This page shows what was measured, who it was measured in, and what that does not settle.
What Oxcarbazepine does in the body
The body immediately reduces it to a related molecule, the 10-monohydroxy derivative, and that is what acts.
The tablet itself does almost nothing. It works the same way carbamazepine does: it binds sodium pores in nerve membranes that have just fired and keeps them shut, so a cell firing repeatedly runs out of usable pores and the burst dies out. The chemical difference matters because the body reaches this metabolite by a simple reduction rather than by the oxidation that turns carbamazepine into a reactive epoxide, so there is far less enzyme induction and no self-induction.
Why people take it. Focal (partial-onset) epilepsy
What happened in people
Serum sodium below 125 mmol/L in 38 of 1,524 treated patients (2.5%) and in none on placebo or active control across 14 controlled 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.
Oxcarbazepine United States prescribing information: Clinical Studies 14.1 and 14.2, Warnings and Precautions 5.1 to 5.11, Mechanism of Action 12.1, retrieve… · a recorded source, not a stored snapshot
Widely used where carbamazepine efficacy is wanted without carbamazepine interactions, and used off-label in trigeminal neuralgia, an indication it does not hold in the United States
Where it acts
Axonal membrane of cortical neurons, reached by the active metabolite rather than the swallowed drug
Kind of result
A number that stands in for health
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.
What the registries record it as
The substance registry classes this as chemical.
FDA substance registry · VZI5B1W380 · read 2026-08-29
Where each sentence above came from
A person wrote this explanation into the record, with the studies named in the path below.
The recorded use, written for a reader without medical training. Not signed off.
A limit recorded against this substance. Not signed off as a reviewed claim.
The four opening statements run to 126 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Comparator
A comparator is whatever the treatment was measured against.
A picture of it, and where the picture fails
It is like the other runner in a race.
Where that stops being true. A race has one winner. A study can show both arms improved.
What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.
The control condition against which the experimental intervention is assessed.
Randomisation
Randomisation means chance decides who gets which treatment.
A picture of it, and where the picture fails
It is like a coin toss deciding the groups.
Where that stops being true. A coin toss is fair once. Fairness here comes from doing it for everyone.
What people get wrong. It is thought to make groups identical. It makes them similar on average, including on things nobody measured.
Allocation of participants to arms by a chance process, so that unmeasured factors are balanced in expectation.
Absolute difference
An absolute difference is how many more people in a hundred were affected.
A picture of it, and where the picture fails
It is like counting heads in two rooms of a hundred.
Where that stops being true. Heads are easy to count. Study results carry a margin of error too.
What people get wrong. It is confused with a percentage change, which can look far larger.
The arithmetic difference in event rates between arms.
Confidence interval
A confidence interval is the range the true answer is likely to sit in.
A picture of it, and where the picture fails
It is like a weather forecast giving a range rather than one number.
Where that stops being true. A forecast range covers tomorrow. This one covers what the study could resolve.
What people get wrong. The middle number is read as the answer. A range crossing zero means no change is still possible.
An interval estimate that would contain the true parameter in a stated proportion of repeated studies.
What happened in people◇Read 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.
Percentage change in partial-onset seizure frequency from an 8-week baseline, over a 24-week maintenance period
Median reduction 49.9% at 2,400 mg/day, 40.2% at 1,200 mg/day, 26.4% at 600 mg/day against 7.6% on placebo, P=0.0001 at every dose
Repeated elsewhere
Replicated
What this does not prove. Meeting one endpoint in one population does not carry to other goals or other people.
