug directory. 20 of them contain it and nothing else.

    FDA National Drug Code directory · 62756-874 · read 2026-08-29

  • They are sold as injection, injection, solution and powder, taken intramuscular and intravenous.

    FDA National Drug Code directory · 62756-874 · read 2026-08-29

  • The regulator's established pharmacologic class for it is anti-epileptic agent [epc], cytochrome p450 1a2 inducers [moa] and cytochrome p450 2b6 inducers [moa].

    FDA National Drug Code directory · 62756-874 · read 2026-08-29

  • 10 published labels name it as an active ingredient. 10 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · d4c36fad-0ba2-4cd4-9c5e-dcf843f38a5a · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · d4c36fad-0ba2-4cd4-9c5e-dcf843f38a5a · read 2026-08-29

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

    NIH Dietary Supplement Label Database · 13114 · read 2026-08-29

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

    NIH Dietary Supplement Label Database · 13114 · read 2026-08-29

  • CEREBYX is intramuscular at 3 DOSAGE FORMS AND STRENGTHS CEREBYX Injection is a clear, colorless to pale yellow solution available as 50 mg phenytoin sodium equivalents (PE) per mL in: • 10 mL single-dose injection vials, each containing 500 mg PE…, recorded as fda label in effect 2025-08-28 in the United States.

    US prescribing information · d4c36fad-0ba2-4cd4-9c5e-dcf843f38a5a · 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.

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 Fosphenytoin 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 Fosphenytoin 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.

How many documents were read

  • 10 documents were read for this substance.

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
B4SF212641
CAS registry number
93390-81-9
PubChem compound
56339
ChEMBL
CHEMBL1201336
WHO international nonproprietary name list entry
6484
RxNorm concept
72236
EMA substance identifier
100000080442
DrugBank
DB01320

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

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

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Passed

    Safety mode resolved

    Suppression classes recorded: S3.

  • 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

  • 16 approved applications cover products containing this substance. The earliest was NDA020450, approved 19960805 to PARKE DAVIS.

    Drugs@FDA application register · NDA020450 · read 2026-08-29

  • Marketing status on the register: discontinued and prescription.

    Drugs@FDA application register · NDA020450 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20070806.

    FDA National Drug Code directory · 62756-874 · 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

9 questions this page could not answer

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

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

The record as stored

The full record, for auditing

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

Recorded evidence blocks (9)

On the Fosphenytoin label: indicated for what?


"Fosphenytoin sodium injection is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. Fosphenytoin sodium injection can also be substituted, short-term, for oral phenytoin.": indications and usage on Fosphenytoin's label. DailyMed label · a0def32c-e693-43e5-9509-0cef9642441c · 2026-02-18

9 registered trials of Fosphenytoin — at which phases?


Registered studies posting no result
4 of 9

9 registered studies of Fosphenytoin: 3 phase3, 3 phase4, 1 na, 1 na or unstated, 1 phase1, 1 phase2. CLINICALTRIALS_SNAPSHOT · 2026-09-01

38 with a PubMed record

Show the evidence
  • phase3
    3
  • phase4
    3
  • na
    1
  • na or unstated
    1
  • phase1
    1
  • phase2
    1
3 more recorded rows
  • completed
    5
  • terminated
    3
  • unknown
    1

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

3 of Fosphenytoin's trials stopped: accrual/recruitment?


accrual/recruitment (3): Fosphenytoin's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Poor accrual"; 3 of 9 registered studies

Show the evidence

Trial

  • NCT00801931
    terminated; "Poor accrual"
  • NCT01110187
    terminated; "Lack of enrollement"
  • NCT06081283
    terminated; "Low recruitment"

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

Fosphenytoin's half-life is 15 minutes — which schedules were studied?


15 minutes, the half-life Fosphenytoin's label states: "Elimination The conversion half-life of fosphenytoin to phenytoin is approximately 15 minutes." DailyMed label · a0def32c-e693-43e5-9509-0cef9642441c · 2026-02-18

tmax 30 minutes.

Show the evidence
  • half life pharmacokinetics
    15 minutes; Elimination The conversion half-life of fosphenytoin to phenytoin is approximately 15 minutes.
  • tmax pharmacokinetics
    30 minutes; Peak concentrations occur at approximately 30 minutes postdose.
  • metabolism pharmacokinetics
    Metabolism Following parenteral administration of fosphenytoin sodium, fosphenytoin is converted to the anticonvulsant phenytoin.

recorded 2026-02-18 · last checked 2026-09-04

Which 3 trials of Fosphenytoin posted no result?


Posted no result
3 of 3 completed trials
Registrations
NCT00908453, NCT01870024 and NCT03712254
Completion dates
oldest 2010-02; newest 2021-11-01
Show the evidence

Trial

  • NCT00908453
    2010-02
  • NCT01870024
    2018-02-23
  • NCT03712254
    2021-11-01

At the median, Fosphenytoin's trials enrolled 40 people — anything larger?


Median enrolment
40
Largest enrolment
478
Registered trials counted
9

What do 272 spontaneous reports say about Fosphenytoin — 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.

