Oxycodone

Mechanism-of-action class: Full Opioid Agonists.

• Oxycodone hydrochloride tablets are indicated for the management of 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, 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 oxycodone 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.

• Oxycodone hydrochloride is contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions (5.2)]. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment or hypercarbia [see Warnings and Precautions (5.8)].contraindicated

Oxycodone hydrochloride tablets should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. (2.1) Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals. Reserve titration to higher doses of oxycodone hydrochloride for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks. (2.1, 5) Many acute pain conditions (e.g., the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic. Clinical guidelines on opioid prescribing for some acute pain conditions are available. (2.1) Initiate the dosing regimen for each patient individually, taking into account the patient’s underlying case and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse. (2.1, 5.1) Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with oxycodone hydrochloride. Consider this risk when selecting an initial dose and when making dose adjustments. (2.1, 5.2) Discuss opioid overdose reversal agents and options for acquiring them with the patient and/or caregiver, both when initiating and renewing treatment with oxycodone hydrochloride, especially if the patient has additional risk factors for overdose, or close contacts at risk for exposure and overdose.

Opioid-Induced Hyperalgesia and Allodynia : Opioid-Induced Hyperalgesia (OIH) occurs when opioid analgesic paradoxically causes an increase in pain, or an increase in sensitivity to pain. If OIH is suspected, carefully consider appropriately decreasing the dose of the current opioid analgesic, or opioid rotation. (5.7) Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients : Regularly evaluate closely, particularly during initiation and titration. (5.8) Adrenal Insufficiency : If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. (5.9) Severe Hypotension : Regularly evaluate during dosage initiation and titration. Avoid use of oxycodone hydrochloride in patients with circulatory shock. (5.10) Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness : Monitor for sedation and respiratory depression. Avoid use of oxycodone hydrochloride in patients with impaired consciousness or coma. (5.11) 5.1 Addiction, Abuse, and Misuse Oxycodone hydrochloride tablets contains oxycodone, a Schedule II controlled substance. As an opioid, oxycodone hydrochloride exposes users to the risks of addiction, abuse, and misuse [see Drug Abuse and Dependence (9)] . Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed oxycodone hydrochloride. Addiction can occur at recommended dosages and if the drug is misused or abused.

The following serious adverse reactions are described, or described in greater detail, in other sections: Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1)] Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2)] Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions (5.3)] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.4)] Opioid-Induce Hyperalgesia and Allodynia [see Warnings and Precautions (5.7)] Adrenal Insufficiency [see Warnings and Precautions (5.9)] Severe Hypotension [see Warnings and Precautions (5.10)] Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.12)] Seizures [see Warnings and Precautions (5.13)] Withdrawal [see Warnings and Precautions (5.14)] Most common adverse reactions (≥3%) were nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Camber Pharmaceuticals Inc., at 1-866-495-8330 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Oxycodone hydrochloride tablets have been evaluated in open label clinical trials in patients with cancer and nonmalignant pain.

Pregnancy: May cause fetal harm. (8.1) 8.1 Pregnancy Risk Summary Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.4)] . Available data with oxycodone hydrochloride in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage or adverse maternal outcomes. Animal reproduction studies with oral administrations of oxycodone HCl in rats and rabbits during the period of organogenesis at doses 2.6 and 8.1 times, respectively, the human dose of 60 mg/day did not reveal evidence of teratogenicity or embryo-fetal toxicity. In several published studies, treatment of pregnant rats with oxycodone at clinically relevant doses and below, resulted in neurobehavioral effects in offspring [see Data] . Based on animal data, advise pregnant women of the potential risk to a fetus. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Presentation Acute overdose with oxycodone can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and in some cases, pulmonary edema, bradycardia, hypotension, hypoglycemia, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations [see Clinical Pharmacology (12.2)] . Toxic leukoencephalopathy has been reported after opioid overdose and can present hours, days, or weeks after apparent recovery from the initial intoxication. Treatment of Overdose In case of overdose, priorities are the re-establishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life-support measures. For clinically significant respiratory or circulatory depression secondary to opioid overdose, administer an opioid overdose reversal agent such as naloxone or nalmefene.

