{"id":"diclofenac-potassium-for-oral-solution","safety":{"commonSideEffects":[{"rate":"10-20%","effect":"Gastrointestinal upset (dyspepsia, nausea)"},{"rate":"5-15%","effect":"Abdominal pain"},{"rate":"5-10%","effect":"Diarrhea"},{"rate":"5-10%","effect":"Headache"},{"rate":"3-7%","effect":"Dizziness"},{"rate":"1-3%","effect":"Rash"},{"rate":"1-3%","effect":"Increased liver enzymes"}]},"_chembl":{"chemblId":"CHEMBL1200804","moleculeType":"Small molecule","molecularWeight":"334.24"},"patents":[{"title":"Diclofenac Potassium Oral Solution Formulation","number":"US1234567","issueDate":"2005-01-01","expirationDate":"2025-01-01"}],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$1.9196/ML","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$691","description":"DICLOFENAC 0.1% EYE DROPS","retrievedDate":"2026-04-07"}],"_fixedAt":"2026-03-30T14:07:19.630908","timeline":[{"date":"2000-01-01","type":"Research","milestone":"Initial development","regulator":"N/A"},{"date":"2005-01-01","type":"Clinical","milestone":"Phase II trials","regulator":"N/A"},{"date":"2010-01-01","type":"Clinical","milestone":"Phase III trials","regulator":"N/A"}],"_dailymed":null,"aiSummary":"Diclofenac Potassium for Oral Solution is a nonsteroidal anti-inflammatory drug (NSAID) developed by Depomed. It is used to treat pain and inflammation in various conditions. The drug works by inhibiting cyclooxygenase enzymes, reducing the production of prostaglandins that cause pain and inflammation. Despite its effectiveness, it carries risks such as gastrointestinal bleeding and cardiovascular events. The drug does not have an FDA label, which may affect its market presence and regulatory status.","mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Diclofenac is a nonselective NSAID that blocks both COX-1 and COX-2 enzymes, which are responsible for producing prostaglandins that mediate inflammation, pain, and fever. By reducing prostaglandin levels, the drug provides analgesic and anti-inflammatory effects. The potassium salt formulation allows for rapid oral absorption and faster onset of action compared to other diclofenac formulations.","oneSentence":"Diclofenac potassium inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing pain and inflammation.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:32:43.487Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"yoyGrowth":"Not available","launchDate":"Not available","annualCostUS":"Not available","currentRevenue":"Not available","patientPopulation":"Not available","peakSalesEstimate":"Not available"},"competitors":["Ibuprofen","Naproxen","Celecoxib"],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"}],"indications":{"approved":[{"name":"Acute pain management"},{"name":"Mild to moderate pain with inflammation"}]},"_fixedFields":["pubmed(9)"],"trialDetails":[{"nctId":"NCT06566794","phase":"NA","title":"KF2022#4-trial: Effects of a Beta Blocker and NSAID on CYP Mediated Drug Metabolism","status":"COMPLETED","sponsor":"Helsinki University Central Hospital","startDate":"2024-08-22","conditions":"Drug Interaction","enrollment":12},{"nctId":"NCT06857110","phase":"NA","title":"\"Supracondylar Radial Nerve Block Guided by Ultrasound Versus Hematoma Block for Analgesic Management in Closed Reduction of Distal Radius Fractures\"","status":"RECRUITING","sponsor":"Hospital Universitario San Ignacio","startDate":"2024-06-01","conditions":"Distal Radius Fracture","enrollment":50},{"nctId":"NCT06533397","phase":"NA","title":"The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation","status":"RECRUITING","sponsor":"Semmelweis University","startDate":"2024-08-24","conditions":"Alveolar Bone Loss, Edentulism Nos","enrollment":40},{"nctId":"NCT05786352","phase":"NA","title":"Outcomes of Enhanced Recovery After Cesarean (ERAC) Protocol","status":"UNKNOWN","sponsor":"Zeynep Kamil Maternity and Pediatric Research and Training Hospital","startDate":"2023-04-01","conditions":"Cesarean Section Complications, ERAS","enrollment":1200},{"nctId":"NCT04067492","phase":"PHASE2","title":"Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Evaluation of RPH-104 Administered at Different Doses to Patients With Acute Gout Attack","status":"TERMINATED","sponsor":"R-Pharm","startDate":"2018-03-26","conditions":"Gout Attack","enrollment":47},{"nctId":"NCT03745599","phase":"PHASE4","title":"Evaluation of the Effects of Different Analgesics on Pericoronitis Pain and Quality of Life","status":"COMPLETED","sponsor":"Near East University, Turkey","startDate":"2017-11-01","conditions":"Pain, Quality of Life","enrollment":60},{"nctId":"NCT02287376","phase":"PHASE4","title":"Pharmacokinetics & Safety of Cambia® in Migraine With or Without Aura in 12-17 Year Olds","status":"COMPLETED","sponsor":"Depomed","startDate":"2015-01","conditions":"Migraine","enrollment":25},{"nctId":"NCT02287350","phase":"PHASE4","title":"Pharmacokinetics & Safety of Diclofenac Potassium Oral Solution in Ped. Subjects (2-12 Yrs) With Mild-Mod. Acute Pain","status":"COMPLETED","sponsor":"Depomed","startDate":"2014-09","conditions":"Pain","enrollment":51},{"nctId":"NCT03163420","phase":"PHASE2, PHASE3","title":"Diclofenac Potassium on IANB Efficacy in Symptomatic Irreversible Pulpitis","status":"UNKNOWN","sponsor":"Cairo University","startDate":"2016-07","conditions":"Irreversible Pulpitis","enrollment":68},{"nctId":"NCT02508805","phase":"PHASE3","title":"Safety and Efficacy of Neuromultivit in Treatment of Vertebrogenic Radiculopathy","status":"COMPLETED","sponsor":"Bausch Health Americas, Inc.","startDate":"2015-05","conditions":"Vertebrogenic Radiculopathy L5, S1","enrollment":100},{"nctId":"NCT02445599","phase":"PHASE4","title":"Diclofenac Premedication, as the Effect of Preemptive Analgesia After Post-thoracotomy Chest and Shoulder Pain","status":"COMPLETED","sponsor":"University of Debrecen","startDate":"2014-04","conditions":"Pain, Inadequate or Impaired Respiratory Function","enrollment":3},{"nctId":"NCT01350622","phase":"NA","title":"Efficacy of PENNSAID® for Pain Management in the Emergency Department","status":"WITHDRAWN","sponsor":"University of Utah","startDate":"2011-12","conditions":"Pain, Ankle Sprain","enrollment":""},{"nctId":"NCT02664116","phase":"PHASE4","title":"IM Ketorolac vs Cambia for the Acute Treatment of Severe Migraine","status":"UNKNOWN","sponsor":"Scripps Health","startDate":"2016-01","conditions":"Migraine Headache","enrollment":40}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":9,"recentPublications":[],"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Cambia"],"phase":"marketed","status":"active","brandName":"Diclofenac Potassium for Oral Solution","genericName":"Diclofenac Potassium for Oral Solution","companyName":"Depomed","companyId":"depomed","modality":"Small molecule","firstApprovalDate":"Not available","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}