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Oxycodone

  • Prescription medicine
  • Withdrawn
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Oxycodone does in the body

Pain severe enough to need an opioid, when other treatments have not worked

Oxycodone binds the mu-opioid receptor, the same switch the body’s own endorphins use. Where a pain signal enters the spinal cord, the receptor quietens the nerve that would pass it upward; in the brainstem it turns up a descending system that suppresses the signal from above; and in the limbic system it changes how unpleasant the remaining pain feels. Those are three separate effects and the third one — pain that is still there but no longer bothers you — is also the effect that makes the drug pleasurable and habit-forming. The same receptor in the breathing centre of the brainstem is what makes an overdose fatal: it does not raise the alarm when carbon dioxide builds up, and a person stops breathing.

What happened in people

No difference in pain-related function against non-opioid stepped therapy over 12 months in 240 randomised patients (BPI interference 3.4 against 3.3, overall p=0.58)

Source-linked record

Where this came from

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

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

The limit that matters most

That fewer than 1% of opioid-treated pain patients become addicted — traced to four cases among 11,882 hospital inpatients in a 1980 letter, cited 608 times, 80.8% of those citations omitting that the patients were inpatients

Where it acts
Mu-opioid receptors on the presynaptic terminals of the spinal dorsal horn and in the periaqueductal grey and rostral ventromedial medulla; and the same receptor in the pre-Bötzinger complex of the brainstem, which is why the drug that stops pain also stops breathing
Kind of result
What a body can do day to day
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

  • 19 registered substances share the start of this name, which is why a search for it can return more than one thing.

    FDA substance registry · CD35PMG570 · read 2026-08-29

Where each sentence above came from

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

Shown as the opening line on this page.

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

The four opening statements run to 163 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 peopleRead from sources, not yet reviewed

What happened in people

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

Brief Pain Inventory interference (pain-related function) over 12 months, opioid against non-opioid stepped medication therapy in chronic back pain or hip or knee osteoarthritis pain

The study did not show it

Who was studied
NCT01583985 (SPACE, JAMA 2018;319:872-882)
How many people
240
Study design
Pragmatic randomised trial with masked outcome assessment, 12 months
Compared against
Not recorded for this study
Kind of result
What a body can do day to day
What was found
Overall p=0.58; mean 12-month BPI interference 3.4 opioid against 3.3 non-opioid (difference 0.1, 95% CI −0.5 to 0.7)
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. Pain intensity was significantly better on non-opioid therapy (BPI severity 4.0 against 3.5, difference 0.5, 95% CI 0.0 to 1.0, overall p=0.03), and adverse medication-related symptoms were twice as common on opioids (1.8 against 0.9, difference 0.9, 95% CI 0.3 to 1.5, overall p=0.03). 234 of 240 patients (97.5%) completed.

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

Form and route. Oral immediate-release tablets, capsules and solution; oral extended-release tablets and capsules; also supplied in fixed combination with paracetamol or aspirin. Schedule II controlled substance in the United States.

Interval reported. 95% CI −0

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

Maximum drug-liking score on a 0-100 bipolar visual analogue scale after intranasal administration of finely crushed reformulated OXYCONTIN, finely crushed original OxyContin, powdered oxycodone hydrochloride or placebo, in recreational opioid users with a history of intranasal abuse

The study showed what it set out to show

Who was studied
OXYCONTIN intranasal abuse-deterrence crossover study (label section 9.2, NDA 022272)
How many people
30
Study design
Randomised, double-blind, placebo-controlled, five-period crossover
Compared against
A dummy treatment
Kind of result
A number that stands in for health
What was found
Mean maximum drug liking 80.4 (SE 3.9) for reformulated OXYCONTIN against 94.0 (2.7) for original OxyContin and 89.3 (3.1) for oxycodone powder; take-drug-again 64.0 (7.1) against 89.6 (3.9) and 86.6 (4.4)
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. Twenty-seven of 30 completed. Approximately 44% (n=12) had no reduction in drug liking relative to oxycodone powder at all. Incomplete dosing from granules falling out of the nostril occurred in 34% of subjects with the reformulated product against 7% with the original, which is a delivery difference rather than a pharmacological one. The label states abuse by the intranasal, injection and oral routes is still possible.

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

Form and route. Oral immediate-release tablets, capsules and solution; oral extended-release tablets and capsules; also supplied in fixed combination with paracetamol or aspirin. Schedule II controlled substance in the United States.

Interval reported. Not recorded in this summary

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

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 it changes in the bodyRead from sources, not yet reviewed

The path through the body

From what a person takes to what changes. A solid line is a step measured in people. A dashed line is a step nobody has measured that way.

  1. Start

    Oxycodone

    What a person takes: Oral immediate-release tablets, capsules and solution; oral extended-release tablets and capsules; also supplied in fixed combination with paracetamol or aspirin. Schedule II controlled substance in the United States..

    The measurement behind this step

    Immediate-release oxycodone acts within about an hour and is dosed several times a day; the extended-release matrix is designed to release over about twelve hours and is explicitly not indicated as an as-needed analgesic. Absorption of the extended-release product is a two-phase process built into the matrix rather than a property of the molecule. The oral bioavailability of oxycodone is high compared with morphine, which is why oral-to-oral potency comparisons between the two do not match their intravenous ratio.

