Oxycodone
Oxycodon G.L., Oxycodon Hameln, Oxycodon-Hcl Ratiopharm, Oxycontin · ATC code N02AA05
Also known as: Oxycodon, Oksikodon · Brand names: Oxycodon G.L., Oxycodon Hameln, Oxycodon-Hcl Ratiopharm, Oxycontin, Oxygerolan, Carenoxal, Oxycan Uno, Oxycodonhydrochlorid, Oxycon, Oxyconoica, Oxygesic, Oxypro, Oxicut, Oxopane, Roxicodone …
- Key facts
- Active substance
- Oxycodone
- Drug class
- Opioid
- ATC code
- N02AA05
- Authorisation
- authorised nationally; no central EU authorisation
- Information as of
- 2026-10-27
Boxed warning
Addiction, Abuse, and Misuse
Because the use of oxycodone 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 oxycodone hydrochloride tablets, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of oxycodone hydrochloride tablets are essential [see Warnings and Precautions (5.2)] .
Accidental Ingestion
Accidental ingestion of even one dose of oxycodone hydrochloride tablets, especially by children, can result in a fatal overdose of oxycodone [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 oxycodone 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)] .
Cytochrome P450 3A4 Interaction
The concomitant use of oxycodone hydrochloride tablets with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Regularly evaluate patients receiving oxycodone hydrochloride tablets and any CYP3A4 inhibitor or inducer [see Warnings and Precautions (5.6), Drug Interactions (7), Clinical Pharmacology (12.3)].
Key facts
Oxycodone is an opioid analgesic for pain severe enough to require an opioid and for which alternative treatments are inadequate.
What it is used for
- Pain severe enough to require an opioid analgesic, when alternative treatments are inadequate
- Because of addiction, abuse and overdose risks, reserved for patients in whom alternatives are ineffective, not tolerated or inadequate
Dosing
- Lowest effective dosage for the shortest duration; dosing individualized
- First opioid analgesic: 5 to 15 mg every 4 to 6 hours as needed, titrated to response
- Conversion from other opioids: conservative, with close observation
- Hepatic impairment: lower starting dose and careful titration
- Access to an opioid overdose reversal agent (e.g. naloxone) discussed
Contraindications
- Significant respiratory depression
- Acute or severe bronchial asthma in an unmonitored setting or without resuscitative equipment
- Known or suspected gastrointestinal obstruction including paralytic ileus
- Known hypersensitivity to oxycodone
Important warnings
- Boxed warning: addiction, abuse and misuse, which can lead to overdose and death; assess risk before and during therapy
- Boxed warning: life-threatening respiratory depression, especially at initiation and after dose increases
- Boxed warning: accidental ingestion, especially by children, can be fatal
- Boxed warning: with benzodiazepines or other CNS depressants including alcohol, profound sedation, respiratory depression, coma and death
- Neonatal opioid withdrawal syndrome with prolonged use in pregnancy
- Adrenal insufficiency, severe hypotension, seizures, opioid-induced hyperalgesia
Side effects
- Common at initiation: nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, somnolence
- Serious: respiratory depression, respiratory arrest, circulatory depression, cardiac arrest, hypotension, shock
Interactions
- CYP3A4 inhibitors (more so with CYP2D6 inhibitors) increase oxycodone levels; stopping them can cause loss of effect or withdrawal
- Benzodiazepines and other CNS depressants only when alternatives are inadequate
Pregnancy and breastfeeding
- Prolonged use in pregnancy may cause neonatal opioid withdrawal syndrome; data on birth defect risk are insufficient
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
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For patients
Patient information (US)
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
Austria
- Oxycodon G.L.G.L. Pharma Gmbh · 1 register entry
- Oxycodon HamelnHameln Pharma Gmbh · 1 register entry
- Oxycodon-Hcl RatiopharmTeva B.V · 1 register entry
- OxycontinMundipharma Gesellschaft M.B.H. · 2 register entries
- OxygerolanG.L. Pharma Gmbh · 3 register entries
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Germany
- CarenoxalZentiva Pharma Gmbh · 1 register entry
- Oxycan UnoHormosan Pharma Gmbh · 1 register entry
