Prescription medicine
Nelarabine Brand names: Arranon
Nelarabine (Arranon) is a prescription medicine with an FDA approval on record since 2005. FDA's NDC Directory lists it from 12 generic labelers.
- Generic listed
- Boxed warning
Check it at the source: the nelarabine FDA label on DailyMed (effective March 31, 2025, Sandoz Inc); the NDA 21877 record on Drugs@FDA; every nelarabine label on DailyMed.
Highlights of the record
FDA label of March 31, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
NEUROLOGIC ADVERSE REACTIONS.
Severe neurologic adverse reactions have been reported with the use of ARRANON ® . These adverse reactions have included altered mental states including severe somnolence, central nervous system effects including convulsions, and peripheral neuropathy ranging from numbness and paresthesias to motor weakness and paralysis. There have also been reports of adverse reactions associated with demyelination, and ascending peripheral neuropathies similar in appearance to Guillain-Barré syndrome [see Warnings and Precautions (5.1)]. Full recovery from these adverse reactions has not always occurred with cessation of therapy with ARRANON. Monitor frequently for signs and symptoms of neurologic toxicity during treatment with ARRANON. Discontinue ARRANON for neurologic adverse reactions of NCI Common Toxicity Criteria for Adverse Events (CTCAE) Grade 2 or greater [see Warnings and Precautions (5.1)]. WARNING: NEUROLOGIC ADVERSE REACTIONS See full prescribing information for complete boxed warning. Severe neurologic adverse reactions have been reported with the use of ARRANON. These adverse reactions have included altered mental states including severe somnolence, central nervous system effects including convulsions, and peripheral neuropathy ranging from numbness and paresthesias to motor weakness and paralysis. […]
Used for
From the label: indications and usageARRANON is indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens.
Forms and strengths
- 5 mg/ml
Injection; injection (solution).
On the market
- Earliest approval on file
- October 28, 2005 Arranon, Sandoz; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 10 first November 17, 2021; 10 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 13 of which 12 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)
- 2 since 2025 0 Class I among all firms' recalls; latest February 13, 2025
- FAERS reports
- 956 through July 30, 2026
What is nelarabine used for?
From the label: indications and usageARRANON is indicated for the treatment of T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens. ARRANON is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) in adult and pediatric patients age 1 year and older whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.
Conditions named in the indications of nelarabine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Nucleoside Metabolic Inhibitor.
Source: FDA drug label (Arranon), Sandoz Inc, effective March 31, 2025 (SPL set 0f9051de-5c4d-4c0f-8c19-e15214498cca), via openFDA; the full label on DailyMed
What does the patient leaflet for nelarabine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about ARRANON?ARRANON may cause blood related adverse reactions. Your doctor will do blood tests regularly during treatment to monitor blood counts, including platelets. ARRANON may cause serious nervous system problems including: • extreme sleepiness • seizures • coma • numbness and tingling in the hands, fingers, feet, or toes (peripheral neuropathy) • weakness and paralysis Call the doctor right away if you or your child has the following symptoms: • seizures • numbness and tingling in the hands, fingers, feet, or toes • problems with fine motor skills such as buttoning clothes • unsteadiness while walking • increased tripping while walking • weakness when getting out of a chair or walking upstairs These symptoms may not go away even when treatment with ARRANON is stopped.
From the patient leaflet: What should you or your child avoid during treatment with ARRANON?You or your child should not drive or operate dangerous machines. ARRANON may cause sleepiness during and for several days after treatment. • You or your child should not receive vaccines made with live germs during treatment with ARRANON.
Source: FDA drug label (Arranon), Sandoz Inc, effective March 31, 2025 (SPL set 0f9051de-5c4d-4c0f-8c19-e15214498cca), via openFDA; the full label on DailyMed
Is there a generic for nelarabine (Arranon)?
The FDA approved the first generic nelarabine on November 17, 2021. 10 generic applications are approved; 10 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 nelarabine from 12 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.
- 2005 earliest approval on file
- 2021 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has nelarabine been recalled?
The FDA's Enforcement Report lists 2 recalls naming nelarabine since 2025: 0 Class I (the most serious), 2 Class II, 0 Class III; 2 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| February 13, 2025 | Class II | Zydus Pharmaceuticals (USA) Inc | Failed Impurities/Degradation Specifications |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the nelarabine label say about other medicines?
The nelarabine label names 3 other medicines in its interaction, contraindication or warning sections. 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 |
|---|---|---|
| Adenosine | drug interactions | DRUG INTERACTIONS Administration of ARRANON in combination with adenosine deaminase (ADA) inhibitors, such as pentostatin, is not recommended [see Clinical Pharmacology (12.3)]. |
| Allopurinol | warnings and precautions | Consideration should be given to the use of allopurinol in patients at risk of hyperuricemia [see Dosage and Administration ( 2.4 )]. |
| Pentostatin | drug interactions | DRUG INTERACTIONS Administration of ARRANON in combination with adenosine deaminase (ADA) inhibitors, such as pentostatin, is not recommended [see Clinical Pharmacology (12.3)]. |
Source: FDA drug label (Arranon), Sandoz Inc, effective March 31, 2025 (SPL set 0f9051de-5c4d-4c0f-8c19-e15214498cca), via openFDA; the full label on DailyMed
What do FAERS reports show for nelarabine?
The FDA Adverse Event Reporting System holds 956 reports that list nelarabine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 210 are coded as a death and 321 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 nelarabine?
36 other medicines are given the same way (intravenous) and in the same FDA class as nelarabine 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 |
|---|---|---|---|---|
| Clofarabine | Leukemia, lymphoma and myeloma | 9 labelers | n/a | No current entry |
| Fludarabine | Leukemia, lymphoma and myeloma | 6 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 nelarabine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to nelarabine
- 36 medicines for the same use
- Other nucleoside metabolic inhibitors
- the pharmacologic class, with prices and generics
- Nelarabine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other