The limits of this study, and where it came from
Main limit. Over 65% of the 2,400 mg/day group discontinued for adverse events and only 46 of 174 (27%) completed the 28-week study, a fact the label places in the efficacy section rather than the safety section.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral film-coated tablet, oral suspension and extended-release tablet
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
Oxcarbazepine United States prescribing information: Clinical Studies 14.1 and 14.2, Warnings and Precautions 5.1 to 5.11, Mechanism of Action 12.1, retrieve… · a recorded source, not a stored snapshot
Median reduction 34.8% against 9.4% on placebo, P=0.0001
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. 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. Oral film-coated tablet, oral suspension and extended-release tablet
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
Oxcarbazepine United States prescribing information: Clinical Studies 14.1 and 14.2, Warnings and Precautions 5.1 to 5.11, Mechanism of Action 12.1, retrieve… · a recorded source, not a stored snapshot
Time to meet pre-specified exit criteria after substitution for carbamazepine monotherapy
✓ The study showed what it set out to show
Who was studied
Monotherapy substitution trial, oxcarbazepine 2,400 mg/day against 300 mg/day
How many people
143
Study design
Randomised withdrawal, double-blind, 126 days
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
P=0.0001 in favour of the 2,400 mg/day group
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. The comparator is a sub-therapeutic dose of the same molecule, so the trial establishes dose-response rather than efficacy against an alternative treatment.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral film-coated tablet, oral suspension and extended-release tablet
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
Oxcarbazepine United States prescribing information: Clinical Studies 14.1 and 14.2, Warnings and Precautions 5.1 to 5.11, Mechanism of Action 12.1, retrieve… · a recorded source, not a stored snapshot
Time to meet exit criteria on continuous video-EEG monitoring
✗ The study did not show it
Who was studied
Paediatric monotherapy trial, 10 mg/kg/day against 40 to 60 mg/kg/day
How many people
92
Study design
Randomised, rater-blind, inpatient continuous video-EEG, 5 days
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
No statistically significant difference between groups, P=0.90
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. The paediatric monotherapy indication was granted on adult data plus pharmacokinetic and pharmacodynamic extrapolation rather than on this trial.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral film-coated tablet, oral suspension and extended-release tablet
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
Oxcarbazepine United States prescribing information: Clinical Studies 14.1 and 14.2, Warnings and Precautions 5.1 to 5.11, Mechanism of Action 12.1, retrieve… · a recorded source, not a stored snapshot
Co-primary: time to treatment failure and time to 12-month remission across five first-line drugs
✗ The study did not show it
Who was studied
SANAD arm A (ISRCTN38354748)
How many people
1721
Study design
Unblinded randomised controlled trial, five parallel arms
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Oxcarbazepine separated significantly from no comparator on either outcome: lamotrigine versus oxcarbazepine HR 1.15 (95% CI 0.86 to 1.54) for treatment failure, carbamazepine versus oxcarbazepine HR 0.92 (0.73 to 1.18) for 12-month remission
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. The oxcarbazepine arm was the smallest of the five, so its intervals are the widest in the trial and the absence of a difference is weak evidence of equivalence.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral film-coated tablet, oral suspension and extended-release tablet
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
Oxcarbazepine United States prescribing information: Clinical Studies 14.1 and 14.2, Warnings and Precautions 5.1 to 5.11, Mechanism of Action 12.1, retrieve… · a recorded source, not a stored snapshot
RNAWiki holds 5 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What it changes in the body◇Read 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.
Start
Oxcarbazepine
What a person takes: Oral film-coated tablet, oral suspension and extended-release tablet.
The measurement behind this step
There is no intravenous oxcarbazepine, so it plays no part in emergency seizure management. The extended-release tablet Oxtellar XR is a separate FDA application with its own registration trial rather than a reformulation of Trileptal, and the two are not interchangeable at the pharmacy counter.
Getting in
Swallowed, then almost entirely converted before it can act
The tablet is absorbed and then rapidly reduced by the liver to a different molecule. That metabolite is the drug that does the work, and it is what blood tests measure.
╌╌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
Oxcarbazepine is reduced by cytosolic arylketone reductase to the 10-monohydroxy derivative (MHD), which the label identifies as the species primarily responsible for pharmacological activity. Because the route is reduction rather than oxidation, no 10,11-epoxide is formed, there is no autoinduction, and CYP3A4 induction is modest by comparison with carbamazepine.
Oxcarbazepine United States prescribing information: Clinical Studies 14.1 and 14.2, Warnings and Precautions 5.1 to 5.11, Mechanism of Action 12.1, retrieve… · a recorded source, not a stored snapshot
MHD passes into brain tissue and reaches the outer membranes of nerve cells, which is where sodium pores sit.
╌╌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
MHD circulates as a mixture of two mirror-image forms created when the 10-keto group is reduced. The two are not made in equal amounts, and the S form is marketed separately as the prodrug eslicarbazepine acetate. The relevant compartment is the axonal membrane of cortical neurons.
