This page shows what was measured, who it was measured in, and what that does not settle.
What Tapentadol does in the body
Severe pain needing an opioid, including the nerve pain of diabetes, when other options are inadequate
Tapentadol does two things at once. It binds the mu-opioid receptor, weakly compared with oxycodone or morphine. And it blocks the reuptake of noradrenaline in the spinal cord, which strengthens the body’s own descending pain-suppression pathway — the same trick antidepressants like duloxetine use for nerve pain. The idea is that combining a weak push on each system gives full pain relief with less of the nausea and constipation that come from pushing hard on the opioid one alone. The prescribing information is careful about this: it says the exact mechanism of action is unknown, that the two properties come from preclinical studies, and that their clinical relevance is unclear.
What happened in people
A 0.56-point mean reduction against placebo on an 11-point pain scale at 12 weeks, NNTB 16 (95% CI 9 to 57)
✎ 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.
NUCYNTA (tapentadol) tablets United States prescribing information — Indications 1, boxed warning, Clinical Pharmacology 12.1 Mechanism of Action (NDA 022304… · a recorded source, not a stored snapshot
NUCYNTA ER (tapentadol extended-release tablets) United States prescribing information — Indications 1 and Clinical Studies 14.3, including the enrolment and… · a recorded source, not a stored snapshot
The limit that matters most
That noradrenaline reuptake inhibition explains the tolerability advantage — a mechanism the label calls preclinical and of unclear clinical relevance
Where it acts
Mu-opioid receptors of the spinal cord and brainstem, and the noradrenaline transporter on descending inhibitory neurons of the dorsal horn
Kind of result
Symptoms and quality of life
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
Its recorded molecular formula is C14H23NO∙HCl, weighing 257.80.
US prescribing information · 80938c30-9fe3-4c7d-9d9c-5476638cfb2d · read 2026-08-30
Where each sentence above came from
No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
A limit recorded against this substance. Not signed off as a reviewed claim.
The four opening statements run to 149 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 was measured, goal by goal
One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.
Registered studies list 11 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.
There is no single score. A strong test result and a weak life result are different facts.
Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
Goal
Life outcome
What a body can do
How a person feels
A test result
A step in the body
Harms
How long
Who was studied
Pain
∅Nothing in the sources checkedNo registered study lists a life outcome for this goal.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
…Waiting for a reviewer3 registered symptom measure.
∅Nothing in the sources checkedNo registered study lists a test result for this goal.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Pain
sum of pain intensity differences; time to reach the peak of pain in the btcp; post operative pain
Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.
What each mark on this table means
∅ Nothing in the sources checked
No registered study lists a life outcome for this goal.
… Waiting for a reviewer
3 registered symptom measure.
— Not recorded
Harms were not a registered measure for this goal.
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.
Mean change in pain intensity on an 11-point numerical rating scale at 12 weeks in chronic osteoarthritis or low back pain, tapentadol extended release against placebo and against oxycodone
✓ The study showed what it set out to show
Who was studied
Cochrane CD009923 — four oxycodone-controlled trials of tapentadol ER
How many people
4094
Study design
Systematic review and meta-analysis of four parallel-design randomised trials of moderate quality
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Against placebo, mean reduction 0.56 points (95% CI 0.92 to 0.20), responder RR 1.36 (1.13 to 1.64), NNTB 16 (9 to 57). Against oxycodone, 0.24 points (95% CI 0.43 to 0.05); responder RR 1.46 (0.92 to 2.32), not significant
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. All studies used last-observation-carried-forward imputation; the reviewers requested baseline-observation-carried-forward analyses and unpublished data from the manufacturer and were refused. Two of four oxycodone-controlled and one of three placebo-controlled studies reported no responder-rate data. Two studies were judged at high risk of bias. Moderate to high heterogeneity affected most efficacy and safety estimates.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral immediate-release tablets and oral solution, and oral extended-release tablets. Schedule II controlled substance in the United States.
Interval reported. 95% CI 0
Written into the record, not signed off as a reviewed claim.
