Yes. 1 FDA-approved labels for Ergotamine carry a boxed warning, and its subject is serious and/or life-threatening peripheral ischemia has been associated with the coadministration of ergotamine tartrate with.... 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 Ergotamine warning opens on one specific label, identified underneath it. Only one Ergotamine label carrying a boxed warning is currently in the FDA database, so there is no second version to compare this wording against.
WARNING Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of ergotamine tartrate with potent CYP 3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because CYP 3A4 inhibition elevates the serum levels of ergotamine tartrate, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Hence, concomitant use of these medications is contraindicated. (See also CONTRAINDICATIONS and WARNINGS section)
ERGOTAMINE TARTRATE, Pangea Pharmaceuticals LLC, label version effective 25 February 2025. 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. Ergotamine 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 Ergotamine, its label may word the serious and/or life-threatening peripheral ischemia has been associated with the coadministration of ergotamine tartrate with... warning differently while describing the same hazard, and this page would then show more than one version.
Ergotamine 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 Ergotamine have a black box warning?
Yes. 1 FDA-approved labels for Ergotamine carry a boxed warning, and its subject is serious and/or life-threatening peripheral ischemia has been associated with the coadministration of ergotamine tartrate with.... 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 Ergotamine 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 25 February 2025, the warning concerns serious and/or life-threatening peripheral ischemia has been associated with the coadministration of ergotamine tartrate with.... The full text is linked so the exact version can be read rather than summarised.
Does the Ergotamine boxed warning mean the drug is unsafe or being withdrawn?
No. It means the FDA requires the risk of serious and/or life-threatening peripheral ischemia has been associated with the coadministration of ergotamine tartrate with... to be communicated prominently so prescribers weigh it explicitly. Ergotamine 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 Ergotamine 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 Ergotamine label carrying a boxed warning is published at present, so there is no second wording to compare against.
Should I stop taking Ergotamine because of this warning?
This page does not answer that and cannot. The warning about serious and/or life-threatening peripheral ischemia has been associated with the coadministration of ergotamine tartrate with... is written for a prescriber deciding whether Ergotamine 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 Ergotamine 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.
- ERGOTAMINE TARTRATE prescribing information, Pangea Pharmaceuticals LLC, effective 25 February 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.