Prescription medicine
Procarbazine Brand names: Matulane
Procarbazine (Matulane) is a prescription medicine with an FDA approval on record since 1969. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the procarbazine FDA label on DailyMed (effective September 16, 2024, Leadiant Biosciences, Inc.); the NDA 16785 record on Drugs@FDA; every procarbazine label on DailyMed.
Highlights of the record
FDA label of September 16, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
It is recommended that MATULANE be given only by or under the supervision of a physician experienced in the use of potent antineoplastic drugs. Adequate clinical and laboratory facilities should be available to patients for proper monitoring of treatment.
Used for
From the label: indications and usageMatulane is indicated for use in combination with other anticancer drugs for the treatment of Stage III and IV Hodgkin's disease.
Forms and strengths
- 50 mg
Capsule.
On the market
- Earliest approval on file
- July 22, 1969 Matulane, Leadiant Biosci Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- 4,488 through July 30, 2026
What is procarbazine used for?
From the label: indications and usageMatulane is indicated for use in combination with other anticancer drugs for the treatment of Stage III and IV Hodgkin's disease. Matulane is used as part of the MOPP (nitrogen mustard, vincristine, procarbazine, prednisone) regimen.
FDA pharmacologic class: Alkylating Drug.
Source: FDA drug label (Matulane), Leadiant Biosciences, Inc., effective September 16, 2024 (SPL set 1aa75a3a-18c9-49e1-91a6-293d0b7da756), via openFDA; the full label on DailyMed
Is there a generic for procarbazine (Matulane)?
No generic procarbazine is approved (Drugs@FDA, October 8, 2026).
- 1969 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the procarbazine label say about other medicines?
The procarbazine label names 4 other medicines in its interaction, contraindication or warning sections. The labels of 5 other medicines name procarbazine. 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 |
|---|---|---|
| Amitriptyline | warnings | Because Matulane exhibits some monoamine oxidase inhibitory activity, sympathomimetic drugs, tricyclic antidepressant drugs (eg, amitriptyline HCI, imipramine HCI) and other drugs and foods with known high tyramine content, such as wine, yogurt, ripe cheese and bananas, should be avoided. |
| Disulfiram | warnings | Ethyl alcohol should not be used since there may be an Antabuse (disulfiram)-like reaction. |
| Ethyl alcohol | warnings | Ethyl alcohol should not be used since there may be an Antabuse (disulfiram)-like reaction. |
| Imipramine | warnings | Because Matulane exhibits some monoamine oxidase inhibitory activity, sympathomimetic drugs, tricyclic antidepressant drugs (eg, amitriptyline HCI, imipramine HCI) and other drugs and foods with known high tyramine content, such as wine, yogurt, ripe cheese and bananas, should be avoided. |
Other labels that name procarbazine
Source: FDA drug label (Matulane), Leadiant Biosciences, Inc., effective September 16, 2024 (SPL set 1aa75a3a-18c9-49e1-91a6-293d0b7da756), via openFDA; the full label on DailyMed
What do FAERS reports show for procarbazine?
The FDA Adverse Event Reporting System holds 4,488 reports that list procarbazine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 323 are coded as a death and 580 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 next?
- Other alkylating drugs
- the pharmacologic class, with prices and generics
- Procarbazine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other