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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Results first post date
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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)
Fluconazole
Tradename
Company
Number
Date
Products
DIFLUCANPfizerN-019949 RX1990-01-29
4 products, RLD, RS
DIFLUCANPfizerN-020090 RX1993-12-23
2 products, RLD, RS
Show 6 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
ciclopirox 8% / fluconazole 1% / terbinafine hcl 1%unapproved drug other2019-04-24
diflucanNew Drug Application2025-03-25
direct rxANDA2015-08-03
fluconazoleANDA2025-03-12
fluconazole 4% / ibuprofen 2% / itraconazole 1% / terbinafine hcl 4%unapproved drug other2019-04-24
fluconazole in sodium chlorideANDA2024-06-03
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
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
BurnsD002056—T30.0———1—1
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFluconazole
INNfluconazole
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.
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Classification
Small molecule
Drug classsystemic antifungals (miconazole type)
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Structure (InChI/SMILES or Protein Sequence)
OC(Cn1cncn1)(Cn1cncn1)c1ccc(F)cc1F
Identifiers
PDB—
CAS-ID86386-73-4
RxCUI—
ChEMBL IDCHEMBL106
ChEBI ID46081
PubChem CID3365
DrugBankDB00196
UNII ID8VZV102JFY (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Diflucan – Pfizer
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Estimated US medical usage
Fluconazole
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 38,978 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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22,153 adverse events reported
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