Prescription medicine
Oxymorphone First approved as Opana
Oxymorphone (Opana) is a prescription medicine with an FDA approval on record since 1959. FDA's NDC Directory lists it from 9 generic labelers.
- Generic listed
- Boxed warning
- DEA Schedule II
Check it at the source: the oxymorphone FDA label on DailyMed (effective June 29, 2026, Aurolife Pharma, LLC); the NDA 11707 record on Drugs@FDA; every oxymorphone label on DailyMed.
Highlights of the record
FDA label of June 29, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYMORPHONE HYDROCHLORIDE TABLETS WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYMORPHONE HYDROCHLORIDE TABLETS.
Addiction, Abuse, and Misuse Because the use of oxymorphone hydrochloride tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.1)]. Life-threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of oxymorphone hydrochloride tablets, especially during initiation or following a dose increase. To reduce the risk of respiratory depression, proper dosing and titration of oxymorphone hydrochloride tablets are essential [see Warnings and Precautions (5.2) ]. Accidental Ingestion Accidental ingestion of even one dose of oxymorphone hydrochloride tablets, especially by children, can result in a fatal overdose of oxymorphone [see Warnings and Precautions (5.2)]. Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. […]
Used for
From the label: indications and usageOxymorphone hydrochloride tablets is indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Forms and strengths
- 5 mg
- 7.5 mg
- 10 mg
- 15 mg
- 20 mg
- 30 mg
- 40 mg
Film-coated extended-release tablet; tablet.
On the market
- Earliest approval on file
- April 2, 1959 Opana, Endo Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 13 first June 14, 2010; 7 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 9 of which 9 under generic applications, 0 under brand applications, repackagers included
- Last listed patent
- November 22, 2029 Opana ER tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 11,596 through July 30, 2026
What is oxymorphone used for?
From the label: indications and usageOxymorphone 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 dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including oxymorphone hydrochloride tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. […]
Conditions named in the indications of oxymorphone's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Opioid Agonist.
Source: FDA drug label (Oxymorphone Hydrochloride), Aurolife Pharma, LLC, effective June 29, 2026 (SPL set 22c7652a-aa16-4fa8-89d9-517e69059068), via openFDA; the full label on DailyMed
Is there a generic for oxymorphone (Opana)?
The FDA approved the first generic oxymorphone on June 14, 2010. 13 generic applications are approved; 7 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists oxymorphone from 9 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 2 patents for Opana ER tablets: the compound patent runs to November 22, 2029. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1959 earliest approval on file
- 2010 first generic approved
- 2029 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the oxymorphone label say about other medicines?
The oxymorphone label names 17 other medicines in its interaction, contraindication or warning sections. The labels of 9 other medicines name oxymorphone. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Buprenorphine | drug interactions | Examples; butorphanol, nalbuphine, pentazocine, buprenorphine, |
| Butorphanol | drug interactions | Examples; butorphanol, nalbuphine, pentazocine, buprenorphine, |
| Cimetidine | drug interactions | Cimetidine Clinical Impact Cimetidine can potentiate opioid-induced respiratory depression. Intervention Evaluate patients for respiratory depression when oxymorphone hydrochloride tablets and cimetidine are used concurrently. Serotonergic Drugs: Concomitant use may result in serotonin syndrome. … |
| Cyclobenzaprine | drug interactions | … serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). |
| Gabapentin | drug interactions | Examples; Benzodiazepines and other sedatives/hypnotics, anxiolytics tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), other opioids, alcohol. |
| Linezolid | drug interactions | … monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). |
| Metaxalone | drug interactions | … neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). |
| Methylene blue | drug interactions | … inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). |
| Mirtazapine | drug interactions | Examples; Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e. … |
| Nalbuphine | drug interactions | Examples; butorphanol, nalbuphine, pentazocine, buprenorphine, |
| Nalmefene | warnings and precautions | Patient Access to an Opioid Overdose Reversal Agent for the Emergency Treatment of Opioid Overdose Inform patients and caregivers about opioid overdose reversal agents (e.g., naloxone, nalmefene). |
| Naloxone | warnings and precautions | Patient Access to an Opioid Overdose Reversal Agent for the Emergency Treatment of Opioid Overdose Inform patients and caregivers about opioid overdose reversal agents (e.g., naloxone, nalmefene). |
| Phenelzine | drug interactions | Examples; phenelzine, tranylcypromine, linezolid |
| Pregabalin | drug interactions | Examples; Benzodiazepines and other sedatives/hypnotics, anxiolytics tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), other opioids, alcohol. |
Every other medicine the oxymorphone label names
| Medicine named | Section | What the label says |
|---|---|---|
| Tramadol | drug interactions | … the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to … |
| Tranylcypromine | drug interactions | Examples; phenelzine, tranylcypromine, linezolid |
| Trazodone | drug interactions | … that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those … |
Other labels that name oxymorphone
Source: FDA drug label (Oxymorphone Hydrochloride), Aurolife Pharma, LLC, effective June 29, 2026 (SPL set 22c7652a-aa16-4fa8-89d9-517e69059068), via openFDA; the full label on DailyMed
What do FAERS reports show for oxymorphone?
The FDA Adverse Event Reporting System holds 11,596 reports that list oxymorphone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 5,716 are coded as a death and 738 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2018 (5,823, against a median of 70 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as oxymorphone?
36 other medicines are given the same way (oral) and in the same FDA class as oxymorphone or labeled mainly for the same use (pain), the same class first. Pain lists all 80 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Acetaminophen and hydrocodone | Pain | 38 labelers | $0.152 per tablet 10-325 mg tablet | No current entry |
| Oxycodone | Pain | 34 labelers | $0.0884 per tablet 5 mg tablet | No current entry |
| Acetaminophen and oxycodone | Pain | 30 labelers | $0.183 per tablet 7.5-325 mg tablet | A presentation being discontinued |
| Tramadol | Pain | 40 labelers | $0.0248 per tablet 50 mg tablet | No current entry |
| Morphine | Pain | 17 labelers | $0.226 per tablet 15 mg tablet | In shortage |
| Acetaminophen and codeine | Pain | 25 labelers | $0.256 per tablet 3 tablet | No current entry |
| Hydromorphone | Pain | 11 labelers | $0.219 per tablet 4 mg tablet | In shortage |
| Methadone | Pain | 17 labelers | $0.177 per tablet 10 mg tablet | No current entry |
Every medicine labeled for the same conditions as oxymorphone
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does oxymorphone compare with medicines for the same use?
5 side-by-side pages set oxymorphone beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to oxymorphone
- 36 medicines for the same use
- Other opioids
- the pharmacologic class, with prices and generics
- Oxymorphone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other