  2. Getting in

    A tablet, and a matrix designed to be hard to break

    Immediate-release oxycodone works within an hour. The extended-release tablet holds the drug in a plastic-like matrix that turns to gel in water, so it is hard to crush or inject — which is not the same as hard to abuse.

    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 current OXYCONTIN matrix uses high-molecular-weight polyethylene oxide, which resists crushing and forms a viscous hydrogel resisting passage through a needle. The label’s section 9.2 states these properties are expected to make injection difficult and to reduce intranasal abuse, and that abuse by these routes and by the oral route is still possible.

  3. Reaching the cell

    The liver turns some of it into something stronger

    Before it acts, the drug passes the liver, where one enzyme converts a fraction of it into a considerably more powerful opioid and another enzyme destroys most of the rest. How much of each you have is partly inherited and partly decided by your other medicines.

    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

    CYP2D6 O-demethylates oxycodone to oxymorphone; CYP3A4 N-demethylates it to noroxycodone, which is far less active. CYP3A4 inhibition or the withdrawal of a CYP3A4 inducer raises oxycodone concentrations, which the label’s boxed warning names as a route to fatal respiratory depression.

  4. What it acts on

    It sits on the mu receptor, the endorphin switch

    Oxycodone binds the same receptor the body’s own endorphins use, and turns it fully on rather than partly on.

    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

    Full agonism at the mu-opioid receptor, a Gi/o-coupled seven-transmembrane receptor, with weaker kappa and delta activity. Agonism inhibits adenylyl cyclase, opens G-protein-coupled inwardly rectifying potassium channels and closes voltage-gated calcium channels, hyperpolarising the neuron and reducing transmitter release.

  5. The change it makes

    Three different places, three different effects

    In the spinal cord it blocks the pain signal from getting through. In the brainstem it turns up the system that suppresses pain from above. In the emotional centres it makes the pain that remains matter less — and that third effect is also the one people come back for.

    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

    Presynaptic inhibition of substance P and glutamate release in the dorsal horn; disinhibition of descending inhibitory output from the periaqueductal grey through the rostral ventromedial medulla; and mu agonism in the ventral tegmental area and nucleus accumbens producing the affective and reinforcing component.

  6. What that does for a person

    The same receptor stops the breathing reflex

    The brainstem circuit that senses rising carbon dioxide and makes you breathe carries the same receptor. Enough drug, and it stops sounding the alarm. That is what an overdose is.

    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 agonism in the pre-Bötzinger complex and the parabrachial/Kölliker-Fuse region blunts the hypercapnic ventilatory response. The label’s boxed warning names serious, life-threatening or fatal respiratory depression, and states that concomitant benzodiazepines, other CNS depressants or alcohol may result in profound sedation, respiratory depression, coma and death.

  7. What that does for a person

    What twelve months of it produced in a trial

    In the one year-long randomised comparison against ordinary painkillers, function was no better, pain was slightly worse, and side effects were twice as common.

    Measured in people. Written by a person from the study named beside the step. Not signed off as a reviewed claim.

    The measurement behind this step

    SPACE, 240 randomised patients: BPI interference 3.4 against 3.3 at 12 months (overall p=0.58); BPI severity 4.0 against 3.5 (overall p=0.03, favouring non-opioid); medication-related symptoms 1.8 against 0.9 (overall p=0.03).

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 is missing or unclearRead from sources, not yet reviewed

Were people like you studied?

RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.

Who was studied

People similar to this profile were included.

  • People after surgery or serious injury; people with cancer pain; and a large population with long-term non-cancer pain, which is the use with the weakest trial evidence and the strongest promotional history.

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 of OXYCONTIN in pediatric patients was evaluated in 155 patients previously receiving and tolerating opioids for at least 5 consecutive days with a minimum of 20 mg per day of oxycodone or its equivalent on the two days immediately preceding dosing with OXYCONTIN.”

    US prescribing information · bfdfe235-d717-4855-a3c8-a13d26dadede · read 2026-08-30

  • On older people, the label states: “In controlled pharmacokinetic studies in elderly subjects (greater than 65 years) the clearance of oxycodone was slightly reduced.”

    US prescribing information · bfdfe235-d717-4855-a3c8-a13d26dadede · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.4) ] .”

    US prescribing information · bfdfe235-d717-4855-a3c8-a13d26dadede · read 2026-08-30

  • On people who are breastfeeding, the label states: “Published lactation studies report variable concentrations of oxycodone in breast milk with administration of immediate-release oxycodone to nursing mothers in the early postpartum period.”

    US prescribing information · bfdfe235-d717-4855-a3c8-a13d26dadede · read 2026-08-30

  • On people with reduced liver function, the label states: “A study of OXYCONTIN in patients with hepatic impairment demonstrated greater plasma concentrations than those seen at equivalent doses in persons with normal hepatic function [see Clinical Pharmacology (12.3) ] .”

    US prescribing information · bfdfe235-d717-4855-a3c8-a13d26dadede · read 2026-08-30

  • On people with reduced kidney function, the label states: “In patients with renal impairment, as evidenced by decreased creatinine clearance (<60 mL/min), the concentrations of oxycodone in the plasma are approximately 50% higher than in subjects with normal renal function [see Clinical Pharmacology (12.3) ] .”

