Lomustine: uses, dosing, side effects & brands
Lomustine is an alkylating drug sold in the U.S. under 2 brand and generic names, for brain neoplasms, colonic neoplasms 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
- Drug class
- Alkylating Drug
- Treats
- Brain Neoplasms, Colonic Neoplasms and Hodgkin Disease
- Available as
- Capsule
- Sold as
- 2 products — Gleostine and Lomustine
- Prescription?
- Prescription only
- Generic available?
- Yes
- Half-life
- about 16 to 48 hours — but note this is the half-life of lomustine's metabolites, not the parent drug
- Boxed warning
- Boxed warning
How lomustine is dosed
From the FDA label for Gleostine (application NDA017588). Other lomustine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Recommended dose in adult and pediatric patients is 130 mg/m 2 orally every 6 weeks. ( 2.1 ) Round dose to nearest 10 mg. Give as a single oral dose and do not repeat for at least 6 weeks. 2.1 Important Prescribing and Dispensing Information PRESCRIBE ONLY ONE DOSE FOR EACH TREATMENT CYCLE. DO NOT DISPENSE ENTIRE CONTAINER. Dispense only a sufficient number of capsules for one dose. Confirm the total dose prescribed by the physician and the appropriate combination of capsule strengths. Dispense only the appropriate number of Gleostine capsules required for the administration of a single dose. The prescribed dose may consist of two or more different strengths and colors of capsules. Instruct patients that Gleostine is taken as a single oral dose and will not be repeated for at least 6 weeks. Taking more than the recommended dose causes toxicities, including fatal outcomes [see Warnings and Precautions ( 5.2 ) and Overdosage ( 10 )] . Gleostine is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1 To minimize the risk of dermal exposure, always wear impervious gloves when handling bottles containing Gleostine capsules. Do not break Gleostine capsules; avoid exposure to broken capsules. If dermal contact occurs, wash areas of skin contact immediately and thoroughly. 2.2 Recommended Dose The recommended dose of Gleostine in adult and pediatric patients…
Lomustine side effects
The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Delayed myelosuppression [see Warnings and Precautions ( 5.1 )] Risks of overdosage [see Warnings and Precautions ( 5.2 )] Pulmonary toxicity [see Warnings and Precautions ( 5.3 )] Secondary malignancies [see Warnings and Precautions ( 5.4 )] Hepatotoxicity [see Warnings and Precautions ( 5.5 )] Nephrotoxicity [see Warnings and Precautions ( 5.6 )] The following adverse reactions associated with the use of Gleostine were identified in clinical trials or postmarketing reports. Because these reactions were reported from a population of uncertain size, it is not possible to estimate their frequency, reliability, or establish a causal relationship to drug exposure. Gastrointestinal disorders: nausea, vomiting, and stomatitis Ocular disorders: optic atrophy, visual disturbances, and blindness Neurologic disorders: disorientation, lethargy, ataxia, and dysarthria Other: alopecia Common adverse reactions include delayed myelosupression, nausea, vomiting, stomatitis, and alopecia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Who shouldn’t take lomustine
None.
Every lomustine product we track (2)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Capsule | No data | — | View → | |
| 2 | Not yet rated | Prescription | Capsule | No data | — | View → |
What lomustine 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 |
|---|---|---|---|---|
| CPL;3031;40;mg | 40 mg | green, white | capsule | — |
| CPL;3030;10;mg | 10 mg | white | capsule | — |
| CPL;3032;100;mg | 100 mg | green | capsule | — |
| CPL;3031;40;mg | 40 mg | green, white | capsule | — |
| CPL;3030;10;mg | 10 mg | white | capsule | — |
| CPL;3032;100;mg | 100 mg | green | capsule | — |
| CP;114 | 10 mg | white, white | capsule | — |
| CP;115 | 40 mg | green, white | capsule | — |
| CP;116 | 100 mg | green, green | capsule | — |
| CPL;3031;40;mg | 40 mg | green, white | capsule | — |
| CPL;3030;10;mg | 10 mg | white | capsule | — |
| CPL;3032;100;mg | 100 mg | green | capsule | — |
Can you crush or split lomustine?
