Prescription medicine
Bleomycin First approved as Blenoxane
Bleomycin (Blenoxane) is a prescription medicine with an FDA approval on record since 1973. FDA's NDC Directory lists it from 5 generic labelers, and pharmacies paid $26.45 per bleomycin sulfate 15 unit vial in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the bleomycin FDA label on DailyMed (effective October 10, 2024, Fresenius Kabi USA, LLC); the NDA 50443 record on Drugs@FDA; every bleomycin label on DailyMed.
Highlights of the record
FDA label of October 10, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
It is recommended that Bleomycin for Injection, USP be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available. Pulmonary fibrosis is the most severe toxicity associated with bleomycin. The most frequent presentation is pneumonitis occasionally progressing to pulmonary fibrosis. Its occurrence is higher in elderly patients and in those receiving greater than 400 units total dose, but pulmonary toxicity has been observed in young patients and those treated with low doses. A severe idiosyncratic reaction consisting of hypotension, mental confusion, fever, chills, and wheezing has been reported in approximately 1% of lymphoma patients treated with bleomycin.
Used for
From the label: indications and usageBleomycin for Injection, USP should be considered a palliative treatment.
Forms and strengths
Injection (powder) (lyophilized) for solution; powder for solution.
On the market
- Earliest approval on file
- July 31, 1973 Blenoxane, Bristol Myers Squibb; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 8 first June 3, 1996; 4 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 5 of which 5 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $26.45 per vial Bleomycin sulfate 15 unit vial
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 3 since 2013 1 Class I among all firms' recalls; latest December 21, 2023; 1 more by firms not listed as its makers
- FAERS reports
- 10,269 through July 30, 2026
What is bleomycin used for?
From the label: indications and usageBleomycin for Injection, USP should be considered a palliative treatment. It has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents: Squamous Cell Carcinoma: Head and neck (including mouth, tongue, tonsil, nasopharynx, oropharynx, sinus, palate, lip, buccal mucosa, gingivae, epiglottis, skin, larynx), penis, cervix, and vulva. The response to Bleomycin for Injection is poorer in patients with previously irradiated head and neck cancer. Lymphomas: Hodgkin’s disease, non-Hodgkin’s lymphoma. Testicular Carcinoma: Embryonal cell, choriocarcinoma, and teratocarcinoma. […]
Conditions named in the indications of bleomycin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Cytoprotective Agent.
Source: FDA drug label (Bleomycin), Fresenius Kabi USA, LLC, effective October 10, 2024 (SPL set b5806c40-12ce-48e3-8abd-9f8997ef4428), via openFDA; the full label on DailyMed
Is there a generic for bleomycin (Blenoxane)?
The FDA approved the first generic bleomycin on June 3, 1996. 8 generic applications are approved; 4 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 bleomycin from 5 labelers 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.
- 1973 earliest approval on file
- 1996 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for bleomycin (Blenoxane)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $26.45 per Bleomycin sulfate 15 unit vial, down 17% from $31.78 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Bleomycin sulfate 15 unit vial (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Bleomycin sulfate 15 unit vial | Generic | $26.45 per vial | n/a | -17% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has bleomycin been recalled?
The FDA's Enforcement Report lists 4 recalls naming bleomycin since 2013: 1 Class I (the most serious), 2 Class II, 1 Class III; 1 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of bleomycin and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| December 21, 2023 | Class I | PFIZER | Presence of particulate matter: glass |
| August 5, 2021 | Class III | Hikma Pharmaceuticals USA Inc. | Labeling: Not elsewhere classified: Mislabeling |
| June 12, 2019 | Class II | Infusion Options, Inc. | Lack of Assurance of Sterility |
| November 1, 2013 | Class II | Natures Pharmacy & Compounding Center not a listed maker | Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the bleomycin label say about other medicines?
The bleomycin label names no other medicine on this site. The labels of 10 other medicines name bleomycin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name bleomycin
Source: FDA drug label (Bleomycin), Fresenius Kabi USA, LLC, effective October 10, 2024 (SPL set b5806c40-12ce-48e3-8abd-9f8997ef4428), via openFDA; the full label on DailyMed
What do FAERS reports show for bleomycin?
The FDA Adverse Event Reporting System holds 10,269 reports that list bleomycin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,370 are coded as a death and 3,290 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 cytoprotective agents
- the pharmacologic class, with prices and generics
- Bleomycin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other