Chlorambucil: uses, dosing, side effects & brands
Chlorambucil is a medicine sold in the U.S. under one brand, for breast neoplasms, choriocarcinoma and hodgkin disease. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Breast Neoplasms, Choriocarcinoma and Hodgkin Disease
- Available as
- Tablet
- Sold as
- Leukeran
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Boxed warning
- Boxed warning
How chlorambucil is dosed
From the FDA label for Leukeran (application NDA010669). Other chlorambucil products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
The usual oral dosage is 0.1 to 0.2 mg/kg body weight daily for 3 to 6 weeks as required. This usually amounts to 4 to 10 mg per day for the average patient. The entire daily dose may be given at one time. These dosages are for initiation of therapy or for short courses of treatment. The dosage must be carefully adjusted according to the response of the patient and must be reduced as soon as there is an abrupt fall in the white blood cell count. Patients with Hodgkin’s disease usually require 0.2 mg/kg daily, whereas patients with other lymphomas or chronic lymphocytic leukemia usually require only 0.1 mg/kg daily. When lymphocytic infiltration of the bone marrow is present, or when the bone marrow is hypoplastic, the daily dose should not exceed 0.1 mg/kg (about 6 mg for the average patient). Alternate schedules for the treatment of chronic lymphocytic leukemia employing intermittent, biweekly, or once-monthly pulse doses of chlorambucil have been reported. Intermittent schedules of chlorambucil begin with an initial single dose of 0.4 mg/kg. Doses are generally increased by 0.1 mg/kg until control of lymphocytosis or toxicity is observed. Subsequent doses are modified to produce mild hematologic toxicity. It is felt that the response rate of chronic lymphocytic leukemia to the biweekly or once-monthly schedule of chlorambucil administration is similar or better to that…
Chlorambucil side effects
To report SUSPECTED ADVERSE REACTIONS, contact Waylis Therapeutics LLC Toll-Free at 1-888-514-4727 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Hematologic The most common side effect is bone marrow suppression, anemia, leukopenia, neutropenia, thrombocytopenia, or pancytopenia. Although bone marrow suppression frequently occurs, it is usually reversible if the chlorambucil is withdrawn early enough. However, irreversible bone marrow failure has been reported. Gastrointestinal Gastrointestinal disturbances such as nausea and vomiting, diarrhea, and oral ulceration occur infrequently. CNS Tremors, muscular twitching, myoclonia, confusion, agitation, ataxia, flaccid paresis, and hallucinations have been reported as rare adverse experiences to chlorambucil which resolve upon discontinuation of drug. Rare, focal and/or generalized seizures have been reported to occur in both children and adults at both therapeutic daily doses and pulse-dosing regimens, and in acute overdose (see PRECAUTIONS: General). Dermatologic Allergic reactions such as urticaria and angioneurotic edema have been reported following initial or subsequent dosing. Skin hypersensitivity (including rare reports of skin rash progressing to erythema multiforme, toxic epidermal necrolysis, and Stevens-Johnson syndrome) has been reported (see WARNINGS). Miscellaneous Other reported adverse reactions include:…
Who shouldn’t take chlorambucil
Chlorambucil should not be used in patients whose disease has demonstrated a prior resistance to the agent. Patients who have demonstrated hypersensitivity to chlorambucil should not be given the drug. There may be cross-hypersensitivity (skin rash) between chlorambucil and other alkylating agents.
Chlorambucil drug interactions
There are no known drug/drug interactions with chlorambucil.
Every chlorambucil product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Leukeran.
What chlorambucil pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| GX;EG3;L | 2 mg | brown | round | — |
Chlorambucil recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
What people report to the FDA about chlorambucil
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 3,336 reports naming chlorambucil, and the FDA flagged 97% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- pneumonia243 reports
- neutropenia241 reports
- pyrexia199 reports
- febrile neutropenia165 reports
- thrombocytopenia160 reports
- acute myeloid leukaemia132 reports
- anaemia117 reports
- progressive multifocal leukoencephalopathy102 reports
Read these as a signal, not a rate. A report does not mean chlorambucil caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is chlorambucil?
LEUKERAN (chlorambucil) was first synthesized by Everett et al. It is a bifunctional alkylating agent of the nitrogen mustard type that has been found active against selected human neoplastic diseases.
Can you take chlorambucil with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run chlorambucil against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does chlorambucil come in?
Across the brands we track, chlorambucil is currently marketed as tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic chlorambucil?
We do not currently list a generic-labelled chlorambucil product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Has chlorambucil been recalled?
The FDA's Enforcement database lists 1 recall record whose product description mentions chlorambucil. The most recent: Chlorambucil Container Description: The product packed in double self-seal cover… (Feb 7, 2025). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Chlorambucil: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/chlorambucil
- MLA
- “Chlorambucil: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/chlorambucil.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for chlorambucil on DailyMed (NIH) ↗ — including its boxed warning in full.