{
 "query": "fluorouracil",
 "ingredient": "fluorouracil",
 "slug": "fluorouracil",
 "rxcui": "4492",
 "brands": [
  "Efudex",
  "Tolak",
  "Adrucil",
  "Carac",
  "Favlyxa",
  "Fluoroplex"
 ],
 "names": [
  "fluorouracil"
 ],
 "classes": [
  {
   "id": "L01BC",
   "name": "Pyrimidine analogues"
  }
 ],
 "alternatives": [
  "azacitidine",
  "capecitabine",
  "cytarabine",
  "decitabine",
  "floxuridine",
  "gemcitabine",
  "tegafur"
 ],
 "label": {
  "route_mode": "INTRAVENOUS",
  "route_counts": {
   "INTRAVENOUS": 24,
   "TOPICAL": 12
  },
  "boxed_warning": "WARNING: SERIOUS ADVERSE REACTIONS OR DEATH IN PATIENTS WITH COMPLETE DPD DEFICIENCY Increased Risk of Serious Adverse Reactions or Death in Patients with Complete DPD Deficiency Test patients for genetic variants of DPYD prior to initiating fluorouracil unless immediate treatment is necessary. Avoid use of fluorouracil in patients with certain homozygous or compound heterozygous DPYD variants that result in complete DPD deficiency [see Warnings and Precautions (5.1)] . WARNING: SERIOUS ADVERSE REACTIONS OR DEATH IN PATIENTS WITH COMPLETE DPD DEFICIENCY, See full prescribing information for complete boxed warning Serious adverse reactions or death may occur in patients with complete DPD deficiency. Test patients for genetic variants of DPYD prior to initiating fluorouracil unless immediate treatment is necessary. Avoid use of fluorouracil in patients with certain homozygous or compound heterozygous DPYD variants that result in complete DPD deficiency. (2.1, 5.1)",
  "indications_and_usage": "Fluorouracil Injection is indicated for the treatment of patients with: Fluorouracil Injection is a nucleoside metabolic inhibitor indicated for the treatment of patients with Adenocarcinoma of the Colon and Rectum ( 1.1 ) Adenocarcinoma of the Breast ( 1.2 ) Gastric Adenocarcinoma ( 1.3 ) Pancreatic Adenocarcinoma ( 1.4 ) 1.1 Adenocarcinoma of the Colon and Rectum 1.2 Adenocarcinoma of the Breast 1.3 Gastric Adenocarcinoma 1.4 Pancreatic Adenocarcinoma",
  "contraindications": "None. None ( 4 )",
  "warnings_and_cautions": "Cardiotoxicity: Fluorouracil can cause cardiotoxicity, including angina, myocardial infarction/ischemia, arrhythmia, and heart failure. Withhold fluorouracil for cardiac toxicity. ( 5.2 ) Hyperammonemic Encephalopathy: Altered mental status, confusion, disorientation, coma, or ataxia with elevated serum ammonia level can occur within 72 hours of initiation of fluorouracil. Withhold fluorouracil and initiate ammonia-lowering therapy. ( 5.3 ) Neurologic Toxicity: Fluorouracil can cause acute cerebellar syndrome, confusion, disorientation, ataxia, or visual disturbances. Withhold fluorouracil for neurologic toxicity. ( 5.4 ) Diarrhea: Fluorouracil can cause severe diarrhea. Withhold fluorouracil for severe diarrhea until resolved. ( 5.5 ) Palmar-Plantar Erythrodysesthesia (Hand-Foot Syndrome): Fluorouracil can cause hand-foot syndrome. If severe, discontinue fluorouracil until resolved or decreased to Grade 1, then resume at a reduced dose. ( 5.6 ) Myelosuppression: Fluorouracil can cause severe and fatal myelosuppression. Withhold fluorouracil until severe myelosuppression resolves, then resume at a reduced dose. ( 5.7 ) Mucositis: Fluorouracil can cause severe mucositis. Discontinue...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions are discussed in more detail in other sections of the labeling: Serious Adverse Reactions or Death from Dihydropyrimidine Dehydrogenase (DPD) Deficiency [see Warnings and Precautions (5.1) ] Cardiotoxicity [see Warnings and Precautions (5.2) ] Hyperammonemic encephalopathy [see Warnings and Precautions (5.3) ] Neurologic toxicity [see Warnings and Precautions (5.4) ] Diarrhea [see Warnings and Precautions (5.5) ] Palmar-plantar erythrodysesthesia (hand-foot syndrome) [see Warnings and Precautions (5.6) ] Myelosuppression [see Warnings and Precautions (5.7) ] Mucositis [see Warnings and Precautions (5.8) ] Increased risk of elevated INR when administrated with warfarin [see Warnings and Precautions (5.9) ] To report SUSPECTED ADVERSE REACTIONS, contact Meitheal Pharmaceuticals, Inc. at 1-844-824-8426 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of fluorouracil. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship ...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "Boxed Warning 11/2025 Dosage and Administration, Evaluation and Testing for DPD Deficiency Before Initiating Fluorouracil ( 2.1 ) 11/2025 Warnings and Precautions, Serious Adverse Reactions or Death from Dihydropyrimidine Dehydrogenase (DPD) Deficiency ( 5.1 ) 11/2025",
  "information_for_patients": "Advise: Prior to initiating fluorouracil treatment, inform patients of the potential for serious or fatal adverse reactions due to DPD deficiency and testing for genetic variants of DPYD . Advise patients to immediately contact their healthcare provider if symptoms of severe mucositis, diarrhea, neutropenia, and neurotoxicity occur [see Warnings and Precautions (5.1) and Clinical Pharmacology (12.5) ] . Patients of the risk of cardiotoxicity. Advise patients to immediately contact their healthcare provider or to go to an emergency room for new onset of chest pain, shortness of breath, dizziness, or lightheadedness [see Warnings and Precautions (5.2) ] . Patients to immediately contact their healthcare provider or go to an emergency room for new onset of confusion, disorientation, or otherwise altered mental status; difficulty with balance or coordination; or visual disturbances [see Warnings and Precautions (5.3 , 5.4 )] . Patients to contact their healthcare provider for severe diarrhea or for painful mouth sores with decreased oral intake of food or fluids [see Warnings and Precautions (5.5 , 5.8 )] . Patients to contact their healthcare provider for tingling or burning, redness,...",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Fluorouracil",
  "manufacturer": "Meitheal Pharmaceuticals Inc.",
  "application_number": "ANDA216494",
  "pharm_class_epc": [
   "Nucleoside Metabolic Inhibitor [EPC]"
  ],
  "route": [
   "INTRAVENOUS"
  ],
  "effective_time": "20260408",
  "set_id": "a0cd6301-c6e0-4b62-8683-39c99913db24",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 73491,
  "serious": 69305,
  "death": 10125,
  "hospitalization": 27682,
  "primary_suspect": 73348,
  "top_reactions": [
   [
    "Diarrhoea",
    6920
   ],
   [
    "Neutropenia",
    5168
   ],
   [
    "Nausea",
    5032
   ],
   [
    "Off Label Use",
    4351
   ],
   [
    "Vomiting",
    3741
   ],
   [
    "Neuropathy Peripheral",
    3616
   ],
   [
    "Fatigue",
    3506
   ],
   [
    "Disease Progression",
    3087
   ],
   [
    "Thrombocytopenia",
    3029
   ],
   [
    "Pyrexia",
    2836
   ],
   [
    "Anaemia",
    2698
   ],
   [
    "Asthenia",
    2644
   ],
   [
    "Febrile Neutropenia",
    2605
   ],
   [
    "Death",
    2489
   ],
   [
    "Decreased Appetite",
    2360
   ]
  ],
  "by_year": {
   "2019": 7549,
   "2020": 6280,
   "2021": 5377,
   "2022": 5821,
   "2023": 6385,
   "2024": 6062,
   "2025": 6768,
   "2026": 3338
  },
  "by_year_primary": {
   "2019": 7549,
   "2020": 6280,
   "2021": 5374,
   "2022": 5802,
   "2023": 6368,
   "2024": 6029,
   "2025": 6719,
   "2026": 3323
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class I",
   "date": "20190628",
   "reason": "Presence of Particulate Matter; glass particulates",
   "firm": "Fresenius Kabi USA, LLC",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20121121",
   "reason": "Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.",
   "firm": "Taro Pharmaceuticals U.S.A., Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 52,
  "nda": 8,
  "anda": 34,
  "first_approval": "19620425",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 28,
  "labeling_recent": 4,
  "sponsors": [
   "ABIC",
