Semi-synthetic opioid analgesic (μ-agonist)
ATC code: N02AA05 (Oxycodone)
Oxycodone is a semi-synthetic μ-opioid receptor agonist with potency similar to morphine (1 mg oral oxycodone ≈ 1.5 mg oral morphine). Also binds κ-receptors, producing more anxiolytic and sedative effects than pure μ-agonists. Metabolized via CYP3A4 and CYP2D6; CYP2D6 generates the active metabolite oxymorphone.
Third line
Severe acute pain uncontrolled by non-opioid analgesics or weak opioids: postoperative pain, severe trauma, acute breakthrough cancer pain, renal colic refractory to NSAIDs. Per SED 2024 and SEMERGEN 2023 – third-line after paracetamol, NSAIDs, and weak opioids. Dose: 5-10 mg every 4-6 hours (immediate release) or 10-20 mg every 12 hours (controlled release). Short course ≤7 days outside oncology. Taper at discontinuation to avoid withdrawal.
The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.
Not recommended
Long-term therapy of chronic non-cancer pain – osteoarthritis, back pain, fibromyalgia. In the 2000-2010s oxycodone was aggressively marketed as a safe long-term opioid, driving the US opioid epidemic with >600,000 deaths. Per CDC 2022 Clinical Practice Guideline and SED-SEMERGEN 2023, long-term opioids are not used as first or second-line for chronic non-cancer pain: 3-month efficacy matches placebo, addiction rate 8-12%, overdose risk rises beyond 50 morphine milligram equivalents. If oxycodone was prescribed for back pain over months, consider getting a second opinion and treatment-plan review.
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Boxed warning
FDA Black Box: risk of addiction, abuse, and misuse; life-threatening respiratory depression; neonatal opioid withdrawal syndrome with use in pregnancy; fatal interactions with benzodiazepines and alcohol.
Oxycodone is evaluated for the following indications with varying evidence strength: Acute pain (evidence tier A), Chronic pain (evidence tier D). See the full indication matrix with dosing and citations above on this page.
Common side effects of Oxycodone (≥ 1 in 100): Constipation, Nausea, vomiting, Drowsiness, sedation, Dry mouth, Dizziness, Pruritus. See the Safety section for uncommon and serious reactions.
FDA category C. Long-term use causes neonatal opioid withdrawal. Short courses for labor pain or post-cesarean are acceptable. For women on chronic oxycodone in pregnancy, plan a taper with an obstetrician and addiction specialist.
Single doses are compatible (RID about 3.5%, Hale L3). Long-term use and high doses are not recommended – infant sedation risk, especially in CYP2D6 ultra-rapid metabolizer mothers (FDA Safety Communication 2017). Monitor infant for sedation, poor feeding, respiratory depression.
Oxycodone is contraindicated in: Hypersensitivity; Respiratory depression, severe COPD, asthma exacerbation; Paralytic ileus; Acute abdomen of undetermined cause; Acute alcohol or psychotropic intoxication. Full list in the Safety section.
Long-term use causes neonatal opioid withdrawal. Short courses for labor pain or post-cesarean are acceptable. For women on chronic oxycodone in pregnancy, plan a taper with an obstetrician and addiction specialist.
Single doses are compatible (RID about 3.5%, Hale L3). Long-term use and high doses are not recommended – infant sedation risk, especially in CYP2D6 ultra-rapid metabolizer mothers (FDA Safety Communication 2017). Monitor infant for sedation, poor feeding, respiratory depression.
Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.
FDA Black Box: risk of addiction, abuse, and misuse; life-threatening respiratory depression; neonatal opioid withdrawal syndrome with use in pregnancy; fatal interactions with benzodiazepines and alcohol.