Yes. 12 FDA-approved labels for Cisplatin carry a boxed warning, and its subject is cisplatin should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic.... A boxed warning is the most serious warning the FDA requires on a prescription label. It is applied to the drug and to the situations in which it is used, not to any particular person taking it.
What the warning says
Below is how the Cisplatin warning opens on one specific label, identified underneath it. Of the 12 Cisplatin labels sampled, 4 carried materially different wordings, and this was the most common, used by 5 of them.
WARNING Cisplatin 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.
CISPLATIN, Sagent Pharmaceuticals, label version effective 20 January 2024. Opening of the warning; read the full label on DailyMed.Why the wording differs between manufacturers
There is no single official text of a boxed warning. The FDA sets what a warning must cover, and each manufacturer writes its own label within that. Of the 12 Cisplatin labels sampled for this page, 4 carried materially different wordings of the same warning, and the version quoted above was used by 5 of them.
The hazard does not change between those 4 versions. Only the sentences do, which is why a refill from a different manufacturer can carry warning text that reads differently without anything about Cisplatin or its risks having changed.
Cisplatin is dispensed under 12 current FDA labels despite this warning, which is the point worth holding onto: a boxed warning is a disclosure requirement, not a verdict. What a boxed warning does and does not mean sets out the distinction.
Common questions
Does Cisplatin have a black box warning?
Yes. 12 FDA-approved labels for Cisplatin carry a boxed warning, and its subject is cisplatin should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic.... A boxed warning is the strongest warning the FDA requires on a prescription label, and it is applied to the drug, not to any individual taking it.
What does the Cisplatin boxed warning say?
The wording is set by each manufacturer within FDA requirements, so it varies. In the version quoted on this page, taken from a label effective 20 January 2024, the warning concerns cisplatin should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic.... The full text is linked so the exact version can be read rather than summarised.
Does the Cisplatin boxed warning mean the drug is unsafe or being withdrawn?
No. It means the FDA requires the risk of cisplatin should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic... to be communicated prominently so prescribers weigh it explicitly. Cisplatin remains FDA-approved and is dispensed under 12 current labels. A boxed warning is a disclosure requirement, not a judgement that a drug should not be used.
Why do different pharmacies show different warning text for the same drug?
Because each manufacturer writes its own label within the FDA's requirements. Of 12 Cisplatin labels sampled here, 4 carried materially different wordings of the same warning. The hazard described is the same; the sentences are not. This is a common source of confusion when a prescription is refilled with a different manufacturer's product.
Should I stop taking Cisplatin because of this warning?
This page does not answer that and cannot. The warning about cisplatin should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic... is written for a prescriber deciding whether Cisplatin suits a particular patient, and stopping a prescribed medicine carries its own risks that this page knows nothing about. Raise it with the prescriber or a pharmacist, who can see the whole picture.
Where this page's information comes from
The quotation above is from one Cisplatin label, linked below by its DailyMed set identifier so the exact version can be opened rather than taken on trust. The figure of 12 labels, and the count of 4 distinct wordings among 12 sampled, were computed from the openFDA labelling API on 30 August 2026.
- CISPLATIN prescribing information, Sagent Pharmaceuticals, effective 20 January 2024.
- openFDA drug labelling API, the source of the label counts and variant counts on this page.
Labels are revised over time. The version linked above is the one this page was written against, and a newer revision may differ. Counts reflect the labels present in openFDA on the retrieval date.