Prescription medicine
Oxaliplatin First approved as Eloxatin
Oxaliplatin (Eloxatin) is a prescription medicine with an FDA approval on record since 2002. FDA's NDC Directory lists it from 16 generic labelers.
- Generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the oxaliplatin FDA label on DailyMed (effective August 24, 2026, Gland Pharma Limited); the NDA 21492 record on Drugs@FDA; every oxaliplatin label on DailyMed.
Highlights of the record
FDA label of August 24, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS.
Serious and fatal hypersensitivity adverse reactions, including anaphylaxis, can occur with oxaliplatin within minutes of administration and during any cycle. Oxaliplatin is contraindicated in patients with hypersensitivity reactions to oxaliplatin and other platinum-based drugs [see Contraindications (4) ]. Immediately and permanently discontinue oxaliplatin for hypersensitivity reactions and administer appropriate treatment for management of the hypersensitivity reaction [see Warnings and Precautions (5.1) ]. WARNING: HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS See full prescribing information for complete boxed warning. Serious and fatal hypersensitivity adverse reactions, including anaphylaxis, can occur with oxaliplatin within minutes of administration and during any cycle. Oxaliplatin is contraindicated in patients with hypersensitivity reactions to oxaliplatin and other platinum-based drugs. Immediately and permanently discontinue oxaliplatin for hypersensitivity reactions and administer appropriate treatment.
Used for
From the label: indications and usageOxaliplatin injection, in combination with infusional fluorouracil and leucovorin, is indicated for: adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor.
Forms and strengths
- 5 mg/ml
- 50 mg/10ml
- 100 mg/20ml
- 200 mg/40ml
Injection (solution); injection (solution) (concentrate); injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- August 9, 2002 Eloxatin, Sanofi Aventis Us; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 28 first August 7, 2009; 13 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 16 of which 16 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- None current 6 past records
- Recalls by its makers (FDA)
- 0 since 2019 0 Class I among all firms' recalls; 1 more by firms not listed as its makers
- FAERS reports
- 73,749 through July 30, 2026
What is oxaliplatin used for?
From the label: indications and usageOxaliplatin injection, in combination with infusional fluorouracil and leucovorin, is indicated for: adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. treatment of advanced colorectal cancer. Oxaliplatin is a platinum-based drug used in combination with infusional fluorouracil and leucovorin, which is indicated for: adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor. ( 1 ) treatment of advanced colorectal cancer.
Conditions named in the indications of oxaliplatin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Platinum-based Drug.
Source: FDA drug label (Oxaliplatin), Gland Pharma Limited, effective August 24, 2026 (SPL set a6f89dc3-a594-4b5b-8728-272e20c1ecb5), via openFDA; the full label on DailyMed
What does the patient leaflet for oxaliplatin say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about oxaliplatin injection?Oxaliplatin injection can cause serious allergic reactions, including allergic reactions that can lead to death. Oxaliplatin injection is a platinum-based medicine. Serious allergic reactions including death can happen in people who take oxaliplatin injection and who have had previous allergic reactions to platinum-based medicines. Serious allergic reactions can happen within a few minutes of your oxaliplatin injection infusion or any time during your treatment with oxaliplatin injection. Get emergency help right away if you: have trouble breathing feel like your throat is closing up chest tightness Call your doctor right away if you have any of the following signs or symptoms of an allergic reaction: rash flushed face hives itching swelling of your lips or tongue, face or eyelids wheezing sudden cough dizziness or feel faint sweating chest pain See “What are the possible side effects of oxaliplatin injection?” for information about other serious side effects.
From the patient leaflet: What should I avoid while receiving oxaliplatin injection?Avoid cold temperatures and cold objects. Cover your skin if you go outdoors in cold temperatures. Do not drink cold drinks or use ice cubes in drinks. Do not put ice or ice packs on your body. Oxaliplatin injection can cause dizziness, vision problems, or vision loss that can affect your ability to drive or use machines. You should not drive or operate machinery if you develop these symptoms while receiving oxaliplatin injection. See “How can I reduce the side effects caused by cold temperatures?” for more information. Talk with your doctor and nurse about your level of activity during treatment with oxaliplatin injection. Follow their instructions.
