Prescription medicine
Vincristine First approved as Oncovin
Vincristine (Oncovin) is a prescription medicine with an FDA approval on record since 1963. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
- Boxed warning
Check it at the source: the vincristine FDA label on DailyMed (effective February 17, 2026, Hospira, Inc.); the NDA 14103 record on Drugs@FDA; every vincristine label on DailyMed.
Highlights of the record
FDA label of February 17, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Caution–This preparation should be administered by individuals experienced in the administration of Vincristine Sulfate Injection. It is extremely important that the intravenous needle or catheter be properly positioned before any vincristine is injected. Leakage into surrounding tissue during intravenous administration of Vincristine Sulfate Injection 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 OVERDOSAGE section for the treatment of patients given intrathecal Vincristine Sulfate Injection. WARNINGS This preparation is for intravenous use only. It should be administered by individuals experienced in the administration of Vincristine Sulfate Injection. The intrathecal administration of Vincristine Sulfate Injection usually results in death. […]
Used for
From the label: indications and usageVincristine Sulfate Injection is indicated in acute leukemia.
Forms and strengths
- 1 mg/ml
Injection (solution).
On the market
- Earliest approval on file
- July 10, 1963 Oncovin, Lilly; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 6 first July 17, 1987; 1 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
- 29,131 through July 30, 2026
What is vincristine used for?
From the label: indications and usageVincristine Sulfate Injection is indicated in acute leukemia. Vincristine Sulfate Injection has also been shown to be useful in combination with other oncolytic agents in Hodgkin's disease, non–Hodgkin's malignant lymphomas, rhabdomyosarcoma, neuroblastoma, and Wilms' tumor.
Conditions named in the indications of vincristine's FDA labels, with every medicine labeled for each:
From other vincristine labelsLeukemia, lymphoma and myeloma: INDICATIONS AND USAGE Vincristine Sulfate Injection is indicated in acute leukemia.
FDA pharmacologic class: Vinca Alkaloid.
Source: FDA drug label (VinCRIStine Sulfate), Hospira, Inc., effective February 17, 2026 (SPL set b22e4c8e-dbe1-4d4b-a026-e1812974071c), via openFDA; the full label on DailyMed
Is there a generic for vincristine (Oncovin)?
The FDA approved the first generic vincristine on July 17, 1987. 6 generic applications are approved; 1 of them carries 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 vincristine 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.
- 1963 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 vincristine been recalled?
The FDA's Enforcement Report lists 1 recall naming vincristine 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 vincristine label say about other medicines?
The vincristine label names 4 other medicines in its interaction, contraindication or warning sections. The labels of 23 other medicines name vincristine. 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 |
|---|---|---|
| Fluconazole | drug interactions | Concurrent administration of vincristine sulfate with itraconazole or fluconazole (known inhibitors of the CYP3A metabolic pathway) has been reported to cause an earlier onset and/or an increased severity of neuromuscular side effects (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. |
| Itraconazole | drug interactions | Concurrent administration of vincristine sulfate with itraconazole or fluconazole (known inhibitors of the CYP3A metabolic pathway) has been reported to cause an earlier onset and/or an increased severity of neuromuscular side effects (see ADVERSE REACTIONS ). |
| Phenytoin | drug interactions | Drug Interactions The simultaneous oral or intravenous administration of phenytoin and antineoplastic chemotherapy combinations that included vincristine sulfate has been reported to reduce blood levels of the anticonvulsant and to increase seizure activity. |
Other labels that name vincristine
Source: FDA drug label (VinCRIStine Sulfate), Hospira, Inc., effective February 17, 2026 (SPL set b22e4c8e-dbe1-4d4b-a026-e1812974071c), via openFDA; the full label on DailyMed
What do FAERS reports show for vincristine?
The FDA Adverse Event Reporting System holds 29,131 reports that list vincristine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 5,379 are coded as a death and 14,062 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 vincristine?
36 other medicines are given the same way (intravenous) and in the same FDA class as vincristine 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 |
|---|---|---|---|---|
| Vinblastine | 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 vincristine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to vincristine
- 36 medicines for the same use
- Other vinca alkaloids
- the pharmacologic class, with prices and generics
- Vincristine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other