{"id":"indom","rwe":[],"tags":[],"safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[{"effect":"Headache","drugRate":"","severity":"common","organSystem":""},{"effect":"Dizziness","drugRate":"","severity":"common","organSystem":""},{"effect":"Dyspepsia","drugRate":"","severity":"common","organSystem":""},{"effect":"Nausea","drugRate":"","severity":"common","organSystem":""}],"contraindications":["Acute hemorrhage","Asthma","Bacterial infectious disease","Blood coagulation disorder","Blurring of visual image","Cardiovascular event risk","Cerebral hemorrhage","Chronic heart failure","Congenital Heart Defect Requiring Open Patent Ductus Arteriosus","Corneal deposit","Coronary artery bypass graft","Dehydration","Depressive disorder","Disease of liver","Disorder of cardiovascular system","Diverticular disease","Duodenal ulcer disease","Epilepsy","Esophageal dysmotility","Gastric ulcer","Gastrointestinal hemorrhage","Gastrointestinal perforation","Gastrointestinal ulcer","Heart failure","Hemorrhoids","Hyperkalemia","Hypertensive disorder","Hyponatremia","Intraventricular Hemorrhage In Newborn","Kidney disease","Liver function tests abnormal","Malignant tumor of colon","Myocardial infarction","Necrotizing enterocolitis in fetus OR newborn","Parkinsonism","Pregnancy, function","Proctitis","Psychiatric Disturbance","Rectal hemorrhage","Seizure disorder","Sepsis of the newborn","Smokes tobacco daily","Stomatitis","Thrombocytopenic disorder","Ulcerative colitis"],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[{"effect":"Cardiovascular Thrombotic Events","drugRate":"","severity":"serious"},{"effect":"GI Bleeding, Ulceration and Perforation","drugRate":"","severity":"serious"},{"effect":"Hepatotoxicity","drugRate":"","severity":"serious"},{"effect":"Hypertension","drugRate":"","severity":"serious"},{"effect":"Heart Failure and Edema","drugRate":"","severity":"serious"},{"effect":"Renal Toxicity and Hyperkalemia","drugRate":"","severity":"serious"},{"effect":"Anaphylactic Reactions","drugRate":"","severity":"serious"},{"effect":"Serious Skin Reactions","drugRate":"","severity":"serious"},{"effect":"Hematologic Toxicity","drugRate":"","severity":"serious"},{"effect":"Fulminant Necrotizing Fasciitis","drugRate":"","severity":"serious"}]},"trials":[],"_chembl":null,"aliases":["Indomethacin 5 MG/ML Ophthalmic Suspension"],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=Indom","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:20:37.889755+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:20:44.193396+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Indom","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:20:44.970190+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Cyclooxygenase inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:20:45.535897+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL6/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:20:45.436884+00:00"}},"offLabel":[],"timeline":[],"_dailymed":{"setId":"41af7776-36bc-4820-b635-e7c69f26997e","title":"INDOMETHACIN CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]"},"ecosystem":[],"mechanism":{"target":"Aldo-keto reductase family 1 member C4, Dehydrogenase/reductase SDR family member 9, Nicotinate phosphoribosyltransferase"},"_scrapedAt":"2026-03-28T01:15:57.307Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"references":[],"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:20:47.292519+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"competitors":[],"dataSources":[{"url":"https://drugcentral.org","name":"DrugCentral","fields":["indications","contraindications","safety","target","drugInteractions"],"retrievedDate":"2026-04-07"}],"indications":{"approved":[{"name":"Ankylosing spondylitis","diseaseId":"ankylosing-spondylitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Bursitis","diseaseId":"bursitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Bursitis of shoulder","diseaseId":"bursitis-of-shoulder","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Gout","diseaseId":"gout","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Osteoarthritis","diseaseId":"osteoarthritis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Patent ductus arteriosus","diseaseId":"patent-ductus-arteriosus","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Rheumatoid arthritis","diseaseId":"rheumatoid-arthritis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Shoulder Tendonitis","diseaseId":"shoulder-tendonitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Synovitis","diseaseId":"synovitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Tendinitis","diseaseId":"tendinitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Tenosynovitis","diseaseId":"tenosynovitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT03597867","phase":"PHASE3","title":"PGE2 Levels in Patient Treated With NSAIDs","status":"COMPLETED","sponsor":"University of Trieste","startDate":"2018-04-25","conditions":"Ocular Inflammation","enrollment":104}],"_emaApprovals":[],"_faersSignals":[{"count":1,"reaction":"AZOTAEMIA"},{"count":1,"reaction":"BLOOD BILIRUBIN DECREASED"},{"count":1,"reaction":"BLOOD CREATININE INCREASED"},{"count":1,"reaction":"BLOOD LACTATE DEHYDROGENASE DECREASED"},{"count":1,"reaction":"BLOOD PHOSPHORUS INCREASED"},{"count":1,"reaction":"BLOOD URIC ACID INCREASED"},{"count":1,"reaction":"CENTRAL SEROUS CHORIORETINOPATHY"},{"count":1,"reaction":"GLOMERULAR FILTRATION RATE DECREASED"},{"count":1,"reaction":"HAEMOGLOBIN DECREASED"},{"count":1,"reaction":"LIPASE INCREASED"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{},"crossReferences":{"chemblId":"CHEMBL6"},"formularyStatus":[],"_approvalHistory":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":5,"therapeuticAreas":["Immunology"],"biosimilarFilings":[],"companionDiagnostics":[],"genericManufacturerList":[],"phase":"marketed","status":"active","brandName":"Indom","genericName":"Indom","companyName":"University of Trieste","companyId":"university-of-trieste","modality":"Small molecule","firstApprovalDate":"","aiSummary":"","enrichmentLevel":3,"visitCount":1,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":1,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:20:47.292519+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"verified","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":true,"score":3}}