Yes. 28 FDA-approved labels for Doxorubicin carry a boxed warning, and its subject is cardiomyopathy and infusion-related reactions. 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 Doxorubicin warning opens on one specific label, identified underneath it. Of the 25 Doxorubicin labels sampled, 13 carried materially different wordings, and this was the most common, used by 5 of them.
WARNING: CARDIOMYOPATHY and INFUSION-RELATED REACTIONS Doxorubicin hydrochloride liposome injection can cause myocardial damage, including acute left ventricular failure. The risk of cardiomyopathy was 11% when the cumulative anthracycline dose was between 450 mg/m 2 to 550 mg/m 2 . Assess left ventricular cardiac function prior to initiation of doxorubicin hydrochloride liposome injection and during and after treatment [see Warnings and Precautions ( 5.1 )] . Serious, life-threatening, and fatal infusion-related reactions can occur with doxorubicin hydrochloride liposome injection. Acute infusion-related reactions occurred in 11% of patients with solid tumors.
DOXORUBICIN HYDROCHLORIDE, Lupin Pharmaceuticals, Inc., label version effective 30 November 2025. 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 25 Doxorubicin labels sampled for this page, 13 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 13 versions. Only the sentences do, which is why a refill from a different manufacturer can carry warning text that reads differently without anything about Doxorubicin or its risks having changed.
Doxorubicin is dispensed under 28 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 Doxorubicin have a black box warning?
Yes. 28 FDA-approved labels for Doxorubicin carry a boxed warning, and its subject is cardiomyopathy and infusion-related reactions. 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 Doxorubicin 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 30 November 2025, the warning concerns cardiomyopathy and infusion-related reactions. The full text is linked so the exact version can be read rather than summarised.
Does the Doxorubicin boxed warning mean the drug is unsafe or being withdrawn?
No. It means the FDA requires the risk of cardiomyopathy and infusion-related reactions to be communicated prominently so prescribers weigh it explicitly. Doxorubicin remains FDA-approved and is dispensed under 28 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 25 Doxorubicin labels sampled here, 13 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 Doxorubicin because of this warning?
This page does not answer that and cannot. The warning about cardiomyopathy and infusion-related reactions is written for a prescriber deciding whether Doxorubicin 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 Doxorubicin label, linked below by its DailyMed set identifier so the exact version can be opened rather than taken on trust. The figure of 28 labels, and the count of 13 distinct wordings among 25 sampled, were computed from the openFDA labelling API on 30 August 2026.
- DOXORUBICIN HYDROCHLORIDE prescribing information, Lupin Pharmaceuticals, Inc., effective 30 November 2025.
- 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.