NUCYNTA (tapentadol) tablets United States prescribing information — Indications 1, boxed warning, Clinical Pharmacology 12.1 Mechanism of Action (NDA 022304… · a recorded source, not a stored snapshot
NUCYNTA ER (tapentadol extended-release tablets) United States prescribing information — Indications 1 and Clinical Studies 14.3, including the enrolment and… · a recorded source, not a stored snapshot
A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) Extended Release in Patients With Moderate to Severe Chronic Low Back Pain — Clinical… · a recorded source, not a stored snapshot
Change from baseline in average pain intensity on an 11-point numerical rating scale over the last week of the 12-week maintenance period
✓ The study showed what it set out to show
Who was studied
NCT00449176 (tapentadol ER in moderate to severe chronic low back pain)
How many people
981
Study design
Phase 3, randomised, quadruple-masked, parallel-group, oxycodone- and placebo-controlled
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
Mean change −2.9 (SD 2.66) on tapentadol ER (n=312), −2.9 (SD 2.52) on oxycodone CR (n=323) and −2.1 (SD 2.33) on placebo (n=316); tapentadol against placebo mean difference −0.8 (95% CI −1.22 to −0.47), ANCOVA p<0.001
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 trial was powered against placebo, not against oxycodone: the posted analysis plan states the primary null hypothesis was that tapentadol ER did not differ from placebo, with 314 subjects per group giving 90% power to detect a mean difference of 0.7. No tapentadol-against-oxycodone comparison is posted, and the two active arms reported an identical mean change of −2.9. This is one of the three 12-week phase 3 studies pooled in the Cochrane review.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral immediate-release tablets and oral solution, and oral extended-release tablets. Schedule II controlled substance in the United States.
Interval reported. 95% CI −1
Written into the record, not signed off as a reviewed claim.
NUCYNTA (tapentadol) tablets United States prescribing information — Indications 1, boxed warning, Clinical Pharmacology 12.1 Mechanism of Action (NDA 022304… · a recorded source, not a stored snapshot
NUCYNTA ER (tapentadol extended-release tablets) United States prescribing information — Indications 1 and Clinical Studies 14.3, including the enrolment and… · a recorded source, not a stored snapshot
A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) Extended Release in Patients With Moderate to Severe Chronic Low Back Pain — Clinical… · a recorded source, not a stored snapshot
What we know
RNAWiki holds 2 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What happened in people◇Read from sources, not yet reviewed
How close this is to real life
The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.
□Living longer, or avoiding a major eventNo evidence recorded. Death, a heart attack, a stroke, a hospital stay.No registered study measures this.
■What a body can do day to dayEvidence recorded. Walking, dressing, breathing, recovering.1 registered measure of this kind.
■Measured performanceEvidence recorded. How much was lifted, how far was run, how fast.1 registered measure of this kind.
■Symptoms and quality of lifeEvidence recorded. Pain, tiredness, mood, sleep, as the person rated it.3 registered measures of this kind.
□A number that stands in for healthNo evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.No registered study measures this.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
□AnimalsNo evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
□Cells in a dishNo evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
□A guess from softwareNo evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.
Higher on these steps means closer to something a person would feel. It does not mean better done.
What it changes in the 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
Tapentadol
What a person takes: Oral immediate-release tablets and oral solution, and oral extended-release tablets. Schedule II controlled substance in the United States..
The measurement behind this step
The immediate-release tablet is dosed several times a day for acute pain and is licensed down to age 6 at a body weight of at least 40 kg; the extended-release tablet is twice daily and is the form studied in the chronic pain and diabetic neuropathy programmes. Tapentadol is not a prodrug and does not require CYP2D6 activation, so the metaboliser variability that dominates codeine and tramadol does not apply; clearance is chiefly by glucuronidation.
Getting in
One molecule designed to do two jobs
Tapentadol was built from the working half of tramadol, as a single compound rather than a mixture that the liver has to activate. It does not depend on a liver enzyme to become a painkiller.
╌╌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
A single-enantiomer 3-aryl-propylamine, C14H23NO, with two adjacent stereocentres. Unlike tramadol and codeine it is not a CYP2D6 prodrug; it is cleared chiefly by glucuronidation, which removes the metaboliser lottery those drugs carry.
NUCYNTA (tapentadol) tablets United States prescribing information — Indications 1, boxed warning, Clinical Pharmacology 12.1 Mechanism of Action (NDA 022304… · a recorded source, not a stored snapshot
NUCYNTA ER (tapentadol extended-release tablets) United States prescribing information — Indications 1 and Clinical Studies 14.3, including the enrolment and… · a recorded source, not a stored snapshot
What it acts on
A weaker grip on the opioid receptor
It binds the mu-opioid receptor much less tightly than morphine or oxycodone. On its own that would make it a poor painkiller.
╌╌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
Mu-opioid receptor agonism with substantially lower affinity than morphine. The label states the exact mechanism of action is unknown and that the MOR agonist and noradrenaline reuptake inhibitor properties are shown in preclinical studies whose clinical relevance is unclear.
