{"id":"fexofenadine-hcl-and-pseudoephedrine-hcl","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nervousness or insomnia"},{"rate":null,"effect":"Dry mouth"},{"rate":null,"effect":"Tachycardia"},{"rate":null,"effect":"Dizziness"}]},"_chembl":{"chemblId":"CHEMBL1200724","moleculeType":"Small molecule","molecularWeight":"201.70"},"_dailymed":{"setId":"3a878985-3a0e-1960-db0e-e3b8fd9d5c63","title":"FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCL TABLET, EXTENDED RELEASE [CVS PHARMACY, INC]"},"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Fexofenadine is a selective peripheral H1-receptor antagonist that prevents histamine-mediated allergic responses without significant central nervous system penetration. Pseudoephedrine is a sympathomimetic amine that causes vasoconstriction in nasal blood vessels, reducing nasal congestion. Together, they provide combined antihistamine and decongestant effects for allergic rhinitis symptoms.","oneSentence":"Fexofenadine blocks histamine H1 receptors to reduce allergy symptoms, while pseudoephedrine acts as a nasal decongestant by stimulating alpha-adrenergic receptors.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:21:57.603Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Allergic rhinitis with nasal congestion"},{"name":"Seasonal and perennial allergic rhinitis"}]},"trialDetails":[{"nctId":"NCT05720455","phase":"PHASE4","title":"Study to Assess Safety and Efficacy of Fexofenadine Hydrochloride (HCL) + Pseudoephedrine HCL Fixed Dose Combination in Indian Male and Female Participants With Allergic Rhinitis (AR) Who Are 12 Years and Above","status":"COMPLETED","sponsor":"Sanofi","startDate":"2025-06-15","conditions":"Rhinitis Allergic","enrollment":203},{"nctId":"NCT01306721","phase":"PHASE3","title":"Fexofenadine HCL - Pseudoephedrine HCL Combination Versus Allegra in Patients With Seasonal Allergic Rhinitis","status":"COMPLETED","sponsor":"Sanofi","startDate":"2011-02","conditions":"Rhinitis Seasonal","enrollment":520},{"nctId":"NCT01133483","phase":"PHASE1","title":"Bioequivalence Study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr.Reddy's Under Fed Conditions","status":"COMPLETED","sponsor":"Dr. Reddy's Laboratories Limited","startDate":"2007-04","conditions":"Healthy","enrollment":38},{"nctId":"NCT01133470","phase":"PHASE1","title":"Bioequivalence Study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr. Reddy's and Allegra D 24 Hour ER Tablets Under Fasting Conditions","status":"COMPLETED","sponsor":"Dr. Reddy's Laboratories Limited","startDate":"2007-02","conditions":"Healthy","enrollment":54}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[{"date":"20160126","type":"SUPPL","sponsor":"DR REDDYS LABS LTD","applicationNumber":"ANDA079043"},{"date":"20110622","type":"SUPPL","sponsor":"DR REDDYS LABS LTD","applicationNumber":"ANDA079043"},{"date":"20100528","type":"SUPPL","sponsor":"DR REDDYS LABS LTD","applicationNumber":"ANDA079043"},{"date":"20220517","type":"SUPPL","sponsor":"DR REDDYS LABS LTD","applicationNumber":"ANDA079043"},{"date":"20100317","type":"ORIG","sponsor":"DR REDDYS LABS LTD","applicationNumber":"ANDA079043"}],"publicationCount":3,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["ALLEGRA® D"],"phase":"marketed","status":"active","brandName":"Fexofenadine HCL and pseudoephedrine HCL","genericName":"Fexofenadine HCL and pseudoephedrine HCL","companyName":"Sanofi","companyId":"sanofi","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Fexofenadine blocks histamine H1 receptors to reduce allergy symptoms, while pseudoephedrine acts as a nasal decongestant by stimulating alpha-adrenergic receptors. Used for Allergic rhinitis with nasal congestion, Seasonal and perennial allergic rhinitis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}