{"id":"oxycodone","brandName":"OxyContin","genericName":"oxycodone","companyId":"purdue-pharma","companyName":"Purdue Pharma","phase":"marketed","status":"active","modality":"","aliases":[],"developmentCodes":[],"firstApprovalDate":null,"firstApprovalCountry":null,"aiSummary":"","enrichmentLevel":3,"visitCount":1,"mechanism":{"target":"Delta-type opioid receptor, Kappa-type opioid receptor, Mu-type opioid receptor"},"administration":{"route":"Oral"},"safety":{"boxedWarnings":["WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYCODONE HYDROCHLORIDE TABLETS 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)] . WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYCODONE HYDROCHLORIDE TABLETS See full prescribing information for complete boxed warning. Oxycodone hydrochloride tablets exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing and reassess regularly for these behaviors and conditions. (5.1) Serious, life-threatening, or fatal respiratory depression may occur, 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. (5.2) Accidental ingestion of oxycodone hydrochloride tablets, especially by children, can result in a fatal overdose of oxycodone. (5.2) 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 for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation. (5.3, 7) 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. (5.4) 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. (5.5) Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of oxycodone from oxycodone hydrochloride tablets. (5.6, 7, 12.3)"],"safetySignals":[{"date":"","signal":"DRUG DEPENDENCE","source":"FDA FAERS","actionTaken":"102987 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"68744 reports"},{"date":"","signal":"OVERDOSE","source":"FDA FAERS","actionTaken":"59089 reports"},{"date":"","signal":"EMOTIONAL DISTRESS","source":"FDA FAERS","actionTaken":"50102 reports"},{"date":"","signal":"DRUG WITHDRAWAL SYNDROME","source":"FDA FAERS","actionTaken":"38329 reports"},{"date":"","signal":"DEATH","source":"FDA FAERS","actionTaken":"33856 reports"},{"date":"","signal":"DEPENDENCE","source":"FDA FAERS","actionTaken":"22768 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"19573 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"18575 reports"},{"date":"","signal":"TOXICITY TO VARIOUS AGENTS","source":"FDA FAERS","actionTaken":"18316 reports"}],"drugInteractions":[],"commonSideEffects":[{"effect":"nausea","drugRate":"≥3%","_validated":true,"placeboRate":""},{"effect":"constipation","drugRate":"≥3%","_validated":true,"placeboRate":""},{"effect":"vomiting","drugRate":"≥3%","_validated":true,"placeboRate":""},{"effect":"headache","drugRate":"≥3%","_validated":true,"placeboRate":""},{"effect":"pruritus","drugRate":"≥3%","_validated":true,"placeboRate":""},{"effect":"insomnia","drugRate":"≥3%","_validated":true,"placeboRate":""},{"effect":"dizziness","drugRate":"≥3%","_validated":true,"placeboRate":""},{"effect":"asthenia","drugRate":"≥3%","_validated":true,"placeboRate":""},{"effect":"somnolence","drugRate":"≥3%","_validated":true,"placeboRate":""}],"contraindications":["Acute Thromboembolic Stroke","Acute abdominal pain","Acute erosive gastritis","Acute nephropathy","Alcohol intoxication","Alcohol withdrawal delirium","Alcoholism","Aluminum intoxication","Anemia","Anemia due to enzyme deficiency","Asthenia","Benign intracranial hypertension","Benign prostatic hyperplasia","Blood coagulation disorder","Bradycardia","Breastfeeding (mother)","Cardiovascular event risk","Central nervous system depression","Chronic diarrhea","Chronic heart failure","Coma","Conduction disorder of the heart","Constipation","Cor pulmonale","Coronary artery bypass graft","Decreased respiratory function","Dehydration","Dependent drug abuse","Diarrhea","Disease of liver","Disorder of gallbladder","Drug-induced psychosis","Dysfunction of sphincter of Oddi","Exacerbation of asthma","Factor II deficiency","Fecal impaction","Gastrointestinal hemorrhage","Gastrointestinal obstruction","Gastrointestinal perforation","Gastrointestinal ulcer","Gout","Hemophilia","Hemorrhoids","Hepatic failure","Hypercapnia","Hypertensive disorder","Hypophosphatemia","Hypothyroidism","Hypoxia","Inflammatory bowel disease","Injury of head","Kidney disease","Lesion of brain","Low blood pressure","Mood swings","Morbid obesity","Myocardial infarction","Nasal polyp","Neoplasm of brain","Operation on gastrointestinal tract","Poisoning by acetaminophen","Pregnancy, function","Primary adrenocortical insufficiency","Pulmonary emphysema","Retention of urine","Reye's syndrome","Seizure disorder","Shock","Skin irritation","Smokes