At least one lomustineproduct is labelled to be swallowed whole — crushing an extended-release tablet releases the whole day’s dose at once. Which applies depends on the form you were given.
What each lomustine label says about crushing, splitting and chewingHow long lomustine keeps
No lomustine label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does lomustine expire? The in-use limits and storage rules from its labelsWhat people report to the FDA about lomustine
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 1,849 reports naming lomustine, and the FDA flagged 79% 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:
- thrombocytopenia170 reports
- fatigue147 reports
- nausea134 reports
- neutropenia126 reports
- vomiting77 reports
- malignant neoplasm progression75 reports
- headache72 reports
- platelet count decreased72 reports
Read these as a signal, not a rate. A report does not mean lomustine 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.
How long lomustine stays in your system
The elimination half-life of lomustine is about 16 to 48 hours — but note this is the half-life of lomustine's metabolites, not the parent drug. Important scope: the Gleostine (lomustine) FDA label does NOT report an elimination half-life for the parent drug. Its Pharmacokinetics section (12.3, "Elimination") states only that "the serum half-life of lomustine metabolites ranges from 16 hours to 48 hours." Lomustine (a nitrosourea) is rapidly and extensively metabolized after oral dosing — the parent is essentially not quantified, and its active metabolites are the pharmacologically and clinically relevant species, which is why the label tracks metabolite half-life rather than parent. The label does not resolve this into distribution vs. terminal phases; the 16–48 h is the single range given. Specific populations: the label explicitly says the impact of age, sex, race, renal impairment, and hepatic impairment on lomustine pharmacokinetics is UNKNOWN — no adjustment values are provided. This figure is not a drug-test detection window and not dosing guidance.
Gleostine (lomustine) FDA label — DailyMed, §12.3 Pharmacokinetics ↗Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.
Related calculators
Frequently asked questions
What is lomustine?
Gleostine (Lomustine) is an alkylating drug used to treat Brain Neoplasms, Colonic Neoplasms, Hodgkin Disease, Kidney Neoplasms.
What kind of drug is lomustine?
The FDA classifies lomustine as an alkylating drug. Alkylating chemotherapy drugs attach chemical groups to a cell's DNA, forming cross-links that lock the two DNA strands together. This damage stops the cell from copying its DNA and dividing, which triggers it to die; because they are not limited to one phase of the cell cycle, they can act on cells whether or not they are actively dividing. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
How long does lomustine stay in your system?
The elimination half-life of lomustine is about 16 to 48 hours — but note this is the half-life of lomustine's metabolites, not the parent drug — that is how long the body takes to clear half of a dose. Important scope: the Gleostine (lomustine) FDA label does NOT report an elimination half-life for the parent drug. Its Pharmacokinetics section (12.3, "Elimination") states only that "the serum half-life of lomustine metabolites ranges from 16 hours to 48 hours." Lomustine (a nitrosourea) is rapidly and extensively metabolized after oral dosing — the parent is essentially not quantified, and its active metabolites are the pharmacologically and clinically relevant species, which is why the label tracks metabolite half-life rather than parent. The label does not resolve this into distribution vs. terminal phases; the 16–48 h is the single range given. Specific populations: the label explicitly says the impact of age, sex, race, renal impairment, and hepatic impairment on lomustine pharmacokinetics is UNKNOWN — no adjustment values are provided. This figure is not a drug-test detection window and not dosing guidance. Half-life is not the same as how long a drug test can detect the drug, and it varies with age, kidney and liver function.
Can you take lomustine 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 lomustine against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is lomustine sold under?
We track 2 lomustine-containing products in the U.S.: Gleostine and Lomustine. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does lomustine come in?
Across the brands we track, lomustine is currently marketed as capsule, 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 lomustine?
Yes. Our catalog lists 1 generic lomustine product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Lomustine: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/lomustine
- MLA
- “Lomustine: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/lomustine.
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 lomustine on DailyMed (NIH) ↗ — including its boxed warning in full.