Oxcarbazepine United States prescribing information: Clinical Studies 14.1 and 14.2, Warnings and Precautions 5.1 to 5.11, Mechanism of Action 12.1, retrieve… · a recorded source, not a stored snapshot
Sodium pores spend a moment shut and unavailable right after each firing. The metabolite binds them in that state and holds them there, so recently used pores stay out of service.
╌╌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 label describes blockade of voltage-sensitive sodium channels producing stabilisation of hyperexcited neural membranes, inhibition of repetitive neuronal firing and diminution of propagation of synaptic impulses, and states that the precise mechanism is unknown. It adds increased potassium conductance and modulation of high-voltage-activated calcium channels as possible contributors, and records no significant interaction with brain neurotransmitter or modulator receptor sites.
Oxcarbazepine United States prescribing information: Clinical Studies 14.1 and 14.2, Warnings and Precautions 5.1 to 5.11, Mechanism of Action 12.1, retrieve… · a recorded source, not a stored snapshot
Occasional firing is barely affected. Rapid repeated firing loses more pores with every spike, so the burst cannot sustain itself or spread to the next region.
╌╌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
Cumulative use-dependent block reduces sustained high-frequency firing and the propagation of synaptic impulses across the cortex. The same property that suppresses focal seizure spread is thought to underlie the warning that generalised seizure types can be aggravated instead.
Oxcarbazepine United States prescribing information: Clinical Studies 14.1 and 14.2, Warnings and Precautions 5.1 to 5.11, Mechanism of Action 12.1, retrieve… · a recorded source, not a stored snapshot
A median seizure reduction of about half, at a dose most people could not hold
At 2,400 mg a day the median seizure count fell 49.9% against 7.6% on placebo. In that same arm, more than 65% of patients stopped because of side effects.
╌╌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
Efficacy is established against placebo as adjunctive therapy at 600, 1,200 and 2,400 mg/day with an orderly dose-response, and in children at 30 to 46 mg/kg/day. The monotherapy indication rests largely on high-dose against low-dose randomised withdrawal designs rather than against an active comparator, and SANAD later found no significant separation from carbamazepine.
Oxcarbazepine United States prescribing information: Clinical Studies 14.1 and 14.2, Warnings and Precautions 5.1 to 5.11, Mechanism of Action 12.1, retrieve… · a recorded source, not a stored snapshot
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 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 is missing or unclear◇Read 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.
People with focal epilepsy, particularly where carbamazepine interactions are the problem rather than carbamazepine efficacy. It is also used off-label in trigeminal neuralgia, an indication it does not carry in the United States.
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: “Oxcarbazepine tablets is indicated for use as adjunctive therapy for partial-onset seizures in patients aged 2 to 16 years.”
US prescribing information · 4ebcb0e5-1c93-4b3f-8749-6835c56afce5 · read 2026-08-30
On older people, the label states: “There were 52 patients over age 65 in controlled clinical trials and 565 patients over the age of 65 in other trials.”
US prescribing information · 4ebcb0e5-1c93-4b3f-8749-6835c56afce5 · 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 AEDs, such as oxcarbazepine tablets, during pregnancy.”
US prescribing information · 4ebcb0e5-1c93-4b3f-8749-6835c56afce5 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary Oxcarbazepine and its active metabolite (MHD) are present in human milk after oxcarbazepine tablets administration.”
US prescribing information · 4ebcb0e5-1c93-4b3f-8749-6835c56afce5 · read 2026-08-30
On people with reduced kidney function, the label states: “Dose adjustment is recommended for renally impaired patients (CLcr <30 mL/min) [ see Dosage and Administration (2.7) and Clinical Pharmacology (12.3) ].”
US prescribing information · 4ebcb0e5-1c93-4b3f-8749-6835c56afce5 · read 2026-08-30
Where the result stopped carrying
The paediatric monotherapy trial in 92 children found no difference between a full dose and a token dose (P=0.90); the paediatric monotherapy indication came from extrapolation instead
The highest and most effective adjunctive dose was abandoned by over 65% of the patients assigned to it
The reactive-epoxide explanation for carbamazepine hypersensitivity, which motivated the whole molecule, did not survive contact with the cross-reactivity data
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 take◇Read 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 take◇Read 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
Oral film-coated tablet, oral suspension and extended-release tablet
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
RNAWiki has not recorded a supervision or regulatory status for this substance.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
No register row and no identity class settled the question.
No source is stored against this line.