    US prescribing information · bfdfe235-d717-4855-a3c8-a13d26dadede · read 2026-08-30

Where the result stopped carrying

  • The primary endpoint of the only 12-month randomised trial against non-opioid medicines
  • The reduced-abuse-liability labelling claim, removed by the FDA in July 2001
  • The 2010 abuse-deterrent reformulation at population level: opioid deaths fell and heroin deaths rose to replace them, with no reduction in combined mortality
  • Oxycodone 5 mg as a single postoperative dose, which the Cochrane overview lists under no evidence of analgesic effect
  • This is a scope explorer, not a diagnosis engine.
  • It shows who was studied so you can see whether people similar to you were included.

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

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

Why it might seem to do nothing

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

It was studied in different people

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

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

The evidence may simply be wrong

Small early studies often do not hold up.

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

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

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

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

What taking it involves

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

How it is supplied

Withdrawn

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, capsules and solution; oral extended-release tablets and capsules; also supplied in fixed combination with paracetamol or aspirin. 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: S1, S2, S5, S6, S8.

No source is stored against this line.

What is in the pack

Immediate-release oxycodone acts within about an hour and is dosed several times a day; the extended-release matrix is designed to release over about twelve hours and is explicitly not indicated as an as-needed analgesic.

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: Absorption of the extended-release product is a two-phase process built into the matrix rather than a property of the molecule. The oral bioavailability of oxycodone is high compared with morphine, which is why oral-to-oral potency comparisons between the two do not match their intravenous ratio.

No source is stored against this line.

Where it is registered

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

Counted from records

Where this came from

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

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

No source is stored against this line.

Why people stop

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

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

No source is stored against this line.

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

What can go wrong

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

Worth asking a clinician aboutWritten into the record from the studies named on this page

Boxed warnings cover addiction, abuse and misuse at any dose and any duration; life-threatening respiratory depression; fatal overdose from accidental ingestion of a single extended-release tablet, especially by a child; profound sedation, respiratory depression, coma and death with concomitant benzodiazepines, other CNS depressants or alcohol; neonatal opioid withdrawal syndrome after prolonged use in pregnancy; the opioid analgesic REMS; and cytochrome P450 3A4 interaction. The label states that crushing, chewing or dissolving an extended-release tablet can release a potentially fatal dose, and that parenteral abuse risks tissue necrosis, endocarditis, pulmonary granulomas, thrombotic microangiopathy and transmission of hepatitis and HIV.

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

Where this came from

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

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

What is missing or unclearRead from sources, not yet reviewed

Does the exact form matter?

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

The form that was studied

Oral immediate-release tablets, capsules and solution; oral extended-release tablets and capsules; also supplied in fixed combination with paracetamol or aspirin. 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

Absorption of the extended-release product is a two-phase process built into the matrix rather than a property of the molecule. The oral bioavailability of oxycodone is high compared with morphine, which is why oral-to-oral potency comparisons between the two do not match their intravenous ratio.

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

  • 313 products list this as an active ingredient in the United States drug directory. 176 of them contain it and nothing else.

    FDA National Drug Code directory · 72162-1337 · read 2026-08-29

  • They are sold as capsule, capsule, extended release, powder, solution, tablet and tablet, coated, taken oral.

    FDA National Drug Code directory · 72162-1337 · read 2026-08-29

  • The regulator's established pharmacologic class for it is full opioid agonists [moa] and opioid agonist [epc].

    FDA National Drug Code directory · 72162-1337 · read 2026-08-29

  • 167 published labels name it as an active ingredient. 87 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 916ff456-a27e-49dc-a312-274126a8c30c · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 916ff456-a27e-49dc-a312-274126a8c30c · read 2026-08-29

  • OxyContin is oral at 3 DOSAGE FORMS AND STRENGTHS Extended-release tablets: 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, and 80 mg. 10 mg film-coated extended-release tablets (round, white-colored, bi-convex tablets debossed with OP on one sid…, recorded as fda label in effect 2026-06-24 in the United States.

    US prescribing information · bfdfe235-d717-4855-a3c8-a13d26dadede · read 2026-08-30

  • Recorded price in US: 0.04717–2.17027 USD per one millilitre, across 9 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: 0.08652–0.37626 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 74 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..

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

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

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

What you could measure

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

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

Questions worth asking

  • Which of the trials of Oxycodone studied people like me?
  • What was measured, and for how long?
  • Was the result a laboratory value or a health outcome?
  • What would we watch for, and when would we stop?

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

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

What is missing or unclearRead from sources, not yet reviewed

Claims that go past the evidence

Things said about this substance that sound reasonable, and the exact step that is missing between the evidence and the claim.

Goes past the evidence

That fewer than 1% of opioid-treated pain patients become addicted — traced to four cases among 11,882 hospital inpatients in a 1980 letter, cited 608 times, 80.8% of those citations omitting that the patients were inpatients

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 controlled-release matrix reduces a drug’s abuse liability — approved into the 1995 label as a belief and deleted in 2001

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 abuse-deterrent labelling means fewer overdoses; the labelled studies measure tablet hardness and drug liking, not mortality

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 short-term analgesic efficacy licenses indefinite prescribing, which is the inference SPACE was designed to test and did not support

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

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

What would change this

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

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

What is missing or unclearRead from sources, not yet reviewed

What nobody knows yet

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

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 Oxycodone are recorded. Results from one form may not transfer to another.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Mechanism not reviewed

No reviewed mechanism story exists for this substance.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

What happened in peopleRead from sources, not yet reviewed

Check any of this yourself

Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.

Every line above can be traced to the study named beside it. Follow the link and read it.