• Dec 7, 1983ANDAANDA087463Specgx Llc
• Jun 25, 1999ANDAANDA040330Ozantri
• Aug 31, 2000NDANDA021011Specgx Llc
• Apr 5, 2010NDANDA022272Knoa Pharma
• Oct 20, 2010NDANDA200535Genus Lifesciences
• Jun 17, 2011NDANDA202080Zyla
• Apr 26, 2016NDANDA208090Collegium Pharm Inc
• Apr 20, 2017NDANDA209777Protega Pharms

1. 1Drug Dependence102,95427%
2. 2Pain68,36118%
3. 3Overdose58,86016%
4. 4Emotional Distress50,06513%
5. 5Drug Withdrawal Syndrome38,21710%
6. 6Death33,4938.9%
7. 7Dependence22,7556.0%
8. 8Nausea18,9925.0%
9. 9Drug Ineffective18,3114.9%
10. 10Toxicity To Various Agents18,1984.8%
11. 11Fatigue18,0674.8%
12. 12Diarrhoea13,5243.6%
13. 13Vomiting13,1663.5%
14. 14Anxiety12,8713.4%
15. 15Depression12,7323.4%

Recent PubMed references pinned to Oxycodone as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Assessment of the acceptability of effervescent oxycodone/paracetamol in the management of moderate-to-severe pain: the FirAlgos study.
  European review for medical and pharmacological sciences · 2026 · Vellucci R, Tur E, Lepri A, et al.
  PMID 42237960DOI 10.26355/eurrev_202605_37822
• Oxycodone versus Sufentanil for Postoperative Analgesia and Early Recovery After Radical Gastrectomy: A Propensity Score-Matched Study.
  Drug design, development and therapy · 2026 · Wang Y, Hu L, Chen Z, et al.
  PMID 42232092DOI 10.2147/DDDT.S606394
• Effects of oxycodone and sufentanil on the quality of recovery after laparoscopic total hysterectomy: A randomized controlled trial.
  Medicine · 2026 · Liu Z, Guo S
  PMID 42216335DOI 10.1097/MD.0000000000048778
• Tegileridine, a Biased μ-Opioid Receptor Agonist, versus Oxycodone for Postoperative Analgesia and Postoperative Nausea and Vomiting After Total Laparoscopic Hysterectomy: A Randomized, Double-Blind, Single-Center, Controlled Trial.
  Drug design, development and therapy · 2026 · Fu Y, Chen X, Gao FP, et al.
  PMID 42199806DOI 10.2147/DDDT.S598457
• Postnatal environment differentially modulates neurodevelopmental outcomes following voluntary prenatal oxycodone exposure in rats.
  Neurotoxicology and teratology · 2026 · Gildawie KR, Budge KE, Isgate SB, et al.
  PMID 42031343DOI 10.1016/j.ntt.2026.107603
• Pharmacological Mechanisms and Clinical Applications of Oxycodone in Cancer Pain Management: A Narrative Review.
  Drug design, development and therapy · 2026 · Xia Y, Huang G
  PMID 42007393DOI 10.2147/DDDT.S594973
• Behavioural, pharmacokinetic, and genetic evidence of a cannabidiol-oxycodone drug-drug interaction in mice.
  Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie · 2026 · Scicluna RL, Kang JWM, Everett NA, et al.
  PMID 41904896DOI 10.1016/j.biopha.2026.119277
• Dexmedetomidine in oxycodone patient-controlled analgesia after lumbar spinal fusion: A randomized, double-blind, placebo-controlled trial.
  Journal of clinical anesthesia · 2026 · Mäkelä S, Gröhn J, Rantakokko J, et al.
  PMID 41903479DOI 10.1016/j.jclinane.2026.112191

