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Flucytosine

Flucytosine is an antifungal medicine used to treat serious infections caused by Candida and Cryptococcus fungi, including infections of the blood, heart, urinary tract, lungs, and brain.

Brand name Ancobon
Drug class Nucleoside Analog Antifungal
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 12, 2026 Content updated Oct 1, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 10 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

How we combine label and product data →
✓No current FDA shortage listed · checked Oct 2, 2026
Flucytosine at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written
Flucytosine is a powerful antifungal reserved for serious infections like cryptococcal meningitis and systemic candidiasis, and it is almost always used alongside amphotericin B to prevent resistance. Because it is cleared by the kidneys and can harm the bone marrow and liver, close monitoring with regular blood tests is not optional — it is a required part of treatment. Take it exactly as prescribed and keep all your lab appointments.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Flucytosine must be used with extreme caution in anyone with impaired kidney function. Because the drug is eliminated almost entirely by the kidneys, even mild kidney problems can cause dangerously high drug levels to build up in the body. Throughout treatment, your doctor must closely monitor your blood counts, kidney function, and liver function with regular lab tests. Make sure your care team is aware of any kidney issues before you start this medication.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asCapsule
On the market since1971
Companies that make it19
FDA label last updatedFeb 2, 2022
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide — a plain-language walkthrough of Flucytosine, written from its FDA label.

What Flucytosine is used for

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Flucytosine capsules are indicated only for serious fungal infections caused by susceptible strains of Candida or Cryptococcus. Supported uses include:

  • Candida septicemia (bloodstream infection) — supported by both Ancobon and generic Flucytosine capsules
  • Candida endocarditis (heart valve infection) — supported by both Ancobon and generic Flucytosine capsules
  • Candida urinary tract infections — supported by both Ancobon and generic Flucytosine capsules
  • Candida pulmonary (lung) infections — limited trial data support use with both Ancobon and generic Flucytosine capsules
  • Cryptococcal meningitis (brain and spinal cord lining infection) — supported by both Ancobon and generic Flucytosine capsules
  • Cryptococcal pulmonary infections — supported by both Ancobon and generic Flucytosine capsules
  • Cryptococcal septicemia and urinary tract infections — limited data, but good responses have been reported with both Ancobon and generic Flucytosine capsules
  • Both Ancobon and generic Flucytosine capsules are used in combination with amphotericin B for systemic candidiasis and cryptococcosis to reduce the risk of resistance

How Flucytosine works

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Flucytosine gets into fungal cells using a transport protein called cytosine permease. Once inside, the fungal cell converts it into fluorouracil (a compound that damages the fungus's ability to function). That compound is then turned into active metabolites that either get falsely built into the fungus's RNA — disrupting protein production — or block an enzyme called thymidylate synthetase, which the fungus needs to replicate its DNA. The end result: the fungus can't grow or reproduce.

Resistance can develop when fungi lose the enzymes needed to take up or convert flucytosine, or when they overproduce competing compounds. This is why flucytosine is almost always paired with amphotericin B — together, they are harder for the fungus to resist.

Flucytosine dosage

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Flucytosine capsules are taken by mouth, divided into doses given every 6 hours throughout the day. To ease stomach upset, it helps to take the capsules a few at a time spread over about 15 minutes rather than all at once. Your exact dose will be determined by your prescriber based on your weight and kidney function — never adjust it on your own.

  • Both Ancobon and generic Flucytosine capsules follow the same every-6-hours schedule
  • If you have any sign of reduced kidney function, your starting dose will be lower and will be monitored closely
  • Always used in combination with amphotericin B for systemic candidiasis or cryptococcosis

Dosing details from the FDA-approved label

From the Flucytosine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Usual dosage (systemic candidiasis and cryptococcosis, used in combination with amphotericin B)
    • 50 to 150 mg/kg/day administered in divided doses at 6-hour intervals
    • If BUN or serum creatinine is elevated, or other signs of renal impairment, the initial dose should be at the lower level; nausea or vomiting may be reduced or avoided if capsules are given a few at a time over a 15-minute period
Read the label’s full dosing text

DOSAGE AND ADMINISTRATION The usual dosage of Flucytosine Capsules, USP is 50 to 150 mg/kg/day administered in divided doses at 6-hour intervals. Nausea or vomiting may be reduced or avoided if the capsules are given a few at a time over a 15-minute period. If the BUN or the serum creatinine is elevated, or if there are other signs of renal impairment, the initial dose should be at the lower level (see WARNINGS ). Flucytosine Capsules, USP should be used in combination with amphotericin B for the treatment of systemic candidiasis and cryptococcosis because of the emergence of resistance to Flucytosine Capsules, USP (see MICROBIOLOGY ).