Twelve months against paracetamol and ibuprofen, and it did not win
In plain words
The only randomised trial to run opioids against ordinary painkillers for a full year, in people with chronic back or knee or hip pain, found no advantage in function, slightly worse pain on the opioid, and twice as many side effects.
What was measured
Brief Pain Inventory interference over 12 months, opioid against non-opioid stepped therapy
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
SPACE was a pragmatic 12-month randomised trial with masked outcome assessment in Veterans Affairs primary care. Of 265 patients enrolled, 240 were randomised (mean age 58.3, 13.0% women) and 234 (97.5%) completed. Both arms followed a treat-to-target strategy with three medication steps; the opioid arm started with immediate-release morphine, oxycodone or hydrocodone/paracetamol, the non-opioid arm with paracetamol or an NSAID. The primary outcome, Brief Pain Inventory interference over 12 months, did not differ (overall p=0.58); mean 12-month BPI interference was 3.4 opioid against 3.3 non-opioid (difference 0.1, 95% CI −0.5 to 0.7). Pain intensity was significantly better in the non-opioid group (overall p=0.03): mean 12-month BPI severity 4.0 against 3.5 (difference 0.5, 95% CI 0.0 to 1.0). Adverse medication-related symptoms were more common on opioids (overall p=0.03): 1.8 against 0.9 at 12 months (difference 0.9, 95% CI 0.3 to 1.5). The authors concluded that the results do not support initiation of opioid therapy for moderate to severe chronic back pain or hip or knee osteoarthritis pain.
Source
Krebs EE, Gravely A, Nugent S, et al. Effect of Opioid vs Nonopioid Medications on Pain-Related Function in Patients With Chronic Back Pain or Hip or Knee Osteoarthritis Pain: The SPACE Randomized Clinical Trial. JAMA 2018;319(9):872-882 (NCT01583985)
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 abuse-liability sentence that was approved in 1995 and deleted in 2001
In plain words
The original OxyContin label said the slow-release design was believed to make the drug less abusable. That sentence was approved on a belief, used as the centrepiece of the marketing, and removed by the regulator six years later. The company later pleaded guilty to a felony for the claim.
What was measured
That a controlled-release matrix reduces the abuse liability of the drug inside it — approved into a label as a belief in 1995, deleted in 2001, and the subject of two federal guilty pleas
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The 1995 approval of OxyContin under NDA 020553 carried labelling stating that delayed absorption, as provided by OxyContin tablets, is believed to reduce the abuse liability of a drug. Van Zee’s account in the American Journal of Public Health records that the 1996 labelling also described iatrogenic addiction as very rare when opioids are legitimately used, that in July 2001 the label was revised to state that the data were insufficient to establish the true incidence of addiction, and that the reduced-abuse-liability sentence was removed. On 10 May 2007 The Purdue Frederick Company pleaded guilty to felony misbranding of OxyContin with intent to defraud and mislead, and three executives pleaded guilty to misdemeanour misbranding; the total paid was US$634,515,475. On 21 October 2020 Purdue Pharma L.P. pleaded guilty to three further federal felonies — one dual-object conspiracy to defraud the United States and violate the Food, Drug and Cosmetic Act and two anti-kickback conspiracies — agreeing to a US$3.544 billion criminal fine and US$2 billion in criminal forfeiture.
Source
Van Zee A. The Promotion and Marketing of OxyContin: Commercial Triumph, Public Health Tragedy. Am J Public Health 2009;99(2):221-227; United States Department of Justice release, Opioid Manufacturer Purdue Pharma Pleads Guilty to Fraud and Kickback Conspiracies, 21 October 2020
Role in the trial
Not matched to a registered study
Identity check
no open identity hold
Audit mark
retracted
Review state
Written into the record, not signed off as a reviewed claim
The abuse-deterrent reformulation, in its own label’s numbers
In plain words
The 2010 crush-resistant OxyContin is described as abuse-deterrent. In the study on the label, 44% of the recreational users who snorted it liked it exactly as much as ordinary oxycodone powder, and the label states plainly that abuse by mouth is still possible.
What was measured
Maximum drug-liking score after intranasal administration in 27 recreational opioid users, and national heroin mortality before and after August 2010
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Section 9.2 of the current OXYCONTIN prescribing information describes a randomised, double-blind, placebo-controlled five-period crossover study in 30 recreational opioid users with a history of intranasal abuse, of whom 27 completed. Against powdered oxycodone hydrochloride, approximately 44% (n=12) had no reduction in drug liking with the reformulated product; 33% (n=9) had a reduction of at least 30% and 22% (n=6) a reduction of at least 50%. The label’s own summary reads: the in vitro data demonstrate physicochemical properties expected to make abuse via injection difficult, and the clinical data indicate properties expected to reduce abuse via the intranasal route, "However, abuse of OXYCONTIN by these routes, as well as by the oral route, is still possible." The population-level consequence was measured independently: Evans, Lieber and Power found that opioid consumption stopped rising in August 2010, heroin deaths began climbing the following month, growth in heroin deaths was greater where pre-reformulation access to heroin and opioids was greater, and the reformulation produced no reduction in combined heroin and opioid mortality — each prevented opioid death was replaced by a heroin death.
