{"id":"drops-intilation-otocerum","safety":{"commonSideEffects":[{"rate":null,"effect":"Local irritation or itching in the ear canal"},{"rate":null,"effect":"Temporary hearing impairment during treatment"},{"rate":null,"effect":"Allergic contact dermatitis"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The drops contain surfactants and emollients that penetrate and break down the lipid-protein matrix of impacted cerumen, reducing its adhesion to the ear canal wall and making it easier to remove mechanically or allow natural drainage. This non-invasive approach reduces the need for manual cerumen extraction procedures that can cause discomfort or trauma to the delicate ear canal epithelium.","oneSentence":"Otocerum is a cerumenolytic ear drop formulation designed to soften and facilitate the removal of impacted cerumen (earwax) from the external auditory canal.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-27T23:45:03.875Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Impacted cerumen (earwax) removal in the external auditory canal"}]},"trialDetails":[{"nctId":"NCT00765635","phase":"PHASE4","title":"Chlorobutanol, Potassium Carbonate, and Irrigation in Cerumen Removal","status":"COMPLETED","sponsor":"Hospital Clinic of Barcelona","startDate":"2008-09","conditions":"Ear Infection, Hearing Loss, Vertigo","enrollment":90}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"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":[],"phase":"marketed","status":"active","brandName":"drops intilation (Otocerum®)","genericName":"drops intilation (Otocerum®)","companyName":"Hospital Clinic of Barcelona","companyId":"hospital-clinic-of-barcelona","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Otocerum is a cerumenolytic ear drop formulation designed to soften and facilitate the removal of impacted cerumen (earwax) from the external auditory canal. Used for Impacted cerumen (earwax) removal in the external auditory canal.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}