Source: FDA drug label (Oxaliplatin), Gland Pharma Limited, effective August 24, 2026 (SPL set a6f89dc3-a594-4b5b-8728-272e20c1ecb5), via openFDA; the full label on DailyMed
Is there a generic for oxaliplatin (Eloxatin)?
The FDA approved the first generic oxaliplatin on August 7, 2009. 28 generic applications are approved; 13 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists oxaliplatin from 16 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.
- 2002 earliest approval on file
- 2009 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is oxaliplatin in shortage?
No oxaliplatin presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 6 records are all marked to be discontinued, the latest updated June 29, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Oxaliplatin, Injection, 5 mg/1 mL (NDC 0781-3315-70) | Sandoz Inc. | To Be Discontinued | October 20, 2025 |
| Oxaliplatin, Injection, 5 mg/1 mL (NDC 0781-3317-80) | Sandoz Inc. | To Be Discontinued | October 20, 2025 |
| Oxaliplatin, Injection, 5 mg/1 mL (NDC 25021-233-10) | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | To Be Discontinued | June 29, 2026 |
| Oxaliplatin, Injection, 5 mg/1 mL (NDC 25021-233-20) | Jiangsu Hengrui Pharmaceuticals Co., Ltd. | To Be Discontinued | June 29, 2026 |
| Oxaliplatin, Injection, 5 mg/mL (NDC 63323-750-10) | Fresenius Kabi USA, LLC | To Be Discontinued | February 25, 2026 |
| Oxaliplatin, Injection, 5 mg/mL (NDC 63323-750-20) | Fresenius Kabi USA, LLC | To Be Discontinued | February 25, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has oxaliplatin been recalled?
The FDA's Enforcement Report lists 1 recall naming oxaliplatin since 2019: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of oxaliplatin 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 |
|---|---|---|---|
| June 12, 2019 | Class II | Infusion Options, Inc. not a listed maker | Lack of Assurance of Sterility |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the oxaliplatin label say about other medicines?
The oxaliplatin label names no other medicine on this site. The labels of 2 other medicines name oxaliplatin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name oxaliplatin
Source: FDA drug label (Oxaliplatin), Gland Pharma Limited, effective August 24, 2026 (SPL set a6f89dc3-a594-4b5b-8728-272e20c1ecb5), via openFDA; the full label on DailyMed
What do FAERS reports show for oxaliplatin?
The FDA Adverse Event Reporting System holds 73,749 reports that list oxaliplatin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 10,724 are coded as a death and 29,031 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 oxaliplatin?
8 other medicines are given the same way (intravenous) and in the same FDA class as oxaliplatin or labeled mainly for the same use (colorectal cancer), the same class first. Colorectal cancer lists all 23 medicines labeled for it, by any route. 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 |
|---|---|---|---|---|
| Fluorouracil | Colorectal cancer | 12 labelers | n/a | No current entry |
| Irinotecan | Colorectal cancer | 12 labelers | n/a | A presentation being discontinued |
| Levoleucovorin | Colorectal cancer | 8 labelers | n/a | No current entry |
| Bevacizumab | Colorectal cancer | none listed | n/a | No current entry |
| Aflibercept | Colorectal cancer | none listed | n/a | No current entry |
| Bevacizumab-maly | Colorectal cancer | none listed | n/a | No current entry |
| Cetuximab | Colorectal cancer | none listed | n/a | No current entry |
| Panitumumab | Colorectal cancer | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as oxaliplatin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does oxaliplatin compare with medicines for the same use?
1 side-by-side page set oxaliplatin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to oxaliplatin
- 8 medicines for the same use
- Other platinum-based drugs
- the pharmacologic class, with prices and generics
- Oxaliplatin side effects
- the label's list beside FAERS reports
- Oxaliplatin shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other