{
 "query": "fluconazole",
 "ingredient": "fluconazole",
 "slug": "fluconazole",
 "rxcui": "4450",
 "brands": [
  "Diflucan"
 ],
 "names": [
  "fluconazole"
 ],
 "classes": [
  {
   "id": "D01AC",
   "name": "Imidazole and triazole derivatives"
  },
  {
   "id": "J02AC",
   "name": "Triazole and tetrazole derivatives"
  }
 ],
 "alternatives": [
  "bifonazole",
  "clotrimazole",
  "econazole",
  "efinaconazole",
  "fenticonazole",
  "flutrimazole",
  "isavuconazole",
  "isoconazole",
  "itraconazole",
  "ketoconazole",
  "luliconazole",
  "miconazole",
  "omoconazole",
  "oteseconazole",
  "oxiconazole",
  "posaconazole",
  "sertaconazole",
  "sulconazole",
  "thiabendazole",
  "tioconazole",
  "voriconazole"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 93,
   "INTRAVENOUS": 3
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE DIFLUCAN (fluconazole) is indicated for the treatment of: 1. Vaginal candidiasis (vaginal yeast infections due to Candida ). 2. Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, DIFLUCAN was also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candida infections including candidemia, disseminated candidiasis, and pneumonia. 3. Cryptococcal meningitis. Before prescribing DIFLUCAN (fluconazole) for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIES section. Studies comparing DIFLUCAN to amphotericin B in non-HIV infected patients have not been conducted. Prophylaxis: DIFLUCAN is also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy. Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these re...",
  "contraindications": "CONTRAINDICATIONS DIFLUCAN (fluconazole) is contraindicated in patients who have shown hypersensitivity to fluconazole or to any of its excipients. There is no information regarding cross-hypersensitivity between fluconazole and other azole antifungal agents. Caution should be used in prescribing DIFLUCAN to patients with hypersensitivity to other azoles. Coadministration of other drugs known to prolong the QT interval and which are metabolized via the enzyme CYP3A4 such as erythromycin, pimozide, and quinidine are contraindicated in patients receiving fluconazole. (See CLINICAL PHARMACOLOGY: Drug Interaction Studies and PRECAUTIONS .)",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS (1) Hepatic injury: DIFLUCAN should be administered with caution to patients with liver dysfunction. DIFLUCAN has been associated with rare cases of serious hepatic toxicity, including fatalities primarily in patients with serious underlying medical conditions. In cases of DIFLUCAN-associated hepatotoxicity, no obvious relationship to total daily dose, duration of therapy, sex, or age of the patient has been observed. DIFLUCAN hepatotoxicity has usually, but not always, been reversible on discontinuation of therapy. Patients who develop abnormal liver function tests during DIFLUCAN therapy should be monitored for the development of more severe hepatic injury. DIFLUCAN should be discontinued if clinical signs and symptoms consistent with liver disease develop that may be attributable to DIFLUCAN. (2) Anaphylaxis: In rare cases, anaphylaxis has been reported. (3) Dermatologic: Exfoliative skin disorders during treatment with DIFLUCAN have been reported. Fatal outcomes have been reported in patients with serious underlying diseases. Patients with deep seated fungal infections who develop rashes during treatment with DIFLUCAN should be monitored closely and the drug discontinu...",
  "adverse_reactions": "ADVERSE REACTIONS DIFLUCAN is generally well tolerated. In some patients, particularly those with serious underlying diseases such as AIDS and cancer, changes in renal and hematological function test results and hepatic abnormalities have been observed during treatment with fluconazole and comparative agents, but the clinical significance and relationship to treatment is uncertain. In Patients Receiving a Single Dose for Vaginal Candidiasis: During comparative clinical studies conducted in the United States, 448 patients with vaginal candidiasis were treated with DIFLUCAN, 150 mg single dose. The overall incidence of side effects possibly related to DIFLUCAN was 26%. In 422 patients receiving active comparative agents, the incidence was 16%. The most common treatment-related adverse events reported in the patients who received 150 mg single dose fluconazole for vaginitis were headache (13%), nausea (7%), and abdominal pain (6%). Other side effects reported with an incidence equal to or greater than 1% included diarrhea (3%), dyspepsia (1%), dizziness (1%), and taste perversion (1%). Most of the reported side effects were mild to moderate in severity. Rarely, angioedema and anaphyla...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "",