NUCYNTA (tapentadol) tablets United States prescribing information — Indications 1, boxed warning, Clinical Pharmacology 12.1 Mechanism of Action (NDA 022304… · a recorded source, not a stored snapshot
NUCYNTA ER (tapentadol extended-release tablets) United States prescribing information — Indications 1 and Clinical Studies 14.3, including the enrolment and… · a recorded source, not a stored snapshot
The change it makes
And a block on the noradrenaline transporter
At the same time it stops the spinal cord clearing away noradrenaline, which is the signal the brain uses to turn pain down from above. That is the same pathway antidepressants use in nerve pain.
╌╌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
Inhibition of the noradrenaline transporter SLC6A2 in the spinal dorsal horn, raising synaptic noradrenaline at descending inhibitory terminals. The label attributes analgesia in animal models to both properties together.
NUCYNTA (tapentadol) tablets United States prescribing information — Indications 1, boxed warning, Clinical Pharmacology 12.1 Mechanism of Action (NDA 022304… · a recorded source, not a stored snapshot
NUCYNTA ER (tapentadol extended-release tablets) United States prescribing information — Indications 1 and Clinical Studies 14.3, including the enrolment and… · a recorded source, not a stored snapshot
What that does for a person
What that produced on the pain scale
Against a dummy tablet, 0.56 of a point out of ten. Against oxycodone, 0.24 of a point. Sixteen people treated for one extra responder over placebo.
╌╌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
Cochrane CD009923: against placebo, mean 11-point NRS reduction 0.56 (95% CI 0.92 to 0.20) at 12 weeks, responder risk ratio 1.36 (1.13 to 1.64), NNTB 16 (9 to 57). Against oxycodone, 0.24 points (0.43 to 0.05), responder risk ratio 1.46 (0.92 to 2.32), not significant.
NUCYNTA (tapentadol) tablets United States prescribing information — Indications 1, boxed warning, Clinical Pharmacology 12.1 Mechanism of Action (NDA 022304… · a recorded source, not a stored snapshot
NUCYNTA ER (tapentadol extended-release tablets) United States prescribing information — Indications 1 and Clinical Studies 14.3, including the enrolment and… · a recorded source, not a stored snapshot
What that does for a person
And on the reason people stop taking it
Half as many people quit tapentadol for side effects as quit oxycodone. Six patients treated, one fewer withdrawal. This is the finding the drug actually earns.
╌╌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
50% relative reduction in discontinuation for adverse effects against oxycodone (95% CI 42% to 60%), NNTB 6 (5 to 7) over 12 weeks; 9% reduction in overall adverse effects (NNTH 18). Against placebo, a 2.7-fold increase in discontinuation for adverse effects (NNTH 10).
NUCYNTA (tapentadol) tablets United States prescribing information — Indications 1, boxed warning, Clinical Pharmacology 12.1 Mechanism of Action (NDA 022304… · a recorded source, not a stored snapshot
NUCYNTA ER (tapentadol extended-release tablets) United States prescribing information — Indications 1 and Clinical Studies 14.3, including the enrolment and… · a recorded source, not a stored snapshot
What that does for a person
The part the trials could not check
Every trial assumed a person who dropped out kept the pain score they had when they left. The reviewers asked for the analysis done the other way. The manufacturer said no.
╌╌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
All four included studies used last-observation-carried-forward imputation. Baseline-observation-carried-forward analyses and unpublished data were requested from the manufacturer and denied. Two of four oxycodone-controlled and one of three placebo-controlled studies reported no responder rates. Two studies were at high risk of bias.
NUCYNTA (tapentadol) tablets United States prescribing information — Indications 1, boxed warning, Clinical Pharmacology 12.1 Mechanism of Action (NDA 022304… · a recorded source, not a stored snapshot
NUCYNTA ER (tapentadol extended-release tablets) United States prescribing information — Indications 1 and Clinical Studies 14.3, including the enrolment and… · a recorded source, not a stored snapshot
No suggested links are held for this record, so nothing is hidden from this path.
What we know
The record describes 6 steps from taking it to an effect in a person.
How we know it
Each step names the study behind it in the technical detail beside it.
What this does not prove
A change inside the body is a reason to look. It is not a result in a person.
Why it matters
A reader can see exactly where the chain stops being measured in people.
What we still do not know
No reviewed claim binds any of these steps to a named population.
What it would be like to take◇Read from sources, not yet reviewed
Felt, measured, or meaningful
Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.
Felt
Things a person could notice without a test.
sum of pain intensity differences
time to reach the peak of pain in the btcp
post operative pain
Measured
Things only a test, a scale or a device shows.
No registered study measured anything of this kind.
Meaningful
Things that change how a life goes, not only a number.
changes in gait variability
A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.
Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.
Measured, but not felt. A number moves. The person notices nothing. Both can be true.
Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.
Matters, but takes years. The result that counts may take longer than anyone would keep watching.
