Prescription medicine
Carboplatin Brand names: Kyxata; first approved as Paraplatin
Carboplatin (Kyxata) is a prescription medicine with an FDA approval on record since 1989. FDA's NDC Directory lists it from 10 generic labelers.
- Generic listed
- In shortage
- Boxed warning
Check it at the source: the carboplatin FDA label on DailyMed (effective January 10, 2025, Eugia US LLC); the NDA 19880 record on Drugs@FDA; every carboplatin label on DailyMed.
Highlights of the record
FDA label of January 10, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Carboplatin injection 10 mg/mL should 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 treatment facilities are readily available. Bone marrow suppression is dose related and may be severe, resulting in infection and/or bleeding. Anemia may be cumulative and may require transfusion support. Vomiting is another frequent drug-related side effect. Anaphylactic-like reactions to carboplatin have been reported and may occur within minutes of carboplatin injection administration. Epinephrine, corticosteroids, and antihistamines have been employed to alleviate symptoms.
Used for
From the label: indications and usageInitial Treatment of Advanced Ovarian Carcinoma Carboplatin injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents.
Forms and strengths
- 10 mg/ml
- 50 mg/5ml
- 80 mg/8ml
- 150 mg/15ml
- 450 mg/45ml
- 500 mg/50ml
- 600 mg/60ml
Injection (solution); injection.
On the market
- Earliest approval on file
- March 3, 1989 Paraplatin, Corden Pharma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 34 first October 14, 2004; 13 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 11 of which 10 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- April 1, 2045 Kyxata injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- 25 of 35 presentations limited or unavailable updated October 6, 2026
- Recalls by its makers (FDA)
- 5 since 2012 3 Class I among all firms' recalls; latest August 13, 2013; 2 more by firms not listed as its makers
- FAERS reports
- 126,274 through July 30, 2026
What is carboplatin used for?
From the label: indications and usageInitial Treatment of Advanced Ovarian Carcinoma Carboplatin injection is indicated for the initial treatment of advanced ovarian carcinoma in established combination with other approved chemotherapeutic agents. One established combination regimen consists of carboplatin and cyclophosphamide. Two randomized controlled studies conducted by the NCIC and SWOG with carboplatin versus cisplatin, both in combination with cyclophosphamide, have demonstrated equivalent overall survival between the two groups (see CLINICAL STUDIES ). […]
FDA pharmacologic class: Platinum-based Drug.
Source: FDA drug label (CARBOPLATIN), Eugia US LLC, effective January 10, 2025 (SPL set f5fe9a20-47a5-45b9-ab06-c6158d9b6aca), via openFDA; the full label on DailyMed
What does the patient leaflet for carboplatin say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while taking carboplatin?If you are pregnant or think you might be pregnant, or if you are breastfeeding, let your doctor know right away. Carboplatin may harm your developing fetus or breastfeeding baby. If you are a woman of childbearing age, you should use birth control to avoid getting pregnant while you are taking carboplatin. You should avoid contact with adults and children who have infections, and tell your doctor right away if you show signs of infection such as cough, fever, and/or chills. Also, while you are being treated with carboplatin or after you stop treatment, first check with your doctor before getting any immunizations (vaccinations). Avoid contact with adults or children who have received oral polio vaccine since they can pass the polio virus to you.
Source: FDA drug label (CARBOPLATIN), Eugia US LLC, effective January 10, 2025 (SPL set f5fe9a20-47a5-45b9-ab06-c6158d9b6aca), via openFDA; the full label on DailyMed
Is there a generic for carboplatin (Kyxata)?
The FDA approved the first generic carboplatin on October 14, 2004. 34 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.
FDA's NDC Directory lists carboplatin from 10 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 1 patent for Kyxata injection, the last expiring on April 1, 2045. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1989 earliest approval on file
- 2004 first generic approved
- 2045 last listed patent
- 2023 to now in shortage
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is carboplatin in shortage?
The FDA Drug Shortage Database lists 25 of 35 carboplatin presentations as limited or unavailable (updated October 6, 2026); the first entry was posted on April 28, 2023. 4 more presentations are on the list as available.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Carboplatin, Injection, 10 mg/1 mL (NDC 0703-4239-01) | Teva Pharmaceuticals USA, Inc. | Current | October 1, 2026 |
| Carboplatin, Injection, 10 mg/1 mL (NDC 0703-4244-01) | Teva Pharmaceuticals USA, Inc. | Current | October 1, 2026 |
| Carboplatin, Injection, 10 mg/1 mL (NDC 0703-4246-01) | Teva Pharmaceuticals USA, Inc. | Current | October 1, 2026 |
| Carboplatin, Injection, 10 mg/1 mL (NDC 0703-4248-01) | Teva Pharmaceuticals USA, Inc. | Current | October 1, 2026 |
| Carboplatin, Injection, 10 mg/1 mL (NDC 16729-295-12) | Accord Healthcare Inc. | Current | October 3, 2026 |
| Carboplatin, Injection, 10 mg/1 mL (NDC 16729-295-31) | Accord Healthcare Inc. | Current | October 3, 2026 |
| Carboplatin, Injection, 10 mg/1 mL (NDC 16729-295-33) | Accord Healthcare Inc. | Current | October 3, 2026 |
| Carboplatin, Injection, 10 mg/1 mL (NDC 16729-295-34) | Accord Healthcare Inc. | Current | October 3, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
Has carboplatin been recalled?
The FDA's Enforcement Report lists 7 recalls naming carboplatin since 2012: 3 Class I (the most serious), 3 Class II, 1 Class III; 0 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of carboplatin and that hold 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 |
| March 18, 2015 | Class I | Mylan Institutional LLC not a listed maker | Presence of Particulate Matter |
| August 13, 2013 | Class II | Teva Pharmaceuticals USA, Inc. | Lack of Assurance of Sterility: The required reduction of endotoxin was not met during the annual revalidation of the vial washer. |
| November 8, 2012 | Class I | Hospira Inc. | Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. … |
| July 2, 2012 | Class III | Hospira Inc. | Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended out of specification low pH. |
| June 27, 2012 | Class II | Hospira Inc. | The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are beig recalled due to visible … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the carboplatin label say about other medicines?
The carboplatin label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 16 other medicines name carboplatin. 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 |
|---|---|---|
| Cisplatin | contraindications | CONTRAINDICATIONS Carboplatin injection is contraindicated in patients with a history of severe allergic reactions to cisplatin or other platinum-containing compounds, or mannitol. |
| Epinephrine | boxed warning | Epinephrine, corticosteroids, and antihistamines have been employed to alleviate symptoms. |
Other labels that name carboplatin
Source: FDA drug label (CARBOPLATIN), Eugia US LLC, effective January 10, 2025 (SPL set f5fe9a20-47a5-45b9-ab06-c6158d9b6aca), via openFDA; the full label on DailyMed
What do FAERS reports show for carboplatin?
The FDA Adverse Event Reporting System holds 126,274 reports that list carboplatin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 20,032 are coded as a death and 54,088 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 platinum-based drugs
- the pharmacologic class, with prices and generics
- Carboplatin side effects
- the label's list beside FAERS reports
- Carboplatin shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other