Prescription medicine
Vinblastine First approved as Velban
Vinblastine (Velban) is a prescription medicine with an FDA approval on record since 1965. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
- Boxed warning
Check it at the source: the vinblastine FDA label on DailyMed (effective April 15, 2025, Fresenius Kabi USA, LLC); the NDA 12665 record on Drugs@FDA; every vinblastine label on DailyMed.
Highlights of the record
FDA label of April 15, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Caution: This preparation should be administered by individuals experienced in the administration of vinblastine sulfate. It is extremely important that the intravenous needle or catheter be properly positioned before any vinblastine sulfate is injected. Leakage into surrounding tissue during intravenous administration of vinblastine sulfate may cause considerable irritation. If extravasation occurs, the injection should be discontinued immediately, and any remaining portion of the dose should then be introduced into another vein. Local injection of hyaluronidase and the application of moderate heat to the area of leakage help disperse the drug and are thought to minimize discomfort and the possibility of cellulitis. FOR INTRAVENOUS USE ONLY – FATAL IF GIVEN BY OTHER ROUTES. See WARNINGS for the treatment of patients given intrathecal vinblastine sulfate injection.
Used for
From the label: indications and usageVinblastine Sulfate Injection is indicated in the palliative treatment of the following: I.
Forms and strengths
- 1 mg/ml
Injection.
On the market
- Earliest approval on file
- November 25, 1965 Velban, Lilly; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 3 first April 9, 1987; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 1 under generic applications, 0 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)
- 1 since 2019 0 Class I among all firms' recalls; latest June 12, 2019
- FAERS reports
- 1,941 through July 30, 2026
What is vinblastine used for?
From the label: indications and usageVinblastine Sulfate Injection is indicated in the palliative treatment of the following: I. Frequently Responsive Malignancies
Generalized Hodgkin’s disease (Stages III and IV, Ann Arbor modification of Rye staging system)
Lymphocytic lymphoma (nodular and diffuse, poorly and well differentiated)
Histiocytic lymphoma
Mycosis fungoides (advanced stages)
Advanced carcinoma of the testis
Kaposi’s sarcoma
Letterer-Siwe disease (histiocytosis X) II. […]
Conditions named in the indications of vinblastine's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Vinca Alkaloid.
Source: FDA drug label (Vinblastine Sulfate), Fresenius Kabi USA, LLC, effective April 15, 2025 (SPL set f073b58e-56d6-4c8d-a2ce-b37719402d77), via openFDA; the full label on DailyMed
Is there a generic for vinblastine (Velban)?
The FDA approved the first generic vinblastine on April 9, 1987. 3 generic applications are approved; 2 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 vinblastine from 1 labeler under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1965 earliest approval on file
- 1987 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has vinblastine been recalled?
The FDA's Enforcement Report lists 1 recall naming vinblastine since 2019: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 12, 2019 | Class II | Infusion Options, Inc. | Lack of Assurance of Sterility |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the vinblastine label say about other medicines?
The vinblastine label names 5 other medicines in its interaction, contraindication or warning sections. The labels of 21 other medicines name vinblastine. 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 |
|---|---|---|
| Erythromycin | drug interactions | Enhanced toxicity has been reported in patients receiving concomitant erythromycin (see ADVERSE REACTIONS ). |
| Hyaluronidase | boxed warning | Local injection of hyaluronidase and the application of moderate heat to the area of leakage help disperse the drug and are thought to minimize discomfort and the possibility of cellulitis. |
| Phenytoin | drug interactions | Drug Interactions The simultaneous oral or intravenous administration of phenytoin and antineoplastic chemotherapy combinations that included vinblastine sulfate has been reported to have reduced blood levels of the anticonvulsant and to have increased seizure activity. |
| Pyridoxine | warnings | Pyridoxine has been given at a dose of 50 mg every 8 hours by intravenous infusion over 30 minutes. |
| Vincristine | warnings | However, based on the published management of survival cases involving the related vinca alkaloid vincristine sulfate 1-3 , if vinblastine sulfate is mistakenly given by the intrathecal route, the following treatment should be initiated immediately after the injection: |
Other labels that name vinblastine
Source: FDA drug label (Vinblastine Sulfate), Fresenius Kabi USA, LLC, effective April 15, 2025 (SPL set f073b58e-56d6-4c8d-a2ce-b37719402d77), via openFDA; the full label on DailyMed
What do FAERS reports show for vinblastine?
The FDA Adverse Event Reporting System holds 1,941 reports that list vinblastine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 274 are coded as a death and 776 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 vinblastine?
36 other medicines are given the same way (intravenous) and in the same FDA class as vinblastine 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 |
|---|---|---|---|---|
| Vincristine | Leukemia, lymphoma and myeloma | 1 labeler | n/a | No current entry |
| Cyclophosphamide | Leukemia, lymphoma and myeloma | 15 labelers | n/a | No current entry |
| 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 |
| Bendamustine | Leukemia, lymphoma and myeloma | 4 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 vinblastine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to vinblastine
- 36 medicines for the same use
- Other vinca alkaloids
- the pharmacologic class, with prices and generics
- Vinblastine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other