Fludarabine Injection
Fludarabine Injection is a chemotherapy medicine used intravenously to treat B-cell chronic lymphocytic leukemia (CLL) in adults whose disease has not responded to standard prior treatment.
🧬 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 6 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 →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
This medication carries a boxed warning — the FDA's most serious safety alert — covering three major risks:
Nervous system toxicity: High doses of fludarabine have caused blindness, coma, and death. Even at the standard recommended dose, serious neurological effects such as seizures, confusion, and coma have been reported. Report any new neurological symptoms to your doctor immediately.
Autoimmune hemolytic anemia (the immune system destroying red blood cells): Life-threatening and sometimes fatal cases have occurred after one or more treatment cycles. This can happen even in patients with no prior history of this problem.
Fatal lung toxicity when combined with pentostatin: Using fludarabine together with the drug pentostatin caused an unacceptably high rate of fatal lung toxicity in clinical studies. These two drugs must not be used together.
📖 Fludarabine Injection: Patient Information Guide
A plain-language walkthrough of Fludarabine Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Fludarabine Injection is a chemotherapy medicine approved for intravenous use in adults with a specific type of blood cancer.
- B-cell chronic lymphocytic leukemia (CLL) — refractory disease: Fludarabine Injection is indicated for adult patients with B-cell CLL whose disease has not responded to, or has gotten worse during, at least one standard chemotherapy regimen containing an alkylating agent.
- Fludarabine Injection is not established as effective in CLL patients who are newly diagnosed (treatment-naïve) or whose disease is still responding to current therapy.
⚙️How it works▾
Fludarabine is classified as a nucleotide metabolic inhibitor — a type of chemotherapy that disrupts how cancer cells make DNA. After it is infused into the bloodstream, it is rapidly converted into its active form. That active form enters cancer cells and blocks key enzymes — including DNA polymerase, ribonucleotide reductase, and DNA primase — that the cells need to copy their genetic material. Without the ability to replicate their DNA, cancer cells cannot divide and multiply.
The full mechanism may involve more than one pathway, and researchers note it is not yet completely understood. The drug's effects on normal bone marrow cells are also significant, which is why it can cause serious reductions in blood cell counts.
💊How it's taken▾
Fludarabine Injection is given intravenously (by IV) in a clinical or hospital setting — always administered by a healthcare professional, never at home. It is infused over about 30 minutes, once daily for five consecutive days. This five-day course is then repeated every 28 days.
- Patients with moderate kidney impairment require a dose reduction; those with severe kidney impairment should not receive this drug.
- Older patients, those with bone marrow impairment, or those with reduced kidney function are monitored more closely for toxicity.
- The number of treatment cycles is individualized — your doctor will continue treatment to maximal response, then typically recommend three additional cycles before stopping.
🤒Side effects — in detail▾
Fludarabine Injection commonly affects the blood and can cause a wide range of side effects. The most frequently reported include:
- Low white blood cell count (neutropenia), increasing infection risk
- Low platelet count (thrombocytopenia), increasing bleeding risk
- Anemia (low red blood cell count), causing fatigue and weakness
- Fever and chills
- Nausea, vomiting, and loss of appetite
- Diarrhea
- Cough and pneumonia
- Skin rash
- Fatigue, weakness, and malaise
- Swelling (edema)
Serious reactions requiring prompt medical attention include severe nervous system effects (confusion, seizures, vision changes, coma), life-threatening autoimmune destruction of red blood cells, tumor lysis syndrome, and severe lung toxicity. Report any new or worsening symptoms to your care team right away.
⚠️Warnings & precautions▾
- Bone marrow suppression: Fludarabine can severely reduce blood cell production, leading to life-threatening infections, bleeding, and anemia. Blood counts must be monitored throughout treatment.
- Nervous system toxicity: Confusion, agitation, seizures, vision problems, and coma can occur — even at standard doses. Higher doses greatly increase this risk. The drug may also affect your ability to drive or operate machinery.
- Autoimmune cytopenias: The immune system may begin attacking its own blood cells, causing life-threatening hemolytic anemia, low platelets, or acquired hemophilia. This can happen even in patients with no prior history of such conditions.
