Yes. 1 FDA-approved labels for Amphotericin B carry a boxed warning, and its subject is this drug should be used primarily for treatment of patients with progressive and potentially life-threatening fungal.... 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 Amphotericin B warning opens on one specific label, identified underneath it. Only one Amphotericin B label carrying a boxed warning is currently in the FDA database, so there is no second version to compare this wording against.
WARNING This drug should be used primarily for treatment of patients with progressive and potentially life-threatening fungal infections; it should not be used to treat noninvasive forms of fungal disease such as oral thrush, vaginal candidiasis and esophageal candidiasis in patients with normal neutrophil counts. Amphotericin B for Injection should not be given in doses greater than 1.5 mg/kg. EXERCISE CAUTION to prevent inadvertent overdosage, which may result in potentially fatal cardiac or cardiopulmonary arrest (see WARNINGS , OVERDOSAGE and DOSAGE AND ADMINISTRATION ). Verify the product name and dosage pre-administration, especially if dose exceeds 1.5 mg/kg.
AMPHOTERICIN B, XGen Pharmaceuticals DJB, Inc., label version effective 03 January 2022. read the full label on DailyMed.Only one label carries this warning
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, so most drugs in this section carry several different wordings. Amphotericin B is a case where only one label carrying a boxed warning is currently in the FDA database, so the wording quoted above is simply the wording, with nothing to compare it against.
That usually reflects a single supplier rather than any special agreement about the text. If another manufacturer begins producing Amphotericin B, its label may word the this drug should be used primarily for treatment of patients with progressive and potentially life-threatening fungal... warning differently while describing the same hazard, and this page would then show more than one version.
Amphotericin B is dispensed under 1 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 Amphotericin B have a black box warning?
Yes. 1 FDA-approved labels for Amphotericin B carry a boxed warning, and its subject is this drug should be used primarily for treatment of patients with progressive and potentially life-threatening fungal.... 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 Amphotericin B 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 03 January 2022, the warning concerns this drug should be used primarily for treatment of patients with progressive and potentially life-threatening fungal.... The full text is linked so the exact version can be read rather than summarised.
Does the Amphotericin B boxed warning mean the drug is unsafe or being withdrawn?
No. It means the FDA requires the risk of this drug should be used primarily for treatment of patients with progressive and potentially life-threatening fungal... to be communicated prominently so prescribers weigh it explicitly. Amphotericin B remains FDA-approved and is dispensed under 1 current labels. A boxed warning is a disclosure requirement, not a judgement that a drug should not be used.
Is this the only version of the Amphotericin B warning?
It is the only one currently in the FDA label database. Most drugs have several manufacturers, each writing its own label within the FDA's requirements, which is why their warning text varies. Only one Amphotericin B label carrying a boxed warning is published at present, so there is no second wording to compare against.
Should I stop taking Amphotericin B because of this warning?
This page does not answer that and cannot. The warning about this drug should be used primarily for treatment of patients with progressive and potentially life-threatening fungal... is written for a prescriber deciding whether Amphotericin B 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 Amphotericin B label, linked below by its DailyMed set identifier so the exact version can be opened rather than taken on trust. The figure of 1 labels, and the count of 1 distinct wordings among 1 sampled, were computed from the openFDA labelling API on 30 August 2026.
- AMPHOTERICIN B prescribing information, XGen Pharmaceuticals DJB, Inc., effective 03 January 2022.
- 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.