What is in the pack
There is no intravenous oxcarbazepine, so it plays no part in emergency seizure management.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold. The rest of the recorded wording: The extended-release tablet Oxtellar XR is a separate FDA application with its own registration trial rather than a reformulation of Trileptal, and the two are not interchangeable at the pharmacy counter.
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 take◇Read 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
No boxed warning. The distinctive risk is hyponatraemia: serum sodium below 125 mmol/L in 2.5% of treated patients across 14 controlled studies and in none of the controls, usually in the first 3 months but occasionally after a year, with confusion and worsening seizures on the symptom list. Approximately 25% to 30% of people who reacted to carbamazepine react to this drug too, and Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, anaphylaxis and angioedema are all on the label. Cognitive dysfunction, somnolence and coordination problems are common. Primary generalised seizures can be aggravated, especially in children. The class-wide suicidality warning applies: 0.43% against 0.24% across 199 pooled placebo-controlled trials of 11 anti-seizure drugs, an adjusted relative risk of 1.8 (95% CI 1.2 to 2.7).
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
Where this came from
Oxcarbazepine United States prescribing information: Clinical Studies 14.1 and 14.2, Warnings and Precautions 5.1 to 5.11, Mechanism of Action 12.1, retrieve… · 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 unclear◇Read 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
Oral film-coated tablet, oral suspension and extended-release tablet
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
A recorded note compares this form with the others that are sold. It is kept below, word for word.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
The recorded note, unchanged: The extended-release tablet Oxtellar XR is a separate FDA application with its own registration trial rather than a reformulation of Trileptal, and the two are not interchangeable at the pharmacy counter.
No source is stored against this line.
What is recorded as being sold
160 products list this as an active ingredient in the United States drug directory. 160 of them contain it and nothing else.
FDA National Drug Code directory · 72205-354 · read 2026-08-29
They are sold as for suspension, powder, suspension, tablet, tablet, extended release and tablet, film coated, taken oral.
FDA National Drug Code directory · 72205-354 · read 2026-08-29
The regulator's established pharmacologic class for it is anti-epileptic agent [epc] and decreased central nervous system disorganized electrical activity [pe].
FDA National Drug Code directory · 72205-354 · read 2026-08-29
76 published labels name it as an active ingredient. 76 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 4ebcb0e5-1c93-4b3f-8749-6835c56afce5 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 4ebcb0e5-1c93-4b3f-8749-6835c56afce5 · read 2026-08-29
OXCARBAZEPINE is oral at 3 DOSAGE FORMS AND STRENGTHS 150 mg Film-Coated Tablets: beige, film-coated, modified oval shaped tablet, scored on both sides, debossed "B2 | 92" on one side and plain on the other side. 300 mg Film-Coated Tablets: bei…, recorded as fda label in effect 2026-08-12 in the United States.
US prescribing information · 4ebcb0e5-1c93-4b3f-8749-6835c56afce5 · read 2026-08-30
Recorded price in US: 0.10375–0.31301 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 55 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
Recorded price in US: 0.11675 USD per one millilitre, 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 take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.
Questions worth asking
Which of the trials of Oxcarbazepine 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 unclear◇Read 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 oxcarbazepine monotherapy has been shown superior or equal to an established alternative: two of its four monotherapy trials compared 2,400 mg with 300 mg of the same drug, and SANAD later found no significant separation from carbamazepine in either direction
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 removing the reactive epoxide removed the hypersensitivity risk, when a quarter to a third of carbamazepine reactors still react
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That a 49.9% median reduction describes what the 2,400 mg dose achieves in practice, when most of that arm did not stay on it
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 it is a safe substitute in any epilepsy syndrome, when the label warns it can aggravate primary generalised seizures
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 unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
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Missing long-term data
No completed tested study window is recorded.
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Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
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A study that measures it, and a reviewer to sign it off.
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Formulation uncertainty
Several salts, forms or products of Oxcarbazepine 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.
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A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Mechanism not reviewed
No reviewed mechanism story exists for this substance.
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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 people◇Read 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.
Adjunctive trial in 692 adults: a clear, dose-ordered reduction against placebo
In plain words
Adults whose seizures were not controlled added oxcarbazepine or a dummy tablet on top of what they already took. At the highest dose the median seizure count fell by half; on placebo it fell by 7.6%. The effect got bigger at every dose step.
