Oxycodone hydrochloride capsule: US FDA label indications

US FDA labelNot medical advice

The product name above is taken from the label's own indications text; the source record has no brand or generic name field.

Indications and usage (label excerpt)

1 INDICATIONS AND USAGE Oxycodone hydrochloride capsule is an opioid analgesic, indicated for the management of moderate to severe acute and chronic pain where use of an opioid analgesic is appropriate. Oxycodone hydrochloride is an opioid agonist indicated for the management of moderate to severe acute and chronic pain where the use of an opioid analgesic is appropriate. ( 1 )

Warnings (label excerpt)

5 WARNINGS AND PRECAUTIONS Respiratory depression: Increased risk in elderly, debilitated patients, those suffering from conditions accompanied by hypoxia, hypercapnia, or upper airway obstruction. ( 5.1 ) Misuse, Abuse and Diversion: Oxycodone hydrochloride is a Schedule II controlled substance with an abuse liability similar to other opioids. ( 5.2 ) CNS effects: Additive CNS depressive effects when used in conjunction with alcohol, other opioids, or illicit drugs. ( 5.3 ) Elevation of intracranial pressure: May be markedly exaggerated in the presence of head injury, other intracranial lesions. ( 5.4 ) Hypotensive effect: Increased risk with compromised ability to maintain blood pressure. ( 5.5 ) Prolonged gastric obstruction: In patients with gastrointestinal obstruction, especially paralytic ileus. ( 5.6 ) Sphincter of Oddi spasm and diminished biliary/pancreatic secretions. Increased risk with biliary tract disease. ( 5.7 ) Special Risk Groups: Use with caution and in reduced dosa…

Excerpts are shortened. Read the full label, and ask a pharmacist or prescriber about any medicine. Full label on DailyMed(opens in a new tab) For products sold in Canada, see the Health Canada Drug Product Database(opens in a new tab).

Trials whose interventions mention this drug

Canadian trials first. Showing 50 of 61. A match on the drug name does not mean the trial studied this specific product.

