{"id":"generic-fluorouracil-cream","safety":{"commonSideEffects":[{"rate":"60–90","effect":"Local skin irritation and erythema"},{"rate":"40–80","effect":"Burning and pain at application site"},{"rate":"20–50","effect":"Erosion and ulceration"},{"rate":"10–30","effect":"Photosensitivity"},{"rate":"5–15","effect":"Allergic contact dermatitis"}]},"_chembl":{"chemblId":"CHEMBL2108947","moleculeType":"Unknown"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Fluorouracil (5-FU) acts as an antimetabolite by blocking the enzyme thymidylate synthase, which is essential for DNA synthesis. It also incorporates into RNA, disrupting protein synthesis. As a topical cream formulation, it is used to treat precancerous and cancerous skin lesions by inducing apoptosis in abnormal keratinocytes.","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":"2026-03-28T01:13:53.369Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Actinic keratosis (precancerous skin lesions)"},{"name":"Superficial basal cell carcinoma"},{"name":"Squamous cell carcinoma in situ"}]},"trialDetails":[{"nctId":"NCT03996252","phase":"EARLY_PHASE1","title":"Combination Topical Therapy for Treatment of Scalp Actinic Keratoses","status":"TERMINATED","sponsor":"Tulane University","startDate":"2019-07-01","conditions":"Actinic Keratoses","enrollment":15},{"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":"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":11,"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":"Generic Fluorouracil Cream","genericName":"Generic 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 (precancerous skin lesions), Superficial basal cell carcinoma, Squamous cell carcinoma in situ.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}