This page shows what was measured, who it was measured in, and what that does not settle.
What Oxymorphone does in the body
Oxymorphone binds the mu-opioid receptor and turns it fully on, the same way morphine does, at a lower milligram dose.
It is also what your liver makes out of part of an oxycodone tablet, so anyone taking oxycodone is producing a little of this molecule already. It is poorly absorbed by mouth, which is why the tablets carry more milligrams than a comparable morphine tablet — and that gap between what is in the tablet and what reaches the bloodstream by mouth is precisely what made the extended-release version attractive to inject.
Why people take it. Severe long-term pain needing an opioid, when other options are inadequate
What happened in people
181 HIV diagnoses in Scott County, Indiana between 18 November 2014 and 1 November 2015
✎ 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.
Endo Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application for OPANA (Oxymorphone Hydrochloride) Extended-Release Tablets. 85 FR 83972, 23 … · a recorded source, not a stored snapshot
Determination That OPANA ER (Oxymorphone Hydrochloride) Drug Products Covered by New Drug Application 21-610 Were Not Withdrawn From Sale for Reasons of Safe… · a recorded source, not a stored snapshot
The limit that matters most
That a crush-resistant matrix reduces abuse, when the documented effect was a shift in route from nasal to injection
Where it acts
Mu-opioid receptors of the spinal dorsal horn and brainstem — the same receptor oxycodone reaches partly by being converted into this molecule
Kind of result
The kind of result is not recorded
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.
What the registries record it as
The substance registry classes this as chemical.
FDA substance registry · 9VXA968E0C · read 2026-08-29
Its recorded molecular formula is C17H19NO4•HCl, weighing 337.80.
US prescribing information · 3eb971cf-ab82-49f3-a46c-4d76a8ce599e · read 2026-08-30
Where each sentence above came from
A person wrote this explanation into the record, with the studies named in the path below.
The recorded use, written for a reader without medical training. Not signed off.
A limit recorded against this substance. Not signed off as a reviewed claim.
The four opening statements run to 117 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Biomarker
A biomarker is a number from a test that stands in for something about health.
A picture of it, and where the picture fails
A biomarker is like a fuel gauge.
Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.
What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.
A measurable indicator used as a substitute for a clinical outcome of interest.
Placebo
A placebo is a dummy treatment given so the real one can be compared with it.
A picture of it, and where the picture fails
A placebo is like a blank control in an experiment.
Where that stops being true. A blank does nothing. People given a placebo often do get better.
What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.
An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.
Comparator
A comparator is whatever the treatment was measured against.
A picture of it, and where the picture fails
It is like the other runner in a race.
Where that stops being true. A race has one winner. A study can show both arms improved.
What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.
The control condition against which the experimental intervention is assessed.
What happened in 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.
Identification of the extent and cause of an HIV outbreak in Scott County, Indiana, and the risk factors associated with infection
✓ The study showed what it set out to show
Who was studied
Peters et al., N Engl J Med 2016;375:229-239 — Indiana HIV outbreak investigation
How many people
181
Study design
Field epidemiological outbreak investigation with HIV-1 pol phylogenetic analysis
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
87.8% of 181 diagnosed cases reported injecting extended-release oxymorphone; 92.3% coinfected with hepatitis C; 157 of 159 sequenced HIV-1 pol genes (98.7%) highly related; adjusted risk ratio 1.9 per naming as a syringe-sharing partner, p<0.001
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. This is an outbreak investigation, not a randomised trial: it establishes a transmission network and a shared exposure, not a counterfactual. What makes the attribution unusually strong is the phylogenetic result — 157 of 159 sequences from a single closely related cluster — in a population overwhelmingly reporting one specific reformulated product.
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 extended-release tablets; the injectable and the branded Opana line are discontinued. 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.