  "spl_medguide": "",
  "clinical_studies": "CLINICAL STUDIES Cryptococcal meningitis: In a multicenter study comparing DIFLUCAN (200 mg/day) to amphotericin B (0.3 mg/kg/day) for treatment of cryptococcal meningitis in patients with AIDS, a multivariate analysis revealed three pretreatment factors that predicted death during the course of therapy: abnormal mental status, cerebrospinal fluid cryptococcal antigen titer greater than 1:1024, and cerebrospinal fluid white blood cell count of less than 20 cells/mm 3 . Mortality among high risk patients was 33% and 40% for amphotericin B and DIFLUCAN patients, respectively (p=0.58), with overall deaths 14% (9 of 63 subjects) and 18% (24 of 131 subjects) for the 2 arms of the study (p=0.48). Optimal doses and regimens for patients with acute cryptococcal meningitis and at high risk for treatment failure remain to be determined. (Saag, et al . N Engl J Med 1992; 326:83-9.) Vaginal candidiasis: Two adequate and well-controlled studies were conducted in the U.S. using the 150 mg tablet. In both, the results of the fluconazole regimen were comparable to the control regimen (clotrimazole or miconazole intravaginally for 7 days) both clinically and statistically at the one month post-trea...",
  "brand_name": "Diflucan",
  "manufacturer": "Roerig",
  "application_number": "NDA020090",
  "pharm_class_epc": [
   "Azole Antifungal [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20260402",
  "set_id": "f694c617-3383-416c-91b6-b94fda371204",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 55947,
  "serious": 46307,
  "death": 9021,
  "hospitalization": 23581,
  "primary_suspect": 55346,
  "top_reactions": [
   [
    "Drug Ineffective",
    4724
   ],
   [
    "Off Label Use",
    4543
   ],
   [
    "Pyrexia",
    3076
   ],
   [
    "Nausea",
    2887
   ],
   [
    "Fatigue",
    2730
   ],
   [
    "Diarrhoea",
    2708
   ],
   [
    "Drug Interaction",
    2466
   ],
   [
    "Headache",
    2465
   ],
   [
    "Pain",
    2367
   ],
   [
    "Acute Kidney Injury",
    2299
   ],
   [
    "Pneumonia",
    2155
   ],
   [
    "Rash",
    2046
   ],
   [
    "Febrile Neutropenia",
    2013
   ],
   [
    "Dyspnoea",
    1783
   ],
   [
    "Death",
    1758
   ]
  ],
  "by_year": {
   "2019": 6037,
   "2020": 5609,
   "2021": 5195,
   "2022": 4520,
   "2023": 4153,
   "2024": 4455,
   "2025": 4302,
   "2026": 1807
  },
  "by_year_primary": {
   "2019": 6032,
   "2020": 5605,
   "2021": 5149,
   "2022": 4408,
   "2023": 4043,
   "2024": 4353,
   "2025": 4165,
   "2026": 1744
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20170515",
   "reason": "Lack of assurance of sterility: customer complaints received for the presence of leaks.",
   "firm": "Baxter Healthcare Corporation",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20170105",
   "reason": "Failed Dissolution Specifications",
   "firm": "The Harvard Drug Group",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20170105",
   "reason": "Failed Dissolution Specifications",
   "firm": "The Harvard Drug Group",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20161228",
   "reason": "Failed Dissolution Specifications; 18 month stability time point",
   "firm": "Dr. Reddy's Laboratories, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20161228",
   "reason": "Failed Dissolution Specifications; 18 month stability time point",
   "firm": "Dr. Reddy's Laboratories, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20161228",
   "reason": "Failed Dissolution Specifications; 18 month stability time point",
   "firm": "Dr. Reddy's Laboratories, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20161228",
   "reason": "Failed Dissolution Specifications; 18 month stability time point",
   "firm": "Dr. Reddy's Laboratories, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20161206",
   "reason": "Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.",
   "firm": "Baxter Healthcare Corporation",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20141223",