The 10 most recently updated of 757 ClinicalTrials.gov registrations naming Oxycodone as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Pain Relief After Trapeziectomy: Ibuprofen & Acetaminophen Versus Oxycodone
  Recruiting · Phase 2 · Interventional · 121 enrolled · Stanford University
  NCT04676802updated 2026-06-11
• MCID and PASS for Acute Pain and Quality of Recovery After Orthopedic Surgery
  Recruiting · Observational · 300 enrolled · University Health Network, Toronto
  NCT04811209updated 2026-06-10
• A Study on Reducing Opioid Use After Ankle Arthroscopy
  Completed · Interventional · 112 enrolled · Second Affiliated Hospital, School of Medicine, Zhejiang University
  NCT07154433updated 2026-06-08
• Evaluating a Potential Pharmacokinetic Kratom-oxycodone Interaction Concurrent With Clinical Endpoints
  Recruiting · Early phase 1 · Interventional · 16 enrolled · Washington State University
  NCT05846451updated 2026-06-03
• Opioid Use After Laparoscopic Salpingectomy
  Recruiting · Phase 4 · Interventional · 38 enrolled · Johns Hopkins University
  NCT06434233updated 2026-06-03
• Nonopioid Pain Control Regimen After Arthroscopic Hip Procedures
  Completed · Phase 4 · Interventional · 86 enrolled · Mayo Clinic
  NCT05076110updated 2026-06-03
• Suzetrigine for Opioid-Sparing Postoperative Analgesia Following Transvaginal Pelvic Reconstructive Surgery
  Not yet recruiting · Phase 4 · Interventional · 120 enrolled · University of California, Los Angeles
  NCT07600697updated 2026-06-02
• Biased Opioid Agonists for Treatment of Opioid Withdrawal in OUD
  Terminated · Phase 2 · Interventional · 5 enrolled · National Institute on Drug Abuse (NIDA)
  NCT04316559updated 2026-06-02
• Sparrow Link Neuromodulation Device for Opioid Withdrawal Management in Hospitalized Adults With Opioid Use Disorder
  Recruiting · Interventional · 50 enrolled · Payel Roy
  NCT07079826updated 2026-06-01
• Opioid-Free Pain Control Regimen Following Robotic Radical Prostatectomy
  Terminated · Phase 2 · Phase 3 · Interventional · 58 enrolled · Wake Forest University Health Sciences
  NCT05597878updated 2026-06-01

CPIC-curated drug–gene pairs for Oxycodone. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

• COMTCPIC CClinPGx 3
  CYP2D6, OPRM1, COMT, and Opioids
• CYP2D6CPIC CClinPGx 2A
  CYP2D6, OPRM1, COMT, and Opioids
• OPRM1CPIC CClinPGx 3
  CYP2D6, OPRM1, COMT, and Opioids

Ranked by 2D fingerprint (Tanimoto) similarity over PubChem structures. Structural proximity only — not a claim of therapeutic equivalence.

• OxymorphoneOpioid Agonist100%
• NaloxoneOpioid Antagonist98%
• NaltrexoneOpioid Antagonist98%
• HydrocodoneOpioid Agonist95%
• HydromorphoneOpioid Agonist95%
• CodeineOpium alkaloids and derivatives84%
• MorphineOpioid Agonist84%
• BuprenorphinePartial Opioid Agonist83%

Frequently asked questions

How does Oxycodone work?

Mechanism-of-action class: Full Opioid Agonists.

What is Oxycodone used for?

According to FDA labeling, Oxycodone carries indications including: Oxycodone hydrochloride tablets are indicated for the management of 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, 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 oxycodone 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Oxycodone?

Oxycodone is classified as Natural opium alkaloids, Opioid Agonist, Full Opioid Agonists, Analgesia, Decreased GI Motility, Decreased Medullary Respiratory Drive, Decreased Organized Electrical Activity, Increased Histamine Production.

What are the brand names for Oxycodone?

Oxycodone is marketed under brand names including Endocet, Nalocet, Oxaydo, Oxycontin, Percocet, Primlev, Prolate, Roxicodone.

What are the contraindications for Oxycodone?

Oxycodone labeling lists contraindications including: Oxycodone hydrochloride is contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions (5.2)]. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment or hypercarbia [see Warnings and Precautions (5.8)].. Always consult the full prescribing information and a clinician.