Names that fit none of the three (7)
responder rate
pharmacokinetic profile
severity of adverse events
colonic transit geometric center at 24 hours
rate constant
number and duration of episodes of btcp
maximum intensity of btcp
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
What it would be like to take◇Read from sources, not yet reviewed
How long anything takes
Nine different lengths of time that get confused with each other. None of them is worked out from another.
Before anything is noticed.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before a test result moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before performance moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
How long the result was watched.No finished study window is recorded for a study that tested this substance.
How long people took it.How long people actually took it is not stored. The study window is not the same thing.
How long people were followed.Follow-up length is not stored separately. It is never read off the study window, which would be a different thing.
How fast the body clears it. 4 hours hours
Read from the label, which states: “The terminal half-life is on average 4 hours after oral administration.”
How long effects linger.RNAWiki does not store this separately, and never works it out from another figure on this page.
Beyond the studies. Nothing is recorded about the long term.
The longest finished study sets the edge of what anyone measured.
A study window is not how long people took it, and neither is how long they were followed. Where RNAWiki holds only one of the three, it shows one.
What is missing or 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.
Adults with severe pain including diabetic nerve pain, and — for the immediate-release tablet only — children aged 6 and over weighing at least 40 kg.
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “The safety and effectiveness of NUCYNTA (tapentadol) tablets in pediatric patients less than 6 years of age have not been established.”
US prescribing information · 80938c30-9fe3-4c7d-9d9c-5476638cfb2d · read 2026-08-30
On older people, the label states: “Of the total number of patients in Phase 2/3 double-blind, multiple-dose clinical studies of NUCYNTA tablets, 19% were 65 and over, while 5% were 75 and over.”
US prescribing information · 80938c30-9fe3-4c7d-9d9c-5476638cfb2d · read 2026-08-30
On people who are pregnant, the label states: “Data Animal Data Tapentadol HCl was evaluated for teratogenic effects in pregnant rats and rabbits following subcutaneous exposure during organogenesis.”
US prescribing information · 80938c30-9fe3-4c7d-9d9c-5476638cfb2d · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of tapentadol in human milk, the effects on the breastfed infant, or the effects on milk production.”
US prescribing information · 80938c30-9fe3-4c7d-9d9c-5476638cfb2d · read 2026-08-30
On people with reduced liver function, the label states: “Administration of tapentadol resulted in higher exposures and serum levels of tapentadol in subjects with impaired hepatic function compared to subjects with normal hepatic function [see Clinical Pharmacology (12.3) ] .”
US prescribing information · 80938c30-9fe3-4c7d-9d9c-5476638cfb2d · read 2026-08-30
On people with reduced kidney function, the label states: “Use of NUCYNTA tablets in patients with severe renal impairment (creatinine clearance less than 30 mL/minute) is not recommended.”
US prescribing information · 80938c30-9fe3-4c7d-9d9c-5476638cfb2d · read 2026-08-30
Where the result stopped carrying
The responder-rate comparison against oxycodone, which was not statistically significant (RR 1.46, 95% CI 0.92 to 2.32)
The request for baseline-observation-carried-forward analyses and unpublished data, denied by the manufacturer
Responder-rate reporting in three of the seven relevant study comparisons, absent altogether
The mechanism claim as a regulatory statement: exact mechanism unknown, clinical relevance unclear, animal models
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 for a different goal
The studies measured something else entirely.
On this record: Some registered studies measured things that match no goal on this page.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to 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 immediate-release tablets and oral solution, and oral extended-release tablets. Schedule II controlled substance in the United States.
✎ 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: S2, S5, S6.
No source is stored against this line.
What is in the pack
The immediate-release tablet is dosed several times a day for acute pain and is licensed down to age 6 at a body weight of at least 40 kg; the extended-release tablet is twice daily and is the form studied in the chronic pain and diabetic neuropathy programmes.
✎ 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: Tapentadol is not a prodrug and does not require CYP2D6 activation, so the metaboliser variability that dominates codeine and tramadol does not apply; clearance is chiefly by glucuronidation.
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
Class boxed warnings for addiction, abuse and misuse; life-threatening respiratory depression; accidental ingestion; neonatal opioid withdrawal syndrome; risks from concomitant benzodiazepines, other CNS depressants and alcohol; and the opioid analgesic REMS. Because of the noradrenergic mechanism, monoamine oxidase inhibitors are contraindicated and serotonin syndrome is a warning when combined with serotonergic drugs — a class of interaction that does not apply to morphine or oxycodone. Against placebo the drug carries a 2.7-fold higher risk of discontinuation for adverse effects; against oxycodone, about half.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
NUCYNTA (tapentadol) tablets United States prescribing information — Indications 1, boxed warning, Clinical Pharmacology 12.1 Mechanism of Action (NDA 022304… · a recorded source, not a stored snapshot
NUCYNTA ER (tapentadol extended-release tablets) United States prescribing information — Indications 1 and Clinical Studies 14.3, including the enrolment and… · 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 immediate-release tablets and oral solution, and oral extended-release tablets. Schedule II controlled substance in the United States.
