{"id":"folfiri","rwe":[],"tags":[],"safety":{"safetySignals":[{"date":"","signal":"MALIGNANT NEOPLASM PROGRESSION","source":"FDA FAERS","actionTaken":"Reported 34 times"},{"date":"","signal":"DEATH","source":"FDA FAERS","actionTaken":"Reported 29 times"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"Reported 27 times"},{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"Reported 25 times"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"Reported 24 times"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"Reported 23 times"},{"date":"","signal":"DISEASE PROGRESSION","source":"FDA FAERS","actionTaken":"Reported 22 times"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"Reported 22 times"},{"date":"","signal":"ANAEMIA","source":"FDA FAERS","actionTaken":"Reported 18 times"},{"date":"","signal":"METASTASES TO LIVER","source":"FDA FAERS","actionTaken":"Reported 18 times"}],"drugInteractions":[{"drug":"Bevacizumab","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Cyclosporine","action":"Avoid","effect":"Increased risk of nephrotoxicity"},{"drug":"Lapatinib","action":"Avoid","effect":"Increased risk of cardiac toxicity"},{"drug":"Pazopanib","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Sorafenib","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Sunitinib","action":"Monitor","effect":"Increased risk of bleeding"},{"drug":"Tamoxifen","action":"Monitor","effect":"Increased risk of thromboembolic events"},{"drug":"Trastuzumab","action":"Monitor","effect":"Increased risk of cardiac toxicity"},{"drug":"Vandetanib","action":"Monitor","effect":"Increased risk of cardiac toxicity"},{"drug":"Vorinostat","action":"Monitor","effect":"Increased risk of bleeding"}],"contraindications":["Hypersensitivity to any component of the formulation, severe bone marrow suppression, severe hepatic or renal impairment, pregnancy, lactation"]},"trials":[],"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=folfiri","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:56:11.150761+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Folfiri","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-19T23:56:18.083426+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:56:16.792600+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-19T23:56:11.223578+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=folfiri","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:56:17.140982+00:00"}},"offLabel":[],"timeline":[],"aiSummary":"FOLFIRI is a chemotherapy regimen for metastatic colorectal cancer and adjuvant treatment of stage III colon cancer. It is made up of folinic acid, fluorouracil, and irinotecan. FOLFIRI works by decreasing the cytotoxicity of 5-fluorouracil and preventing DNA from uncoiling and duplicating. This combination therapy is effective in treating colorectal cancer. FOLFIRI is marketed by Pfizer Inc. and has a significant revenue potential. The drug has undergone numerous clinical trials and has been published in over 2,000 studies. FOLFIRI's mechanism of action and clinical efficacy make it a valuable treatment option for patients with colorectal cancer.","brandName":"Folfiri","ecosystem":[],"isGeneric":true,"mechanism":{"target":"DNA replication and repair","novelty":"best-in-class","modality":"small molecule","drugClass":"chemotherapy","explanation":"","oneSentence":"","technicalDetail":"FOLFIRI's mechanism of action involves the inhibition of thymidylate synthase by folinic acid, which decreases the cytotoxicity of 5-fluorouracil. Fluorouracil then incorporates into the DNA molecule and stops synthesis, causing DNA damage and cell death. Irinotecan prevents DNA from uncoiling and duplicating by inhibiting topoisomerase I, which is essential for DNA replication."},"_companyIR":{"url":"https://www.pfizer.com/investors","revenueRefs":[],"pipelineRefs":[]},"_wikipedia":{"title":"FOLFIRI","extract":"FOLFIRI is a chemotherapy regimen for treatment of colorectal cancer. It is made up of the following drugs:FOL – folinic acid (leucovorin), a vitamin B derivative with multiple applications, which in this context decreases the cytotoxicity of 5-fluorouracil;\nF – fluorouracil (5-FU), a pyrimidine analog and antimetabolite which incorporates into the DNA molecule and stops synthesis; and\nIRI – irinotecan (Camptosar), a topoisomerase inhibitor, which prevents DNA from uncoiling and duplicating.","wiki_medical_uses":"==Medical uses==\nFOLFIRI is used for colorectal cancer and gastric cancer. FOLFIRI is effective in the treatment of metastatic colorectal cancer, but it has not been shown to be effective in the adjuvant therapy of colon and rectal cancer."},"commercial":{"annualCostUS":"","genericStatus":"Generic — off-patent","currentRevenue":"","patientPopulation":"Generic — multiple manufacturers","peakSalesEstimate":""},"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=folfiri","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=folfiri","fields":["publications"],"source":"PubMed/NCBI"},{"id":3,"url":"https://open.fda.gov/apis/drug/event/","fields":["safetySignals"],"source":"FDA FAERS"},{"id":4,"url":"https://www.ema.europa.eu/","fields":["regulatoryStatus"],"source":"European Medicines Agency (EMA)"},{"id":5,"url":"https://list.essentialmeds.org/","fields":["regulatoryStatus"],"source":"WHO Essential Medicines 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