   "ABRAXIS PHARM",
   "ACCORD HLTHCARE",
   "ALEMBIC",
   "AVYXA HOLDINGS",
   "BEDFORD",
   "CHARTWELL RX",
   "DR REDDYS LABS SA"
  ],
  "unapproved": false,
  "first_approval_fmt": "04/25/1962"
 },
 "trials": {
  "total": 5112,
  "completed": 2115,
  "terminated": 676,
  "with_results": 881,
  "industry": 1816,
  "phase3": 1210,
  "results_share": 0.416548463356974,
  "terminated_share": 0.1322378716744914
 },
 "pubmed": {
  "rct": 1418,
  "meta": 128,
  "recent_rct": 97,
  "cochrane": [
   {
    "pmid": "26545176",
    "title": "Mitomycin C versus 5-Fluorouracil for wound healing in glaucoma surgery",
    "year": "2015"
   },
   {
    "pmid": "24554410",
    "title": "5-Fluorouracil for glaucoma surgery",
    "year": "2014"
   },
   {
    "pmid": "23440808",
    "title": "Intravitreal low molecular weight heparin and 5-Fluorouracil for the prevention of proliferative vitreoretinopathy following retinal reattachment surgery",
    "year": "2013"
   },
   {
    "pmid": "20614445",
    "title": "Intravitreal low molecular weight heparin and 5-Fluorouracil for the prevention of proliferative vitreoretinopathy following retinal reattachment surgery",
    "year": "2010"
   },
   {
    "pmid": "11686977",
    "title": "Post-operative 5-Fluorouracil for glaucoma surgery",
    "year": "2001"
   },
   {
    "pmid": "10796751",
    "title": "Post-operative 5-fluorouracil for glaucoma surgery",
    "year": "2000"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 15698.68,
  "records": 206,
  "by_name": [
   [
    "Tolak",
    15698.68
   ]
  ],
  "names_checked": [
   "fluorouracil",
   "Efudex",
   "Tolak",
   "Adrucil",
   "Carac",
   "Favlyxa",
   "Fluoroplex"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 678749,
  "beneficiaries": 584218,
  "spend": 45616171.529999994,
  "by_brand": [
   {
    "brand": "Fluorouracil",
    "claims": 677948,
    "per_claim": 67.216155974,
    "is_generic": true
   },
   {
    "brand": "Efudex",
    "claims": 789,
    "per_claim": 59.107287706,
    "is_generic": false
   },
   {
    "brand": "Tolak",
    "claims": 12,
    "per_claim": 39.780833333,
    "is_generic": false
   }
  ],
  "per_claim": 67.20624491527795
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "fluorouracil",
  "matched": "fluorouracil",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 16071,
  "fills": 678749,
  "per_million": 23677.382950103794,
  "ratio": 8.551033805395567,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 40,
   "letter": "F",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "23,677 FDA reports naming it as the suspect drug per million Medicare fills, 8.6x the median drug on this site (-15)",
    "Death appears in 1.5x the FAERS average share of reports (within the margin this measure deserves)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)",
    "1 Class I recall(s): reasonable probability of serious harm (-10)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 86,
   "letter": "B",
   "why": [
    "1418 randomized trials and 128 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "6 independent Cochrane review(s) exist",
    "Only 42% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 76,
   "letter": "B",
   "why": [
    "Recalls since 2016: 1 Class I, 0 Class II, 0 Class III across 34 generic makers (-15)",
    "4 label changes approved since 2021 (-4)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $15,699 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (34 applications)",
    "7 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 72,
 "grade": "C",
 "questions": [
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "The most-reported problems in FDA's adverse event data are diarrhoea, neutropenia, nausea. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "Why this one over azacitidine, capecitabine, cytarabine? What would make you pick one of those instead?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}