✎ 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
Tapentadol is not a prodrug and does not require CYP2D6 activation, so the metaboliser variability that dominates codeine and tramadol does not apply; clearance is chiefly by glucuronidation.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on which forms are sold and how they compare.
No source is stored against this line.
What is recorded as being sold
26 products list this as an active ingredient in the United States drug directory. 26 of them contain it and nothing else.
FDA National Drug Code directory · 17180-9780 · read 2026-08-29
They are sold as powder, solution, tablet, film coated and tablet, film coated, extended release, taken oral.
FDA National Drug Code directory · 17180-9780 · read 2026-08-29
The regulator's established pharmacologic class for it is opioid agonist [epc] and opioid agonists [moa].
FDA National Drug Code directory · 17180-9780 · read 2026-08-29
6 published labels name it as an active ingredient. 6 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 80938c30-9fe3-4c7d-9d9c-5476638cfb2d · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 80938c30-9fe3-4c7d-9d9c-5476638cfb2d · read 2026-08-29
Nucynta is oral at 3 DOSAGE FORMS AND STRENGTHS Tablets: 50 mg, 75 mg, 100 mg. 50 mg: round, biconvex and film-coated yellow tablets with "O-M" on one side and "50" on the other side. 75 mg: round, biconvex and film-coated yellow-orange t…, recorded as fda label in effect 2025-12-30 in the United States.
US prescribing information · 80938c30-9fe3-4c7d-9d9c-5476638cfb2d · read 2026-08-30
Recorded price in US: 8.89848–14.09962 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 6 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.
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 Tapentadol 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 noradrenaline reuptake inhibition explains the tolerability advantage — a mechanism the label calls preclinical and of unclear clinical relevance
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 tapentadol is a meaningfully better analgesic than oxycodone, on a pooled difference of 0.24 of a point on an 11-point scale
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That the randomised-withdrawal results in diabetic neuropathy estimate the benefit for an unselected patient starting the drug
Why it sounds right. It follows from something real on this page: a body step, an animal result or a related finding.
The missing step. Nobody measured this in people for this use, or the study that did measure it did not show it.
What would change this
A study in people, for this exact use, measuring this exact thing, that a reviewer signs off.
RNAWiki has not yet published a reviewed conclusion for this use.
✗Goes past the evidence
That the reported efficacy is robust to how dropouts were handled, when only last-observation-carried-forward analyses exist and the alternative was refused
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.
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 Tapentadol 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 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.
Against oxycodone, a quarter of a point on a ten-point scale
In plain words
Four trials in over four thousand patients compared tapentadol with oxycodone. On pain, tapentadol was ahead by 0.24 of a point out of ten. Against placebo it was ahead by 0.56 of a point, with sixteen people needing treatment for one extra responder.
What was measured
Mean change in pain intensity on an 11-point numerical rating scale at 12 weeks, tapentadol against placebo and against oxycodone
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Santos and colleagues included four parallel-design randomised trials of moderate quality, totalling 4,094 patients with osteoarthritis, back pain or both. Three were 12-week phase 3 studies and the fourth a 52-week open-label safety study; all four were oxycodone-controlled and three were also placebo-controlled. Against placebo, tapentadol gave a mean reduction of 0.56 points (95% CI 0.92 to 0.20) on the 11-point numerical rating scale at 12 weeks and a 1.36-fold increase in the chance of responding (95% CI 1.13 to 1.64), giving a number needed to treat for one additional beneficial outcome of 16 (95% CI 9 to 57) over 12 weeks. Against oxycodone, pooled data showed a 0.24-point greater reduction in pain intensity (95% CI 0.43 to 0.05), and the two studies that reported responder rates showed a non-significant 1.46-fold increase in responding (95% CI 0.92 to 2.32). Moderate to high heterogeneity was found for the efficacy estimates. The reviewers conclude that tapentadol extended release reduces pain intensity compared with placebo and oxycodone, but that the clinical significance is uncertain because of the modest difference between interventions, the heterogeneity, high withdrawal rates, missing responder data and the imputation problem.
Written into the record, not signed off as a reviewed claim
The manufacturer refused the data the reviewers needed
In plain words
Every trial handled dropouts by assuming the last pain score a person gave still applied after they quit. The Cochrane team asked the manufacturer for the analysis done the other way, and for the unpublished data. The request was denied.
