{"id":"brompheniramine-pseudoephedrine","safety":{"commonSideEffects":[{"rate":"10-30","effect":"Drowsiness/sedation"},{"rate":"5-15","effect":"Dry mouth"},{"rate":"5-10","effect":"Nervousness/insomnia"},{"rate":"2-5","effect":"Tachycardia"},{"rate":"2-5","effect":"Headache"},{"rate":"2-5","effect":"Dizziness"}]},"_chembl":null,"_dailymed":{"setId":"1045e307-f60d-482d-8e06-40e72b84c651","title":"BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [ACELLA PHARMACEUTICALS, LLC]"},"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Brompheniramine is a first-generation antihistamine that crosses the blood-brain barrier and competitively antagonizes H1 receptors, reducing itching, sneezing, and urticaria associated with allergic reactions. Pseudoephedrine is a sympathomimetic amine that acts as an alpha-1 adrenergic agonist on nasal mucosa vasculature, causing vasoconstriction and reducing nasal congestion. Together, they provide complementary symptomatic relief for allergic rhinitis and upper respiratory congestion.","oneSentence":"Brompheniramine blocks histamine H1 receptors to reduce allergic symptoms, while pseudoephedrine stimulates alpha-adrenergic receptors to constrict nasal blood vessels and relieve congestion.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:49:50.012Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Allergic rhinitis with nasal congestion"},{"name":"Urticaria and pruritus associated with allergies"},{"name":"Upper respiratory allergy symptoms"}]},"trialDetails":[{"nctId":"NCT01393548","phase":"PHASE3","title":"Efficacy and Safety of Combination of Brompheniramine and Phenylephrine for the Symptoms Relief of Rhinitis","status":"COMPLETED","sponsor":"Ache Laboratorios Farmaceuticos S.A.","startDate":"2014-08","conditions":"Nasal Congestion and Inflammations, Rhinitis","enrollment":879},{"nctId":"NCT01177852","phase":"PHASE3","title":"Evaluation of Efficacy and Safety in Control Cough and the Relief of Nasal Symptoms in Children 2-12 Years Old,Suffering From Cough and Acute Rhinitis","status":"WITHDRAWN","sponsor":"Ache Laboratorios Farmaceuticos S.A.","startDate":"2011-10","conditions":"Inflammation, Cough, Rhinitis","enrollment":""}],"_emaApprovals":[],"_faersSignals":[{"count":14,"reaction":"NAUSEA"},{"count":10,"reaction":"HEADACHE"},{"count":8,"reaction":"DIARRHOEA"},{"count":8,"reaction":"PAIN"},{"count":7,"reaction":"COVID-19"},{"count":7,"reaction":"FATIGUE"},{"count":7,"reaction":"INFLUENZA"},{"count":7,"reaction":"VOMITING"},{"count":6,"reaction":"PNEUMONIA"},{"count":6,"reaction":"SINUSITIS"}],"_approvalHistory":[{"date":"20200714","type":"ORIG","sponsor":"ALKEM LABS LTD","applicationNumber":"ANDA210647"}],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Group 2"],"phase":"marketed","status":"active","brandName":"Brompheniramine + pseudoephedrine","genericName":"Brompheniramine + pseudoephedrine","companyName":"Ache Laboratorios Farmaceuticos S.A.","companyId":"ache-laboratorios-farmaceuticos-s-a","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Brompheniramine blocks histamine H1 receptors to reduce allergic symptoms, while pseudoephedrine stimulates alpha-adrenergic receptors to constrict nasal blood vessels and relieve congestion. Used for Allergic rhinitis with nasal congestion, Urticaria and pruritus associated with allergies, Upper respiratory allergy symptoms.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}