Endo Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application for OPANA (Oxymorphone Hydrochloride) Extended-Release Tablets. 85 FR 83972, 23 … · a recorded source, not a stored snapshot
Determination That OPANA ER (Oxymorphone Hydrochloride) Drug Products Covered by New Drug Application 21-610 Were Not Withdrawn From Sale for Reasons of Safe… · a recorded source, not a stored snapshot
Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee — meeting announcem… · a recorded source, not a stored snapshot
Whether the benefits of reformulated Opana ER continue to outweigh its risks in light of postmarketing abuse data
✗ The study did not show it
Who was studied
Joint Drug Safety and Risk Management / Anesthetic and Analgesic Drug Products Advisory Committee vote on reformulated Opana ER, March 2017
How many people
27
Study design
Regulatory advisory committee vote (meeting announced at 82 FR 3333)
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Vote 18 to 8 against, with one abstention, that the benefits no longer outweigh the risks
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. Several committee members stated a preference for keeping the product on the market with additional regulatory restrictions rather than removing it, so the vote records a benefit-risk judgement rather than unanimity on the remedy. This row is a regulatory vote rather than a clinical trial, and is included because it is the measurement that most directly captured expert judgement on this product before its withdrawal.
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 extended-release tablets; the injectable and the branded Opana line are discontinued. 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.
Endo Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application for OPANA (Oxymorphone Hydrochloride) Extended-Release Tablets. 85 FR 83972, 23 … · a recorded source, not a stored snapshot
Determination That OPANA ER (Oxymorphone Hydrochloride) Drug Products Covered by New Drug Application 21-610 Were Not Withdrawn From Sale for Reasons of Safe… · a recorded source, not a stored snapshot
Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee — meeting announcem… · 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 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
Oxymorphone
What a person takes: Oral immediate-release tablets and oral extended-release tablets; the injectable and the branded Opana line are discontinued. Schedule II controlled substance in the United States..
The measurement behind this step
Oral bioavailability is low and rises substantially with food, which is why the timing instruction relative to meals is part of the product rather than a convenience. The extended-release tablet was reformulated in 2012 with a crush-resistant matrix under NDA 201655; that formulation was removed from the market in 2017 and its approval withdrawn in 2020. Generic immediate-release and extended-release oxymorphone products remain available.
Getting in
A tablet with more milligrams than it seems to need
Oxymorphone is poorly absorbed from the gut, so an oral tablet has to carry a lot of drug for a modest amount to reach the blood. That surplus is what made the extended-release tablet valuable to anyone bypassing the gut.
╌╌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
Low oral bioavailability with substantial food effect, so oral tablet strengths are high relative to the systemic exposure achieved. The 2012 reformulation of Opana ER used a crush-resistant matrix intended to prevent nasal and injection abuse of that content.
Endo Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application for OPANA (Oxymorphone Hydrochloride) Extended-Release Tablets. 85 FR 83972, 23 … · a recorded source, not a stored snapshot
Determination That OPANA ER (Oxymorphone Hydrochloride) Drug Products Covered by New Drug Application 21-610 Were Not Withdrawn From Sale for Reasons of Safe… · a recorded source, not a stored snapshot
Reaching the cell
No liver enzyme has to switch it on
Unlike codeine, tramadol or oxycodone, oxymorphone does not need converting into anything. What you swallow is what acts.
╌╌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
Cleared chiefly by glucuronidation, with no dependence on CYP2D6 or CYP3A4 activation. This is the same transformation in reverse: oxymorphone is the product CYP2D6 makes when it O-demethylates oxycodone.
Endo Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application for OPANA (Oxymorphone Hydrochloride) Extended-Release Tablets. 85 FR 83972, 23 … · a recorded source, not a stored snapshot
Determination That OPANA ER (Oxymorphone Hydrochloride) Drug Products Covered by New Drug Application 21-610 Were Not Withdrawn From Sale for Reasons of Safe… · a recorded source, not a stored snapshot
What it acts on
Full agonism, at higher affinity than its parent
It binds the mu-opioid receptor more tightly than oxycodone does and turns it fully 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 Gi/o-coupled mu-opioid receptor: adenylyl cyclase inhibition, GIRK channel opening, N-type calcium channel closure. Higher receptor affinity than oxycodone, which is a potency statement rather than an efficacy one.
Endo Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application for OPANA (Oxymorphone Hydrochloride) Extended-Release Tablets. 85 FR 83972, 23 … · a recorded source, not a stored snapshot
Determination That OPANA ER (Oxymorphone Hydrochloride) Drug Products Covered by New Drug Application 21-610 Were Not Withdrawn From Sale for Reasons of Safe… · a recorded source, not a stored snapshot
The change it makes
The reformulation that changed the route, not the behaviour
In 2012 the tablet was made crush-resistant. People who had been snorting it began injecting it instead.