What was measured
Availability of baseline-observation-carried-forward sensitivity analyses and unpublished trial data on request: denied
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
The Cochrane review states that all trials reported last-observation-carried-forward as the imputation method, that the reviewers requested baseline-observation-carried-forward imputed analyses and any unpublished data from the manufacturer, and that the manufacturers denied the request. The choice of imputation is not a technicality here. LOCF credits a patient who withdraws with whatever improvement they had recorded at the moment of withdrawal; BOCF resets them to their starting pain. In a trial designed around the claim that fewer patients withdraw on the drug than on the comparator, the imputation method interacts directly with the primary endpoint, and the direction of that interaction favours the arm with fewer withdrawals. The review also records that two of the four oxycodone-controlled studies and one of the three placebo-controlled studies did not provide responder-rate data at all, and that two studies were at high risk of bias. The reviewers list "impossibility to use BOCF as imputation method" among the explicit reasons the clinical significance of the results is uncertain.
Written into the record, not signed off as a reviewed claim
The dual mechanism is preclinical, and the label says its relevance is unclear
In plain words
Tapentadol is sold on doing two things at once: opioid receptor plus noradrenaline. The prescribing information says the exact mechanism of action is unknown, that both properties come from preclinical studies, and that the clinical relevance is unclear.
What was measured
That tapentadol’s tolerability advantage is produced by its noradrenaline reuptake inhibition sparing mu-opioid load — a mechanism the label describes as preclinical, of unclear clinical relevance, and resting on an exact mechanism it says is unknown
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Section 12.1 of the NUCYNTA label reads in full: "Tapentadol is a centrally-acting synthetic analgesic. The exact mechanism of action is unknown. Although the clinical relevance is unclear, preclinical studies have shown that tapentadol is a mu-opioid receptor (MOR) agonist and a norepinephrine reuptake inhibitor (NRI). Analgesia in animal models is derived from both of these properties." Three qualifications in four sentences: mechanism unknown, relevance unclear, animal models. The commercial account — that a lower mu-opioid load explains the reduced gastrointestinal burden and that noradrenergic action makes up the analgesia — is a mechanism-to-outcome inference the regulator explicitly declines to endorse. What has been measured is the outcome, not the mechanism: half the discontinuation for adverse effects against oxycodone, and 0.24 of a point more pain relief. Those two findings are compatible with the dual-mechanism story and also with several others, and no trial in the programme was designed to distinguish between them.
Source
NUCYNTA (tapentadol) United States prescribing information, Clinical Pharmacology 12.1 Mechanism of Action (NDA 022304)
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
contested
Review state
Written into the record, not signed off as a reviewed claim
The tolerability advantage is real, and it is the strongest thing on this page
In plain words
Compared with oxycodone, half as many people stopped tapentadol because of side effects. Six patients treated, one fewer withdrawal. That is the drug’s genuine finding.
What was measured
Risk of discontinuation due to adverse effects over 12 weeks, tapentadol against oxycodone and against placebo
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
In the same Cochrane analysis, tapentadol against oxycodone was associated with a 50% reduction in the risk of discontinuing treatment due to adverse effects (95% CI 42% to 60%), giving a number needed to treat for one additional beneficial outcome of 6 (95% CI 5 to 7) over 12 weeks. It was also associated with a 9% reduction in the overall risk of adverse effects (95% CI 4% to 15%, NNTH 18, 95% CI 12 to 35) and a non-significant 43% reduction in serious adverse effects. Against placebo the direction reverses, as it must: tapentadol carried a 2.7-fold increase in the risk of discontinuing for adverse effects (95% CI 2.05 to 3.52, NNTH 10, 95% CI 7 to 12). Read together, those two comparisons say what the drug is: an opioid, with an opioid’s adverse-effect burden relative to nothing, and about half of oxycodone’s burden relative to an equally analgesic opioid. Moderate to high heterogeneity applies to most of these safety estimates.
Written into the record, not signed off as a reviewed claim
The nerve-pain licence rests on two enriched-enrolment withdrawal trials
In plain words
The diabetic nerve pain indication comes from two studies where everyone first took the drug openly for three weeks, and only those who tolerated it and improved were randomised. In the first, 591 started and 389 were randomised; a third dropped out during the open phase.