What was measured
Median percentage change in partial-onset seizure frequency from baseline, by fixed dose, against placebo
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Trial 2 of the label adjunctive programme enrolled 692 patients aged 15 to 66 on 1 to 3 concomitant anti-seizure drugs, stabilised over an 8-week baseline and randomised to fixed doses of oxcarbazepine 600, 1,200 or 2,400 mg/day or placebo, then maintained 24 weeks. Median percentage reduction in partial-onset seizure frequency was 49.9% at 2,400 mg/day (n=174), 40.2% at 1,200 mg/day (n=177), 26.4% at 600 mg/day (n=168) and 7.6% on placebo (n=173), p=0.0001 at every dose. The companion paediatric trial randomised 264 patients aged 3 to 17 to 30 to 46 mg/kg/day or placebo, with median reductions of 34.8% against 9.4%, p=0.0001.
Source
Oxcarbazepine United States prescribing information, Clinical Studies 14.2, Table 8 (openFDA drug label endpoint)
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 dose that halved seizures is the dose two-thirds of patients stopped taking
In plain words
The 49.9% figure comes from the 2,400 mg group. In that same group, more than 65% of patients quit because of side effects and only 46 of 174 finished the study. The number that gets quoted and the number of people who could live with it are not the same number.
What was measured
Discontinuation for adverse events above 65%, and 27% study completion, in the 2,400 mg/day arm
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
The label states directly, in the clinical studies section rather than in the safety section, that in the high-dose group of the adult adjunctive trial over 65% of patients discontinued treatment because of adverse events, and that only 46 patients (27%) in that group completed the 28-week study. It further notes this was an outcome not seen in the monotherapy studies. A median percentage reduction computed over a cohort that mostly left is a statement about the people who stayed, and the label does not report a responder analysis that carries the drop-outs forward.
Source
Oxcarbazepine United States prescribing information, Clinical Studies 14.2 (openFDA drug label endpoint)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
The monotherapy licence rests mostly on the drug being compared with itself
In plain words
Four trials support using oxcarbazepine on its own. Two of them compared 2,400 mg of oxcarbazepine with 300 mg of oxcarbazepine. That design shows the drug does more at a higher dose. It does not compare the drug with an alternative treatment.
What was measured
Time to meet pre-specified exit criteria, high dose against low dose of the same drug
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The label describes four randomised controlled double-blind monotherapy trials in a predominantly adult population: two against placebo and two using a randomised-withdrawal design comparing high dose (2,400 mg) with low dose (300 mg) after substituting oxcarbazepine for existing drugs. Of the two placebo-controlled trials, one enrolled 102 patients aged 11 to 62 who had been withdrawn from all anti-seizure drugs as inpatients during a pre-surgical evaluation and required 2 to 10 seizures in the 48 hours before randomisation, with an endpoint of time to meet exit criteria over roughly 10 days (p=0.0001); the other enrolled 67 untreated patients with newly diagnosed seizures with time to first seizure as the endpoint over 84 days (p=0.046). The two withdrawal trials enrolled 143 and 87 patients. The largest single number in the monotherapy programme is 143, and the comparator in that trial was a sub-therapeutic dose of the same molecule.
Source
Oxcarbazepine United States prescribing information, Clinical Studies 14.1 (openFDA drug label endpoint)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
caution
Review state
Written into the record, not signed off as a reviewed claim
The paediatric monotherapy trial found no difference between high and low dose
In plain words
A trial in 92 children compared a full dose with a token dose over five days on continuous video-EEG. The two were indistinguishable, p=0.90.
What was measured
Time to meet exit criteria on continuous video-EEG, high dose against low dose
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
A monotherapy trial in 92 paediatric patients aged 1 month to 16 years with inadequately controlled or new-onset partial seizures randomised them in hospital to oxcarbazepine 10 mg/kg/day or titration to 40 to 60 mg/kg/day within 3 days while the previous drug was withdrawn on day 2. Seizures were recorded by continuous video-EEG from day 3 to day 5, with exit criteria of three study-specific seizures or one prolonged seizure. The between-group difference in time to exit was not statistically significant (p=0.90). The label states in the same paragraph that the effectiveness of oxcarbazepine as monotherapy in children aged 4 to 16 was determined from the adult data plus pharmacokinetic and pharmacodynamic considerations, which is the mechanism by which a paediatric indication survived a failed paediatric trial.