╌╌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
FDA’s stated basis for the June 2017 removal request was a review of all available postmarketing data demonstrating a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation.
Endo Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application for OPANA (Oxymorphone Hydrochloride) Extended-Release Tablets. 85 FR 83972, 23 … · a recorded source, not a stored snapshot
Determination That OPANA ER (Oxymorphone Hydrochloride) Drug Products Covered by New Drug Application 21-610 Were Not Withdrawn From Sale for Reasons of Safe… · a recorded source, not a stored snapshot
What that does for a person
What injection did in one county
A hundred and eighty-one people in rural Indiana were diagnosed with HIV in a single year. Almost nine in ten reported injecting extended-release oxymorphone.
╌╌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
181 diagnosed cases from 18 November 2014 to 1 November 2015; 87.8% reported injecting extended-release oxymorphone; 92.3% coinfected with hepatitis C; 157 of 159 sequenced HIV-1 pol genes (98.7%) highly related on phylogenetic analysis. Public health emergency declared 26 March 2015.
Endo Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application for OPANA (Oxymorphone Hydrochloride) Extended-Release Tablets. 85 FR 83972, 23 … · a recorded source, not a stored snapshot
Determination That OPANA ER (Oxymorphone Hydrochloride) Drug Products Covered by New Drug Application 21-610 Were Not Withdrawn From Sale for Reasons of Safe… · a recorded source, not a stored snapshot
What that does for a person
And what the regulator did about it
An advisory committee voted 18 to 8 that the benefits no longer outweighed the risks. The FDA asked for the product to be removed — the first such request for a marketed opioid. Every branded application is now discontinued.
╌╌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
Joint advisory committee vote 18-8 with one abstention, March 2017; FDA removal request 8 June 2017; Endo voluntary withdrawal announced 6 July 2017; formal withdrawal of approval of NDA 201655 published at 85 FR 83972 on 23 December 2020.
Endo Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application for OPANA (Oxymorphone Hydrochloride) Extended-Release Tablets. 85 FR 83972, 23 … · a recorded source, not a stored snapshot
Determination That OPANA ER (Oxymorphone Hydrochloride) Drug Products Covered by New Drug Application 21-610 Were Not Withdrawn From Sale for Reasons of Safe… · 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 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 persistent pain, now on generic products. The branded Opana line no longer exists.
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: “Safety and effectiveness for pediatric patients, 0 to 17 years, have not been established.”
US prescribing information · 3eb971cf-ab82-49f3-a46c-4d76a8ce599e · read 2026-08-30
On older people, the label states: “Oxymorphone hydrochloride should be used with caution in elderly patients [see Clinical Pharmacology ( 12.3 )] .”
US prescribing information · 3eb971cf-ab82-49f3-a46c-4d76a8ce599e · 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 ) and Clinical Considerations].”
US prescribing information · 3eb971cf-ab82-49f3-a46c-4d76a8ce599e · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary: There is no information regarding the presence of oxymorphone in human or animal milk, the effects on the breastfed infant, or the effects on milk production.”
US prescribing information · 3eb971cf-ab82-49f3-a46c-4d76a8ce599e · read 2026-08-30
On people with reduced liver function, the label states: “In a study of extended-release oxymorphone tablets, patients with mild hepatic impairment were shown to have an increase in bioavailability compared to the subjects with normal hepatic function.”
US prescribing information · 3eb971cf-ab82-49f3-a46c-4d76a8ce599e · read 2026-08-30
On people with reduced kidney function, the label states: “In a study of extended-release oxymorphone tablets, patients with moderate to severe renal impairment were shown to have an increase in bioavailability compared to the subjects with normal renal function [see Clinical Pharmacology ( 12.3 )] .”
