Prescription medicine
Flucytosine Brand names: Ancobon
Flucytosine (Ancobon) is a prescription medicine with an FDA approval on record since 1971. FDA's NDC Directory lists it from 9 generic labelers.
- Generic listed
- Boxed warning
Check it at the source: the flucytosine FDA label on DailyMed (effective February 2, 2022, Bausch Health US LLC); the NDA 17001 record on Drugs@FDA; every flucytosine label on DailyMed.
Highlights of the record
FDA label of February 2, 2022; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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 and usageANCOBON is indicated only in the treatment of serious infections caused by susceptible strains of Candida and/or Cryptococcus.
Forms and strengths
- 250 mg
- 500 mg
Capsule.
On the market
- Earliest approval on file
- November 26, 1971 Ancobon, Bausch; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 7 first June 28, 2011; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 10 of which 9 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,369 through July 30, 2026
What is flucytosine used for?
From the label: indications and usageANCOBON 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. Studies in septicemias and urinary tract infections are limited, but good responses have been reported. ANCOBON should be used in combination with amphotericin B for the treatment of systemic candidiasis and cryptococcosis because of the emergence of resistance to ANCOBON (see MICROBIOLOGY ).
Conditions named in the indications of flucytosine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Nucleoside Analog Antifungal.
Source: FDA drug label (ANCOBON), Bausch Health US LLC, effective February 2, 2022 (SPL set aea0df00-a88c-4a16-abcf-750f3ff2004e), via openFDA; the full label on DailyMed
Is there a generic for flucytosine (Ancobon)?
The FDA approved the first generic flucytosine on June 28, 2011. 7 generic applications are approved; 5 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists flucytosine from 9 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1971 earliest approval on file
- 2011 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the flucytosine label say about other medicines?
The flucytosine label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 3 other medicines name flucytosine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Fluorouracil | warnings | Fluorouracil is a metabolite of flucytosine. |
Other labels that name flucytosine
Source: FDA drug label (ANCOBON), Bausch Health US LLC, effective February 2, 2022 (SPL set aea0df00-a88c-4a16-abcf-750f3ff2004e), via openFDA; the full label on DailyMed
What do FAERS reports show for flucytosine?
The FDA Adverse Event Reporting System holds 1,369 reports that list flucytosine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 486 are coded as a death and 628 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as flucytosine?
8 other medicines are given the same way (oral) and in the same FDA class as flucytosine or labeled mainly for the same use (fungal infections), the same class first. Fungal infections lists all 33 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Fluconazole | Fungal infections | 38 labelers | $0.380 per tablet 200 mg tablet | No current entry |
| Voriconazole | Fungal infections | 21 labelers | $1.88 per tablet 200 mg tablet | A presentation being discontinued |
| Terbinafine | Fungal infections | 22 labelers | $0.143 per tablet 250 mg tablet | No current entry |
| Nystatin | Fungal infections | 21 labelers | $0.0569 per mL 100,000 unit/mL suspension | No current entry |
| Posaconazole | Fungal infections | 21 labelers | $2.03 per tablet 100 mg tablet | A presentation being discontinued |
| Griseofulvin | Fungal infections | 10 labelers | $3.74 per tablet 250 mg tablet | No current entry |
| Itraconazole | Fungal infections | 11 labelers | $0.910 per capsule 100 mg capsule | A presentation being discontinued |
| Clotrimazole | Fungal infections | 3 labelers | $0.292 per troche 10 mg troche | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does flucytosine compare with medicines for the same use?
1 side-by-side page set flucytosine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Flucytosine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other