Source
Oxcarbazepine United States prescribing information, Clinical Studies 14.1 (openFDA drug label endpoint)
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
Sodium below 125 mmol/L in 2.5% of treated patients and in none of the controls
In plain words
Across fourteen controlled epilepsy studies, 38 of 1,524 patients on oxcarbazepine dropped their blood sodium below 125. Nobody on placebo, carbamazepine, phenobarbital, phenytoin or valproate did.
What was measured
Proportion of patients recording a serum sodium below 125 mmol/L at any point during controlled treatment
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The label reports clinically significant hyponatraemia, defined as serum sodium below 125 mmol/L, in 2.5% of oxcarbazepine-treated patients (38 of 1,524) across the 14 controlled epilepsy studies, against no such patients on placebo or on the active controls, which were carbamazepine and phenobarbital in the adjunctive and substitution studies and phenytoin and valproate in the monotherapy initiation studies. It generally appeared in the first 3 months, though some patients first crossed the threshold more than a year in. Most were asymptomatic, but patients in trials were frequently monitored and some had the dose reduced or stopped, and the label states plainly that whether those manoeuvres prevented more severe events is unknown. Symptoms listed include nausea, malaise, headache, lethargy, confusion, obtundation, and an increase in seizure frequency or severity.
Source
Oxcarbazepine United States prescribing information, Warnings and Precautions 5.1 (openFDA drug label endpoint)
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 epoxide was removed. The hypersensitivity was not.
In plain words
Oxcarbazepine exists because the reactive metabolite of carbamazepine was blamed for its rashes and its toxicity. The redesign removed that metabolite. Between a quarter and a third of people who reacted to carbamazepine still react to oxcarbazepine.
What was measured
That removing the reactive epoxide metabolite would remove the hypersensitivity risk. It removed the interactions, not the rash.
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The design rationale was that placing a ketone at the 10-position prevents formation of carbamazepine-10,11-epoxide, forcing reduction to the 10-monohydroxy derivative instead of oxidation, and the pharmacokinetic half of that prediction held: there is no autoinduction and far less CYP3A4 induction. The immunological half did not. The label states that approximately 25% to 30% of patients who have had hypersensitivity reactions to carbamazepine will experience hypersensitivity reactions with oxcarbazepine, instructs that patients be specifically questioned about prior carbamazepine experience, and lists Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, anaphylaxis and angioedema among the reactions. The carbamazepine label separately notes limited evidence that HLA-B*1502 is a risk factor for SJS and TEN with other anti-seizure drugs and advises considering avoidance of them in carriers. The reactive-epoxide hypothesis for carbamazepine hypersensitivity therefore lost most of its explanatory force, and HLA-restricted immune recognition of the shared tricyclic scaffold replaced it.
Source
Oxcarbazepine United States prescribing information, Warnings and Precautions 5.2 and 5.3; carbamazepine United States prescribing information, HLA-B*1502 section (openFDA drug label endpoint)
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
SANAD: statistically indistinguishable from the drug it was built to replace
In plain words
In the largest first-line trial in focal epilepsy, oxcarbazepine and carbamazepine could not be separated on either of the two main outcomes, and both were behind lamotrigine on tolerability.
What was measured
Time to treatment failure and time to 12-month remission against four comparators
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
SANAD arm A randomised 1,721 patients across carbamazepine, gabapentin, lamotrigine, oxcarbazepine and topiramate. For time to treatment failure, lamotrigine had a non-significant advantage over oxcarbazepine (HR 1.15, 95% CI 0.86 to 1.54) while being significantly better than carbamazepine, gabapentin and topiramate. For time to 12-month remission, carbamazepine held a non-significant advantage over oxcarbazepine (HR 0.92, 95% CI 0.73 to 1.18). Oxcarbazepine recruited the smallest number of the five arms, so its confidence intervals are the widest in the trial and an absence of a significant difference here is weaker evidence of equivalence than it would be in a larger arm.
Written into the record, not signed off as a reviewed claim
EURAP: 3.0% malformation rate, inside the range the authors called background
In plain words
Ten of 333 pregnancies exposed to oxcarbazepine alone ended in a major birth defect. That is 3.0%, roughly half the carbamazepine figure and a third of the valproate one.