What was measured
That the randomised-withdrawal result in diabetic peripheral neuropathy estimates the benefit for a patient starting tapentadol — when 34% of Study DPN-1 and 28% of Study DPN-2 were removed before randomisation for intolerance or non-response
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The NUCYNTA ER label describes both DPN studies: patients received open-label tapentadol ER for three weeks and were titrated to an individually stable dose, and only those who had tolerated the drug and shown at least a 1-point improvement in pain intensity on the 11-point NRS were randomised to continue or switch to placebo for 12 weeks. In Study DPN-1, 591 patients entered open-label treatment and 389 met the randomisation criteria; 34% discontinued open-label tapentadol ER during titration. In Study DPN-2, 459 entered and 320 were randomised; 22% discontinued during titration and a further 6% were not randomised because they failed to achieve a 1-point improvement. Both studies then showed significantly greater pain reduction on tapentadol ER than placebo over 12 weeks. That is a valid measurement of what happens when the drug is withdrawn from people it was already suiting. It is not an estimate of what happens to an unselected patient with diabetic neuropathy who starts it, and the label’s own figures — a third of DPN-1 lost before randomisation — show how large the difference between those two populations is.
Source
NUCYNTA ER (tapentadol extended-release tablets) United States prescribing information, Clinical Studies 14.3 Neuropathic Pain Associated with Diabetic Peripheral Neuropathy (NDA 200533)
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
Sixty-three times the price, for a quarter of a point
In plain words
A tapentadol tablet costs pharmacies about twelve dollars fifty. An oxycodone tablet costs about twenty cents. The measured pain difference between them is 0.24 of a point on a scale of ten.
What was measured
Pharmacy acquisition cost per unit against pooled pain-intensity difference on an 11-point scale, tapentadol against oxycodone
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
The CMS National Average Drug Acquisition Cost survey effective 19 August 2026 lists tapentadol at US$12.52 per unit across 8 generic products and oxycodone at US$0.1974 per unit across 193 — a ratio of about 63 to 1. The pooled Cochrane comparison of the two, across four trials and 4,094 patients, found tapentadol ahead by 0.24 points on an 11-point scale (95% CI 0.43 to 0.05), with a non-significant responder-rate difference. In the largest of the individual low back pain studies, NCT00449176, the posted registry result gives an identical mean pain change of −2.9 on tapentadol ER (n=312) and −2.9 on oxycodone CR (n=323), against −2.1 on placebo (n=316); the trial was powered to beat placebo, not the active comparator, and no tapentadol-against-oxycodone analysis is posted. The measured advantage that survives is tolerability: NNTB 6 for avoiding a discontinuation due to adverse effects over 12 weeks. That is a real clinical good and it is the basis on which the price should be argued, rather than on analgesic superiority, which the data do not support at any clinically meaningful size. Nothing here says the drug should not be used; it says what it is being bought.
This order is fixed in code and does not count clicks or time on the page.
What is not here
3 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 it may clash with — found nothing in the sources checked.
Other ways to the same goal — found nothing in the sources checked.
What changed on this page — found nothing in the sources checked.
The record as stored
The full record, for auditing
Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.
The older medicine-wide conclusion held in this record
Written for a clinical reader, and about the medicine as a whole rather than about one indication, population and set of trials. RNAWiki does not treat it as a programme conclusion and no reviewer has signed it off in that form. It is here word for word because it is what the record holds.
A mu-opioid agonist and noradrenaline reuptake inhibitor whose Cochrane review of four trials and 4,094 patients found it beat placebo by 0.56 of a point on an 11-point pain scale (NNT 16, 95% CI 9 to 57) and oxycodone by 0.24 of a point, with genuinely halved discontinuation for adverse effects against oxycodone (NNTB 6) — sold at about US$12.52 a tablet against US$0.20 for oxycodone, on a dual mechanism its own label calls preclinical and of unclear clinical relevance, and with the manufacturer having refused the reviewers’ request for the unpublished data needed to check the imputation method.
Recorded evidence blocks (10)
Q2
What did Tapentadol's largest trial (1089 people) and its longest (4.9 years) measure?
1089 people in Tapentadol's largest registered study, 4.9 years in its longest registered window, measuring Pharmacokinetic Profile of Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Adolescents (Age 12 to Less Than 18 Years). ClinicalTrials.gov · 2026-09-01
13 phase3, 11 phase2, 7 phase4, 3 na, 2 na or unstated, 2 phase1; NCT00472303; 2012-06; no ageing endpoint recorded. Last human test completed 2025, NCT07320781.
Interpretation These counts include studies where Tapentadol was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.
Show the evidence
phase3
13
phase2
11
phase4
7
na
3
na or unstated
2
phase1
2
1 more recorded row
Last recorded human testNCT07320781
2025-10-10
recorded 2026-09-01 · last checked 2026-09-04
Q3
Tapentadol was tested only in human — what did it show?
Pharmacokinetic Profile of Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Adolescents (Age 12 to Less Than 18 Years). — the recorded outcome words.