US prescribing information · 3eb971cf-ab82-49f3-a46c-4d76a8ce599e · read 2026-08-30
Where the result stopped carrying
The 2012 abuse-deterrent reformulation, whose stated purpose was achieved and whose population effect was to move abuse into the vein
Endo’s August 2012 citizen petition to have the original formulation declared unsafe, rejected by FDA in June 2013
The product itself: removal requested 8 June 2017, voluntary withdrawal announced 6 July 2017, approval formally withdrawn 23 December 2020
Every branded oxymorphone application in Drugs@FDA, all now listed as discontinued
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Prescription only
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Oral immediate-release tablets and oral extended-release tablets; the injectable and the branded Opana line are discontinued. 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.
No source is stored against this line.
What is in the pack
Oral bioavailability is low and rises substantially with food, which is why the timing instruction relative to meals is part of the product rather than a convenience. The extended-release tablet was reformulated in 2012 with a crush-resistant matrix under NDA 201655; that formulation was removed from the market in 2017 and its approval withdrawn in 2020. Generic immediate-release and extended-release oxymorphone products remain available.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to 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; interaction with benzodiazepines, other CNS depressants and alcohol; and the opioid analgesic REMS. Beyond the class risks, the specific documented hazards of this product’s history are injection-route abuse of the reformulated extended-release tablet, associated with an HIV and hepatitis C outbreak and with cases of thrombotic microangiopathy — a clotting disorder of small blood vessels — which together formed the FDA’s stated basis for requesting its removal.
Nobody counted how many people took this and were fine, so this cannot be turned into a rate.
Endo Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application for OPANA (Oxymorphone Hydrochloride) Extended-Release Tablets. 85 FR 83972, 23 … · a recorded source, not a stored snapshot
Determination That OPANA ER (Oxymorphone Hydrochloride) Drug Products Covered by New Drug Application 21-610 Were Not Withdrawn From Sale for Reasons of Safe… · 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 extended-release tablets; the injectable and the branded Opana line are discontinued. 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
The extended-release tablet was reformulated in 2012 with a crush-resistant matrix under NDA 201655; that formulation was removed from the market in 2017 and its approval withdrawn in 2020. Generic immediate-release and extended-release oxymorphone products remain available.
✎ 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
37 products list this as an active ingredient in the United States drug directory. 37 of them contain it and nothing else.
FDA National Drug Code directory · 0115-1233 · read 2026-08-29
They are sold as powder, tablet and tablet, film coated, extended release, taken oral.
FDA National Drug Code directory · 0115-1233 · 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 · 0115-1233 · read 2026-08-29
9 published labels name it as an active ingredient. 9 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 3eb971cf-ab82-49f3-a46c-4d76a8ce599e · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 3eb971cf-ab82-49f3-a46c-4d76a8ce599e · read 2026-08-29
Oxymorphone Hydrochloride is oral at 3 DOSAGE FORMS AND STRENGTHS Oxymorphone Hydrochloride Tablets, USP are available as 5 mg and 10 mg for oral administration. 5 mg tablet is supplied as a round, white to off-white, standard biconvex tablet debossed with…, recorded as fda label in effect 2025-12-12 in the United States.
US prescribing information · 3eb971cf-ab82-49f3-a46c-4d76a8ce599e · read 2026-08-30
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to 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 Oxymorphone 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 a crush-resistant matrix reduces abuse, when the documented effect was a shift in route from nasal to injection
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 testing predicts population harm, when it measures tablet properties and drug liking by a route fixed in advance
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 original Opana ER had been discontinued for reasons of safety, as asserted in a citizen petition and rejected by FDA
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 higher mu-receptor affinity than oxycodone makes oxymorphone a better analgesic, which no head-to-head trial has shown
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.
How much did people take in the studies?
The sources RNAWiki checked hold nothing for this field.
Why it matters. A result belongs to an amount. Without the amount the result floats free.
What would answer it
A stored source that records it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Oxymorphone 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.
The first opioid the FDA ever asked to have taken off the market for abuse
In plain words
On 8 June 2017 the FDA asked Endo to withdraw reformulated Opana ER. It was the first time the agency had ever requested removal of a marketed opioid painkiller because of the public health consequences of abusing it. Endo withdrew it the following month.
