Fluconazole
Diflucan (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 (generic drugs available since 2004-07-29)
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 |
|---|---|---|
| diflucan | New Drug Application | 2022-06-24 |
| fluconazole | ANDA | 2023-06-14 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| aids-related opportunistic infections | — | D017088 | — |
| blastomycosis | EFO_0007174 | D001759 | B40 |
| chronic mucocutaneous candidiasis | Orphanet_1334 | D002178 | B37.2 |
| coccidioidomycosis | EFO_0007211 | D003047 | B38 |
| cryptococcal meningitis | EFO_0007228 | D016919 | B45.1 |
| fungemia | — | D016469 | B49 |
| histoplasmosis | EFO_0007310 | D006660 | B39 |
| mycoses | — | D009181 | B35-B49 |
| oral candidiasis | EFO_0007406 | D002180 | B37.0 |
| pneumonia | EFO_0003106 | D011014 | J18 |
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Agency Specific
FDA
EMA
No data
Patent Expiration
No data
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
199 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | 3 | 4 | 6 | 2 | 23 | 37 |
| Healthy volunteers/patients | — | 21 | 1 | — | 1 | 4 | 26 | ||
| Cryptococcal meningitis | D016919 | EFO_0007228 | B45.1 | 1 | 6 | 3 | 1 | 18 | 26 |
| Candidiasis | D002177 | B37 | 3 | 1 | 9 | 6 | 6 | 24 | |
| Mycoses | D009181 | B35-B49 | 2 | 3 | 10 | 1 | 4 | 20 | |
| Vulvovaginal candidiasis | D002181 | EFO_0007543 | B37.3 | 1 | 6 | 8 | 3 | — | 17 |
| Oral candidiasis | D002180 | EFO_0007406 | B37.0 | — | 1 | 2 | 2 | 2 | 7 |
| Fungemia | D016469 | B49 | — | 1 | 2 | 1 | — | 4 | |
| Coccidioidomycosis | D003047 | EFO_0007211 | B38 | — | — | 1 | 1 | 1 | 3 |
| Cryptococcosis | D003453 | EFO_0007229 | B45 | — | — | 1 | 1 | 1 | 3 |
Show 9 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Candidemia | D058387 | EFO_1001282 | — | 2 | 7 | — | — | 9 | |
| Invasive candidiasis | D058365 | EFO_1001283 | B37 | — | 2 | 6 | — | — | 8 |
| Neoplasms | D009369 | C80 | 5 | — | 1 | — | — | 6 | |
| Hiv | D006678 | O98.7 | — | 2 | 2 | — | — | 3 | |
| Myeloid leukemia acute | D015470 | C92.0 | 1 | 1 | 1 | — | 1 | 3 | |
| Lymphoma | D008223 | C85.9 | 2 | — | 1 | — | — | 3 | |
| Leukemia | D007938 | C95 | — | — | 1 | — | 1 | 2 | |
| Infections | D007239 | EFO_0000544 | — | 1 | 2 | — | — | 2 | |
| Vaginitis | D014627 | EFO_0005757 | N76 | 1 | — | 1 | — | — | 2 |
| Aspergillosis | D001228 | EFO_0007157 | B44 | — | — | 1 | — | 1 | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Crohn disease | D003424 | EFO_0000384 | K50 | — | 3 | — | — | — | 3 |
| Stomatitis | D013280 | EFO_1001904 | K12.1 | — | 2 | — | — | — | 2 |
| Meningitis | D008581 | EFO_0000584 | G03 | — | 1 | — | — | 1 | 2 |
| Vulvovaginitis | D014848 | EFO_1001240 | N76.0 | — | 2 | — | — | — | 2 |
| Sporotrichosis | D013174 | EFO_0007494 | B42 | — | 2 | — | — | — | 2 |
| Histoplasmosis | D006660 | EFO_0007310 | B39 | — | 1 | — | — | 1 | 2 |
| Nephrolithiasis | D053040 | N20.0 | — | 1 | — | — | — | 1 | |
| Hypercalciuria | D053565 | R82.994 | — | 1 | — | — | — | 1 | |
| Nephrocalcinosis | D009397 | HP_0000121 | — | 1 | — | — | — | 1 | |
| Meningoencephalitis | D008590 | EFO_0007364 | A69.22 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Graft vs host disease | D006086 | D89.81 | 1 | — | — | — | 1 | 2 | |
| Drug interactions | D004347 | 2 | — | — | — | — | 2 | ||
| Therapeutic equivalency | D013810 | 2 | — | — | — | — | 2 | ||
| Stem cell transplantation | D033581 | 1 | — | — | — | — | 1 | ||
| Overactive urinary bladder | D053201 | EFO_1000781 | N32.81 | 1 | — | — | — | — | 1 |
| Prostatic neoplasms | D011471 | C61 | 1 | — | — | — | — | 1 | |
| Endometriosis | D004715 | EFO_0001065 | N80 | 1 | — | — | — | — | 1 |
| Mantle-cell lymphoma | D020522 | C83.1 | 1 | — | — | — | — | 1 | |
| Large b-cell lymphoma diffuse | D016403 | C83.3 | 1 | — | — | — | — | 1 | |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Vascular diseases | D014652 | EFO_0004264 | I77 | — | — | — | — | 1 | 1 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | — | — | 1 | 1 |
| Cerebral hemorrhage | D002543 | — | — | — | — | 1 | 1 | ||
| Subarachnoid hemorrhage | D013345 | EFO_0000713 | I60 | — | — | — | — | 1 | 1 |
| Drug monitoring | D016903 | — | — | — | — | 1 | 1 | ||
| Myelodysplastic syndromes | D009190 | D46 | — | — | — | — | 1 | 1 | |
| Multiple myeloma | D009101 | C90.0 | — | — | — | — | 1 | 1 | |
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | — | — | — | — | 1 | 1 |
| Hematopoietic stem cell transplantation | D018380 | — | — | — | — | 1 | 1 | ||
| Bone marrow transplantation | D016026 | — | — | — | — | 1 | 1 |
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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 | 4450 |
| ChEMBL ID | CHEMBL106 |
| ChEBI ID | 46081 |
| PubChem CID | 3365 |
| DrugBank | DB00196 |
| UNII ID | 8VZV102JFY (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
No data
Variants
Clinical Variant
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Financial
Diflucan - Pfizer
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Trends
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Additional graphs summarizing 31,842 documents
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Safety
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Adverse Events
Top Adverse Reactions
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21 adverse events reported
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