Fosphenytoin appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 272 reaction mentions were counted: status epilepticus 50; hypotension 44; toxicity to various agents 29; seizure 27. FAERS via Open Targets · CHEMBL1201336 · 2026-06-24

Show the evidence
  • status epilepticus
    50
  • hypotension
    44
  • toxicity to various agents
    29
  • seizure
    27
  • bradycardia
    26
  • hepatic function abnormal
    26
4 more recorded rows
  • blood pressure decreased
    18
  • drug reaction with eosinophilia and systemic symptoms
    18
  • tachycardia
    17
  • thrombocytopenia
    17

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

Which 10 reactions does Fosphenytoin's label not list?


blood pressure decreased, bradycardia and drug reaction with eosinophilia and systemic symptoms and 7 more reported for Fosphenytoin, absent from its label. FAERS via Open Targets · CHEMBL1201336 · 2026-06-24

2 label terms; 10 reported and unlisted; a0def32c-e693-43e5-9509-0cef9642441c

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  • blood pressure decreased
    count not stated
  • bradycardia
    count not stated
  • drug reaction with eosinophilia and systemic symptoms
    count not stated
  • hepatic function abnormal
    count not stated
  • hypotension
    count not stated
  • seizure
    count not stated
4 more recorded rows
  • status epilepticus
    count not stated
  • tachycardia
    count not stated
  • thrombocytopenia
    count not stated
  • toxicity to various agents
    count not stated

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

Fosphenytoin and CYP2C9 and CYTOCHROME P450: shared by which compounds?


CYP2C9 and CYTOCHROME P450 appear in Fosphenytoin's recorded interaction sentences, 8 in all. DailyMed label · a0def32c-e693-43e5-9509-0cef9642441c · 2026-02-18

CYP2C19, CYP2C19, CYP2C9, CYP2C9; 4 shared nodes; drug_interactions, pharmacokinetics, clinical_pharmacology

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Interaction statement

  • drug_interactions
    Phenytoin is primarily metabolized by the hepatic cytochrome P450 enzyme CYP2C9 and to a lesser extent by CYP2C19 and is particularly susceptible to inhibitory drug interactions because it is subject to saturable metabolism.
  • pharmacokinetics
    Metabolism Phenytoin derived from administration of fosphenytoin sodium is extensively metabolized in the liver by the cytochrome P450 enzyme CYP2C9 and to a lesser extent by CYP2C19.
  • pharmacokinetics
    Drug Interaction Studies Phenytoin derived from administration of fosphenytoin sodium is extensively metabolized in the liver by the cytochrome P450 enzyme CYP2C9 and to a lesser extent by CYP2C19 [see Drug Interactions (7.1 , 7.2 )] .
  • clinical_pharmacology
    Metabolism Phenytoin derived from administration of fosphenytoin sodium is extensively metabolized in the liver by the cytochrome P450 enzyme CYP2C9 and to a lesser extent by CYP2C19.
  • clinical_pharmacology
    Drug Interaction Studies Phenytoin derived from administration of fosphenytoin sodium is extensively metabolized in the liver by the cytochrome P450 enzyme CYP2C9 and to a lesser extent by CYP2C19 [see Drug Interactions (7.1 , 7.2 )] .
  • clinical_pharmacology
    The pharmacokinetics and protein binding of fosphenytoin, phenytoin, and diazepam were not altered when diazepam and fosphenytoin sodium were concurrently administered in single submaximal doses. figure-1 12.5 Pharmacogenomics CYP2C9 activity is decreased in individuals with genetic variants such as the CYP2C9*2 and CYP2C9*3 alleles.
2 more recorded rows
  • Interaction statement clinical_pharmacology
    Other decreased or nonfunctional CYP2C9 alleles may also result in decreased clearance of phenytoin (e.g., *5, *6, *8, *11).
  • Interaction statement clinical_pharmacology
    The prevalence of the CYP2C9 poor metabolizer phenotype is approximately 2-3% in the White population, 0.5-4% in the Asian population, and <1% in the African American population.

CYP2C19

  • FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Golodirsen, Naldemedine, Etravirine
  • FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Golodirsen, Naldemedine, Etravirine

CYP2C9

  • FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Golodirsen, Tinidazole, Naldemedine
  • FINGOLIMOD LAURYL SULFATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Golodirsen, Tinidazole, Naldemedine

recorded 2026-02-18 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1201336
PubChem CID
56339
CAS number
93390-81-9
RxCUI
72236
InChIKey
XWLUWCNOOVRFPX-UHFFFAOYSA-N
Also called
Fosfenitoina, Fosphenytoine, Np-06, fos, fpht, FOSPHENYTOIN SODIUM, 2,4-IMIDAZOLIDINEDIONE, 5,5-DIPHENYL-3-((PHOSPHONOOXY)METHYL)-, DISODIUM SALT, 3-(Hydroxymethyl)-5,5-diphenylhydantoin, disodium phosphate (ester), FOSPHENYTOIN DISODIUM SALT [MI], FOSPHENYTOIN SODIUM [MART.], FOSPHENYTOIN SODIUM [ORANGE BOOK], FOSPHENYTOIN SODIUM [USAN]
Salt form
ACC-9653-010 (SODIUM SALT), Fosphenytoin disodium salt
Trade name
Cerebyx, Pro-epanutin, Sesquient, Cerebyx / Sesquient
Development code
CI 982
Sources (5)

Sources

ChEMBL 37 — CC BY-SA 3.0 Unported · ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 5 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
  • no raw internal fields: enforced by the copy-contract test over the rendered page

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