tobacco daily","Substance abuse","Suicidal thoughts","Thrombocytopenic disorder","Thrombotic thrombocytopenic purpura","Ulcerative colitis","Urethral stricture","Vitamin K deficiency","von Willebrand disorder"],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"trials":["NCT05598905","NCT01053637","NCT02295124","NCT01675622","NCT05929937","NCT06435949","NCT02787928","NCT05795478","NCT04811209","NCT03365817","NCT04112550","NCT02101840","NCT06534801","NCT01677065","NCT00737737","NCT02449369","NCT07264556","NCT06186141","NCT07484867","NCT01456507","NCT04939987","NCT01871285","NCT01267825","NCT04574791","NCT06041425","NCT02747875","NCT04121416","NCT02152592","NCT03250481","NCT00654069","NCT05761860","NCT03471442","NCT03011905","NCT03765346","NCT03415581","NCT04094701","NCT02625181","NCT03867539","NCT05180149","NCT04307940","NCT02707874","NCT02029235","NCT04330547","NCT00449176","NCT07307495","NCT01402375","NCT00964808","NCT02293525","NCT01775189","NCT02211625"],"indications":{"approved":[{"name":"Acute postoperative pain","diseaseId":"acute-postoperative-pain","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Chronic Pain with Opioid Tolerance","diseaseId":"chronic-pain-with-opioid-tolerance","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Severe pain","diseaseId":"severe-pain","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":[]},"commercial":null,"patents":[{"type":"Formulation","number":"9737530","applicant":"COLLEGIUM PHARMACEUTICAL INC","territory":"US","tradeName":"XTAMPZA ER","expiryDate":"2036-09-02"},{"type":"Formulation","number":"9682075","applicant":"COLLEGIUM PHARMACEUTICAL INC","territory":"US","tradeName":"XTAMPZA ER","expiryDate":"2030-12-10"},{"type":"Formulation","number":"9968598","applicant":"COLLEGIUM PHARMACEUTICAL INC","territory":"US","tradeName":"XTAMPZA ER","expiryDate":"2036-09-02"},{"type":"Formulation","number":"10004729","applicant":"COLLEGIUM PHARMACEUTICAL INC","territory":"US","tradeName":"XTAMPZA ER","expiryDate":"2030-12-10"},{"type":"Formulation","number":"10188644","applicant":"COLLEGIUM PHARMACEUTICAL INC","territory":"US","tradeName":"XTAMPZA ER","expiryDate":"2036-09-02"},{"type":"Formulation","number":"10646485","applicant":"COLLEGIUM PHARMACEUTICAL INC","territory":"US","tradeName":"XTAMPZA ER","expiryDate":"2036-09-02"},{"type":"Formulation","number":"10668060","applicant":"COLLEGIUM PHARMACEUTICAL INC","territory":"US","tradeName":"XTAMPZA ER","expiryDate":"2030-12-10"},{"type":"Formulation","number":"7771707","applicant":"COLLEGIUM PHARMACEUTICAL INC","territory":"US","tradeName":"XTAMPZA ER","expiryDate":"2028-10-09"}],"timeline":[],"rwe":[],"competitors":[],"ownershipHistory":[],"trialDetails":[{"nctId":"NCT05598905","phase":"Phase 4","title":"Combined Effect of Pregabalin and Oxycodone, and Lacosamide and Oxycodone, on Breathing: an Exploratory Study in Healthy Volunteers (The Polo Study)","status":"COMPLETED","sponsor":"Leiden University Medical Center","isPivotal":false,"enrollment":24,"indication":"Opioid-induced Respiratory 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Ltd","isPivotal":true,"enrollment":242,"indication":"Cancer","completionDate":"2012-07"},{"nctId":"NCT05929937","phase":"Phase 4","title":"No Opioids vs. Minimal Opioids Following Inguinal Hernia Repair","status":"ACTIVE_NOT_RECRUITING","sponsor":"Clayton Petro","isPivotal":false,"enrollment":904,"indication":"Postoperative Pain, Inguinal Hernia","completionDate":"2027-07"},{"nctId":"NCT06435949","phase":"EARLY/Phase 1","title":"Effect of Propofol in Combination With Oxycodone on Anxiety State in Painless Abortion - A Multicenter Randomized Controlled Trial","status":"NOT_YET_RECRUITING","sponsor":"Ruijin Hospital","isPivotal":false,"enrollment":300,"indication":"Abortion Complication","completionDate":"2026-06-30"},{"nctId":"NCT02787928","phase":"Phase 1","title":"Dose and Response of Intrathecal Hydromorphone in Patients Undergoing Cesarean Section at Virginia Commonwealth University Health System","status":"TERMINATED","sponsor":"Virginia Commonwealth University","isPivotal":false,"enrollment":14,"indication":"Cesarean Section, Obstetric Anesthesia","completionDate":"2017-12-31"},{"nctId":"NCT05795478","phase":"NA","title":"Effects of Oxycodone Combined With Pregabalin on Chronic Postsurgical Pain in Spinal Surgery: a Randomized Control, Double-blinded, Factorial Design Trial","status":"RECRUITING","sponsor":"Beijing Tiantan Hospital","isPivotal":false,"enrollment":264,"indication":"Chronic Post Operative Pain, Oxycodone","completionDate":"2024-12-31"},{"nctId":"NCT04811209","phase":"N/A","title":"Determining the