{"id":"naproxen-sodium-codeine","safety":{"commonSideEffects":[{"rate":null,"effect":"Gastrointestinal upset (nausea, dyspepsia)"},{"rate":null,"effect":"Dizziness or drowsiness"},{"rate":null,"effect":"Constipation"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Respiratory depression"}]},"_chembl":{"chemblId":"CHEMBL1200806","moleculeType":"Small molecule","molecularWeight":"252.25"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Naproxen sodium is a nonsteroidal anti-inflammatory drug (NSAID) that blocks COX-1 and COX-2 enzymes, reducing prostaglandin synthesis and thereby decreasing inflammation, pain, and fever. Codeine is an opioid analgesic and antitussive that binds to mu opioid receptors in the central nervous system. The combination provides synergistic pain relief for moderate pain conditions.","oneSentence":"Naproxen sodium inhibits cyclooxygenase (COX) enzymes to reduce inflammation and pain, while codeine acts as an opioid agonist to provide additional analgesic and antitussive effects.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-27T23:56:39.114Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Moderate pain relief"},{"name":"Pain with inflammatory component"}]},"trialDetails":[{"nctId":"NCT06916234","phase":"PHASE4","title":"Evaluation of the Analgesic Efficacy of the Combination of Dexketoprofen + Paracetamol and the Combination of Naproxen Sodium + Codeine in Patients With Acute Dental Pain","status":"COMPLETED","sponsor":"ibrahim doğru","startDate":"2023-01-10","conditions":"Acute Dental Pain","enrollment":100},{"nctId":"NCT06917118","phase":"NA","title":"Multimodal Pain Management After Wide Awake Local Anesthesia No Tourniquet Orthopedic Hand Surgery: A Randomized Control Trial","status":"NOT_YET_RECRUITING","sponsor":"University of Puerto Rico","startDate":"2025-05-01","conditions":"Pain Management","enrollment":100},{"nctId":"NCT05463367","phase":"PHASE2","title":"Project 1 Aim 2, Adaptations of the Brain in Chronic Pain With Opioid Exposure","status":"ACTIVE_NOT_RECRUITING","sponsor":"Northwestern University","startDate":"2021-01-01","conditions":"Opioid Use, Opioid Dependence, Opioid-use Disorder","enrollment":60},{"nctId":"NCT06484192","phase":"PHASE4","title":"Pain Control After Lumbar Spine Fusion","status":"ENROLLING_BY_INVITATION","sponsor":"Rothman Institute Orthopaedics","startDate":"2024-06-28","conditions":"Spine Fusion, NSAID (Non-Steroidal Anti-Inflammatory Drug), Postoperative Pain","enrollment":428},{"nctId":"NCT04285853","phase":"PHASE4","title":"Are Opioids Needed After ACL Reconstruction","status":"COMPLETED","sponsor":"Emory University","startDate":"2020-09-16","conditions":"Anterior Cruciate Ligament Rupture","enrollment":98},{"nctId":"NCT03879408","phase":"PHASE2","title":"Naproxen Sodium/Acetaminophen Proof of Concept Dosing Study","status":"COMPLETED","sponsor":"Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division","startDate":"2019-05-28","conditions":"Pain","enrollment":290},{"nctId":"NCT05161221","phase":"PHASE3","title":"Post Operative Pain Management Through Adductor Canal Block With Bupivacaine for ACL Reconstruction","status":"UNKNOWN","sponsor":"Rothman Institute Orthopaedics","startDate":"2021-12-06","conditions":"Pain, Postoperative, ACL","enrollment":154},{"nctId":"NCT05154682","phase":"PHASE3","title":"Pain Management After Surgery","status":"UNKNOWN","sponsor":"Rothman Institute Orthopaedics","startDate":"2021-11-30","conditions":"Pain, Postoperative","enrollment":200},{"nctId":"NCT03472469","phase":"PHASE4","title":"MAST Trial: Multi-modal Analgesic