Source
OXYCONTIN United States prescribing information, section 9.2 Abuse Deterrence Studies (NDA 022272); Evans WN, Lieber EMJ, Power P. How the Reformulation of OxyContin Ignited the Heroin Epidemic. Rev Econ Stat 2019;101(1):1-15
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 "less than one percent" figure came from a five-sentence letter about inpatients
In plain words
The claim that fewer than one in a hundred pain patients become addicted traces back to a 1980 letter counting four addictions among about twelve thousand hospital inpatients given a narcotic. It was cited 608 times, mostly as proof that addiction is rare, and four out of five of those citations never mentioned that everyone in it was in a hospital bed.
What was measured
That fewer than 1% of patients treated with opioids for pain become addicted — a claim derived from four cases among hospitalised inpatients and applied to years of outpatient prescribing
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Porter and Jick’s 1980 correspondence in the New England Journal of Medicine reported that among 39,946 hospitalised medical patients monitored, 11,882 received at least one narcotic preparation and there were four reasonably well documented cases of addiction, only one of which was major. Leung and colleagues analysed its citation record through 30 March 2017: 608 citations, of which 72.2% used it as evidence that addiction is rare in patients treated with opioids and 80.8% did not note that the patients described were inpatients. Van Zee records separately that Purdue trained its sales representatives to carry the message that the risk of addiction was less than one percent, that the sales force grew from 318 representatives in 1996 to 671 in 2000, and that more than 5,000 physicians, pharmacists and nurses attended all-expenses-paid pain-management symposia between 1996 and 2001. The measurement — a chart audit of short inpatient exposure — cannot support the inference it was used for, which is about years of outpatient prescribing.
Source
Porter J, Jick H. Addiction rare in patients treated with narcotics. N Engl J Med 1980;302(2):123; Leung PTM, Macdonald EM, Stanbrook MB, Dhalla IA, Juurlink DN. A 1980 Letter on the Risk of Opioid Addiction. N Engl J Med 2017;376(22):2194-2195
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
In a single dose after surgery, two over-the-counter tablets measured better
In plain words
The Cochrane overview of single-dose painkillers after surgery ranked 53 drug-and-dose pairs. Ibuprofen plus paracetamol came top. Oxycodone 5 mg is listed under the drugs with no evidence of an analgesic effect.
What was measured
Number needed to treat for at least 50% maximum pain relief over four to six hours after surgery
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Moore and colleagues combined 39 Cochrane reviews of single-dose oral analgesics in acute postoperative pain, producing numbers-needed-to-treat for at least 50% maximum pain relief over four to six hours for 53 drug and dose pairs. NNTs ranged from about 1.5 to 20. The best results were ibuprofen 200 mg plus paracetamol 500 mg (NNT 1.6, 95% CI 1.5 to 1.8), fast-acting ibuprofen 200 mg (2.1, 1.9 to 2.3), ibuprofen 200 mg plus caffeine 100 mg (2.1, 1.9 to 3.1), diclofenac potassium 50 mg (2.1, 1.9 to 2.5) and etoricoxib 120 mg (1.8, 1.7 to 2.0); ibuprofen acid 400 mg had an NNT of 2.5. The review states there was no evidence of analgesic effect for aceclofenac 150 mg, aspirin 500 mg and oxycodone 5 mg, on low-quality evidence. Paracetamol 650 mg plus oxycodone 10 mg does appear among the combinations with a long duration of action of eight hours or more, so the finding is dose-specific and not a claim that oxycodone does nothing.
Source
Moore RA, Derry S, Aldington D, Wiffen PJ. Single dose oral analgesics for acute postoperative pain in adults — an overview of Cochrane reviews. Cochrane Database Syst Rev 2015;(9):CD008659
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
Two liver enzymes decide how much drug a tablet actually delivers
In plain words
Oxycodone is partly converted by the liver into a much stronger opioid, and partly destroyed by a second enzyme. Common medicines block or accelerate the second enzyme, and the label carries a boxed warning about it.
What was measured
Oxycodone plasma exposure as a function of CYP3A4 inhibition or induction, from the label’s drug interaction section
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Oxycodone is O-demethylated by CYP2D6 to oxymorphone, a substantially more potent mu agonist, and N-demethylated by CYP3A4 to the much weaker noroxycodone. The OXYCONTIN label carries a boxed warning stating that concomitant use with all CYP3A4 inhibitors may increase oxycodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression, and that discontinuation of a concomitantly used CYP3A4 inducer may do the same; it directs regular evaluation of any patient on either. The clinical consequence is that the dose written on the prescription is not the exposure delivered, and the size of the gap depends on inherited CYP2D6 activity and on whatever else the person is taking.
Source
OXYCONTIN United States prescribing information, boxed warning and Clinical Pharmacology 12.3 (NDA 022272)
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

