Prescription medicine
Cisplatin First approved as Platinol-Aq
Cisplatin (Platinol-Aq) is a prescription medicine with an FDA approval on record since 1978. FDA's NDC Directory lists it from 9 generic labelers.
- Generic listed
- Boxed warning
Check it at the source: the cisplatin FDA label on DailyMed (effective September 16, 2021, WG Critical Care, LLC); the NDA 18057 record on Drugs@FDA; every cisplatin label on DailyMed.
Highlights of the record
FDA label of September 16, 2021; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Cisplatin Injection 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 diagnostic and treatment facilities are readily available. Cumulative renal toxicity associated with cisplatin is severe. Other major dose-related toxicities are myelosuppression, nausea, and vomiting. Ototoxicity, which may be more pronounced in children, and is manifested by tinnitus, and/or loss of high frequency hearing and occasionally deafness, is significant. Anaphylactic-like reactions to cisplatin have been reported. Facial edema, bronchoconstriction, tachycardia, and hypotension may occur within minutes of cisplatin administration. Epinephrine, corticosteroids, and antihistamines have been effectively employed to alleviate symptoms (see WARNINGS and ADVERSE REACTIONS sections). Exercise caution to prevent inadvertent cisplatin overdose. Doses greater than 100 mg/m 2 /cycle once every 3 to 4 weeks are rarely used. Care must be taken to avoid inadvertent cisplatin overdose due to confusion with carboplatin or prescribing practices that fail to differentiate daily doses from total dose per cycle.
Used for
From the label: indications and usageCisplatin Injection is indicated as therapy to be employed as follows: Metastatic Testicular Tumors In established combination therapy with other approved chemotherapeutic agents in patients with metastatic testicular tumors who have already received appropriate surgical and/or radiotherapeutic procedures.
Forms and strengths
- 50 mg
- 1 mg/ml
- 50 mg/50ml
- 100 mg/100ml
Injection (solution); injection; injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- December 19, 1978 Platinol-Aq, Hq Spclt Pharma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 9 first July 16, 1999; 6 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 10 of which 9 under generic applications, 1 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 2012 0 Class I among all firms' recalls; latest October 1, 2024; 3 more by firms not listed as its makers
- FAERS reports
- 77,664 through July 30, 2026
What is cisplatin used for?
From the label: indications and usageCisplatin Injection is indicated as therapy to be employed as follows: Metastatic Testicular Tumors In established combination therapy with other approved chemotherapeutic agents in patients with metastatic testicular tumors who have already received appropriate surgical and/or radiotherapeutic procedures. Metastatic Ovarian Tumors In established combination therapy with other approved chemotherapeutic agents in patients with metastatic ovarian tumors who have already received appropriate surgical and/or radiotherapeutic procedures. An established combination consists of Cisplatin Injection and cyclophosphamide. […]
FDA pharmacologic class: Platinum-based Drug.
Source: FDA drug label (CISplatin), NDA018057 (Hq Spclt Pharma), as published by WG Critical Care, LLC, effective September 16, 2021 (SPL set 2bf8d2fb-80c8-401d-8e9b-d58463f5e954), via openFDA; the full label on DailyMed
Is there a generic for cisplatin (Platinol-Aq)?
The FDA approved the first generic cisplatin on July 16, 1999. 9 generic applications are approved; 6 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 cisplatin from 9 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.
- 1978 earliest approval on file
- 1999 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has cisplatin been recalled?
The FDA's Enforcement Report lists 4 recalls naming cisplatin since 2012: 0 Class I (the most serious), 4 Class II, 0 Class III; 0 still ongoing. 3 of them are by firms that FDA's NDC Directory does not list as a maker of cisplatin 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 |
|---|---|---|---|
| October 1, 2024 | Class II | ACCORD HEALTHCARE, INC. | Failed Impurities/Degradation Specifications. |
| June 12, 2019 | Class II | Infusion Options, Inc. not a listed maker | Lack of Assurance of Sterility |
| May 25, 2012 | Class II | Franck's Lab Inc., d.b.a. Franck's Compounding Lab not a listed maker | Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the cisplatin label say about other medicines?
The cisplatin label names 3 other medicines in its interaction, contraindication or warning sections. The labels of 32 other medicines name cisplatin. 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 |
|---|---|---|
| Carboplatin | boxed warning | Care must be taken to avoid inadvertent cisplatin overdose due to confusion with carboplatin or prescribing practices that fail to differentiate daily doses from total dose per cycle. |
| Epinephrine | boxed warning | Epinephrine, corticosteroids, and antihistamines have been effectively employed to alleviate symptoms (see WARNINGS and ADVERSE REACTIONS sections). |
| Pyridoxine | drug interactions | In a randomized trial in advanced ovarian cancer, response duration was adversely affected when pyridoxine was used in combination with altretamine (hexamethylmelamine) and cisplatin. |
Other labels that name cisplatin
Source: FDA drug label (CISplatin), NDA018057 (Hq Spclt Pharma), as published by WG Critical Care, LLC, effective September 16, 2021 (SPL set 2bf8d2fb-80c8-401d-8e9b-d58463f5e954), via openFDA; the full label on DailyMed
What do FAERS reports show for cisplatin?
The FDA Adverse Event Reporting System holds 77,664 reports that list cisplatin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 14,919 are coded as a death and 32,401 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
- Cisplatin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other