   "reason": "Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.",
   "firm": "Baxter Healthcare Corp.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20140129",
   "reason": "Defective Container: Tamper evident ring failures discovered on some bottles.",
   "firm": "Pfizer Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 10,
 "drugsfda": {
  "applications": 46,
  "nda": 3,
  "anda": 38,
  "first_approval": "19900129",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 93,
  "labeling_recent": 15,
  "sponsors": [
   "ANI PHARMS",
   "AUROBINDO PHARMA",
   "BAXTER HLTHCARE",
   "BAXTER HLTHCARE CORP",
   "CHARTWELL",
   "DR REDDYS",
   "DR REDDYS LABS INC",
   "FDC LTD"
  ],
  "unapproved": false,
  "first_approval_fmt": "01/29/1990"
 },
 "trials": {
  "total": 308,
  "completed": 210,
  "terminated": 25,
  "with_results": 52,
  "industry": 155,
  "phase3": 67,
  "results_share": 0.24761904761904763,
  "terminated_share": 0.08116883116883117
 },
 "pubmed": {
  "rct": 374,
  "meta": 41,
  "recent_rct": 20,
  "cochrane": [
   {
    "pmid": "25188769",
    "title": "Amphotericin B versus fluconazole for controlling fungal infections in neutropenic cancer patients",
    "year": "2014"
   },
   {
    "pmid": "24563222",
    "title": "Voriconazole versus amphotericin B or fluconazole in cancer patients with neutropenia",
    "year": "2014"
   },
   {
    "pmid": "12076388",
    "title": "Amphotericin B versus fluconazole for controlling fungal infections in neutropenic cancer patients",
    "year": "2002"
   },
   {
    "pmid": "10908468",
    "title": "Amphotericin B vs fluconazole for controlling fungal infections in neutropenic cancer patients",
    "year": "2000"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "fluconazole",
   "Diflucan"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 3763535,
  "beneficiaries": 2157994,
  "spend": 38249186.58,
  "by_brand": [
   {
    "brand": "Fluconazole",
    "claims": 3763187,
    "per_claim": 10.074993502,
    "is_generic": true
   },
   {
    "brand": "Diflucan",
    "claims": 348,
    "per_claim": 962.93681034,
    "is_generic": false
   }
  ],
  "per_claim": 10.16310106854327
 },
 "mdl": [],
 "dsc": [
  {
   "date": "20160426",
   "title": "FDA to review study examining use of oral fluconazole (Diflucan) in pregnancy",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm497482.htm",
   "kind": "drug",
   "matched": "fluconazole"
  },
  {
   "date": "20110803",
   "title": "Diflucan - Use of long-term, high-dose Diflucan (fluconazole) during pregnancy may be associated with birth defects in infants",
   "url": "https://www.fda.gov/Drugs/DrugSafety/ucm266030.htm",
   "kind": "drug",
   "matched": "fluconazole"
  }
 ],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "fluconazole",
  "matched": "fluconazole",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 10262,
  "fills": 3763535,
  "per_million": 2726.6917937524163,
  "ratio": 0.9847386324074039,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 76,
   "letter": "B",
   "why": [
    "FDA issued 2 Drug Safety Communication(s) naming this drug since 2010, most recently 2016 (-16)",
    "2,727 FDA reports naming it as the suspect drug per million Medicare fills, 1.0x the median drug on this site",
    "Death appears in 1.8x the share of reports seen across all of FAERS (-3)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 59,
   "letter": "D",
   "why": [
    "374 randomized trials and 41 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "4 independent Cochrane review(s) exist",
    "Only 25% 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": 86,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 8 Class II, 0 Class III across 38 generic makers (-6)",
    "15 label changes approved since 2021: the safety story is still moving (-8)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $0 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 (38 applications)",
    "21 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 79,
 "grade": "B",
 "questions": [
  "In 2016 the FDA issued a safety communication about this drug (FDA to review study examining use of oral fluconazole (Diflucan) in pregnancy). Does that risk apply to me?",
  "The most-reported problems in FDA's adverse event data are pyrexia, 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 bifonazole, clotrimazole, econazole? 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.)"
 ]
}