- Transfusion-associated graft-versus-host disease: Patients must receive only irradiated blood products during and after treatment to prevent a potentially fatal immune reaction.
- Tumor lysis syndrome: Rapidly dying cancer cells can release substances that cause kidney failure and other dangerous metabolic problems — most likely early in treatment in patients with a large tumor burden.
- Embryo-fetal toxicity: This drug can cause serious harm or death to an unborn baby. Effective contraception is required during and after treatment for both women and men.
- Live vaccines: Must be avoided during and after treatment due to the immune-suppressing effects of fludarabine.
🔀What it interacts with▾
Fludarabine Injection has a critical drug interaction and important considerations regarding other medical interventions:
- Pentostatin (deoxycoformycin): Must NOT be used together with fludarabine — this combination caused a high rate of fatal lung toxicity in clinical trials of patients with CLL.
- Live attenuated vaccines (such as live flu, MMR, or varicella vaccines): Must be avoided during and after treatment, as the weakened immune system may not be able to fight even a vaccine strain of a virus.
- Blood transfusions: Only irradiated blood products may be used — non-irradiated blood can trigger a dangerous and potentially fatal immune reaction (transfusion-associated graft-versus-host disease) in patients treated with fludarabine.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Allergy: Do not use if you are allergic to fludarabine phosphate or any component of the injection.
- Kidney impairment: Dose must be reduced for moderate kidney impairment; fludarabine should not be given to patients with severely reduced kidney function.
- Pregnancy: This drug can harm or kill an unborn baby. Tell your doctor immediately if you are pregnant or become pregnant during treatment.
- Breastfeeding: Breastfeeding is not recommended during treatment or for 1 week after the last dose due to the risk of serious harm to the infant.
- Contraception — women: Use effective birth control during treatment and for 6 months after the last dose.
- Contraception — men: Use effective contraception during treatment and for 3 months after the last dose; fludarabine may also impair male fertility.
- Children: Safety and effectiveness have not been established in patients under 17 years of age.
- Older adults: Patients aged 70 and older may have a higher rate of serious blood-related side effects; close monitoring is essential.
- History of autoimmune hemolytic anemia or a positive Coombs' test: Fludarabine may trigger or worsen immune-mediated destruction of red blood cells — inform your doctor before starting treatment.
- Bone marrow impairment: Pre-existing bone marrow problems increase the risk of severe blood count reductions; close monitoring is required.
🚑If you take too much▾
Taking more fludarabine than the recommended dose can cause severe, life-threatening, or fatal effects. Overdose has been associated with extreme bone marrow suppression (including dangerously low white blood cells, platelets, and red blood cells) and, at doses about four times the standard amount, irreversible nervous system damage including blindness, coma, and death.
There is no specific antidote for fludarabine overdose. Treatment involves stopping the drug immediately and providing supportive medical care. If overdose is suspected, emergency medical help should be sought right away.
📡Pharmacodynamics — effects in the body▾
Fludarabine's most measurable effect on the body is a reduction in blood cell counts — particularly white blood cells called granulocytes and blood platelets. The lower a patient's granulocyte count drops (called the nadir), the more drug exposure they have had, as measured by the area under the concentration-time curve (AUC). This relationship explains why careful dosing and blood count monitoring are so critical during treatment.
🔬Pharmacokinetics — how your body processes it▾
After IV infusion, fludarabine phosphate is converted within minutes into its active form, called 2-fluoro-ara-A. With daily dosing over five days, this active form gradually accumulates in the blood — trough levels roughly double by the end of the five-day course. The active form has a half-life (the time it takes for the body to clear half of it) of approximately 20 hours, meaning it stays in the system for a meaningful period after each dose.
About 40% of the drug is cleared by the kidneys, which is why kidney function directly affects how quickly the body eliminates fludarabine — patients with reduced kidney function eliminate it more slowly and are at greater risk for toxicity at standard doses.
📦How to store it▾
Store refrigerated between 2° and 8°C (36° and 46°F).