What was measured
That making a tablet harder to crush reduces its abuse — the reformulation achieved the physical property and shifted the route of abuse into the vein, which is the outcome the FDA acted on
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
The FDA’s stated basis was a review of all available postmarketing data showing a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s 2012 reformulation, and that injection abuse of the reformulated product had been associated with a serious outbreak of HIV and hepatitis C and with cases of thrombotic microangiopathy. In March 2017 a joint meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee had voted 18 to 8, with one abstention, that the benefits of reformulated Opana ER no longer outweighed its risks; several members said afterwards that they would have preferred additional restrictions to outright removal. Endo announced voluntary withdrawal on 6 July 2017. FDA formally withdrew approval of NDA 201655 at Endo’s request, published at 85 FR 83972 on 23 December 2020, Endo having waived its opportunity for a hearing. Every OPANA and OPANA ER application in Drugs@FDA is now listed as discontinued. The finding this establishes is not about oxymorphone the molecule. It is that an abuse-deterrent formulation can pass its regulatory tests and still make the population outcome worse, by moving abuse to a more dangerous route rather than reducing it.
Source
FDA request for removal of reformulated Opana ER, 8 June 2017; joint advisory committee vote of 18-8 with one abstention, March 2017 (meeting announced at 82 FR 3333, 11 January 2017); Endo Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application for OPANA (Oxymorphone Hydrochloride) Extended-Release Tablets, 85 FR 83972, 23 December 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
One hundred and eighty-one HIV infections in one small county
In plain words
A rural Indiana county of a few thousand people had 181 new HIV diagnoses in a year. Nearly nine in ten of those infected reported injecting extended-release oxymorphone, and more than nine in ten also had hepatitis C. The state declared a public health emergency.
What was measured
HIV diagnoses in the outbreak and the proportion reporting injection of extended-release oxymorphone
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Peters and colleagues investigated an outbreak in Scott County, Indiana. From 18 November 2014 to 1 November 2015, HIV infection was diagnosed in 181 case patients; 87.8% reported having injected the extended-release formulation of the prescription opioid oxymorphone, and 92.3% were coinfected with hepatitis C virus. Among 159 patients with an HIV-1 pol gene sequence, 157 (98.7%) had highly related sequences on phylogenetic analysis, establishing a single transmission network rather than coincident infections. Contact tracing identified 536 named contacts, of whom 468 (87.3%) were located, assessed, tested and linked to care; the number of times a contact was named as a syringe-sharing partner was significantly associated with HIV risk (adjusted risk ratio per naming 1.9, p<0.001). A public health emergency was declared on 26 March 2015 and Indiana established a syringe-service programme for the first time. The phylogenetic result is what makes this evidence rather than association: 157 of 159 sequences from one network, in a population injecting one reformulated product.
Written into the record, not signed off as a reviewed claim
The manufacturer argued its old formulation was unsafe. The FDA disagreed.
In plain words
In 2012 Endo asked the FDA to rule that the original Opana ER had been discontinued for safety reasons, which would have blocked generic copies. In 2013 the FDA ruled it had not, and that generics could go on being approved. The reformulation Endo said was safer was pulled four years later.
What was measured
That the original Opana ER was discontinued for reasons of safety — asserted in a citizen petition that would have blocked generic entry, and rejected by the FDA on the record
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Endo submitted a citizen petition dated 10 August 2012 (Docket No. FDA-2012-P-0895) requesting that the agency determine that OPANA ER products approved under NDA 21-610 had been discontinued for reasons of safety, refuse to approve any pending abbreviated new drug application for a generic version, and suspend and withdraw the approval of any ANDA referencing it. The FDA published its determination at 78 FR 38053 on 25 June 2013: after considering the petition and reviewing agency records, FDA determined under 21 CFR 314.161 that the original OPANA ER was not withdrawn for reasons of safety or effectiveness, that the product would continue to be listed in the Discontinued Drug Product List section of the Orange Book — which covers products discontinued for reasons other than safety or effectiveness — that FDA would not begin procedures to withdraw approval of referencing ANDAs, and that additional ANDAs could be approved. The sequence is what makes this an audit point rather than a regulatory footnote: the safety argument was made about the older formulation in a context where it also blocked competition, the agency rejected it, and the newer formulation was the one that was ultimately removed for a safety consequence nobody had predicted.