50 trials, recruiting first

		Phase	Countries
Targin® for Chronic Pain Management in Patients With Spinal Cord Injury NCT03179475	Completed	Phase 4	Canada	University of British Columbia	2019-09-05
Sensory Effects of Oral Opioid Treatment in Patients With Chronic Low Back Pain NCT02824276	Completed	Phase 1	United States	Brigham and Women's Hospital	2017-01-06
Discontinuation vs Continuation of Long-term Opioid Therapy in Suboptimal and Optimal Responders With Chronic Pain NCT02741076	Terminated	Phase 4	United States	Member Companies of the Opioid PMR Consortium	2016-09-14
Safety and Tolerability of Egalet-002 in Patients With Moderate-to-Severe Chronic Noncancer Pain NCT02603705	Completed	Phase 3	United States	Egalet Ltd	2016-03-07
Efficacy and Safety of Egalet-002 in Patients With Moderate-to-Severe Chronic Low Back Pain NCT02716857	Completed	Phase 3	United States	Egalet Ltd	2016-03
To Demonstrate Equivalence in Analgesic Efficacy & Bowel Function Between OXN PR Higher Dose & Lower Dose Tablet Strengths in Subjects With Non-cancer or Cancer Pain NCT02321397	Completed	Phase 2, Phase 3	Germany	Mundipharma Research GmbH & Co KG	2014-11
Does Duloxetine Reduce Chronic Pain After Total Knee Arthroplasty? NCT02307305	Unknown status	Phase 2	South Korea	Hanyang University Seoul Hospital	2014-08
Determine the Safety and Efficacy of Oxy/Nal Tablets Compared to Oxy PR in Subjects With Cancer Pain NCT01885182	Completed	Phase 3	China	Mundipharma (China) Pharmaceutical Co. Ltd	2013-06-01
Evaluation of the Tolerability of Switching Subjects on Chronic ATC Opioid Therapy to Buprenorphine HCl Buccal Film NCT01871285	Completed	Phase 2	United States	BioDelivery Sciences International	2013-06
Treatment of Chronic Pain From Osteoarthritis NCT02032927	Withdrawn	Phase 4	Italy	Fondazione IRCCS Policlinico San Matteo di Pavia	2013-06
Tapentadol Prolonged Release (PR) Versus Oxycodone/Naloxone Prolonged Release in Severe Chronic Low Back Pain With a Neuropathic Component. NCT01838616	Completed	Phase 4	Austria, Germany, Italy, Spain	Grünenthal GmbH	2013-04
A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Abusers NCT01746901	Completed	Phase 1	Canada	Pfizer	2013-02
A Study to Characterize the Abuse Liability of ALO-02 in Healthy, Non-Dependent, Recreational Opioid Users When ALO-02 Capsules Are Crushed and Snorted NCT01775189	Completed	Phase 1	Canada	Pfizer	2013-02
Safety and Efficacy Study of GRT6005 in Patients With Osteoarthritis (OA) Knee Pain NCT01709214	Completed	Phase 2	United States	Tris Pharma, Inc.	2012-12-04
An Interventional Study to Compare the Efficacy and Tolerability With Targin® in Non-malignant Chronic Pain (GLORY) NCT01811186	Completed	Phase 4	South Korea	Mundipharma Korea Ltd	2012-12
A Non-interventional, Observational Study for Targinact® Treatment in Patients With Chronic Severe Pain NCT01710904	Completed		Belgium	Mundipharma CVA	2012-09
Oxycodone DETERx™ Versus Placebo in Chronic Low Back Pain (CLBP) NCT01685684	Completed	Phase 3	United States	Collegium Pharmaceutical, Inc.	2012-08
A Study to Demonstrate Improvement in Symptoms of Constipation in Subjects That Require Around-the-clock Opioid Pain Killer Therapy NCT01438567	Completed	Phase 3	United Kingdom	Mundipharma Research GmbH & Co KG	2011-09
Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) for Uncontrolled Moderate - Severe Low Back Pain NCT01427270	Completed	Phase 3	Czechia, Italy, Poland, United States	Purdue Pharma LP	2011-08
A Study of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain NCT01427283	Completed	Phase 3	United States	Purdue Pharma LP	2011-08
Evaluation of the Efficacy and Tolerability of Etoricoxib Monotherapy Versus Combination Oxycodone-etoricoxib in Moderate to Severe Pain From Chronic Low Back Pain NCT01344720	Unknown status	Phase 4	Italy	Azienda Sanitaria Locale 4, Teramo	2011-05
Efficacy and Safety of Oxycodone/Naloxone Controlled-release Tablets (OXN) Compared to Placebo in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain NCT01358526	Completed	Phase 3	United States	Purdue Pharma LP	2011-05
A Non-interventional, Observational Study for Targinact® Treatment in Patients With Severe Pain. NCT01983137	Completed		Belgium	Mundipharma CVA	2011-04
Safety Study of Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain NCT01428583	Completed	Phase 3	United States	Pfizer	2010-12
A Safety and Efficacy Study of JNS024 Extended Release (ER) in Japanese and Korean Patients With Chronic Malignant Tumor-Related Cancer Pain NCT01165281	Completed	Phase 3	Japan, South Korea	Janssen Research & Development, LLC	2010-08
Linking Altered Central Pain Processing and Genetic Polymorphism to Drug Efficacy in Chronic Low Back Pain (Predictio) NCT01179828	Completed	Phase 3	Switzerland	Insel Gruppe AG, University Hospital Bern	2010-07