Show the evidence
humanNCT01729728
biomarker; Pharmacokinetic Profile of Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Adolescents (Age 12 to Less Than 18 Years).; 36
3 recorded entries; human; also "Tapentadol 50 mg Oral Tablet", "Tapentadol 100 MG", "Tapentadol 100 MG Oral Tablet"
Show the evidence
human
NCT03121547
Tapentadol 50 mg Oral Tablet
NCT03351517
Tapentadol 100 MG
NCT03604354
Tapentadol 100 MG Oral Tablet
recorded 2026-09-01 · last checked 2026-09-04
Q6
Tapentadol's half-life is 4 hours — which schedules were studied?
4 hours, the half-life Tapentadol's label states. openfda-label · e0ecb809-6a55-4afe-b981-b8f174e5c344 · 2026-08-30
bioavailability 32% %.
Show the evidence
half life
4 hours hours; The terminal half-life is on average 4 hours after oral administration.
bioavailability
32% %; 12.3 PHARMACOKINETICS Absorption The mean absolute bioavailability after single-dose administration (fasting) of NUCYNTA is approximately 32% due to extensive first-pass metabolism.
metabolism
12.3 Pharmacokinetics Absorption The mean absolute bioavailability after single-dose administration (fasting) of tapentadol hydrochloride is approximately 32% due to extensive first-pass metabolism.
recorded 2026-08-30 · last checked 2026-09-04
Q7
Which of changes in gait variability, colonic transit geometric center at 24 hours and maximum intensity of btcp did Tapentadol's trials measure?
changes in gait variability, colonic transit geometric center at 24 hours and maximum intensity of btcp lead 11 outcome terms across Tapentadol's trials. ClinicalTrials.gov · 2026-09-01
sum of pain intensity differences, colonic transit geometric center at 24 hours, rate constant, number and duration of episodes of btcp, time to reach the peak of pain in the btcp and maximum intensity of btcp follow.
Show the evidence
responder rate
1
pharmacokinetic profile
1
severity of adverse events
1
sum of pain intensity differences
1
colonic transit geometric center at 24 hours
1
rate constant
1
5 more recorded rows
number and duration of episodes of btcp
1
time to reach the peak of pain in the btcp
1
maximum intensity of btcp
1
changes in gait variability
1
post operative pain
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
What will the one ongoing trial of Tapentadol report, and when?
"Tapentadol vs Tramadol in Arthroscopic Rotator Cuff Repair"; n 64; "Post-operative pain"; 2029-09-01
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which 13 trials of Tapentadol posted no result?
Posted no result
13 of 13 completed trials
Registrations
NCT00745069, NCT00806247, NCT01877226, NCT01134536, NCT01725087 and NCT01946555, and 7 more
Completion dates
oldest 2005-08; newest 2024-07-05
Show the evidence
Trial
NCT00745069
2005-08
NCT00806247
2005-08
NCT01877226
2008-10
NCT01134536
2013-03
NCT01725087
2014-07
NCT01946555
2015-12
7 further recorded trials
NCT03121547
2016-01-29
NCT03351517
2018-09-07
NCT02604446
2019-02
NCT03314792
2019-02-28
NCT03604354
2020-05-19
NCT05999890
2021-12-30
NCT07587645
2024-07-05
Q10
At the median, Tapentadol's trials enrolled 93 people — anything larger?
Median enrolment
93
Largest enrolment
1089
Registered trials counted
36
Q11
Tapentadol and CYP2C19, CYP2C9 and CYP2D6: shared by which compounds?
CYP2C19, CYP2C9 and CYP2D6 appear in Tapentadol's recorded interaction sentences, 3 in all. openfda-label+europepmc · 2026-08-30
Interpretation pharmacokinetics
Show the evidence
CYP2C19pharmacokinetics
Tapentadol is additionally metabolized to N-desmethyl tapentadol (13%) by CYP2C9 and CYP2C19 and to hydroxy tapentadol (2%) by CYP2D6, which are further metabolized by conjugation.
CYP2C9pharmacokinetics
Tapentadol is additionally metabolized to N-desmethyl tapentadol (13%) by CYP2C9 and CYP2C19 and to hydroxy tapentadol (2%) by CYP2D6, which are further metabolized by conjugation.
CYP2D6pharmacokinetics
Tapentadol is additionally metabolized to N-desmethyl tapentadol (13%) by CYP2C9 and CYP2C19 and to hydroxy tapentadol (2%) by CYP2D6, which are further metabolized by conjugation.
recorded 2026-08-30 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
✗ 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: 8 source rows
✓ no critical contamination: no quarantine open
✓ canonical metadata passed: slug and display name present
✓ no raw internal fields: enforced by the copy-contract test over the rendered page
This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.