{"id":"azelastine-hydrochloride-0-05","safety":{"commonSideEffects":[{"rate":"10-20","effect":"Bitter taste"},{"rate":"5-10","effect":"Nasal irritation"},{"rate":"5-10","effect":"Headache"},{"rate":"1-5","effect":"Somnolence"},{"rate":"1-5","effect":"Epistaxis"}]},"_chembl":null,"_dailymed":{"setId":"7532ed82-5cfa-49da-83e5-c57ffdd3adbb","title":"AZELASTINE HYDROCHLORIDE OPHTHALMIC SOLUTION 0.05% SOLUTION/ DROPS [ALEMBIC PHARMACEUTICALS INC.]"},"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Azelastine is a second-generation antihistamine that selectively antagonizes H1 receptors on mast cells and other immune cells in nasal tissue, preventing histamine release and reducing allergic inflammation. It also has anti-inflammatory properties independent of H1 blockade. The 0.05% nasal spray formulation delivers the drug topically to provide rapid relief of allergic rhinitis symptoms.","oneSentence":"Azelastine hydrochloride is a selective H1-receptor antagonist that blocks histamine-mediated allergic responses in the nasal mucosa.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:20:13.059Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Allergic rhinitis (seasonal and perennial)"},{"name":"Vasomotor rhinitis"}]},"trialDetails":[{"nctId":"NCT06800274","phase":"PHASE4","title":"Clinical and Biological Evaluation of NAAGA Versus Azelastine Eye Drops in Allergic Subjects With Tear Film Dysfunction","status":"COMPLETED","sponsor":"Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona","startDate":"2023-04-21","conditions":"Allergic Conjunctivitis, Dry Eye Disease (DED)","enrollment":134},{"nctId":"NCT06212973","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of Epinastine Hydrochloride Eye Drops in the Treatment of Chinese Seasonal Allergic Conjunctivitis Patients","status":"COMPLETED","sponsor":"Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.","startDate":"2023-03-13","conditions":"Seasonal Allergic Conjunctivitis","enrollment":266},{"nctId":"NCT03599791","phase":"PHASE3","title":"DYmista NAsal Spray in CHInese Patients","status":"COMPLETED","sponsor":"MEDA Pharma GmbH & Co. KG","startDate":"2018-06-29","conditions":"Allergic Rhinitis","enrollment":900},{"nctId":"NCT00845598","phase":"PHASE4","title":"Azelastine Fluticasone Combination vs. Fluticasone","status":"WITHDRAWN","sponsor":"University of Dundee","startDate":"2010-08","conditions":"Allergic Rhinitis","enrollment":""}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":4,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"azelastine hydrochloride 0.05%","genericName":"azelastine hydrochloride 0.05%","companyName":"Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona","companyId":"azienda-ospedaliera-oo-rr-s-giovanni-di-dio-e-ruggi-d-aragona","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Azelastine hydrochloride is a selective H1-receptor antagonist that blocks histamine-mediated allergic responses in the nasal mucosa. Used for Allergic rhinitis (seasonal and perennial), Vasomotor rhinitis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}