Head-to-head clinical analysis & difference comparison: details on mechanism of action, dosing, half-life, interactions, and maternal-fetal safety.
ROXICODONE vs OPANA
Clinician-reviewed, head-to-head comparison of mechanism, dosing, pharmacokinetics, and safety profiles.
Last clinically reviewed: June 2026 · OpiCalc Medical Review Team
Oxycodone is a full opioid agonist with high affinity for mu-opioid receptors, also binding to kappa and delta receptors. It acts primarily on the central nervous system and gastrointestinal tract.
Mu-opioid receptor agonist; produces analgesia by binding to opioid receptors in the CNS, inhibiting ascending pain pathways and altering pain perception.
Management of moderate to severe pain where an opioid analgesic is appropriate
Management of moderate to severe acute pain where use of an opioid is appropriate,Management of moderate to severe chronic pain requiring long-term opioid treatment
5-15 mg orally every 4-6 hours as needed for pain; immediate-release formulation. Maximum 60 mg total daily dose for opioid-naive patients.
5-20 mg orally every 4-6 hours as needed for pain; extended-release tablets: 5 mg orally every 12 hours, titrated up to 20 mg every 12 hours.
3.5-5 hours for immediate-release; 4.5-5.5 hours for extended-release. Accumulation may occur with repeated dosing, especially in elderly or hepatic impairment.
Terminal elimination half-life is 11-16 hours (mean 14 hours) in adults; prolonged in hepatic impairment (up to 30 hours) and elderly.
Hepatic, primarily via CYP3A4 and CYP2D6; major metabolites include noroxycodone and oxymorphone.
For e GFR 30-59 m L/min: administer at 50-75% of usual dose; for e GFR 10-29 m L/min: 50% of usual dose; for e GFR <10 m L/min: avoid use or use 25% of usual dose with extended intervals.
GFR 30-59 m L/min: reduce dose by 25-50%; GFR <30 m L/min: reduce dose by 50% and extend dosing interval to every 12 hours; avoid use in dialysis.
Risk of addiction, abuse, and misuse; life-threatening respiratory depression; accidental ingestion; neonatal opioid withdrawal syndrome; risks from concomitant use with benzodiazepines or other CNS depressants; interaction with alcohol.
First trimester: Increased risk of neural tube defects and congenital heart defects (odds ratio 2.0-3.0 for any opioid). Second and third trimesters: Risk of fetal growth restriction, preterm birth, and neonatal opioid withdrawal syndrome (NOWS). Considered low to moderate teratogenic risk; no specific malformation pattern identified.
Teratogenic risk profile for OPANA (oxymorphone): First trimester: Limited human data; animal studies show no evidence of teratogenicity at clinically relevant doses. Second and third trimesters: Chronic use may cause fetal opioid dependence and neonatal withdrawal syndrome. Use during labor may cause respiratory depression in the neonate.
Roxicodone is a high-potency immediate-release oxycodone formulation. Avoid crushing or chewing tablets. Use with caution in patients with renal impairment (Cr Cl < 60 m L/min) as active metabolite oxymorphone accumulates. Consider naltrexone or naloxone for opioid-induced constipation. Monitor for respiratory depression, especially with concomitant CNS depressants. Do not use in patients with acute or severe bronchial asthma.
Titrate dose cautiously; 10mg oral oxymorphone equivalent to 20mg oral oxymorphone ER. Do not crush, chew, or dissolve ER tablets. Avoid in patients with respiratory depression, paralytic ileus, or acute/severe asthma. Monitor for serotonin syndrome with serotonergic drugs.
No interactions on record
No interactions on record
Common clinical questions about ROXICODONE vs OPANA, answered by our medical review team.
ROXICODONE is a Opioid Analgesic that works by Oxycodone is a full opioid agonist with high affinity for mu-opioid receptors, also binding to kappa and delta receptors. It acts primarily on the central nervous system and gastrointestinal tract.. OPANA is a Opioid Analgesic that works by Mu-opioid receptor agonist; produces analgesia by binding to opioid receptors in the CNS, inhibiting ascending pain pathways and altering pain perception.. They differ in pharmacokinetic profiles, FDA-approved indications, and side effect profiles.
Potency comparisons between ROXICODONE and OPANA depend on the specific clinical indication. These are both Opioid Analgesic agents and are not directly interchangeable by dose. A physician or clinical pharmacist should guide any therapeutic switching decisions.
The standard adult dose of ROXICODONE is: 5-15 mg orally every 4-6 hours as needed for pain; immediate-release formulation. Maximum 60 mg total daily dose for opioid-naive patients.. The standard adult dose of OPANA is: 5-20 mg orally every 4-6 hours as needed for pain; extended-release tablets: 5 mg orally every 12 hours, titrated up to 20 mg every 12 hours.. Dosing should always be individualized based on indication, renal and hepatic function, age, and other patient factors.
No direct drug-drug interaction has been formally documented between ROXICODONE and OPANA in current clinical databases. However, individual patient risk factors including other medications, organ function, and comorbidities should always be evaluated by a qualified healthcare provider.
The maternal-fetal safety profiles differ. ROXICODONE is classified as Category C. First trimester: Increased risk of neural tube defects and congenital heart defects (odds ratio 2.0-3.0 for any opioid). Second and third trimesters: Risk of fetal growth restricti. OPANA is classified as Category C. Teratogenic risk profile for OPANA (oxymorphone): First trimester: Limited human data; animal studies show no evidence of teratogenicity at clinically relevant doses. Second and th. Always consult a maternal-fetal medicine specialist before taking either drug during pregnancy or lactation.
Hepatic via CYP3A4 and CYP2C8 to noroxymorphone and oxymorphone; also undergoes glucuronidation.
Renal excretion: 70-80% as unchanged drug and metabolites (oxymorphone, noroxycodone); fecal: 10-20%.
Primarily renal (approximately 90% as conjugated metabolites, 10% unchanged); biliary/fecal elimination accounts for <10%.
45% bound to albumin.
Approximately 91-94% bound, primarily to albumin and alpha-1-acid glycoprotein.
2.0-2.5 L/kg. Large Vd indicates extensive tissue distribution, including to brain and adipose tissue.
Vd ~ 3.3 L/kg (range 2.5-4.1 L/kg), indicating extensive tissue distribution.
Oral immediate-release: 60-87%; oral extended-release: 40-60% (first-pass metabolism); intravenous: 100%; intramuscular: ~80%.
Oral: ~48% (range 31-54%) due to first-pass metabolism; intranasal: ~46% (comparable to oral); intravenous: 100%.
Child-Pugh Class A: no adjustment; Child-Pugh Class B: reduce dose by 50%; Child-Pugh Class C: avoid use or reduce dose by 75% with extended dosing intervals.
Child-Pugh Class A: no adjustment; Child-Pugh Class B: reduce starting dose by 50%; Child-Pugh Class C: avoid use.
Children aged 11 years and older: 0.1-0.2 mg/kg per dose orally every 4-6 hours as needed; maximum 10 mg per dose. Not recommended for children under 11 years due to limited data.
Not recommended for pediatric patients under 18 years of age; safety and efficacy not established.
Initiate at 3-5 mg orally every 4-6 hours; titrate cautiously. Avoid in patients with severe renal or hepatic impairment. Monitor for respiratory depression, constipation, and falls.
Start at the lower end of the dosing range (2.5-5 mg every 4-6 hours) and titrate cautiously; monitor for respiratory depression and constipation.
Addiction, abuse, and misuse; life-threatening respiratory depression; neonatal opioid withdrawal syndrome; risks from concomitant use with benzodiazepines or other CNS depressants.
Addiction, abuse, and misuse; life-threatening respiratory depression; neonatal opioid withdrawal syndrome; risks from concomitant use with benzodiazepines; severe hypotension; adrenal insufficiency; seizures; risks in patients with head injuries, increased intracranial pressure; severe hypertension; gastrointestinal obstruction; impaired renal or hepatic function; elderly and debilitated patients; pregnancy; lactation.
Respiratory depression; CNS depression; hypotension; adrenal insufficiency; serotonin syndrome; constipation; urinary retention; seizures; increased intracranial pressure; biliary tract spasm; tolerance; physical dependence; withdrawal; impaired mental/physical abilities; risk of death with alcohol or other CNS depressants; elderly/cachectic patients; renal/hepatic impairment; pregnancy; labor and delivery; breastfeeding.
Significant respiratory depression; acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment; known or suspected gastrointestinal obstruction, including paralytic ileus; hypersensitivity to oxycodone or any component of the product.
Hypersensitivity to oxymorphone or any component; significant respiratory depression; acute or severe bronchial asthma in an unmonitored setting or without resuscitative equipment; known or suspected gastrointestinal obstruction including paralytic ileus; concurrent use of MAOIs or within 14 days of such therapy.
Avoid alcohol. No significant food interactions; take with or without food. Grapefruit/grapefruit juice may increase oxycodone levels; limit or avoid.
Avoid alcohol; can increase CNS depression and risk of overdose. Grapefruit juice may potentiate opioid effects; consider avoiding. High-fat meals may delay absorption of extended-release formulations.
Roxicodone (oxycodone) is excreted in breast milk; relative infant dose (RID) is approximately 2.5-5% of maternal weight-adjusted dose. M/P ratio: approximately 3.2:1. Use with caution; monitor infant for respiratory depression, sedation, and withdrawal. If used, lowest effective dose and shortest duration.
Breastfeeding safety: Oxymorphone is excreted in breast milk. The M/P ratio is approximately 2.0 (based on limited data). Caution is advised due to potential for infant sedation and respiratory depression. Use only if benefit outweighs risk, and monitor infant for signs of opioid toxicity.
Increased hepatic metabolism and renal clearance in pregnancy may reduce oxycodone plasma concentrations by 30-50%. Dose adjustments should be based on clinical response; consider 20-30% higher initial doses or more frequent dosing intervals. Avoid NSAID combinations in third trimester.
Pharmacokinetic changes in pregnancy: Increased plasma volume and renal clearance may reduce oxymorphone concentrations. During pregnancy, especially third trimester, higher or more frequent doses may be required to achieve same analgesia. Postpartum, doses should be reduced due to normalization of pharmacokinetics. Individualize based on response and signs of withdrawal.
Take exactly as prescribed; do not increase dose or frequency.,Swallow tablets whole; do not crush, chew, or dissolve.,Avoid alcohol and other sedatives (e.g., benzodiazepines, muscle relaxants).,May cause drowsiness; do not drive or operate machinery until you know how you react.,Store securely out of sight and reach of children and pets.,Do not stop suddenly; taper under medical supervision to avoid withdrawal.,Report signs of serotonin syndrome (agitation, hallucinations, rapid heart rate) or adrenal insufficiency (nausea, vomiting, loss of appetite, fatigue).
Take exactly as prescribed; do not increase dose or frequency without consulting your doctor.,Swallow ER tablets whole; do not crush, chew, or dissolve.,Avoid alcohol and other CNS depressants; may cause dangerous sedation.,Do not stop abruptly; withdrawal may occur. Taper under medical supervision.,Store securely away from others, especially children; dispose of unused medication via drug take-back.