{"id":"loratadine-montelukast-combination","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Somnolence"},{"rate":null,"effect":"Pharyngitis"},{"rate":null,"effect":"Neuropsychiatric effects (montelukast component)"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Loratadine is a selective H1-receptor antagonist that prevents histamine-mediated allergic symptoms such as itching, sneezing, and rhinorrhea. Montelukast is a cysteinyl leukotriene receptor antagonist that blocks inflammatory mediators involved in asthma and allergic rhinitis. Together, they provide dual anti-inflammatory and antihistamine activity targeting complementary pathways in allergic airway disease.","oneSentence":"This combination blocks histamine H1 receptors (loratadine) and cysteinyl leukotriene receptors (montelukast) to reduce allergic and inflammatory responses in the airways.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:19:26.151Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Allergic rhinitis"},{"name":"Asthma with allergic component"}]},"trialDetails":[{"nctId":"NCT01673620","phase":"PHASE3","title":"A Study to Evaluate the Safety of Combination Montelukast/Loratadine in Mexican Participants With Allergic Rhinitis (MK-0476A-484)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2012-07-04","conditions":"Allergic Rhinitis","enrollment":69},{"nctId":"NCT00423995","phase":"PHASE3","title":"Effect of Loratadine/Montelukast Combination on Congestion in SAR Patients Exposed to Pollen in an EEU (Study P04822)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2006-11-01","conditions":"Seasonal Allergic Rhinitis","enrollment":379},{"nctId":"NCT00319995","phase":"PHASE3","title":"Effects of Loratadine/Montelukast vs Pseudoephedrine and Placebo in Patients With Seasonal Allergic Rhinitis (Study P04095) (COMPLETED)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2006-03-01","conditions":"Rhinitis, Allergic, Seasonal","enrollment":1095},{"nctId":"NCT00979901","phase":"PHASE3","title":"Montelukast in Patients With Seasonal Allergic Rhinitis - Spring 2000 Study (MK-0476A-162)(COMPLETED)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2000-03","conditions":"Seasonal Allergic Rhinitis","enrollment":1577},{"nctId":"NCT00963599","phase":"PHASE3","title":"Montelukast in Seasonal Allergic Rhinitis - Fall 1999 Study (0476A-117)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"1999-09","conditions":"Seasonal Allergic Rhinitis","enrollment":907}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Loratadine/montelukast combination","genericName":"Loratadine/montelukast combination","companyName":"Organon and Co","companyId":"organon-and-co","modality":"Small molecule","firstApprovalDate":"","aiSummary":"This combination blocks histamine H1 receptors (loratadine) and cysteinyl leukotriene receptors (montelukast) to reduce allergic and inflammatory responses in the airways. Used for Allergic rhinitis, Asthma with allergic component.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}