How many documents were read

  • 85 documents were read for this substance.

    RNAWiki source record

  • 85 of them state the same volumeOfDistribution, and they agree.

    RNAWiki source record

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

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

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Passed

    Safety mode resolved

    Suppression classes recorded: S1, S2, S5, S6, S8.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

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

  1. Withdrawn in United States, 2013, for "drug misuse" (ChEMBL; Open Targets)

What the approval register records

  • 141 approved applications cover products containing this substance. The earliest was NDA007337, approved 19500412 to ENDO OPERATIONS.

    Drugs@FDA application register · NDA007337 · read 2026-08-29

  • Marketing status on the register: discontinued, none (tentative approval) and prescription.

    Drugs@FDA application register · NDA007337 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 19831207.

    FDA National Drug Code directory · 72162-1337 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

This order is fixed in code and does not count clicks or time on the page.

What is not here

7 questions this page could not answer

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

  • What was measured, goal by goal — found nothing in the sources checked.
  • How close this is to real life — found nothing in the sources checked.
  • Felt, measured, or meaningful — found nothing in the sources checked.
  • How long anything takes — found nothing in the sources checked.
  • What it may clash with — found nothing in the sources checked.
  • Other ways to the same goal — found nothing in the sources checked.
  • 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 full mu-opioid receptor agonist whose short-term analgesia is among the most replicated findings in medicine and whose long-term case collapsed under testing: in the 240-patient SPACE trial it did not beat paracetamol and anti-inflammatories on pain-related function over twelve months (BPI interference 3.4 against 3.3, overall p=0.58), left patients in slightly more pain (4.0 against 3.5, p=0.03) and with twice the medication side effects (1.8 against 0.9, p=0.03).

Recorded evidence blocks (12)

On the Oxycodone label: indicated for what?


"Oxycodone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over…": indications and usage on Oxycodone's label. DailyMed label · 928227bf-89c5-4c64-9823-0e84cc669388 · 2026-08-07

313 registered trials of Oxycodone — at which phases?


Registered studies posting no result
231 of 313

313 registered studies of Oxycodone: 108 phase4, 57 phase1, 50 phase3, 40 phase2, 38 na, 18 na or unstated, 12 early phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01

1027 with a PubMed record

Show the evidence
  • phase4
    108
  • phase1
    57
  • phase3
    50
  • phase2
    40
  • na
    38
  • na or unstated
    18
10 more recorded rows
  • early phase1
    12
  • completed
    201
  • unknown
    35
  • recruiting
    22
  • terminated
    21
  • withdrawn
    11
  • active not recruiting
    9
  • not yet recruiting
    7
  • enrolling by invitation
    4
  • suspended
    3

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

Approved in 1950, withdrawn in 2013: what happened to Oxycodone in United States?


Approved 1950, withdrawn 2013 in United States; the register's words: "drug misuse". Open Targets drug warning · CHEMBL1200890 · 2026-06-24

2 recorded reasons; United States

Show the evidence

Reason

  • "drug misuse"
  • "drug misuse"

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

35 of Oxycodone's trials stopped: futility/efficacy, accrual/recruitment, funding/business, sponsor decision unspecified, other?


futility/efficacy (1), accrual/recruitment (17), funding/business (1), sponsor decision unspecified (1) and other (15): Oxycodone's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Did not reach enrollment goals"; 35 of 313 registered studies

Show the evidence

Trial

  • NCT00414453
    terminated; "Did not reach enrollment goals"
  • NCT00483977
    terminated; "Met criteria for study futility at interim analysis"
  • NCT00484718
    terminated; "See termination reason in detailed description."
  • NCT00626600
    terminated; "Lack of recruitment"
  • NCT00681174
    terminated; "Failure to enroll sufficient patients by expected deadline."
  • NCT00726830
    terminated; "Low Accrual."
14 further recorded trials
  • NCT00916890
    suspended; "difficulties in patients enrolment"
  • NCT00985621
    terminated; "See termination reason in detailed description."
  • NCT01268670
    suspended; "This study is currently suspended due to transition of the investigator."
  • NCT02094807
    withdrawn; "Slow inclusion rate. Awaiting results from NCT02132416."
  • NCT02160301
    withdrawn; "Insufficient infrastructure/funding for enrollment"
  • NCT02240602
    withdrawn; "Lack of internal resources"
  • NCT02293525
    withdrawn; "No subjects were enrolled and the sponsor suspended support at this time"
  • NCT02740114
    terminated; "Per PIs request"
  • NCT02987920
    terminated; "The surgeon changed pain control protocol for all patients. Continued enrollment impossible under approved protocol."
  • NCT03121963
    withdrawn; "This protocol was difficult to enroll into, and changes to personnel have made it difficult to main this study. Data collection was not completed and therefore, no data analysis was performed. The PI has made the decision to close this…"
  • NCT03415581
    terminated; "Study terminated by sponsor due to bad risk/benefit ratio."
  • NCT03426137
    terminated; "The focus of the project has shifted to publishing a protocol for future trials because we were unable to recruit. Three participants signed the consent forms but withdrew before the randomization."
  • NCT03435692
    terminated; "Funding was exhausted prior to enrolling intended number of patients."
  • NCT03478423
    terminated; "Study failed to recruit in sufficient numbers and was determined to not be feasible."

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

Human studies of Oxycodone used oxycodone 15 mg — over how long?


