{"id":"omnicef-cap","safety":{"commonSideEffects":[{"rate":"15","effect":"Diarrhea"},{"rate":"3","effect":"Nausea"},{"rate":"2","effect":"Headache"},{"rate":"4","effect":"Vaginal yeast infection"},{"rate":"2","effect":"Abdominal pain"},{"rate":"2","effect":"Rash"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Cefdinir works by disrupting the cross-linking of peptidoglycan in the bacterial cell wall, leading to cell wall instability and bacterial death. It has broad-spectrum activity against both gram-positive and gram-negative bacteria, making it effective against common respiratory and skin infections. The drug is bactericidal and is typically used for oral treatment of mild to moderate infections.","oneSentence":"Omnicef (cefdinir) is a third-generation cephalosporin antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:58:21.793Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Community-acquired pneumonia"},{"name":"Acute exacerbation of chronic bronchitis"},{"name":"Acute maxillary sinusitis"},{"name":"Pharyngitis/tonsillitis"},{"name":"Uncomplicated skin and skin structure infections"},{"name":"Urinary tract infections"}]},"trialDetails":[{"nctId":"NCT00835484","phase":"PHASE1","title":"Cefdinir Capsules 300 mg, Fasting","status":"COMPLETED","sponsor":"Teva Pharmaceuticals USA","startDate":"2005-07","conditions":"Healthy","enrollment":32},{"nctId":"NCT00834535","phase":"PHASE1","title":"Cefdinir Capsules 300 mg, Non-fasting","status":"COMPLETED","sponsor":"Teva Pharmaceuticals USA","startDate":"2005-07","conditions":"Healthy","enrollment":32},{"nctId":"NCT02891915","phase":"PHASE4","title":"Trial to Evaluate Beta-Lactam Antimicrobial Therapy of Community Acquired Pneumonia in Children","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2016-12-02","conditions":"Pneumonia","enrollment":385},{"nctId":"NCT04664803","phase":"PHASE4","title":"Safety and Efficacy of Cefecin Tab. in Patients With Acute Sinusitis","status":"TERMINATED","sponsor":"Korea United Pharm. Inc.","startDate":"2015-08-31","conditions":"Acute Sinusitis","enrollment":284},{"nctId":"NCT03756324","phase":"PHASE2, PHASE3","title":"The Effect of Chinese Herbal Medicine for Reducing the Application of Antibiotics in the Treatment of Acute Mastitis","status":"UNKNOWN","sponsor":"Beijing University of Chinese Medicine","startDate":"2018-12-20","conditions":"Mastitis Acute Female","enrollment":306},{"nctId":"NCT03400735","phase":"PHASE4","title":"Comparison of Cefdinir and Cefdinir/Clavulanic Acid Combination in Adults","status":"UNKNOWN","sponsor":"Neutec Ar-Ge San ve Tic A.Ş","startDate":"2017-11-01","conditions":"Acute Exacerbation of Chronic Bronchitis, Community-Acquired Pneumoniae","enrollment":50},{"nctId":"NCT00882154","phase":"PHASE1","title":"To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 300 mg Capsule Fed Conditions","status":"COMPLETED","sponsor":"Sandoz","startDate":"2005-04","conditions":"Healthy","enrollment":28},{"nctId":"NCT00882700","phase":"PHASE1","title":"To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicef 300 mg Capsule Fasting Conditions","status":"COMPLETED","sponsor":"Sandoz","startDate":"2005-04","conditions":"Healthy","enrollment":28},{"nctId":"NCT00645073","phase":"PHASE4","title":"Study of the Safety and Efficacy of Cefdinir and Levofloxacin for the Treatment of Subjects With Acute Bacterial Sinusitis","status":"COMPLETED","sponsor":"Abbott","startDate":"2003-11","conditions":"Acute Bacterial Sinusitis","enrollment":271}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":2,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["cefdinir"],"phase":"marketed","status":"active","brandName":"Omnicef Cap.","genericName":"Omnicef Cap.","companyName":"Korea United Pharm. Inc.","companyId":"korea-united-pharm-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Omnicef (cefdinir) is a third-generation cephalosporin antibiotic that inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins. Used for Community-acquired pneumonia, Acute exacerbation of chronic bronchitis, Acute maxillary sinusitis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}