Strategies in Trauma","status":"COMPLETED","sponsor":"The University of Texas Health Science Center, Houston","startDate":"2018-04-02","conditions":"Nonspecific Pain Post Traumatic Injury","enrollment":1561},{"nctId":"NCT04066426","phase":"PHASE4","title":"Efficacy of Naproxen-codeine, Naproxen+Dexamethasone, and Naproxen on Myofascial Pain","status":"COMPLETED","sponsor":"Yuzuncu Yil University","startDate":"2018-03-01","conditions":"Temporomandibular Disorder","enrollment":200},{"nctId":"NCT02132416","phase":"NA","title":"Operative Treatment of Unstable Thoracic Cage Injuries and Chest Wall Deformity in Trauma","status":"COMPLETED","sponsor":"Sahlgrenska University Hospital","startDate":"2014-05","conditions":"Trauma, Flail Chest, Rib Fractures","enrollment":92},{"nctId":"NCT01003639","phase":"PHASE2, PHASE3","title":"Idiopathic Intracranial Hypertension Treatment Trial","status":"COMPLETED","sponsor":"St. Luke's-Roosevelt Hospital Center","startDate":"2010-01","conditions":"Idiopathic Intracranial Hypertension","enrollment":165},{"nctId":"NCT00743587","phase":"PHASE1","title":"A Study To Assess The Ability Of Tramadol, Naproxen And Oxycodone To Affect The Pain Thresholds Of Patients With Osteoarthritis Of The Thumb","status":"COMPLETED","sponsor":"Pfizer","startDate":"2008-09","conditions":"Osteoarthritis Thumbs","enrollment":36},{"nctId":"NCT02094807","phase":"NA","title":"Pain as Indication for Operative Treatment of Traumatic Rib Fractures","status":"WITHDRAWN","sponsor":"Sahlgrenska University Hospital","startDate":"2014-04","conditions":"Trauma, Rib Fractures, Surgery","enrollment":""},{"nctId":"NCT01982799","phase":"NA","title":"Local Anesthesia and Analgesics in Endodontic Pain","status":"WITHDRAWN","sponsor":"University of Minnesota","startDate":"2014-02","conditions":"Odontalgia","enrollment":""},{"nctId":"NCT02501564","phase":"PHASE4","title":"Evaluation of NaproxenSodium and CodeinePhosphate Combination in Osteoarthritis","status":"COMPLETED","sponsor":"Istanbul Medeniyet University","startDate":"2013-05","conditions":"Osteoarthritis","enrollment":135},{"nctId":"NCT02255955","phase":"PHASE4","title":"Postoperative Analgesia in Laminectomy","status":"UNKNOWN","sponsor":"Diskapi Yildirim Beyazit Education and Research Hospital","startDate":"2014-10","conditions":"Postoperative Pain, Postoperative Laminectomy Pain","enrollment":75},{"nctId":"NCT02252614","phase":"PHASE4","title":"Efficacy of Intravenous Naproksen Sodium+Codein and Paracetamol+Codein on Postoperative Pain on Postoperative Pain","status":"UNKNOWN","sponsor":"Diskapi Yildirim Beyazit Education and Research Hospital","startDate":"2014-09","conditions":"Postoperative Pain, PCA Contramal Consumption","enrollment":75},{"nctId":"NCT01952652","phase":"PHASE4","title":"Naproxen Codeine in Arthroscopic Surgery","status":"COMPLETED","sponsor":"Baskent University","startDate":"2013-01","conditions":"Arthroscopic Meniscus Surgery","enrollment":61}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Apranax Plus"],"phase":"marketed","status":"active","brandName":"Naproxen Sodium Codeine","genericName":"Naproxen Sodium Codeine","companyName":"Istanbul Medeniyet University","companyId":"istanbul-medeniyet-university","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Naproxen sodium inhibits cyclooxygenase (COX) enzymes to reduce inflammation and pain, while codeine acts as an opioid agonist to enhance analgesia through central nervous system depression. Used for Moderate pain relief, Pain associated with inflammation.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}