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
FDA
EMA
Diflucan, Fluconazole (discontinued: Diflucan, Fluconazole)
Drug Products
FDA
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 | 2025-10-10 |
| direct rx | ANDA | 2015-08-03 |
| fluconazole | ANDA | 2025-11-18 |
| fluconazole 4% / ibuprofen 2% / itraconazole 1% / terbinafine hcl 4% | unapproved drug other | 2019-04-24 |
| fluconazole in sodium chloride | ANDA | 2025-06-27 |
Indications
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Agency Specific
FDA
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Patent Expiration
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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
325 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 | — | — | 6 | 2 | 5 | 13 |
| Candidemia | D058387 | EFO_1001282 | — | — | — | 5 | 1 | — | 6 |
| Invasive candidiasis | D058365 | EFO_1001283 | B37 | — | — | 3 | 1 | — | 4 |
| Sepsis | D018805 | EFO_0001420 | A41.9 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | — | — | 5 | — | 18 | 23 |
| Meningitis | D008581 | EFO_0000584 | G03 | — | — | 1 | — | 11 | 12 |
| Cryptococcal meningitis | D016919 | EFO_0007228 | B45.1 | — | — | 1 | — | 10 | 11 |
| Infections | D007239 | EFO_0000544 | — | — | — | 5 | — | 2 | 7 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | — | — | 1 | — | 6 | 7 |
| Mycoses | D009181 | — | B35-B49 | — | — | 3 | — | 3 | 6 |
| Communicable diseases | D003141 | — | — | — | — | 3 | — | 1 | 4 |
| Mycobacterium avium-intracellulare infection | D015270 | EFO_0007386 | — | — | — | 1 | — | — | 1 |
| Mycobacterium infections | D009164 | — | A31.9 | — | — | 1 | — | — | 1 |
| Vulvovaginal candidiasis | D002181 | EFO_0007543 | B37.3 | — | — | 1 | — | — | 1 |
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Indications Phases 2
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Therapeutic equivalency | D013810 | — | — | 2 | — | — | — | — | 2 |
| Neoplasms | D009369 | — | C80 | 1 | — | — | — | — | 1 |
| Overactive urinary bladder | D053201 | EFO_1000781 | N32.81 | 1 | — | — | — | — | 1 |
| Urge urinary incontinence | D053202 | EFO_0006865 | N39.41 | 1 | — | — | — | — | 1 |
| Urinary incontinence | D014549 | — | R32 | 1 | — | — | — | — | 1 |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | 1 | — | — | — | — | 1 |
| Dermatitis | D003872 | — | L30.9 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Oral candidiasis | D002180 | EFO_0007406 | B37.0 | — | — | — | — | 3 | 3 |
| Immunologic deficiency syndromes | D007153 | — | D84.9 | — | — | — | — | 3 | 3 |
| Aids-related opportunistic infections | D017088 | — | — | — | — | — | — | 1 | 1 |
| Esophagitis | D004941 | HP_0100633 | K20 | — | — | — | — | 1 | 1 |
| Coccidioidomycosis | D003047 | EFO_0007211 | B38 | — | — | — | — | 1 | 1 |
| Coccidiosis | D003048 | EFO_0007212 | — | — | — | — | — | 1 | 1 |
| Histoplasmosis | D006660 | EFO_0007310 | B39 | — | — | — | — | 1 | 1 |
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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Estimated US medical usage
Fluconazole
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Trends
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Safety
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23,226 adverse events reported
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