{"id":"tacrolimus-mylan","safety":{"commonSideEffects":[{"rate":"10-30","effect":"Nephrotoxicity"},{"rate":"20-40","effect":"Hypertension"},{"rate":"10-25","effect":"Hyperglycemia/new-onset diabetes"},{"rate":"5-15","effect":"Neurotoxicity (tremor, headache)"},{"rate":"15-30","effect":"Infection"},{"rate":"5-15","effect":"Hyperkalemia"},{"rate":"5-10","effect":"Gastrointestinal disturbances"}]},"_chembl":{"chemblId":"CHEMBL3989887","moleculeType":"Small molecule","molecularWeight":"822.05"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Tacrolimus binds to the immunophilin FKBP12, and this complex inhibits calcineurin, a serine/threonine phosphatase essential for T-cell receptor signaling. By preventing NFAT dephosphorylation and nuclear translocation, tacrolimus suppresses the transcription of cytokines (IL-2, TNF-α, IFN-γ) required for T-cell proliferation and differentiation. This potent immunosuppression makes it effective for preventing organ rejection and treating autoimmune conditions.","oneSentence":"Tacrolimus inhibits calcineurin phosphatase, blocking T-cell activation and proliferation by preventing the dephosphorylation of nuclear factor of activated T cells (NFAT).","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:10:51.696Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prophylaxis of organ rejection in allogeneic kidney, heart, and liver transplant recipients"},{"name":"Atopic dermatitis (topical formulation)"},{"name":"Autoimmune conditions including rheumatoid arthritis and lupus nephritis"}]},"trialDetails":[{"nctId":"NCT02014103","phase":"PHASE4","title":"Conversion From Brand to Generic Tacrolimus in High Risk Transplant Recipients","status":"COMPLETED","sponsor":"University of Cincinnati","startDate":"2015-03","conditions":"Complication of Transplant","enrollment":71}],"_emaApprovals":[],"_faersSignals":[{"count":2,"reaction":"BLOOD CREATININE INCREASED"},{"count":2,"reaction":"CYTOMEGALOVIRUS INFECTION"},{"count":2,"reaction":"TRANSPLANT REJECTION"},{"count":1,"reaction":"ACUTE HEPATIC FAILURE"},{"count":1,"reaction":"ACUTE KIDNEY INJURY"},{"count":1,"reaction":"ADENOVIRUS INFECTION"},{"count":1,"reaction":"ALANINE AMINOTRANSFERASE INCREASED"},{"count":1,"reaction":"AORTITIS"},{"count":1,"reaction":"BACK PAIN"},{"count":1,"reaction":"BACTERIURIA"}],"_approvalHistory":[],"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":["Mylan tacrolimus"],"phase":"marketed","status":"active","brandName":"Tacrolimus, Mylan","genericName":"Tacrolimus, Mylan","companyName":"University of Cincinnati","companyId":"university-of-cincinnati","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Tacrolimus inhibits calcineurin phosphatase, blocking T-cell activation and proliferation by preventing the dephosphorylation of nuclear factor of activated T cells (NFAT). Used for Prophylaxis of organ rejection in allogeneic kidney, heart, and liver transplant recipients, Atopic dermatitis (topical formulation), Autoimmune conditions including rheumatoid arthritis and lupus nephritis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}