What was measured
Prevalence of major congenital malformations at 1 year, by drug and dose
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The EURAP prospective registry followed pregnancies on anti-epileptic monotherapy at conception from 42 countries between 1999 and 2016. Major congenital malformation prevalence at one year was 10 of 333 (3.0%) for oxcarbazepine, against 17 of 599 (2.8%) for levetiracetam, 74 of 2,514 (2.9%) for lamotrigine, 6 of 152 (3.9%) for topiramate, 107 of 1,957 (5.5%) for carbamazepine, 8 of 125 (6.4%) for phenytoin, 19 of 294 (6.5%) for phenobarbital and 142 of 1,381 (10.3%) for valproate. The authors placed lamotrigine, levetiracetam and oxcarbazepine within the background range for unexposed offspring. The oxcarbazepine denominator is the second smallest in the study, so the estimate is the least precise of the three. Separately, the label warns that MHD levels may fall through pregnancy and return after delivery.
Written into the record, not signed off as a reviewed claim
It can make generalised seizures worse, and the label says to stop it if that happens
In plain words
In people whose epilepsy is generalised rather than focal, this drug can increase seizures instead of reducing them. That is a recognised warning, not a rare surprise.
What was measured
Reported exacerbation or new onset of primary generalised seizures during treatment
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Warnings and Precautions 5.11 states that exacerbation of, or new onset of, primary generalised seizures has been reported with oxcarbazepine, that the risk is seen especially in children but may also occur in adults, and that oxcarbazepine should be discontinued if seizure aggravation occurs. This is a class property of sodium-channel blockers rather than a peculiarity of this molecule, and it is the reason getting the epilepsy syndrome right matters more than getting the drug right.
Source
Oxcarbazepine United States prescribing information, Warnings and Precautions 5.11 (openFDA drug label endpoint)
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
How many documents were read
76 documents were read for this substance.
RNAWiki source record
69 of them state the same halfLife, and they agree.
RNAWiki source record
39 of them state the same tMax, and they agree.
RNAWiki source record
76 of them state the same volumeOfDistribution, and they agree.
RNAWiki source record
Where else this substance is registered
FDA substance identifier (UNII)
VZI5B1W380
RxNorm concept
312136
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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
40 approved applications cover products containing this substance. The earliest was NDA021014, approved 20000114 to NOVARTIS.
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7 questions this page could not answer
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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.
A carbamazepine redesigned so the body reduces it to an active alcohol instead of oxidising it to a reactive epoxide, which halved seizure frequency at 2,400 mg/day against 7.6% on placebo in 692 adults but at a dose more than 65% of that group stopped taking, and whose monotherapy licence rests largely on trials that compared a high dose of the drug with a low dose of the same drug.
Recorded evidence blocks (10)
Q1
On the Oxcarbazepine label: indicated for what?
"Oxcarbazepine tablets are indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with…": indications and usage on Oxcarbazepine's label. DailyMed label · 4ebcb0e5-1c93-4b3f-8749-6835c56afce5 · 2026-08-12
Q2
46 registered trials of Oxcarbazepine — at which phases?
terminated; "Per PI, this study is not a clinical trial and was inadvertently entered in the system"
recorded 2026-09-01 · last checked 2026-09-04
Q4
Human studies of Oxcarbazepine used Trileptal FCT 300MG.002 — over how long?
Human studies of Oxcarbazepine used "Trileptal FCT 300MG.002". ClinicalTrials.gov · 2026-09-01
5 recorded entries; human; oral; also "2400mg SPN-804", "1200mg SPN-804", "oxcarbazepine 300 mg/5mL oral suspension"
Show the evidence
human
NCT00637234
Trileptal FCT 300MG.002
NCT00772603
2400mg SPN-804
NCT00772603
1200mg SPN-804
NCT00951600
oral; oxcarbazepine 300 mg/5mL oral suspension
NCT00951847
oral; oxcarbazepine 300 mg/5 mL oral suspension
recorded 2026-09-01 · last checked 2026-09-04
Q5
Oxcarbazepine's half-life is 2 hours — which schedules were studied?
2 hours, the half-life Oxcarbazepine's label states: "The half-life of the parent is about 2 hours, while the half-life of MHD is about 9 hours, so that MHD is responsible for most antiepileptic activity." DailyMed label · 4ebcb0e5-1c93-4b3f-8749-6835c56afce5 · 2026-08-12
Show the evidence
half lifepharmacokinetics
2 hours; The half-life of the parent is about 2 hours, while the half-life of MHD is about 9 hours, so that MHD is responsible for most antiepileptic activity.
metabolismpharmacokinetics
Following oral administration of oxcarbazepine tablets, oxcarbazepine is completely absorbed and extensively metabolized to its pharmacologically active 10-monohydroxy metabolite (MHD).
recorded 2026-08-12 · last checked 2026-09-04
Q6
Which 23 trials of Oxcarbazepine posted no result?
