Prescription medicine
Carmustine Brand names: Gliadel; first approved as Bicnu
Carmustine (Bicnu) is a prescription medicine with an FDA approval on record since 1977. FDA's NDC Directory lists it from 10 generic labelers.
- Generic listed
- Boxed warning
Check it at the source: the carmustine FDA label on DailyMed (effective April 9, 2026, Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.); the NDA 17422 record on Drugs@FDA; every carmustine label on DailyMed.
Highlights of the record
FDA label of April 9, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
MYELOSUPPRESSION and PULMONARY TOXICITY Myelosuppression Carmustine for Injection, USP causes suppression of marrow function (including thrombocytopenia and leukopenia), which may contribute to bleeding and overwhelming infections, [see Warnings and Precautions (5.1) and Adverse Reactions (6) ]. Monitor blood counts weekly for at least 6 weeks after each dose. Adjust dosage based on nadir blood counts from the prior dose [see Dosage and Administration (2.1) ]. Do not administer a repeat course of Carmustine for Injection until blood counts recover. Pulmonary Toxicity Carmustine for Injection causes dose-related pulmonary toxicity. Patients receiving greater than 1400 mg /m 2 cumulative dose are at significantly higher risk than those receiving less. Delayed pulmonary toxicity can occur years after treatment, and can result in death, particularly in patients treated in childhood [see Adverse Reactions (6) and Use in Specific Populations (8.4) ]. WARNING: MYELOSUPPRESSION and PULMONARY TOXICITY See full prescribing information for complete boxed warning
Suppression of marrow function, notably thrombocytopenia and leukopenia, is the most common and severe of the toxic effects of Carmustine for Injection. Monitor blood counts. (5, 6).
Pulmonary toxicity from Carmustine for Injection appears to be dose related. […]
Used for
From the label: indications and usageCarmustine for Injection, USP is a nitrosourea indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following: Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors ( 1 ) Multiple myeloma-in combination with prednisone ( 1 ) Relapsed or refractory Hodgkin's lymphoma in com
Forms and strengths
- 7.7 mg
Kit; wafer.
On the market
- Earliest approval on file
- March 7, 1977 Bicnu, Avet Lifesciences; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 11 first September 11, 2018; 7 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 12 of which 10 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
- 4,612 through July 30, 2026
What is carmustine used for?
From the label: indications and usageCarmustine for Injection, USP is a nitrosourea indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following: Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors ( 1 ) Multiple myeloma-in combination with prednisone ( 1 ) Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs ( 1 ) Relapsed or refractory Non-Hodgkin's lymphomas in combination with other approved drugs ( 1 ) Carmustine for Injection, USP is indicated as palliative therapy as a single agent or in established combination therapy in the following: Brain tumors glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors. […]
Conditions named in the indications of carmustine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Alkylating Drug.
Source: FDA drug label (CARMUSTINE), Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., effective April 9, 2026 (SPL set b9b47082-32ee-4abb-a7b2-52292894d3f8), via openFDA; the full label on DailyMed
Is there a generic for carmustine (Bicnu)?
The FDA approved the first generic carmustine on September 11, 2018. 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 carmustine from 10 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.
- 1977 earliest approval on file
- 2018 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the carmustine label say about other medicines?
The carmustine label names 3 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name carmustine. 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 |
|---|---|---|
| Cimetidine | drug interactions | DRUG INTERACTIONS Cimetidine: Increased myelosuppression with concomitant use. (7.1) Phenobarbital: Induces carmustine metabolism, reducing exposure. |
| Phenobarbital | drug interactions | DRUG INTERACTIONS Cimetidine: Increased myelosuppression with concomitant use. (7.1) Phenobarbital: Induces carmustine metabolism, reducing exposure. |
| Phenytoin | drug interactions | May lead to reduced efficacy. (7.1) Phenytoin: Carmustine for Injection may reduce the efficacy of phenytoin. |
Other labels that name carmustine
Source: FDA drug label (CARMUSTINE), Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., effective April 9, 2026 (SPL set b9b47082-32ee-4abb-a7b2-52292894d3f8), via openFDA; the full label on DailyMed
What do FAERS reports show for carmustine?
The FDA Adverse Event Reporting System holds 4,612 reports that list carmustine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,192 are coded as a death and 1,417 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 carmustine?
36 other medicines are given the same way (intravenous) and in the same FDA class as carmustine 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 |
|---|---|---|---|---|
| Cyclophosphamide | Leukemia, lymphoma and myeloma | 15 labelers | n/a | No current entry |
| Bendamustine | Leukemia, lymphoma and myeloma | 4 labelers | n/a | A presentation being discontinued |
| Melphalan | Leukemia, lymphoma and myeloma | 6 labelers | n/a | A presentation being discontinued |
| Doxorubicin | Leukemia, lymphoma and myeloma | 16 labelers | n/a | No current entry |
| Bortezomib | Leukemia, lymphoma and myeloma | 22 labelers | n/a | No current entry |
| Arsenic trioxide | Leukemia, lymphoma and myeloma | 16 labelers | n/a | A presentation being discontinued |
| Nelarabine | Leukemia, lymphoma and myeloma | 12 labelers | n/a | No current entry |
| Idarubicin | Leukemia, lymphoma and myeloma | 2 labelers | n/a | No current entry |
Every medicine labeled for the same conditions as carmustine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to carmustine
- 36 medicines for the same use
- Other alkylating drugs
- the pharmacologic class, with prices and generics
- Carmustine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other