Prescription medicine
Chlorambucil Brand names: Leukeran
Chlorambucil (Leukeran) is a prescription medicine with an FDA approval on record since 1957. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the chlorambucil FDA label on DailyMed (effective January 8, 2025, Waylis Therapeutics LLC); the NDA 10669 record on Drugs@FDA; every chlorambucil label on DailyMed.
Highlights of the record
FDA label of January 8, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
LEUKERAN (chlorambucil) can severely suppress bone marrow function. Chlorambucil is a carcinogen in humans. Chlorambucil is probably mutagenic and teratogenic in humans. Chlorambucil produces human infertility (see WARNINGS and PRECAUTIONS).
Used for
From the label: indications and usageLEUKERAN (chlorambucil) is indicated in the treatment of chronic lymphatic (lymphocytic) leukemia, malignant lymphomas including lymphosarcoma, giant follicular lymphoma, and Hodgkin’s disease.
Forms and strengths
- 2 mg
Film-coated tablet.
On the market
- Earliest approval on file
- March 18, 1957 Leukeran, Waylis Therap; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 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
- 3,917 through July 30, 2026
What is chlorambucil used for?
From the label: indications and usageLEUKERAN (chlorambucil) is indicated in the treatment of chronic lymphatic (lymphocytic) leukemia, malignant lymphomas including lymphosarcoma, giant follicular lymphoma, and Hodgkin’s disease. It is not curative in any of these disorders but may produce clinically useful palliation.
Conditions named in the indications of chlorambucil's FDA labels, with every medicine labeled for each:
From other chlorambucil labelsLeukemia, lymphoma and myeloma: INDICATIONS AND USAGE LEUKERAN (chlorambucil) is indicated in the treatment of chronic lymphatic (lymphocytic) leukemia, malignant lymphomas including lymphosarcoma, giant follicular lymphoma, and Hodgkin’s disease.
FDA pharmacologic class: Alkylating Drug.
Source: FDA drug label (LEUKERAN), Waylis Therapeutics LLC, effective January 8, 2025 (SPL set 58a3c995-5ad6-465d-8437-5970c9088213), via openFDA; the full label on DailyMed
Is there a generic for chlorambucil (Leukeran)?
No generic chlorambucil is approved (Drugs@FDA, October 8, 2026).
- 1957 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the chlorambucil label say about other medicines?
The chlorambucil label names no other medicine on this site. The labels of 2 other medicines name chlorambucil. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name chlorambucil
Source: FDA drug label (LEUKERAN), Waylis Therapeutics LLC, effective January 8, 2025 (SPL set 58a3c995-5ad6-465d-8437-5970c9088213), via openFDA; the full label on DailyMed
What do FAERS reports show for chlorambucil?
The FDA Adverse Event Reporting System holds 3,917 reports that list chlorambucil among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 925 are coded as a death and 1,625 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 chlorambucil?
37 other medicines are given the same way (oral) and in the same FDA class as chlorambucil 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 (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Cyclophosphamide | Leukemia, lymphoma and myeloma | 4 labelers | $1.67 per capsule 50 mg capsule | No current entry |
| Busulfan | Leukemia, lymphoma and myeloma | none listed | n/a | A presentation being discontinued |
| Lenalidomide | Leukemia, lymphoma and myeloma | 18 labelers | n/a | No current entry |
| Dasatinib | Leukemia, lymphoma and myeloma | 14 labelers | $26.46 per tablet 100 mg tablet | No current entry |
| Pomalidomide | Leukemia, lymphoma and myeloma | 11 labelers | n/a | No current entry |
| Imatinib | Leukemia, lymphoma and myeloma | 20 labelers | $0.624 per tablet 100 mg tablet | No current entry |
| Arsenic trioxide | Leukemia, lymphoma and myeloma | none listed | n/a | A presentation being discontinued |
| Nilotinib | Leukemia, lymphoma and myeloma | 6 labelers | n/a | No current entry |
Every medicine labeled for the same conditions as chlorambucil
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to chlorambucil
- 37 medicines for the same use
- Other alkylating drugs
- the pharmacologic class, with prices and generics
- Chlorambucil side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other