{"id":"graded-oral-amoxicillin-challenge","safety":{"commonSideEffects":[{"rate":null,"effect":"Allergic reaction (urticaria, angioedema, anaphylaxis)"},{"rate":null,"effect":"Gastrointestinal upset"}]},"_chembl":{"chemblId":"CHEMBL2105950","moleculeType":"Small molecule","molecularWeight":"387.39"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"This is a diagnostic procedure rather than a therapeutic drug. It involves administering incrementally increasing doses of amoxicillin orally under medical supervision to evaluate whether a patient has a true IgE-mediated allergic reaction or can safely tolerate the antibiotic. The graded approach allows clinicians to identify the threshold dose at which an allergic reaction occurs, if any, enabling accurate allergy classification and guiding future antibiotic selection.","oneSentence":"A graded oral challenge test using amoxicillin to assess tolerance and safely diagnose or rule out amoxicillin allergy in patients with reported penicillin sensitivity.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:39:57.259Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Evaluation of reported amoxicillin or penicillin allergy"},{"name":"Determination of safe amoxicillin tolerance in patients with penicillin sensitivity history"}]},"trialDetails":[{"nctId":"NCT05464615","phase":"EARLY_PHASE1","title":"Geisinger Antibiotic Allergy Pilot Program: Assess and Address","status":"RECRUITING","sponsor":"Geisinger Clinic","startDate":"2024-03-04","conditions":"Penicillin Allergy","enrollment":100},{"nctId":"NCT06303128","phase":"PHASE3","title":"Penicillin Allergy Delabeling After a One-Dose Versus Two-Dose Graded Direct Oral Challenge","status":"RECRUITING","sponsor":"James Tarbox, MD","startDate":"2024-02-03","conditions":"Penicillin Allergy","enrollment":380},{"nctId":"NCT05020327","phase":"PHASE4","title":"Inpatient Penicillin Allergy Delabeling Study","status":"COMPLETED","sponsor":"University Hospitals Cleveland Medical Center","startDate":"2021-09-22","conditions":"Penicillin Allergy, Penicillin Sensitivity, Penicillin Reaction","enrollment":40},{"nctId":"NCT03757052","phase":"NA","title":"Amoxicillin Challenge for Penicillin Allergy Diagnosis","status":"UNKNOWN","sponsor":"CHU de Quebec-Universite Laval","startDate":"2018-11-20","conditions":"Penicillin Allergy","enrollment":1000},{"nctId":"NCT03607734","phase":"NA","title":"Penicillin Allergy De-Labelling in Elective Surgical Patients (PADLES)","status":"COMPLETED","sponsor":"The Leeds Teaching Hospitals NHS Trust","startDate":"2017-04-24","conditions":"Allergy","enrollment":150}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":2,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Amoxicillin Challenge"],"phase":"marketed","status":"active","brandName":"Graded Oral Amoxicillin Challenge","genericName":"Graded Oral Amoxicillin Challenge","companyName":"University Hospitals Cleveland Medical Center","companyId":"university-hospitals-cleveland-medical-center","modality":"Small molecule","firstApprovalDate":"","aiSummary":"A graded oral challenge test using amoxicillin to assess tolerance and safely diagnose or rule out amoxicillin allergy in patients with reported penicillin sensitivity. Used for Evaluation of reported amoxicillin or penicillin allergy, Determination of safe amoxicillin tolerance in patients with penicillin sensitivity history.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}