{
 "query": "ketoconazole",
 "ingredient": "ketoconazole",
 "slug": "ketoconazole",
 "rxcui": "6135",
 "brands": [
  "Ketodan",
  "Extina",
  "Kuric",
  "Nizoral",
  "Xolegel"
 ],
 "names": [
  "ketoconazole",
  "ketoconazole n-oxide"
 ],
 "classes": [
  {
   "id": "H02CA",
   "name": "Anticorticosteroids"
  },
  {
   "id": "D01AC",
   "name": "Imidazole and triazole derivatives"
  },
  {
   "id": "G01AF",
   "name": "Imidazole derivatives"
  },
  {
   "id": "J02AB",
   "name": "Imidazole derivatives"
  }
 ],
 "alternatives": [
  "bifonazole",
  "butoconazole",
  "clotrimazole",
  "econazole",
  "efinaconazole",
  "fenticonazole",
  "fluconazole",
  "flutrimazole",
  "isoconazole",
  "levoketoconazole",
  "luliconazole",
  "metronidazole",
  "miconazole",
  "omoconazole",
  "ornidazole",
  "osilodrostat",
  "oxiconazole",
  "sertaconazole",
  "sulconazole",
  "thiabendazole",
  "tinidazole",
  "tioconazole",
  "trilostane"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "TOPICAL": 56,
   "ORAL": 12,
   "CUTANEOUS": 1
  },
  "boxed_warning": "WARNING Because ketoconazole tablets have been associated with serious adverse reactions (see WARNINGS section), ketoconazole tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or Candida infections. Ketoconazole tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks. Hepatotoxicity Serious hepatotoxicity, including cases with a fatal outcome or requiring liver transplantation has occurred with the use of oral ketoconazole. Some patients had no obvious risk factors for liver disease. Patients receiving this drug should be informed by the physician of the risk and should be closely monitored. See WARNINGS section. QT Prolongation and Drug Interactions Leading to QT Prolongation Coadministration of the following drugs with ketoconazole is contraindicated: dofetilide, quinidine, pimozide, lurasidone, cisapride, methadone, disopyramide, dronedarone, ranolazine. Ketoconazole can cause elevated plasma concentrations of these drugs and may prolong QT intervals, sometimes resulting in life-threatening ventricular dysrhythmias such as...",
  "indications_and_usage": "INDICATIONS AND USAGE Ketoconazole tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or Candida infections. Ketoconazole tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks. Ketoconazole tablets are indicated for the treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. Ketoconazole tablets should not be used for fungal meningitis because it penetrates poorly into the cerebrospinal fluid.",
  "contraindications": "CONTRAINDICATIONS Drug Interactions Coadministration of a number of CYP3A4 substrates such as dofetilide, quinidine, cisapride and pimozide is contraindicated with ketoconazole tablets. Coadministration with ketoconazole can cause elevated plasma concentrations of these drugs and may increase or prolong both therapeutic and adverse effects to such an extent that a potentially serious adverse reaction may occur. For example, increased plasma concentrations of some of these drugs can lead to QT prolongation and sometimes resulting in life-threatening ventricular tachyarrhythmias including occurrences of torsades de pointes, a potentially fatal arrhythmia. (See PRECAUTIONS: Drug Interactions .) Coadministration of ketoconazole tablets with lurasidone is contraindicated since it may result in an increase in lurasidone exposure and the potential for serious adverse reactions (see PRECAUTIONS: Drug Interactions ). Additionally, the following other drugs are contraindicated with ketoconazole tablets: methadone, disopyramide, dronedarone, ergot alkaloids such as dihydroergotamine, ergometrine, ergotamine, methylergometrine, irinotecan, lurasidone, oral midazolam, alprazolam, triazolam, fel...",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS Because of the serious adverse reactions that have been reported in association with ketoconazole, including fatal hepatotoxicity, ketoconazole tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or Candida infections. Ketoconazole tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks. Hepatotoxicity Serious hepatotoxicity, including cases with a fatal outcome or requiring liver transplantation, has occurred with the use of oral ketoconazole. Some patients had no obvious risk factors for liver disease. Serious hepatotoxicity was reported both by patients receiving high doses for short treatment durations and by patients receiving low doses for long durations. The hepatic injury has usually, but not always, been reversible upon discontinuation of ketoconazole treatment. Cases of hepatitis have been reported in children. At baseline, obtain laboratory tests (such as SGGT, alkaline phosphatase, ALT, AST, total bilirubin (TBL), Prothrombin Time (PT), International Normalization Ratio (INR), and testing for viral hepatiti...",
