Fluconazole
Diflucan, Fluconazole (fluconazole) is a small molecule pharmaceutical. Fluconazole was first approved as Diflucan on 1990-01-29. It is used to treat aids-related opportunistic infections, blastomycosis, chronic mucocutaneous candidiasis, coccidioidomycosis, and cryptococcal meningitis amongst others in the USA.
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Commercial
Trade Name
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Diflucan, Fluconazole (discontinued: Diflucan, Fluconazole)
Drug Products
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EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ciclopirox 8% / fluconazole 1% / terbinafine hcl 1% | unapproved drug other | 2019-04-24 |
| diflucan | New Drug Application | 2024-08-28 |
| direct rx | ANDA | 2015-08-03 |
| fluconazole | ANDA | 2024-10-28 |
| fluconazole 4% / ibuprofen 2% / itraconazole 1% / terbinafine hcl 4% | unapproved drug other | 2019-04-24 |
| fluconazole in sodium chloride | ANDA | 2024-06-03 |
Indications
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Agency Specific
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ATC Codes
D: Dermatologicals
— D01: Antifungals for dermatological use
— D01A: Antifungals for topical use
— D01AC: Imidazole and triazole derivatives, topical antifungals
— D01AC15: Fluconazole
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01R: Combinations of antibacterials
— J01RA: Combinations of antibacterials
— J01RA07: Azithromycin, fluconazole and secnidazole
— J02: Antimycotics for systemic use
— J02A: Antimycotics for systemic use
— J02AC: Triazole and tetrazole derivatives
— J02AC01: Fluconazole
HCPCS
Code | Description |
|---|---|
| J1450 | Injection fluconazole, 200 mg |
Clinical
Clinical Trials
317 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Candidiasis | D002177 | — | B37 | 5 | 17 | 30 | 12 | 16 | 78 |
| Mycoses | D009181 | — | B35-B49 | 4 | 9 | 14 | 6 | 14 | 47 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 4 | 6 | 8 | 3 | 27 | 47 |
| Infections | D007239 | EFO_0000544 | — | 1 | 7 | 14 | 3 | 12 | 36 |
| Meningitis | D008581 | HP_0001287 | G03 | 3 | 9 | 6 | 1 | 20 | 35 |
| Cryptococcal meningitis | D016919 | EFO_0007228 | B45.1 | 3 | 9 | 6 | 1 | 19 | 34 |
| Healthy volunteers/patients | — | — | — | 24 | 1 | 1 | 1 | 4 | 30 |
| Vulvovaginal candidiasis | D002181 | EFO_0007543 | B37.3 | 2 | 10 | 9 | 3 | 3 | 26 |
| Communicable diseases | D003141 | — | — | 1 | 3 | 9 | 2 | 6 | 21 |
| Invasive fungal infections | D000072742 | — | — | — | 2 | 5 | 4 | 5 | 16 |
Show 34 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 8 | 3 | 2 | — | — | 12 |
| Leukemia | D007938 | — | C95 | 5 | 6 | 2 | — | 2 | 11 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 6 | 5 | 1 | — | 1 | 8 |
| Myeloid leukemia | D007951 | — | C92 | 4 | 3 | 1 | — | 1 | 6 |
| Aspergillosis | D001228 | EFO_0007157 | B44 | 2 | 1 | 1 | — | 2 | 6 |
| Stomatitis | D013280 | EFO_1001904 | K12.1 | 1 | 4 | 1 | — | — | 6 |
| Mucositis | D052016 | EFO_1001898 | — | 1 | 4 | 1 | — | 1 | 6 |
| Hiv | D006678 | — | — | 1 | 3 | 3 | — | — | 5 |
| Vaginitis | D014627 | EFO_0005757 | N76 | 2 | 1 | 1 | — | 1 | 5 |
| Lymphoma | D008223 | — | C85.9 | 3 | — | 1 | — | — | 4 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Graft vs host disease | D006086 | — | D89.81 | 2 | 1 | — | — | 1 | 4 |
| Vulvovaginitis | D014848 | EFO_1001240 | N76.0 | — | 4 | — | — | — | 4 |