Source
Determination That OPANA ER (Oxymorphone Hydrochloride) Drug Products Covered by New Drug Application 21-610 Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness. 78 FR 38053, 25 June 2013 (responding to citizen petition Docket No. FDA-2012-P-0895)
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
It is not only a drug; it is what a fraction of every oxycodone dose becomes
In plain words
Oxymorphone is oxycodone with one chemical group removed — and that removal is exactly what the liver enzyme CYP2D6 does. Anyone taking oxycodone is making some of this molecule.
What was measured
That oxymorphone’s higher receptor affinity makes it a better analgesic than its parent drug — no head-to-head trial supports this, and the difference that is documented is metabolic predictability rather than efficacy
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Oxymorphone differs from oxycodone by the absence of the 3-methyl ether, and O-demethylation by CYP2D6 is the reaction that converts one into the other in the body. Oxymorphone has substantially higher mu-opioid receptor affinity than its parent. Two consequences follow that are routinely elided. First, any account of oxycodone pharmacology that treats the parent as the sole active species is incomplete, and the size of the metabolite contribution varies with inherited CYP2D6 activity and with any CYP2D6 inhibitor the patient is taking. Second, oxymorphone given directly does not require that conversion and therefore does not carry the CYP2D6 or CYP3A4 dependency that puts a boxed interaction warning on oxycodone — a genuine pharmacological difference between the two, and one that is about predictability rather than about potency or efficacy. No trial has shown that oxymorphone relieves pain better than oxycodone or morphine.
Source
OXYCONTIN United States prescribing information, boxed warning and Clinical Pharmacology 12.3, for the CYP2D6 conversion of oxycodone to oxymorphone (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
Every branded application is discontinued
In plain words
Opana, Opana ER, the reformulated Opana ER and the original Numorphan-era application are all listed as discontinued. The FDA formally withdrew approval of the reformulated product in December 2020.
What was measured
Marketing status of every branded oxymorphone application in Drugs@FDA: discontinued
Effect estimate
No reviewed effect estimate exists for this record.
Limits
This entry records a failure.
From the source
Drugs@FDA lists NDA 011707 (OPANA), NDA 021610 (OPANA ER), NDA 021611 (OPANA) and NDA 201655 (reformulated OPANA ER) as discontinued. FDA published the formal withdrawal of approval for NDA 201655 at 85 FR 83972 on 23 December 2020, recording that Endo requested the withdrawal and waived its opportunity for a hearing. Generic oxymorphone products remain marketed, which is the reason this record is not classified as a withdrawn drug: the molecule is still available and still prescribed, and what was removed was one company’s formulation portfolio. The distinction matters for a reader who finds an oxymorphone prescription in their hand and reads about a withdrawal.
Source
FDA Drugs@FDA records for NDA 011707, NDA 021610, NDA 021611 and NDA 201655, all listed as discontinued; Endo Pharmaceuticals, Inc.; Withdrawal of Approval of a New Drug Application for OPANA (Oxymorphone Hydrochloride) Extended-Release Tablets, 85 FR 83972, 23 December 2020
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
Abuse-deterrent testing measured the routes it thought of
In plain words
The standard package for an abuse-deterrent claim tests how hard a tablet is to crush, dissolve and snort. Nothing in it asks what people will do when snorting stops working.
What was measured
That abuse-deterrent formulation testing predicts population-level harm reduction — the testing measures tablet properties and drug liking by a fixed route, and cannot see substitution to a different and more dangerous route
Effect estimate
No reviewed effect estimate exists for this record.
Limits
See the technical detail.
From the source
Abuse-deterrent formulation assessment rests on in vitro manipulation and extraction studies plus, where available, human abuse-potential studies conducted by a specified route — typically intranasal or oral. Those studies measure tablet properties and drug-liking scores. They do not measure population-level abuse behaviour, and they cannot detect substitution between routes, because the design fixes the route in advance. The Opana ER sequence is the counterexample that establishes the limit: the reformulation achieved the physical property it was designed for, and the FDA’s stated basis for requesting removal in June 2017 was a significant shift in the route of abuse from nasal to injection following the reformulation, with the injection route carrying the HIV, hepatitis C and thrombotic microangiopathy consequences. The general inference — that a formulation property demonstrated in vitro and in a drug-liking study translates into less harm in a population — is the one this record refutes, and it is the same inference the oxycodone page audits from the other direction.