A Clinical Study To Characterize The Pharmacokinetics And The Effects Of Food On Oxycodone In Healthy Volunteers NCT01530542	Completed	Phase 1	United States	Pfizer	2010-07
A Safety and Tolerability Study of JNJ-42160443 in Patients With Moderate to Severe, Chronic Knee Pain From Osteoarthritis NCT01094262	Terminated	Phase 2	Canada, United States	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	2010-04-20
Open-Label Trial Comparing Oxycodone Medications NCT01162304	Terminated	Phase 4	United States	University of Rochester	2010-03
A Long-term Safety Study With Tapentadol ER and Oxycodone CR in Patients With Moderate to Severe Pain Due to Chronic, Painful Diabetic Peripheral Neuropathy (DPN) NCT01063868	Terminated	Phase 3	United States	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	2010-01
OXN PR Compared to OxyPR to Demonstrate Non-inferiority in Pain & Locomotor Function & Improvement in Symptoms of Constipation in OA Subjects NCT00902837	Completed	Phase 3	Belgium, Czechia, Finland, Germany...	Mundipharma Research GmbH & Co KG	2009-05
Methadone, Morphine, or Oxycodone in Treating Pain in Patients With Cancer NCT00726830	Terminated	Not applicable	United States	M.D. Anderson Cancer Center	2009-03
A Study to Compare Oxycodone/Naloxone Prolonged Release Against Codeine/Paracetamol in the Treatment of Moderate to Severe Chronic Low Back Pain or Pain Due to Osteoarthritis NCT00784810	Completed	Phase 4	United Kingdom	Napp Pharmaceuticals Limited	2009-02
Prospective Study About Clinical and Pharmacogenetic Safety of Opioid Use for Chronic Pain NCT00916890	Suspended	Phase 4	Italy	Fondazione IRCCS Policlinico San Matteo di Pavia	2009-02
Opioid Treatment for Chronic Low Back Pain and the Impact of Mood Symptoms NCT01502644	Completed	Phase 4	United States	Brigham and Women's Hospital	2009-02
Fentanyl Buccal Tablets Versus Immediate Release Oxycodone for Breakthrough Pain in Patients With Chronic Pain NCT00813488	Completed	Phase 3	United States	Cephalon	2008-12
A Study Comparing Oxycodone to Oxycodone/Naloxone in Moderate to Severe, Chronic Cancer Pain NCT00513656	Completed	Phase 2	United Kingdom	Mundipharma Research GmbH & Co KG	2007-09
Efficacy and Safety of Fentanyl Buccal Tablets Compared With Oxycodone for the Management of Break Through Pain NCT00463047	Completed	Phase 3	United States	Cephalon	2007-07
A Study to Evaluate the Efficacy and Safety of CG5503 Prolonged Release (PR) in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Knee NCT00486811	Completed	Phase 3	Austria, Croatia, Germany, Hungary...	Grünenthal GmbH	2007-06
A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) Extended Release (ER) in Patients With Moderate to Severe Chronic Low Back Pain NCT00449176	Completed	Phase 3		Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	2007-02
Trial of Analgesia With Lidocaine or Extended-release Oxycodone for Neuropathic Pain Treatment in Multiple Sclerosis NCT00414453	Terminated	Phase 4	United States	University of Rochester	2007-01
Tapentadol (CG5503) NCT00421928	Completed	Phase 3		Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	2007-01
A Study to Evaluate Long-Term Safety of Multiple Doses of Tapentadol (CG5503) Prolonged-Release (PR) and Oxycodone Controlled-Release (CR) in Patients With Chronic Pain NCT00361504	Completed	Phase 3	Canada, United States	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	2006-11
Oxycodone-naloxone Prolonged Release Tablets in Relieving Opioid-related Constipation NCT00412100	Completed	Phase 3		Mundipharma Research GmbH & Co KG	2006-04
A Study of the Effectiveness and Safety of Sustained-release Hydromorphone (a Strong Opioid) in Patients With Chronic Noncancer Pain. NCT00261495	Completed	Phase 3	Czechia, Denmark, France, Germany...	Janssen Pharmaceutica N.V., Belgium	2006-03
Opioid Rotation Versus Combination for Chronic Uncontrolled Cancer Pain NCT00478101	Completed	Phase 2		Gachon University Gil Medical Center	2006-02
Oxycodone-naloxone in Relieving Opioid-related Constipation NCT00412152	Completed	Phase 3		Mundipharma Research GmbH & Co KG	2006-01
A Randomised, Double Blind, Placebo and Active Controlled, Double Dummy,Parallel Group Study to Determine the Safety and Efficacy of Oxycodone/Naloxone Prolonged Release Tablets in Subjects With Moderate to Severe, Chronic Nonmalignant Pain NCT01971632	Completed	Phase 3		Mundipharma Research GmbH & Co KG	2005-01
Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Low Back Pain NCT00313014	Terminated	Phase 3	United States	Purdue Pharma LP	2004-02
The Safety and Efficacy of the Buprenorphine Transdermal System (BTDS) in Subjects With Chronic Back Pain. NCT00315445	Completed	Phase 3	United States	Purdue Pharma LP	1997-12

Source: openFDA drug label (US FDA), snapshot October 2026. Not a Health Canada Product Monograph.