  "adverse_reactions": "ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following adverse reactions were reported in clinical trials: Immune System Disorders: anaphylactoid reaction Endocrine Disorders: gynecomastia Metabolism and Nutrition Disorders: alcohol intolerance, anorexia, hyperlipidemia, increased appetite Psychiatric Disorders: insomnia, nervousness Nervous System Disorders: headache, dizziness, paresthesia, somnolence Eye Disorders: photophobia Vascular Disorders: orthostatic hypotension Respiratory, Thoracic and Mediastinal Disorders: epistaxis Gastrointestinal Disorders: vomiting, diarrhea, nausea, constipation, abdominal pain, abdominal pain upper, dry mouth, dysgeusia, dyspepsia, flatulence, tongue discoloration Hepatobiliary Disorders: hepatitis, jaundice, hepatic function abnormal Skin and Subcutaneous Tissues Disorders: erythema multiforme, rash, dermatitis, erythema, urticaria, pruritus, alopecia, xeroderma Musculoskeletal and Connective Tissue Disorde...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients Patients should be instructed to report any signs and symptoms which may suggest liver dysfunction so that appropriate biochemical testing can be done. Such signs and symptoms may include unusual fatigue, anorexia, nausea and/or vomiting, abdominal pain, jaundice, dark urine or pale stools (see WARNINGS section).",
  "spl_medguide": "MEDICATION GUIDE Ketoconazole (KEE-toe-KON-a-zole) Tablets USP, 200 mg What is the most important information I should know about ketoconazole tablets USP? Ketoconazole tablets is not the only medicine available to treat fungal infections and should only be used when other medicines are not right for you. Talk to your healthcare provider to find out if ketoconazole tablets are right for you. Ketoconazole tablets USP can cause serious side effects, including: liver problems (hepatotoxicity). Some people who were treated with ketoconazole the active ingredient in ketoconazole tablets, had serious liver problems that led to death or the need for a liver transplant. Call your healthcare provider right away if you have any of the following symptoms: loss of appetite or start losing weight (anorexia) nausea or vomiting feel tired stomach pain or tenderness dark urine or light colored stools yellowing of your skin or the whites of your eyes fever or rash changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heart beats that can be life threatening. This can happen when ketoconazole tablets are taken with certain medicines, such as dof...",
  "clinical_studies": "",
  "brand_name": "Ketoconazole",
  "manufacturer": "Sun Pharmaceutical Industries, Inc.",
  "application_number": "ANDA075319",
  "pharm_class_epc": [
   "Azole Antifungal [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20250902",
  "set_id": "8ca815a8-bccb-4ee2-a042-922373329cae",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 17311,
  "serious": 7824,
  "death": 905,
  "hospitalization": 3071,
  "primary_suspect": 17274,
  "top_reactions": [
   [
    "Drug Ineffective",
    2199
   ],
   [
    "Off Label Use",
    1279
   ],
   [
    "Pruritus",
    1098
   ],
   [
    "Rash",
    857
   ],
   [
    "Fatigue",
    845
   ],
   [
    "Diarrhoea",
    739
   ],
   [
    "Nausea",
    739
   ],
   [
    "Headache",
    703
   ],
   [
    "Product Use In Unapproved Indication",
    689
   ],
   [
    "Psoriasis",
    654
   ],
   [
    "Pain",
    652
   ],
   [
    "Alopecia",
    623
   ],
   [
    "Product Use Issue",
    564
   ],
   [
    "Dyspnoea",
    539
   ],
   [
    "Condition Aggravated",
    538
   ]
  ],
  "by_year": {
   "2019": 1495,
   "2020": 1425,
   "2021": 1338,
   "2022": 1296,
   "2023": 1880,
   "2024": 1446,
   "2025": 1721,
   "2026": 1062
  },
  "by_year_primary": {
   "2019": 1495,
   "2020": 1424,
   "2021": 1335,
   "2022": 1288,
   "2023": 1878,
   "2024": 1436,
   "2025": 1718,