Minimum Clinically Important Difference (MCID) and Patient Acceptable Symptom State (PASS) for Acute Pain and Quality of Recovery After Orthopedic Surgery","status":"RECRUITING","sponsor":"University Health Network, Toronto","isPivotal":false,"enrollment":300,"indication":"Pain Management","completionDate":"2024-11-07"},{"nctId":"NCT03365817","phase":"Phase 3","title":"Cognitive Function and Addiction in Patients With Chronic Pain Under Opioid Tapering in a Multidisciplinary Pain Treatment","status":"COMPLETED","sponsor":"Rigshospitalet, Denmark","isPivotal":true,"enrollment":75,"indication":"Chronic Pain, Opioid Use","completionDate":"2014-12-01"},{"nctId":"NCT04112550","phase":"Phase 1","title":"Clinical Effectiveness of Pre-operative Methadone in Single Level Lateral Transpsoas Interbody Fusions: A Randomized, Double-blinded, Controlled Trial","status":"UNKNOWN","sponsor":"The Methodist Hospital Research Institute","isPivotal":false,"enrollment":150,"indication":"Degenerative Disc Disease, Spondylolisthesis, Lumbar Region","completionDate":"2021-12-31"},{"nctId":"NCT02101840","phase":"Phase 4","title":"Abuse Liability of Controlled-Release Oxycodone Formulations","status":"COMPLETED","sponsor":"Centre for Addiction and Mental Health","isPivotal":false,"enrollment":11,"indication":"Substance-Related Disorders","completionDate":"2014-12"},{"nctId":"NCT06534801","phase":"NA","title":"Sequential Method Determination of Oxycodone for Thoracoscope Surgery Median Effective Dose of Acute Pain Treatment","status":"NOT_YET_RECRUITING","sponsor":"Jianbo Wu","isPivotal":false,"enrollment":60,"indication":"Oxycodone, Thoracoscopic Lobectomy","completionDate":"2026-04-01"},{"nctId":"NCT01677065","phase":"N/A","title":"An Open-label, Single-dose, Randomized, Two-way Crossover Study to Estimate the Relative Bioavailability of a Controlled-release Formulation of Oxycodone (40 mg) With Sequestered Naltrexone Compared W","status":"COMPLETED","sponsor":"Pfizer","isPivotal":false,"enrollment":14,"indication":"Healthy","completionDate":"2012-10"},{"nctId":"NCT00737737","phase":"Phase 4","title":"Effects of Chronic Musculoskeletal Pain and Opioidergic Versus Placebo Interventions on Neuroendocrine Function in Men","status":"COMPLETED","sponsor":"National Institute of Nursing Research (NINR)","isPivotal":false,"enrollment":8,"indication":"Chronic Pain, Osteoarthritis","completionDate":"2014-04"},{"nctId":"NCT02449369","phase":"Phase 4","title":"Intra-Venous Acetaminophen and Muscle Relaxants After Total Knee Arthroplasty (TKA). 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A Randomized Controlled Trial Comparing Dermatomal Spread.","status":"COMPLETED","sponsor":"University of Alberta","isPivotal":false,"enrollment":48,"indication":"Breast Cancer, Pain, Postoperative","completionDate":"2021-04-27"},{"nctId":"NCT03011905","phase":"Phase 3","title":"Rebound Pain at Block Resolution After Operations for Distal Radius Fractures With a Volar Plate in Brachial Plexus Block","status":"COMPLETED","sponsor":"Oslo University Hospital","isPivotal":true,"enrollment":53,"indication":"Brachial Plexus Block, Pain, Postoperative","completionDate":"2020-04-05"},{"nctId":"NCT03765346","phase":"Phase 1","title":"A Single-site, Randomized, Double-blind, Double-dummy, Active-comparator, Placebo-controlled, 3-way Crossover Trial in Adult Non-dependent Recreational Opioid Users to Compare the Intranasal Abuse Pot","status":"COMPLETED","sponsor":"Grünenthal GmbH","isPivotal":false,"enrollment":123,"indication":"Substance 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4","title":"Exparel and Education to Avoid Opioids After Carpal Tunnel Release","status":"RECRUITING","sponsor":"Kettering Health Network","isPivotal":false,"enrollment":64,"indication":"Carpal Tunnel Syndrome","completionDate":"2027-12-31"},{"nctId":"NCT05180149","phase":"N/A","title":"Personality and Drug Use (PDU)","status":"WITHDRAWN","sponsor":"Quantified Citizen Technologies Inc.","isPivotal":false,"enrollment":0,"indication":"Personality","completionDate":"2023-04"},{"nctId":"NCT04307940","phase":"Phase 4","title":"A Randomized, Double-Blind, Placebo-Controlled Trial to Compare the Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Hydrocodone/Acetaminophen Tablets in Postsurgical Dental Pain","status":"COMPLETED","sponsor":"Bayer","isPivotal":false,"enrollment":221,"indication":"Pain","completionDate":"2020-10-05"},{"nctId":"NCT02707874","phase":"Phase 4","title":"Comparing the Delivery of Local Anesthetic by Programmed Intermittent Bolus Versus Continuous Infusion 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