- OxycodonKrugmann Gmbh (Germany), 1 A Pharma Gmbh, Kalceks, Zentiva Pharma Gmbh, Aristo Pharma Gmbh (Art 57), Puren Pharma Gmbh & Co. Kg, Ratiopharm Gmbh, Medipha Sante, G.L. Pharma Gmbh, Winthrop Arzneimittel Gmbh, Aurobindo Pharma (Malta) Limited, Acino Ag, Hexal Ag, Betapharm Arzneimittel Gmbh, Aliud Pharma Gmbh, Abz-Pharma Gmbh, Hameln Pharma Gmbh · 34 register entries
- Oxycodonhydrochlorid1 A Pharma Gmbh, Heumann Pharma Gmbh & Co. Generica Kg, Ratiopharm Gmbh, Hennig Arzneimittel Gmbh & Co. Kg, Puren Pharma Gmbh & Co. Kg, Stadapharm Gmbh, G.L. Pharma Gmbh · 9 register entries
- OxyconHexal Ag · 1 register entry
- OxyconoicaGlenmark Arzneimittel Gmbh · 1 register entry
- OxygesicMundipharma Gmbh, Pb Pharma Gmbh · 9 register entries
- OxyproG.L. Pharma Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Turkey
- OxicutACTAVİS İSTANBUL İLAÇ SAN. VE TİC. LTD. ŞTİ. · 9 register entries
- OxopaneTEVA İLAÇ SAN. VE TİC. A.Ş. · 9 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
USA
- RoxicodoneSpecGx LLC · 1 register entry
- RoxyBondProtega Pharmaceuticals Inc · 1 register entry
Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-28
Brand names in 26 more European countries
- Belgium
- Oxycodon Sandoz, Oxycodone Teva, Oxynorm
- Bulgaria
- Oxylan, Оксикодон Актавис
- Croatia
- Oxycontin
- Cyprus
- Oxycontin, Oxynorm
- Czechia
- Oxycodon Lannacher, Oxycodon Sandoz Retard, Oxycodone Accord, Oxycontin, Oxykodon Sandoz S.R.O., Oxykodon Stada
- Denmark
- Codilek Depot, Lindoxa, Oxycodone "hameln", Oxycodone Abboxia, Oxycodone Accord, Oxycodone Hameln, Oxycodone Kalceks, Oxycodone Teva, Oxycodonhydrochlorid G.L., Oxycontin, Oxylan Depot, Oxynorm, Reltebon Depot
- Estonia
- Oxycodone Kalceks, Oxycodone Vitabalans, Oxycontin
- Finland
- Oxanest, Oxycodone Abboxia, Oxycodone G.L. Pharma, Oxycodone Kalceks, Oxycodone Orifarm, Oxycodone Stada, Oxycodone Vitabalans, Oxycontin Depot, Oxycorion Depot, Oxynorm, Oxyratio
- France
- Oxycodone Arrow, Oxycodone Delbert, Oxycodone Kalceks, Oxycodone L.P Arrow, Oxycodone Lp Bgr, Oxycodone Lp Biogaran, Oxycodone Lp Eg, Oxycodone Lp Sandoz, Oxycodone Medac, Oxycodone Renaudin, Oxycodone Sandoz, Oxycodone Viatris Lp, Oxycontin Lp, Oxynorm, Oxynormoro
- Greece
- Viloxidon
- Hungary
- Codoxy, Oxycontin, Reltebon
- Iceland
- Oxikodon Depot Actavis, Oxycodon Hcl Lannacher, Oxycodone Alvogen, Oxycontin, Oxynorm
- Ireland
- Dancex Sr, Oxycodone Hydrochloride Kalceks, Oxycodone Hydrochloride N.A., Oxycodone Hydrochloride Pinewood Laboratories, Oxycodone Hydrochloride Rowex, Oxycontin, Oxynorm
- Italy
- Ossicodone Aurobindo, Ossicodone Molteni, Oxicodone Accord, Oxicodone Sandoz, Oxycontin
- Latvia
- Oxycodone Kalceks, Oxycodone Vitabalans
- Lithuania
- Oxycodone Kalceks
- Luxembourg
- Oxynorm, Oxypro
- Netherlands
- Oxycodon-Hcl Accord, Oxycodon Hcl G.L. Pharma, Oxycodon Hcl Lannacher, Oxycodon-Hcl Retard Accord, Oxycodon Hcl Retard Lannacher, Oxycodon Hcl Sandoz, Oxycodon Hcl Teva, Oxycodon Hydrochloride Aurobindo, Oxycodon Kalceks, Oxycontin, Oxynorm
- Norway
- Oxycodone Abboxia, Oxycodone Accord, Oxycodone Actavis, Oxycodone G.L. Pharma, Oxycodone Hameln, Oxycodone Orifarm, Oxycontin, Oxynorm, Reltebon Depot
- Poland
- Oxycodone Hydrochloride Hameln, Oxycodone Kalceks, Oxycodone Molteni, Oxycodone Vitabalans, Oxycontin, Oxydolor, Reltebon
- Portugal
- Olbete
- Romania
- Oxicodonă Sandoz, Oxidolor
- Slovakia
- Contiroxil, Oxypro
- Slovenia
- Codilek, Oxycontin
- Spain
- Oxicodona Sandoz, Oxycontin, Oxynorm, Taioma
- Sweden
- Lindoxa, Oxikodon Actavis, Oxikodon Depot Actavis, Oxycodone Abboxia, Oxycodone Accord, Oxycodone Depot, Oxycodone G.L., Oxycodone Hameln, Oxycodone Kalceks, Oxycodone Orifarm, Oxycodone Teva, Oxycontin, Oxynorm
EMA – Article 57 product data (EU/EEA), 2026-10-28
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
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Sources
- U.S. Food and Drug Administration. Oxycodone Hydrochloride (Camber Pharmaceuticals Inc) – Prescribing Information, 2026-01-14. DailyMed (NLM), 2026-10-27. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=01db4606-d49c-4b10-a78a-1cf41880a9fb
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-28. https://dailymed.nlm.nih.gov/dailymed/
- Wikidata (CC0): ATC N02AA.
Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error
Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.