OXYMORPHONE HYDROCHLORIDE (OXYMORPHONE HYDROCHLORIDE)
What to know about OXYMORPHONE HYDROCHLORIDE — also sold as OXYMORPHONE HYDROCHLORIDE: uses, side effects, interactions, and safety considerations for people taking it or caring for someone who is.
OXYMORPHONE HYDROCHLORIDE (brand names: OXYMORPHONE HYDROCHLORIDE) is classified as High risk (7 risk points) by AllMeds. It is a S8 medication under the TGA in Australia. FDA approved in the United States. Potent S8 opioid with high respiratory depression and CNS impairment risk requiring strict monitoring.
Key Takeaways
- TGA Schedule: S8 in Australia
- Risk level: High (7 points)
- CNS depressant: May cause sedation, impair driving, and affect work capacity
- Respiratory depression risk: Requires monitoring, especially with other CNS depressants
- Recommended maximum duration: 7 days
- SIRA reportable: Flagged for NSW workers compensation reporting
- OME factor: 3 (oral morphine equivalent conversion)
Scheduling and Classification
| Jurisdiction | Classification | Status |
|---|---|---|
| Australia (TGA) | S8 | Not PBS listed |
| United States (FDA) | Rx only | FDA approved |
Risk Profile
Potent S8 opioid with high respiratory depression and CNS impairment risk requiring strict monitoring.
How OXYMORPHONE HYDROCHLORIDE is regulated
OXYMORPHONE HYDROCHLORIDE is overseen by medicines regulators in each country. The rules below explain how it's scheduled, what oversight applies, and what to discuss with your doctor or pharmacist before starting, changing, or stopping this medication.
Work capacity impact: As a CNS depressant, OXYMORPHONE HYDROCHLORIDE may impair driving, operating machinery, and cognitive function. Work capacity certificates should reflect any medication-related restrictions.
Australia TGA / PBS / State Schemes
Classified as S8 under the Therapeutic Goods Administration (TGA).
Flagged as reportable under SIRA guidelines in NSW. Claims involving this medication may require additional reporting and clinical justification.
SIRA best practice guidelines recommend a maximum opioid duration of 7 days for acute pain. Prescribing beyond this requires documented clinical justification and may trigger a Reasonable and Necessary determination.
WorkSafe Victoria Drugs of Dependence Guidelines require monitoring for all S8 opioids. WorkCover QLD Pain Intervention Guidelines recommend multimodal pain management with opioids as a last resort.
United Kingdom NICE / MHRA / FPM
NICE NG193 (Chronic Pain) recommends against initiating opioids for chronic primary pain. The Faculty of Pain Medicine (FPM) Opioids Aware resource recommends structured opioid prescribing with regular review, dose limits, and documented tapering plans.
For personal injury claims in the UK, opioid prescribing duration and dose should be reviewed against NICE and FPM guidelines. Costs may be recoverable as a disbursement in high-value PI claims.
UK drug driving laws (Section 5A Road Traffic Act 2006) set specific limits for prescription drugs that cause impairment. Employers and occupational health advisors should assess fitness to work.
United States FDA / CDC / State WC
FDA approved for use in the United States.
FDA Boxed Warning: 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. Reserve concomitant prescribing of oxymorphone hydrochloride tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see Warnings and Precautions (5.3), Drug Interactions (7)]. Neonatal Opioid Withdrawal Syndrome (NOWS) Advise pregnant women using opioids for an extended period of time of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery [see Warnings and Precautions (5.4)] . Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription [see Warnings and Precautions (5.5)]. Interaction with Alcohol Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking oxymorphone hydrochloride tablets. The co-ingestion of alcohol with oxymorphone hydrochloride tablets may result in increased plasma levels and a potentially fatal overdose of oxymorphone [see Warnings and Precautions (5.3)]. WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYMORPHONE HYDROCHLORIDE TABLETS See full prescribing information for complete boxed warning. Oxymorphone hydrochloride tablets exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing and monitor regularly for these behaviors and conditions. (5.1) Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. (5.2) Accidental ingestion of oxymorphone hydrochloride tablets, especially by children, can result in a fatal overdose of oxymorphone. (5.2) 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. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation. (5.3, 7) Advise pregnant women using opioids for an extended period of time of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery. (5.4) To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products. (5.5) Instruct patients not to consume alcohol or any product containing alcohol while taking oxymorphone hydrochloride tablets because co-ingestion can result in fatal plasma oxymorphone levels. (5.3)
The CDC Clinical Practice Guideline for Prescribing Opioids (2022) recommends non-opioid therapies as first-line treatment for pain. When opioids are prescribed, the lowest effective dose should be used for the shortest duration needed.
For workers compensation claims, many states require prior authorization for opioids beyond initial acute prescribing. State drug formularies (e.g. California MTUS, Texas, New York) may restrict or require step therapy before opioid approval.
New Zealand ACC / BPAC NZ / Medsafe
BPAC NZ recommends reassessing opioid therapy at regular intervals and limiting duration. The NZ Opioid Prescribing B-QuiCK Guide provides structured prescribing and tapering protocols.
ACC (Accident Compensation Corporation) covers treatment-related medications for accepted claims. Opioid prescribing beyond guidelines may require ACC clinical review and approval.
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Important: This page is general health information, not personal medical advice. If you have questions about your medication — including starting it, stopping it, changing the dose, or combining it with something else — speak with your doctor or pharmacist. For an emergency or suspected overdose, call your local emergency number or poison information service immediately. Information is drawn from regulator and clinical guideline sources (TGA, FDA, MHRA, NICE, PBS, CDC); see our methodology for details.