{"id":"carac-fluorouracil-cream","safety":{"commonSideEffects":[{"rate":"60–90","effect":"Local skin irritation (erythema, burning, pain)"},{"rate":"20–50","effect":"Erosion or ulceration at application site"},{"rate":"10–30","effect":"Photosensitivity"},{"rate":"5–15","effect":"Allergic contact dermatitis"},{"rate":"5–10","effect":"Hyperpigmentation or hypopigmentation"}]},"_chembl":{"chemblId":"CHEMBL2108947","moleculeType":"Unknown"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Fluorouracil (5-FU) is a prodrug that is converted intracellularly to active metabolites (FdUMP and FdUTP). FdUMP inhibits thymidylate synthase, blocking dTMP synthesis and DNA replication. The active metabolites also incorporate into RNA, disrupting protein synthesis. This mechanism preferentially affects rapidly dividing cells, including cancer cells and hyperproliferative skin cells.","oneSentence":"Fluorouracil is a pyrimidine analog that inhibits thymidylate synthase and gets incorporated into DNA and RNA, disrupting nucleotide synthesis and causing cell death in rapidly dividing cells.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:04:54.836Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Actinic keratosis (topical cream formulation)"},{"name":"Superficial basal cell carcinoma (topical)"}]},"trialDetails":[{"nctId":"NCT05513924","phase":"PHASE2, PHASE3","title":"Comparative Study Between Topical 5-fluorouracil and Latanoprost in Vitiligo.","status":"COMPLETED","sponsor":"South Valley University","startDate":"2022-03-15","conditions":"Vitiligo","enrollment":40},{"nctId":"NCT01525329","phase":"PHASE3","title":"Combination Therapy With 5-Fluorouracil and Photodynamic Therapy in Post-transplant Premalignant Skin Disease","status":"TERMINATED","sponsor":"The Cleveland Clinic","startDate":"2011-09","conditions":"Actinic Keratosis, Organ or Tissue Transplant; Complications","enrollment":18},{"nctId":"NCT03727074","phase":"PHASE3","title":"Bioequivalence Study to Compare Sol-Gel Technologies' 5-FU Cream With Efudex® (5-FU) Cream","status":"COMPLETED","sponsor":"Sol-Gel Technologies, Ltd.","startDate":"2018-12-21","conditions":"Actinic Keratosis (AK)","enrollment":462},{"nctId":"NCT02616601","phase":"PHASE3","title":"Multicenter, Double-blind, Placebo Controlled Comparing Test Fluorouracil Cream to Carac Cream in Actinic Keratosis","status":"COMPLETED","sponsor":"Actavis Inc.","startDate":"2015-02-27","conditions":"Actinic Keratosis","enrollment":422},{"nctId":"NCT01059110","phase":"PHASE4","title":"Comparison of Five Treatments in Patients With Plantar Warts","status":"TERMINATED","sponsor":"Assistance Publique - Hôpitaux de Paris","startDate":"2010-02","conditions":"Plantar Warts","enrollment":358},{"nctId":"NCT01354717","phase":"PHASE3","title":"Bioequivalence Study of Generic Fluorouracil 0.5% Cream and 0.5% Carac® and Placebo","status":"COMPLETED","sponsor":"Spear Pharmaceuticals","startDate":"2010-09","conditions":"Actinic Keratoses","enrollment":377}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":161,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["5-FU"],"phase":"phase_3","status":"active","brandName":"Carac® (Fluorouracil) Cream","genericName":"Carac® (Fluorouracil) Cream","companyName":"Actavis Inc.","companyId":"actavis-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Fluorouracil is a pyrimidine analog that inhibits thymidylate synthase and gets incorporated into DNA and RNA, disrupting nucleotide synthesis and causing cell death in rapidly dividing cells. Used for Actinic keratosis (topical cream formulation), Superficial basal cell carcinoma (topical).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}