Source
FDA request for removal of reformulated Opana ER, 8 June 2017, and its stated basis in postmarketing data showing a shift in route of abuse from nasal to injection; OXYCONTIN United States prescribing information, section 9.2, for the structure of a labelled abuse-deterrence package (NDA 022272)
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
How many documents were read
9 documents were read for this substance.
RNAWiki source record
7 of them state the same halfLife, and they agree.
RNAWiki source record
9 of them state the same bioavailability, and they agree.
RNAWiki source record
2 of them state the same tMax, and they agree.
RNAWiki source record
Where else this substance is registered
FDA substance identifier (UNII)
9VXA968E0C
CAS registry number
76-41-5
PubChem compound
5284604
ChEMBL
CHEMBL963
WHO international nonproprietary name list entry
937
RxNorm concept
7814
EMA substance identifier
100000083286
European Chemicals Agency number
200-959-7
DrugBank
DB01192
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.
✓ Passed
Canonical metadata present
slug and display name present
What is missing or unclear◇Read from sources, not yet reviewed
How this medicine reached us
Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.
What the approval register records
18 approved applications cover products containing this substance. The earliest was NDA011707, approved 19590402 to ENDO PHARMS.
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 agonist and the active metabolite of oxycodone, whose 2012 crush-resistant reformulation shifted abuse from the nasal route to injection, was linked to an HIV outbreak in which 181 people were infected and 87.8% reported injecting extended-release oxymorphone, and which on 8 June 2017 became the first marketed opioid the FDA ever asked a manufacturer to withdraw because of the public health consequences of its abuse — after an advisory committee voted 18 to 8 that its benefits no longer outweighed its risks.
Recorded evidence blocks (8)
Q2
On the Oxymorphone label: indicated for what?
"1 INDICATIONS & USAGE Oxymorphone hydrochloride tablets is indicated for the management of acute 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, and misuse, overdose and death which can occur at any…": indications and usage on Oxymorphone's label. DailyMed label · 22c7652a-aa16-4fa8-89d9-517e69059068 · 2026-06-29
Q3
12 registered trials of Oxymorphone — at which phases?
9-11 hours; Elimination Oxymorphone hydrochloride tablets half-life ranges from approximately 9-11 hours after a single oral dose (5-40 mg).
bioavailabilitypharmacokinetics
10 %; Absorption The absolute oral bioavailability of oxymorphone is approximately 10%.
metabolismpharmacokinetics
Metabolism Oxymorphone is highly metabolized, principally in the liver, and undergoes reduction or conjugation with glucuronic acid to form both active and inactive products.
recorded 2026-06-29 · last checked 2026-09-04
Q6
Which 3 trials of Oxymorphone posted no result?
Posted no result
3 of 3 completed trials
Registrations
NCT00857142, NCT00857428 and NCT01210638
Completion dates
oldest 2007-12; newest 2008-06
Show the evidence
Trial
NCT00857142
2007-12
NCT00857428
2007-12
NCT01210638
2008-06
Q7
At the median, Oxymorphone's trials enrolled 42.5 people — anything larger?
Median enrolment
42.5
Largest enrolment
27034
Registered trials counted
12
Q8
What do 586 spontaneous reports say about Oxymorphone — 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.
Oxymorphone appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 586 reaction mentions were counted: drug abuse 205; drug screen positive 54; acute kidney injury 52; drug use disorder 48. FAERS via Open Targets · CHEMBL1200794 · 2026-06-24
Show the evidence
drug abuse
205
drug screen positive
54
acute kidney injury
52
drug use disorder
48
drug dependence
47
thrombotic thrombocytopenic purpura
43
4 more recorded rows
drug diversion
36
endocarditis
34
feeling abnormal
34
respiratory failure
33
recorded 2026-06-24 · last checked 2026-09-04
Q9
Which 10 reactions does Oxymorphone's label not list?
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
✗ required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
✓ public claims reviewed: 0 reviewed claim(s); drafts are never rendered
✓ source coverage passed: 5 source rows
✓ no critical contamination: no quarantine open
✓ canonical metadata passed: slug and display name present
✓ no raw internal fields: enforced by the copy-contract test over the rendered page
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.