📄 Written from Fludarabine Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Fludarabine Injection
17 supplements and herbal products have documented interactions with Fludarabine Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 7
- Minor · 9
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Fludarabine Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is fludarabine being used to treat, and why is it given by IV? ▾
What side effects should I expect, and which ones should I call my doctor about right away? ▾
I heard this drug can affect my immune system — does that mean I need to avoid being around sick people? ▾
Is it safe to get pregnant or father a child while on this treatment? ▾
I have some kidney problems — will that affect my treatment? ▾
How will my doctor know if the treatment is working, and how long will I be on it? ▾
Is Fludarabine Injection available over the counter? ▾
When was Fludarabine Injection first available? ▾
Who makes Fludarabine Injection? ▾
💬 Answers drafted from Fludarabine Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Fludarabine Injection comes
Fludarabine Injection 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.
Injection
How this form is used
- Fludarabine Injection is used intravenously to treat adult patients with B-cell chronic lymphocytic leukemia (CLL) that has not responded to, or progressed during, at least one prior alkylating-agent-containing chemotherapy regimen
- Fludarabine Injection is not established for use in previously untreated or non-refractory CLL patients
- Fludarabine Injection is given as an intravenous infusion over approximately 30 minutes, once daily for five consecutive days, with each five-day course repeated every 28 days
- Fludarabine Injection must be prepared, diluted, and administered by a healthcare professional in a clinical setting — it is not for home use
- Fludarabine Injection dose may be reduced or delayed by your doctor based on kidney function, blood counts, or side effects — do not adjust the dose yourself
- Only irradiated blood products should be used for transfusions in patients receiving or who have received Fludarabine Injection
📊 Fludarabine Injection across the U.S. market
How Fludarabine Injection 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.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Fludarabine Injection is used
A general measure of how commonly Fludarabine Injection 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 Fludarabine Injection 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.
How commonly is Fludarabine Injection prescribed? Of the 1,596 medications we measure, Fludarabine Injection ranks #1,546 by Medicaid prescriptions — more than 3% of them.
Utilization by Fludarabine Injection 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.
2 ML fludarabine phosphate 25 MG/ML Injection
Summed across the 1 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1740865
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 Fludarabine Injection, 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 1 of 8 listed Fludarabine Injection NDCs with Medicaid activity.
🔍 Compare Fludarabine Injection products
A representative set of FDA-listed product records for Fludarabine Injection — 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.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 25 mg/mL | Intravenous | Accord Healthcare, Inc. | UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE | View NDC → |
| 25 mg/mL | Intravenous | Actavis Pharma, Inc. | ANDA | View NDC → |
| 50 mg/2 mL | Intravenous | Actavis Pharma, Inc. × 2 listings | ANDA | View NDC → |
| 25 mg/mL | Intravenous | Areva Pharmaceuticals × 2 listings | ANDA | View NDC → |
| 25 mg/mL | Intravenous | Fresenius Kabi USA, LLC × 2 listings | ANDA | View NDC → |
| 25 mg/mL | Intravenous | Hisun Pharmaceuticals USA, Inc. | ANDA | View NDC → |
| 25 mg/mL | Intravenous | Lannett Company, Inc. | ANDA | View NDC → |
| 25 mg/mL | Intravenous | Leucadia Pharmaceuticals | ANDA | View NDC → |
| 25 mg/mL | Intravenous | Sagent Pharmaceuticals × 2 listings | ANDA | View NDC → |
| 25 mg/mL | Intravenous | Teva Pharmaceuticals, Inc. | UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE | View NDC → |
Showing 14 of 14 products — FDA National Drug Code Directory. See every product, package size and price: browse all 14 Fludarabine Injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Fludarabine Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Fludarabine Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Fludarabine Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
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.
RxCUI 24698 2 dose forms · 3 strengths
-
Dose form (SCDF) Injection RxCUI 1740863In current FDA listingsClinical drug / strength (SCD) phosphate 50 MGRxCUI 17408642 ML fludarabine phosphate 25 MG/MLRxCUI 1740865 -
Dose form (SCDF) Oral Tablet RxCUI 393413No current FDA listingClinical drug / strength (SCD) phosphate 10 MGRxCUI 828706
Look up RxCUI 24698 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.
📦 Supply & shortage status
Whether Fludarabine Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Fludarabine Injection belongs to the Nucleoside Metabolic Inhibitor class.
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.
🔬 Where this comes from
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.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 6 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Fresenius Kabi USA, LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.