Read the full Dosage and Administration section on DailyMed →

Flucytosine side effects

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Common side effects

  • Nausea, vomiting, or abdominal pain
  • Diarrhea or loss of appetite
  • Rash or itching
  • Headache or dizziness (vertigo)
  • Fatigue or weakness
  • Confusion or sedation
  • Elevated liver enzymes (found on blood tests)

When to get medical help

  • Call your doctor right away if you notice unusual bruising, bleeding, or signs of low blood counts (such as fever, chills, or sores in your mouth)
  • Seek help immediately for signs of serious liver problems: yellowing of the skin or eyes (jaundice), dark urine, or severe abdominal pain
  • Tell your doctor if you develop kidney problems: decreased urination, swelling, or a sharp rise in creatinine on lab tests
  • Get emergency help for severe neurological symptoms: seizures, unsteady walking (ataxia), or severe confusion or hallucinations
  • Report severe skin reactions — widespread rash or skin peeling — immediately
  • Cardiac arrest and respiratory arrest have been reported; seek emergency care for chest pain, shortness of breath, or collapse

Flucytosine can cause a range of side effects affecting several organ systems. Common ones include:

  • Nausea, vomiting, diarrhea, or abdominal pain
  • Loss of appetite or dry mouth
  • Rash, itching, or skin sensitivity to sunlight
  • Headache, dizziness, or sedation
  • Confusion or hallucinations
  • Fatigue or weakness
  • Elevated liver enzymes or bilirubin on lab tests

More serious reactions include bone marrow suppression (low blood counts), liver damage, kidney failure, seizures, and in rare cases cardiac or respiratory arrest — contact your doctor immediately if you notice any of these.

Flucytosine warnings and precautions

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  • Kidney impairment: Flucytosine is cleared almost entirely by the kidneys. Reduced kidney function causes dangerous drug buildup — close monitoring and dose adjustment are mandatory.
  • Bone marrow suppression: Flucytosine can severely reduce blood cell production. This can be irreversible and potentially fatal, especially in people who are immunosuppressed or already have bone marrow problems.
  • Liver toxicity: Serious liver injury, including liver cell death, has been reported — particularly in debilitated patients. Regular liver function tests are required.
  • DPD enzyme deficiency: People with complete dihydropyrimidine dehydrogenase (DPD) deficiency cannot safely break down a key metabolite of flucytosine and face a much higher risk of severe toxicity including mucositis, severe diarrhea, dangerously low white blood cell counts, and nerve damage. Flucytosine is contraindicated in complete DPD deficiency.
  • Radiation or immunosuppressive therapy: People receiving treatments that already suppress bone marrow face even greater risk and require especially careful monitoring.

Flucytosine interactions

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Flucytosine has a small but important list of known interactions to be aware of:

  • Cytosine arabinoside (cytarabine): This chemotherapy drug can competitively block flucytosine's antifungal activity, potentially making treatment ineffective — tell your oncology and infectious disease teams if you are on both.
  • Drugs that reduce kidney filtration: Any medication that impairs how well the kidneys filter blood (glomerular filtration) can cause flucytosine to stay in the body longer and reach toxic levels, since the drug is eliminated almost entirely unchanged by the kidneys.

Interactions listed in the FDA-approved label

From the Flucytosine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Cytosine arabinoside: Has been reported to inactivate the antifungal activity of flucytosine by competitive inhibition.
  • Drugs which impair glomerular filtration: May prolong the biological half-life of flucytosine.
Read the label’s full interactions text

Drug Interactions Cytosine arabinoside, a cytostatic agent, has been reported to inactivate the antifungal activity of Flucytosine Capsules USP by competitive inhibition. Drugs which impair glomerular filtration may prolong the biological half-life of flucytosine.

Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Flucytosine

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  • Do not take flucytosine if you have a known allergy or hypersensitivity to it
  • Do not take flucytosine if you have complete DPD (dihydropyrimidine dehydrogenase) enzyme deficiency — this is a contraindication due to serious toxicity risk
  • Tell your doctor if you have kidney disease or any reduced kidney function — dose adjustment and monitoring are required
  • Tell your doctor if you have any blood disorder or bone marrow condition
  • Tell your doctor if you are currently receiving or have received radiation therapy or bone marrow-suppressing drugs
  • Tell your doctor about all medications you take, especially cancer treatments like cytarabine
  • Tell your prescriber if you are pregnant, planning to become pregnant, or breastfeeding
  • Special monitoring is needed in neonates and infants, who clear the drug more slowly than adults and can show significant variation in blood levels

Flucytosine overdose

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Taking too much flucytosine can cause intensified versions of its known side effects — particularly severe diarrhea, nausea, and vomiting; dangerous drops in white blood cells and platelets; and liver inflammation. Blood levels above 100 mcg/mL are associated with a higher risk of these serious effects.

