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Two medicines, side by side

Flucytosine vs fluconazole

Flucytosine and fluconazole are both labeled for fungal infections. Drugs@FDA records approvals of flucytosine since 1971 and of fluconazole since 1990. In FDA's classes, flucytosine is a nucleoside analog antifungal and fluconazole an azole antifungal.

Check it at the source: the flucytosine FDA label on DailyMed (effective February 2, 2022); the fluconazole FDA label on DailyMed (effective April 7, 2026).

Highlights of the flucytosine record

Flucytosine (Ancobon) · label of February 2, 2022

Boxed warning

Use with extreme caution in patients with impaired renal function. Close monitoring of hematologic, renal and hepatic status of all patients is essential. These instructions should be thoroughly reviewed before administration of ANCOBON.

Used for

From the label: indications

ANCOBON is indicated only in the treatment of serious infections caused by susceptible strains of Candida and/or Cryptococcus. Candida: Septicemia, endocarditis and urinary system infections have been effectively treated with flucytosine. Limited trials in pulmonary infections justify the use of flucytosine. Cryptococcus: Meningitis and pulmonary infections have been treated effectively. […]

On the market

Earliest approval on file
November 26, 1971
Generic labelers
9 labelers
Pharmacy cost
Not in the survey

Supply and safety

Shortage
No current entry
Recalls
0

Highlights of the fluconazole record

Fluconazole (Diflucan) · label of April 7, 2026

Used for

From the label: indications

Fluconazole tablets are indicated for the treatment of: Vaginal candidiasis (vaginal yeast infections due to Candida ). Oropharyngeal and esophageal candidiasis. […]

On the market

Earliest approval on file
January 29, 1990
Generic labelers
41 labelers
Pharmacy cost
$0.380 per tablet

Supply and safety

Shortage
No current entry
Recalls
18

Source: FDA drug labels via openFDA (Flucytosine label of February 2, 2022, Fluconazole label of April 7, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)

How do flucytosine and fluconazole differ on the record?

In FDA's classes, flucytosine is a nucleoside analog antifungal and fluconazole an azole antifungal.

Half-life, in each label's words: Flucytosine, “The half-life in the majority of healthy subjects ranged between 2.4 and 4.8 hours.”; Fluconazole, “Peak plasma concentrations (C max ) in fasted normal volunteers occur between 1 and 2 hours with a terminal plasma …”

Only the flucytosine label carries a boxed warning.

Generics: flucytosine since 2011; fluconazole since 2004 (Drugs@FDA).

FlucytosineFluconazole
Labeled forFungal infectionsFungal infections, Urinary tract infections
Pharmacologic classNucleoside Analog AntifungalAzole Antifungal
How it works (label)n/an/a
Half-life (label)The half-life in the majority of healthy subjects ranged between 2.4 and 4.8 hours.Peak plasma concentrations (C max ) in fasted normal volunteers occur between 1 and 2 hours with a terminal plasma elimination half-life of approximately 30 hours (range: 20 to 50 hours) after oral administration.
Earliest approval on file (Drugs@FDA)November 26, 1971January 29, 1990
First generic approvedJune 28, 2011July 29, 2004
Generic labelers (NDC)9 labelers41 labelers
Pharmacy cost (NADAC, each one's most listed form; strengths differ)n/a$0.380 per tablet (Fluconazole 200 mg tablet)
12-month price changen/a-10%
Boxed warningYesNo
Shortage nowNo current entryNo current entry
Recalls recorded018
FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used)1,36969,671
DEA schedulenonenone

Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)

What next?

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