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

20 recorded entries; human; tablet; also "oxycodone 15 mg", "oxycodone 30 mg", "Oxycodone 10 mg"

Show the evidence

human

  • NCT00158184
    oxycodone 15 mg
  • NCT00158184
    oxycodone 30 mg
  • NCT00480142
    Oxycodone 10 mg
  • NCT00733083
    0,1 mg/kg of oxycodone
  • NCT00831051
    Oxycodone HCl 4mg
  • NCT00853216
    tablet; Oxycodone hydrochloride tablet 30 mg
14 more recorded rows
  • human NCT00853216
    tablet; Roxicodone™ tablet 30 mg
  • human NCT00853268
    Controlled-Release Oxycodone Hydrochloride 40 mg
  • human NCT00853268
    tablet; OxyContin® 40 mg tablet
  • human NCT00853320
    tablet; Oxycodone hydrochloride tablet 15 mg
  • human NCT00853320
    tablet; Roxicodone™ tablet 15 mg
  • human NCT00853892
    tablet; Controlled-Release Oxycodone Hydrochloride 40 mg tablet
  • human NCT00864357
    Oxycodone HCl 5 mg / Ibuprofen 400 mg tablets, single dose
  • human NCT01083485
    Oxycodone/Naloxone PR 20/10mg or 10/5mg tablets
  • human NCT01127906
    Oxycodone 20mg
  • human NCT01179828
    Oxycodone 15mg
  • human NCT01402375
    Percocet (Oxycodone 5mg/Acetaminophen 325 mg)
  • human NCT01402375
    Oxycodone 5mg / Acetaminophen 325 mg
  • human NCT01779492
    Oxycodone HCl 20mg
  • human NCT01779492
    Oxycontine CR 10mg

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

Oxycodone's half-life is 6 h — which schedules were studied?


6 h, the half-life Oxycodone's label states: "Table 2: Pharmacokinetic Parameters (Mean±SD) Dose\Parameters AUC (ngxhr/mL) C max (ng/mL) T max (hr) C min (ng/mL) C avg (ng/mL) Half-Life (hr) Single Dose Pharmacokinetics Oxycodone Hydrochloride Tablets 5 mg tabs x 3 133.2±33 22.3±8.2 1.8±1.8 n/a n/a 3.73±0.9 Oxycodone Hydrochloride Tablets 15 mg tab 128.2±35.1…" DailyMed label · 928227bf-89c5-4c64-9823-0e84cc669388 · 2026-08-07

tmax 6 h; bioavailability 96 %.

Show the evidence
  • half life pharmacokinetics
    6 h; Table 2: Pharmacokinetic Parameters (Mean±SD) Dose\Parameters AUC (ngxhr/mL) C max (ng/mL) T max (hr) C min (ng/mL) C avg (ng/mL) Half-Life (hr) Single Dose Pharmacokinetics Oxycodone Hydrochloride Tablets 5 mg tabs x 3 133.2±33 22.3±8.2 1.8±1.8 n/a n/a 3.73±0.9 Oxycodone Hydrochloride Tablets 15 mg tab 128.2±35.1 22.2±7.6 1.4±0.7 n/a n/a 3.55±1.0 Oxycodone Hydrochloride Oral Concentrate Solution…
  • tmax pharmacokinetics
    6 h; Table 2: Pharmacokinetic Parameters (Mean±SD) Dose\Parameters AUC (ngxhr/mL) C max (ng/mL) T max (hr) C min (ng/mL) C avg (ng/mL) Half-Life (hr) Single Dose Pharmacokinetics Oxycodone Hydrochloride Tablets 5 mg tabs x 3 133.2±33 22.3±8.2 1.8±1.8 n/a n/a 3.73±0.9 Oxycodone Hydrochloride Tablets 15 mg tab 128.2±35.1 22.2±7.6 1.4±0.7 n/a n/a 3.55±1.0 Oxycodone Hydrochloride Oral Concentrate Solution…
  • bioavailability pharmacokinetics
    96 %; The relative oral bioavailability of oxycodone hydrochloride tablets 15 mg and 30 mg tablets, compared to the 5 mg oxycodone hydrochloride tablets, is 96% and 101% respectively.
  • metabolism pharmacokinetics
    This high oral bioavailability (compared to other oral opioids) is due to lower presystemic and/or first-pass metabolism of oxycodone.

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

Which 124 trials of Oxycodone posted no result?


Posted no result
124 of 124 completed trials
Registrations
NCT00853216, NCT00853320, NCT00853736, NCT00853268, NCT00853892 and NCT00027014, and 118 more
Completion dates
oldest 2003-02; newest 2024-07-18
Show the evidence

Trial

  • NCT00853216
    2003-02
  • NCT00853320
    2003-02
  • NCT00853736
    2003-02
  • NCT00853268
    2005-04
  • NCT00853892
    2005-04
  • NCT00027014
    2005-05
14 further recorded trials
  • NCT00000273
    2005-11
  • NCT00378937
    2006-02
  • NCT00864357
    2006-10
  • NCT00864526
    2006-10
  • NCT00271973
    2007-01
  • NCT00260260
    2007-12
  • NCT01559701
    2008-02
  • NCT00254631
    2008-12
  • NCT00801788
    2009-02
  • NCT00831051
    2009-02
  • NCT00743587
    2009-03
  • NCT01016808
    2010-03
  • NCT00513656
    2010-06
  • NCT01304134
    2010-08

At the median, Oxycodone's trials enrolled 72 people — anything larger?


Median enrolment
72
Largest enrolment
27034
Registered trials counted
313

What do 13365 spontaneous reports say about Oxycodone — 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.

Oxycodone appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 13365 reaction mentions were counted: pain 1849; drug hypersensitivity 1830; nausea 1476; drug dependence 1466. FAERS via Open Targets · CHEMBL1200890 · 2026-06-24

Show the evidence
  • pain
    1849
  • drug hypersensitivity
    1830
  • nausea
    1476
  • drug dependence
    1466
  • confusional state
    1283
  • vomiting
    1181
4 more recorded rows
  • somnolence
    1133
  • dyspnoea
    1124
  • drug abuser
    1019
  • constipation
    1004

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

Which 10 reactions does Oxycodone's label not list?


confusional state, constipation and drug abuser and 7 more reported for Oxycodone, absent from its label. FAERS via Open Targets · CHEMBL1200890 · 2026-06-24

2 label terms; 10 reported and unlisted; 928227bf-89c5-4c64-9823-0e84cc669388

Show the evidence
  • confusional state
    count not stated
  • constipation
    count not stated
  • drug abuser
    count not stated
  • drug dependence
    count not stated
  • drug hypersensitivity
    count not stated
  • dyspnoea
    count not stated
4 more recorded rows
  • nausea
    count not stated
  • pain
    count not stated
  • somnolence
    count not stated
  • vomiting
    count not stated

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

Oxycodone and CYP3A4 and CYP2D6: shared by which compounds?


CYP3A4 and CYP2D6 appear in Oxycodone's recorded interaction sentences, 8 in all. DailyMed label · 928227bf-89c5-4c64-9823-0e84cc669388 · 2026-08-07

CYP2D6, CYP3A4, CYP3A4, CYP3A4; 4 shared nodes; drug_interactions, pharmacokinetics

Show the evidence

Interaction statement

  • drug_interactions
    Table 1: Clinically Significant Drug Interactions with Oxycodone Hydrochloride Tablets Inhibitors of CYP3A4 and CYP2D6 Clinical Impact: The concomitant use of oxycodone hydrochloride tablets and CYP3A4 inhibitors can increase the plasma concentration of oxycodone, resulting in increased or prolonged opioid effects.
  • drug_interactions
    These effects could be more pronounced with concomitant use of oxycodone hydrochloride tablets and CYP2D6 and CYP3A4 inhibitors, particularly when an inhibitor is added after a stable dose of oxycodone hydrochloride tablets is achieved [see Warnings and Precautions (5.3) ] .
  • drug_interactions
    After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the oxycodone plasma concentration will decrease [see Clinical Pharmacology (12.3) ] , resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to oxycodone.
  • drug_interactions
    If a CYP3A4 inhibitor is discontinued, consider increasing the oxycodone hydrochloride tablets dosage until stable drug effects are achieved.
  • drug_interactions
    CYP3A4 Inducers Clinical Impact: The concomitant use of oxycodone hydrochloride tablets and CYP3A4 inducers can decrease the plasma concentration of oxycodone [see Clinical Pharmacology (12.3) ] , resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to oxycodone [see Warnings and Precautions (5.6) ] .
  • drug_interactions
    After stopping a CYP3A4 inducer, as the effects of the inducer decline, the oxycodone plasma concentration will increase [see Clinical Pharmacology (12.3) ] , which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression.
2 more recorded rows
  • Interaction statement drug_interactions
    If a CYP3A4 inducer is discontinued, consider oxycodone hydrochloride tablets dosage reduction and evaluate patients at frequent intervals for signs of respiratory depression and sedation.
  • Interaction statement pharmacokinetics
    Elimination Metabolism A high portion of oxycodone is N-dealkylated to noroxycodone during first-pass metabolism, and is catalyzed by CYP3A4.
  • CYP2D6
    FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Sofpironium, Fluoxetine

CYP3A4

  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Beclometasone, Rasagiline, Sofpironium
  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Beclometasone, Rasagiline, Sofpironium
  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Beclometasone, Rasagiline, Sofpironium

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

Where do the label and the trials disagree about Oxycodone?


"drug misuse" against "approved": withdrawal status vs register status for Oxycodone.

OPEN_TARGETS_DRUG_WARNING, Drugs@FDA; 1 recorded pair

Show the evidence
  • OPEN_TARGETS_DRUG_WARNING CHEMBL1200890
    drug misuse; 2026-06-24
  • Drugs@FDA NDA201194
    approved; 2026-08-28
Where it is registered

Where it’s registered

Withdrawn in United States, 2013, for "drug misuse" (ChEMBL; Open Targets)

Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1200890
PubChem CID
5462350
CAS number
124-90-3
RxCUI
82063
InChIKey
BRUQQQPBMZOVGD-XFKAJCMBSA-N
Also called
OXYCODONE HYDROCHLORIDE, Endocodone, Oxecta, alo-02, original oxycontin, oxycodone ir, reformulated oxy, OXYCODONE TEREPHTHALATE, (-)-14-hydroxydihydrocodeinone, Dihydrone, Oxicodona, Oxicone
Trade name
Abtard, Candox, Carexil, Dolocodon pr, Leveraxo, Longtec, Lynlor, Oxaydo, Oxeltra, Oxycontin, Oxylan, Oxynorm
Salt form
Anhydrous oxycodone hydrochloride, Oxycodone hcl, Oxycodone hydrochloride cii, Oxycodone hydrochloride component of codoxy, Oxycodone hydrochloride component of combunox, Oxycodone hydrochloride component of oxycet, Oxycodone hydrochloride component of percocet, Oxycodone hydrochloride component of percodan, Oxycodone hydrochloride component of percodan-demi, Oxycodone hydrochloride component of roxicet, Oxycodone hydrochloride component of roxilox, Oxycodone hydrochloride component of roxiprin
Development code
IDS-NO-002, N02AA05, NSC-19043, PF-00345439
Sources (7)

Sources

1 more source

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

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 7 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
  • no raw internal fields: enforced by the copy-contract test over the rendered page

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