If overdose is suspected, the label recommends prompt steps to empty the stomach and maintaining good fluid intake. Blood counts, liver function, and kidney function must be monitored closely. Because hemodialysis (a kidney-filtering treatment) can rapidly lower flucytosine levels in the blood, it may be used in severe cases.

What Flucytosine does in the body

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Flucytosine works selectively against fungal organisms by being converted inside fungal cells into compounds that disrupt two essential processes: building proteins (via false incorporation into RNA) and copying DNA (via inhibition of thymidylate synthetase). Resistance can arise when fungi develop mutations that prevent uptake or conversion of the drug, or when they overproduce competing pyrimidine compounds — which is why combination therapy with amphotericin B is standard practice.

How your body processes Flucytosine

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Flucytosine is well absorbed after oral dosing, with 78–89% of the dose reaching the bloodstream. It is not significantly broken down by the body and passes into the cerebrospinal fluid (the fluid around the brain and spinal cord) at levels high enough to treat meningitis. More than 90% of the drug is excreted unchanged in the urine through kidney filtration.

In people with normal kidney function, the drug clears the body in roughly 2.4 to 4.8 hours (half-life). In people with severe kidney impairment or no kidney function, the half-life can stretch to an average of 85 hours — making drug monitoring and dose adjustment critical in this group. In neonates, the half-life is roughly double that seen in adults, and blood levels can vary widely between infants.

How to store Flucytosine

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Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59°F - 86°F).

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

Flucytosine: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Flucytosine — the kind of thing our pharmacy team would talk through with you at the counter.

Why do I have to take flucytosine with another antifungal? Can't it work on its own?

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That's a great question. Flucytosine can work alone against some fungi, but the problem is that the fungus can develop resistance to it pretty quickly when it's used by itself. Pairing it with amphotericin B makes it much harder for the fungus to escape treatment, and the two drugs actually work better together than either one does alone. Your doctor has prescribed them together for a good reason — stick with both.

The capsules are making me feel sick to my stomach. Is there anything I can do?

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Yes — and this is one of the most practical tips for taking this medication. Instead of swallowing all your capsules at once, try taking a few at a time over about 15 minutes. Spreading them out that way tends to significantly reduce nausea and vomiting. If stomach upset is still a problem, let your care team know — don't just stop taking the drug on your own, because that can allow the infection to come back or become resistant.

Why does my doctor keep ordering blood tests? I feel fine.

▾
Feeling fine is a good sign, but with flucytosine, serious problems — like drops in your blood cell counts or changes in your liver and kidney function — can show up on lab tests before you feel any symptoms. The drug is cleared entirely by your kidneys, so if your kidneys slow down even a little, the drug can build up to dangerous levels in your blood. Those regular blood tests are how your team catches problems early, while they're still easy to manage. Please don't skip them.

What warning signs should I actually call my doctor about right away?

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Watch for unusual bruising or bleeding, mouth sores, fever or chills — these can be signs that your blood counts are dropping. Also call right away if your skin or the whites of your eyes turn yellow, or if you have severe abdominal pain (signs of liver problems). Seizures, severe confusion, or difficulty breathing are emergencies — get help immediately. And if you notice very little urination or swelling, that could point to kidney trouble. Don't wait on any of these.

I have kidney disease. Is it safe for me to take this medication?

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You can take it, but your care team will need to be especially careful. Because flucytosine is eliminated almost entirely by the kidneys, any kidney impairment means the drug can accumulate and reach toxic levels faster. Your dose will likely need to be lower than usual, and your blood levels, kidney function, and blood counts will be monitored very closely throughout treatment. Make sure your prescriber knows the full picture of your kidney health before you start.

How long will I need to take flucytosine?

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The length of treatment depends on the type and severity of your fungal infection — cryptococcal meningitis, for example, typically requires weeks of treatment. Your prescriber will determine the right duration based on how you're responding and what your lab results show. It's important to finish the full course even if you start feeling better, because stopping early can allow the infection to return or become resistant.

Is Flucytosine available over the counter?

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Flucytosine is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.

When was Flucytosine first available?

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Flucytosine has been available in the United States since at least 1971, based on FDA approval history (Drugs@FDA) and product marketing records.

Who makes Flucytosine?

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Flucytosine is supplied by 19 manufacturers listed in the FDA NDC Directory, including Bryant Ranch Prepack, AvPAK, Lupin Pharmaceuticals,Inc..