| Myelodysplastic syndromes | D009190 | — | D46 | — | 1 | — | — | 2 | 3 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 1 | 1 | — | — | 1 | 2 |
| Hematopoietic stem cell transplantation | D018380 | — | — | — | 1 | — | — | 1 | 2 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 1 | 1 | — | — | 1 | 2 |
| Preleukemia | D011289 | — | — | — | 1 | — | — | 1 | 2 |
| Syndrome | D013577 | — | — | — | 1 | — | — | 1 | 2 |
| Sporotrichosis | D013174 | EFO_0007494 | B42 | — | 2 | — | — | — | 2 |
| Histoplasmosis | D006660 | EFO_0007310 | B39 | — | 1 | — | — | 1 | 2 |
Show 17 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | 1 | — | — | — | 2 | 3 |
| Drug interactions | D004347 | — | — | 3 | — | — | — | — | 3 |
| B-cell lymphoma | D016393 | — | — | 3 | — | — | — | — | 3 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | — | — | — | 2 | 3 |
| Therapeutic equivalency | D013810 | — | — | 3 | — | — | — | — | 3 |
| Multiple myeloma | D009101 | — | C90.0 | 1 | — | — | — | 1 | 2 |
| Endometriosis | D004715 | EFO_0001065 | N80 | 2 | — | — | — | — | 2 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 2 | — | — | — | — | 2 |
| Glioblastoma | D005909 | EFO_0000515 | — | 2 | — | — | — | — | 2 |
| Invasive pulmonary aspergillosis | D055744 | — | B44.0 | 2 | — | — | — | — | 2 |
Show 21 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | — | — | — | — | 2 | 2 |
| Hyperemia | D006940 | EFO_0003822 | — | — | — | — | — | 2 | 2 |
| Heart failure | D006333 | HP_0001635 | I50 | — | — | — | — | 1 | 1 |
| Long qt syndrome | D008133 | HP_0001657 | I45.81 | — | — | — | — | 1 | 1 |
| Delirium | D003693 | — | R41.0 | — | — | — | — | 1 | 1 |
| Torsades de pointes | D016171 | EFO_0005307 | I47.21 | — | — | — | — | 1 | 1 |
| Choroid diseases | D015862 | HP_0000610 | H31.9 | — | — | — | — | 1 | 1 |
| White dot syndromes | D000080363 | — | H30.14 | — | — | — | — | 1 | 1 |
| Multifocal choroiditis | D000080364 | — | — | — | — | — | — | 1 | 1 |
| Choroiditis | D002833 | — | H30.9 | — | — | — | — | 1 | 1 |
Show 38 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Fluconazole |
| INN | fluconazole |
| Description | Fluconazole is a member of the class of triazoles that is propan-2-ol substituted at position 1 and 3 by 1H-1,2,4-triazol-1-yl groups and at position 2 by a 2,4-difluorophenyl group. It is an antifungal drug used for the treatment of mucosal candidiasis and for systemic infections including systemic candidiasis, coccidioidomycosis, and cryptococcosis. It has a role as a P450 inhibitor, an environmental contaminant and a xenobiotic. It is a difluorobenzene, a conazole antifungal drug, a triazole antifungal drug and a tertiary alcohol. It is functionally related to a 1,3-difluorobenzene. It derives from a hydride of a 1H-1,2,4-triazole. |
| Classification | Small molecule |
| Drug class | systemic antifungals (miconazole type) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | OC(Cn1cncn1)(Cn1cncn1)c1ccc(F)cc1F |
Identifiers
| PDB | — |
| CAS-ID | 86386-73-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL106 |
| ChEBI ID | 46081 |
| PubChem CID | 3365 |
| DrugBank | DB00196 |
| UNII ID | 8VZV102JFY (ChemIDplus, GSRS) |
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Diflucan – Pfizer
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Fluconazole
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Safety
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20,336 adverse events reported
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