Posted no result
23 of 23 completed trials
Registrations
NCT00142025, NCT00050947, NCT00050934, NCT00616681, NCT00616863 and NCT00154362, and 17 more
Completion dates
oldest 2002-03; newest 2023-06-15
Show the evidence
Trial
NCT00142025
2002-03
NCT00050947
2004-02
NCT00050934
2004-06
NCT00616681
2004-07
NCT00616863
2004-07
NCT00154362
2004-10
14 further recorded trials
NCT00618046
2004-11
NCT00154323
2006-01
NCT00145691
2006-10
NCT00951600
2006-12
NCT00951847
2006-12
NCT00275925
2007-03
NCT00275912
2007-09-28
NCT00637234
2008-07
NCT01702623
2009-09
NCT01703468
2009-10
NCT00918047
2010-11
NCT01302275
2013-05
NCT02705768
2017-03
NCT02104661
2018-01-31
Q7
At the median, Oxcarbazepine's trials enrolled 60 people — anything larger?
Median enrolment
60
Largest enrolment
1037352
Registered trials counted
45
Q8
What do 2718 spontaneous reports say about Oxcarbazepine — 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.
Oxcarbazepine appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 2718 reaction mentions were counted: hyponatraemia 625; convulsion 461; seizure 428; somnolence 247. FAERS via Open Targets · CHEMBL1068 · 2026-06-24
Show the evidence
hyponatraemia
625
convulsion
461
seizure
428
somnolence
247
epilepsy
234
drug interaction
228
4 more recorded rows
abortion spontaneous
153
stevens-johnson syndrome
116
aggression
113
suicide attempt
113
recorded 2026-06-24 · last checked 2026-09-04
Q9
Which 10 reactions does Oxcarbazepine's label not list?
7.2 Effect of Other Drugs on Oxcarbazepine Tablets Strong inducers of cytochrome P450 enzymes and/or inducers of UGT (e.g., rifampin, carbamazepine, phenytoin and phenobarbital) have been shown to decrease the plasma/serum levels of MHD, the active metabolite of oxcarbazepine tablets (25% to 49%) [see Clinical Pharmacology (12.3) ].
drug_interactions
If oxcarbazepine tablets and strong CYP3A4 inducers or UGT inducers are administered concurrently, it is recommended that the plasma levels of MHD be monitored during the period of oxcarbazepine tablets titration.
pharmacokinetics
Pregnancy Due to physiological changes during pregnancy, MHD plasma levels may gradually decrease throughout pregnancy [ see Use in Specific Populations (8.1) ] Drug Interactions: • In Vitro Oxcarbazepine can inhibit CYP2C19 and induce CYP3A4/5 with potentially important effects on plasma concentrations of other drugs.
pharmacokinetics
In addition, several AEDs that are cytochrome P450 inducers can decrease plasma concentrations of oxcarbazepine and MHD.
pharmacokinetics
Oxcarbazepine was evaluated in human liver microsomes to determine its capacity to inhibit the major cytochrome P450 enzymes responsible for the metabolism of other drugs.
pharmacokinetics
Results demonstrate that oxcarbazepine and its pharmacologically active 10-monohydroxy metabolite (MHD) have little or no capacity to function as inhibitors for most of the human cytochrome P450 enzymes evaluated (CYP1A2, CYP2A6, CYP2C9, CYP2D6, CYP2E1, CYP4A9 and CYP4A11) with the exception of CYP2C19 and CYP3A4/5.
2 more recorded rows
Interaction statementpharmacokinetics
Although inhibition of CYP3A4/5 by oxcarbazepine and MHD did occur at high concentrations, it is not likely to be of clinical significance.
Interaction statementpharmacokinetics
In addition, oxcarbazepine and MHD induce a subgroup of the cytochrome P450 3A family (CYP3A4 and CYP3A5) responsible for the metabolism of dihydropyridine calcium antagonists, oral contraceptives and cyclosporine resulting in a lower plasma concentration of these drugs.
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
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