Section 19 · Monograph
Oxycodone
Reviewed Nov 2026FDA label
Roxicodone / OxaydoOpioid agonist (CII)
- Forms
- Tab: 5, 10, 15, 20, 30mg | Soln: 5mg/5mL, 100mg/5mL
- Dose
- Opioid-naive: 5mg PO every 4-6h as needed; titrate to effect
- MOA
- μ-opioid receptor agonism
Black Box Warning
- Addiction, abuse and misuse; life-threatening respiratory depression; accidental ingestion; neonatal opioid withdrawal syndrome; CYP3A4 interaction risk; risks from concomitant use with benzodiazepines or other CNS depressants; opioid analgesic REMS
Indications
- Management of pain severe enough to require an opioid analgesicFDA-labeled
Mechanism of Action
- Full mu-opioid agonist metabolized by CYP3A4 (to noroxycodone) and CYP2D6 (to oxymorphone)
Full Dosing
Adult / usual
- Opioid-naive: 5mg PO every 4-6 hours as needed, titrated to effect
- Concentrate (100mg/5mL) is for opioid-tolerant patients only; take care with measuring devices
Hepatic
- Reduce starting dose in hepatic impairment and with CYP3A4 inhibitors
Contraindications
- Significant respiratory depression
- Acute or severe bronchial asthma in an unmonitored setting
- Known or suspected gastrointestinal obstruction
- Hypersensitivity to oxycodone
Drug Interactions
- CYP3A4 inhibitors (azoles, macrolides, protease inhibitors) raise levels; inducers (rifampin, carbamazepine, phenytoin) lower them and can precipitate withdrawal
- Benzodiazepines and other CNS depressants
- Serotonergic drugs and MAO inhibitors
Adverse Effects
- Constipation, nausea, sedation
- Respiratory depression
- Pruritus, dizziness
- Dependence and withdrawal on abrupt stop
Monitoring Parameters
- Sedation, respiratory rate and pain control
- Bowel function
- Interacting drugs when starting or stopping CYP3A4 modulators
Pregnancy & Lactation
- Neonatal opioid withdrawal syndrome with prolonged use
- Present in milk; monitor infants for sedation