   "2026": 1057
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20220413",
   "reason": "cGMP deviations: Temperature abuse",
   "firm": "Mckesson Medical-Surgical Inc. Corporate Office",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20131118",
   "reason": "Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.",
   "firm": "Fougera Pharmaceuticals  Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20120718",
   "reason": "Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary drug recall by Fougera due to an Out Of Specification result for an unknown degradant product",
   "firm": "Fougera Pharmaceuticals  Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 3,
 "drugsfda": {
  "applications": 28,
  "nda": 6,
  "anda": 21,
  "first_approval": "19810612",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 34,
  "labeling_recent": 2,
  "sponsors": [
   "AAIPHARMA LLC",
   "AUROBINDO PHARMA USA",
   "CHARTWELL RX",
   "COSETTE PHARMS NC",
   "ENCUBE",
   "FOUGERA PHARMS",
   "HERITAGE PHARMA",
   "INA PHARMS"
  ],
  "unapproved": false,
  "first_approval_fmt": "06/12/1981"
 },
 "trials": {
  "total": 218,
  "completed": 162,
  "terminated": 28,
  "with_results": 49,
  "industry": 133,
  "phase3": 26,
  "results_share": 0.30246913580246915,
  "terminated_share": 0.12844036697247707
 },
 "pubmed": {
  "rct": 290,
  "meta": 8,
  "recent_rct": 5,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 50.76,
  "records": 3,
  "by_name": [
   [
    "Ketodan",
    50.76
   ]
  ],
  "names_checked": [
   "ketoconazole",
   "Ketodan",
   "Extina",
   "Kuric",
   "Nizoral",
   "Xolegel"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 4250231,
  "beneficiaries": 2001085,
  "spend": 82188011.11000001,
  "by_brand": [
   {
    "brand": "Ketoconazole",
    "claims": 4250165,
    "per_claim": 19.331081483,
    "is_generic": true
   },
   {
    "brand": "Ketodan",
    "claims": 66,
    "per_claim": 420.07848485,
    "is_generic": false
   }
  ],
  "per_claim": 19.337304515919257
 },
 "mdl": [],
 "dsc": [
  {
   "date": "20160519",
   "title": "FDA warns that prescribing of Nizoral (ketoconazole) oral tablets for unapproved uses including skin and nail infections continues; linked to patient death",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm500597.htm",
   "kind": "drug",
   "matched": "nizoral"
  },
  {
   "date": "20130726",
   "title": "FDA limits usage of Nizoral (ketoconazole) oral tablets due to potentially fatal liver injury and risk of drug interactions and adrenal gland problems",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm362415.htm",
   "kind": "drug",
   "matched": "nizoral"
  }
 ],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "ApplicationRejected",
  "name": "ketoconazole",
  "matched": "ketoconazole",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 4211,
  "fills": 4250231,
  "per_million": 990.7696781657279,
  "ratio": 0.3578142495397232,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 49,
   "letter": "F",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "FDA issued 2 Drug Safety Communication(s) naming this drug since 2010, most recently 2016 (-16)",
    "991 FDA reports naming it as the suspect drug per million Medicare fills, 0.4x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.6x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 43,
   "letter": "F",
   "why": [
    "290 randomized trials and 8 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 30% of completed registered trials posted results (-15)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 95,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 0 Class III across 21 generic makers (-1)",
    "2 label changes approved since 2021 (-4)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $51 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 (21 applications)",
    "23 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 67,
 "grade": "C",
 "questions": [
  "In 2016 the FDA issued a safety communication about this drug (FDA warns that prescribing of Nizoral (ketoconazole) oral tablets for unapproved uses including skin and nail ). Does that risk apply to me?",
  "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 pruritus, rash. 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 bifonazole, butoconazole, clotrimazole? 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.)"
 ]
}