Prescription medicine
Fludarabine First approved as Fludara
Fludarabine (Fludara) is a prescription medicine with an FDA approval on record since 1991. FDA's NDC Directory lists it from 6 generic labelers.
- Generic listed
- Boxed warning
Check it at the source: the fludarabine FDA label on DailyMed (effective October 14, 2024, Fresenius Kabi USA, LLC); the NDA 20038 record on Drugs@FDA; every fludarabine label on DailyMed.
Highlights of the record
FDA label of October 14, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Fludarabine should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy. Fludarabine can severely suppress bone marrow function. When used at high doses in dose-ranging studies in patients with acute leukemia, fludarabine was associated with severe neurologic effects, including blindness, coma, and death. This severe central nervous system toxicity occurred in 36% of patients treated with doses approximately four times greater (96 mg/m 2 /day for 5 to 7 days) than the recommended dose. Similar severe central nervous system toxicity has been rarely (0.2%) reported in patients treated at doses in the range of the dose recommended for chronic lymphocytic leukemia. Instances of life-threatening and sometimes fatal autoimmune hemolytic anemia have been reported to occur after one or more cycles of treatment with fludarabine. Patients undergoing treatment with fludarabine should be evaluated and closely monitored for hemolysis. In a clinical investigation using fludarabine in combination with pentostatin (deoxycoformycin) for the treatment of refractory chronic lymphocytic leukemia (CLL), there was an unacceptably high incidence of fatal pulmonary toxicity. Therefore, the use of fludarabine in combination with pentostatin is not recommended.
Used for
From the label: indications and usageFludarabine Phosphate Injection, USP is indicated for the treatment of patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen.
Forms and strengths
- 25 mg/ml
- 50 mg/2ml
Injection (solution); injection; injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- April 18, 1991 Fludara, Genzyme Corp; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 11 first August 28, 2003; 7 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 6 of which 6 under generic applications, 0 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)
- 1 since 2021 0 Class I among all firms' recalls; latest July 30, 2021
- FAERS reports
- 39,093 through July 30, 2026
What is fludarabine used for?
From the label: indications and usageFludarabine Phosphate Injection, USP is indicated for the treatment of patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen. The safety and effectiveness of Fludarabine Phosphate Injection, USP in previously untreated or non-refractory patients with CLL have not been established.
Conditions named in the indications of fludarabine's FDA labels, with every medicine labeled for each:
From other fludarabine labelsLeukemia, lymphoma and myeloma: INDICATIONS AND USAGE Fludarabine Phosphate Injection, USP is indicated for the treatment of patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least …
FDA pharmacologic class: Nucleoside Metabolic Inhibitor.
Source: FDA drug label (Fludarabine), Fresenius Kabi USA, LLC, effective October 14, 2024 (SPL set cf5255cc-91fd-4132-973b-764dba142eae), via openFDA; the full label on DailyMed
Is there a generic for fludarabine (Fludara)?
The FDA approved the first generic fludarabine on August 28, 2003. 11 generic applications are approved; 7 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 fludarabine from 6 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1991 earliest approval on file
- 2003 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has fludarabine been recalled?
The FDA's Enforcement Report lists 1 recall naming fludarabine since 2021: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 30, 2021 | Class II | Custopharm, Inc. | Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the fludarabine label say about other medicines?
The fludarabine label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 5 other medicines name fludarabine. 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 |
|---|---|---|
| Pentostatin | boxed warning | In a clinical investigation using fludarabine in combination with pentostatin (deoxycoformycin) for the treatment of refractory chronic lymphocytic leukemia (CLL), there was an unacceptably high incidence of fatal pulmonary toxicity. |
Other labels that name fludarabine
Source: FDA drug label (Fludarabine), Fresenius Kabi USA, LLC, effective October 14, 2024 (SPL set cf5255cc-91fd-4132-973b-764dba142eae), via openFDA; the full label on DailyMed
What do FAERS reports show for fludarabine?
The FDA Adverse Event Reporting System holds 39,093 reports that list fludarabine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 11,956 are coded as a death and 11,276 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 fludarabine?
36 other medicines are given the same way (intravenous) and in the same FDA class as fludarabine or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Nelarabine | Leukemia, lymphoma and myeloma | 12 labelers | n/a | No current entry |
| Clofarabine | Leukemia, lymphoma and myeloma | 9 labelers | n/a | No current entry |
| Cytarabine | Leukemia, lymphoma and myeloma | 2 labelers | n/a | No current entry |
| Cytarabine and daunorubicin | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Pentostatin | Leukemia, lymphoma and myeloma | none listed | n/a | In shortage |
| Cyclophosphamide | Leukemia, lymphoma and myeloma | 15 labelers | n/a | No current entry |
| Doxorubicin | Leukemia, lymphoma and myeloma | 16 labelers | n/a | No current entry |
| Bortezomib | Leukemia, lymphoma and myeloma | 22 labelers | n/a | No current entry |
Every medicine labeled for the same conditions as fludarabine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to fludarabine
- 36 medicines for the same use
- Other nucleoside metabolic inhibitors
- the pharmacologic class, with prices and generics
- Fludarabine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other