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Flucytosine on HelloPharmacist

Detailed data & references for Flucytosine Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Flucytosine forms and strengths (how it comes)

Flucytosine is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Capsule

By mouth
Brands Ancobon
How this form is used
What it may be used for
  • Ancobon is used to treat serious Candida infections including bloodstream infections, endocarditis, and urinary tract infections
  • Ancobon is used to treat Cryptococcus infections including meningitis and pulmonary infections
  • Flucytosine capsules are used to treat serious Candida infections including bloodstream infections, endocarditis, and urinary tract infections
  • Flucytosine capsules are used to treat Cryptococcus infections including meningitis and pulmonary infections
Important instructions
  • Ancobon capsules are taken by mouth in divided doses every 6 hours; take a few capsules at a time over 15 minutes to reduce nausea
  • Ancobon should be used in combination with amphotericin B for systemic candidiasis and cryptococcosis to prevent resistance
  • Flucytosine capsules are taken by mouth in divided doses every 6 hours; spreading each dose over 15 minutes can help reduce stomach upset
  • Flucytosine capsules should be used in combination with amphotericin B for systemic candidiasis and cryptococcosis to prevent resistance
Available strengths 2 strengths
58 FDA-listed product records ⓘ

Flucytosine on the U.S. market: products, makers and brands

How Flucytosine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

19 companies list 63 Flucytosine product records with the FDA, mostly as capsule; the earliest marketing or approval year on record is 1971. Brand names on the directory include Ancobon; the rest are generics.

1
Dose forms ⓘ
19
Manufacturers
2
Brand names
63
FDA-listed product records ⓘ
1971
First marketed ⓘ

Also listed with the FDA, not a patient dose form: Powder (5) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack17%
AvPAK10%
Lupin Pharmaceuticals,Inc.10%
American Health Packaging8%
Aurobindo Pharma Limited6%
Sigmapharm Laboratories, LLC6%
Other makers43%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Flucytosine is used (Medicaid data)

A general measure of how commonly Flucytosine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Flucytosine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

355
Medicaid prescriptions filled (Q1–Q4 2025)
$403,890 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Flucytosine prescribed? Of the 1,600 medications we measure, Flucytosine ranks #1,399 by Medicaid prescriptions — more than 13% of them.

Where Flucytosine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Flucytosine product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

flucytosine 500 MG Oral Capsule

355 Medicaid prescriptions (Q1–Q4 2025) 100% of Flucytosine prescriptions shown $403,890 gross reimbursement (before rebates) ≈ $1,138 per prescription (gross)

Summed across the 2 of 28 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 197703

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Flucytosine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 28 listed Flucytosine NDCs with Medicaid activity.

Compare Flucytosine products

A representative set of FDA-listed product records for Flucytosine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 63 of 63 products — FDA National Drug Code Directory. See every product, package size and price: browse all 63 Flucytosine NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Flucytosine RxCUI 4451 3 dose forms · 4 strengths
  1. Dose form (SCDF) Injectable Solution RxCUI 375072 No current FDA listing
    Clinical drug / strength (SCD) 10 MG/ML RxCUI 105320
  2. Dose form (SCDF) Oral Capsule RxCUI 372211 In current FDA listings
    Clinical drug / strength (SCD) 250 MG RxCUI 197702 500 MG RxCUI 197703
  3. Dose form (SCDF) Oral Tablet RxCUI 372212 No current FDA listing
    Clinical drug / strength (SCD) 500 MG RxCUI 199748

Look up RxCUI 4451 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Flucytosine brand names

Flucytosine is sold under one brand name in the FDA directory — Ancobon. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Ancobon

Who makes Flucytosine: manufacturers and labelers

19 companies list Flucytosine products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, AvPAK, Lupin Pharmaceuticals,Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Bryant Ranch Prepack 11 AvPAK 6 Lupin Pharmaceuticals,Inc. 6 American Health Packaging 5 Aurobindo Pharma Limited 4 Sigmapharm Laboratories, LLC 4 Novel Laboratories, Inc. 4 Major Pharmaceuticals 4 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 4 Hikma Pharmaceuticals USA Inc. 2 West-Ward Pharmaceuticals Corp 2 Laurus Labs Limited 2 Cameron Pharmaceuticals, LLC 2 Bausch Health US LLC 2 Maithri Laboratories Private Limited 1 Nantong Jinghua Pharmaceutical Co., Ltd. 1 Calyx Chemicals & Pharmaceuticals Limited 1 Professional Compounding Centers of America dba PCCA 1 Apicore Pharmaceuticals Private Limited 1

Flucytosine drug class (RxNorm)

Flucytosine belongs to the Nucleoside Analog Antifungal class.

Pharmacologic class Nucleoside Analog Antifungal
Drug family (ATC) Other antifungals for topical use, Other antimycotics for systemic use

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Flucytosine page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Feb 2, 2022
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Flucytosine.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Flucytosine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
10
NDC products indexed
63
Distinct labelers/manufacturers represented
19
Linked representative label ⓘ
Bausch Health US LLC
Linked label effective
Feb 2, 2022
Composite sections available
16
Linked SPL Set ID
aea0df00-a88c-4a16-abcf-750f3ff2004e
Linked SPL Document ID
2611b6d9-1f11-4c1d-a2b6-ae818d39d299
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Bausch Health US LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →