Yes. 1 FDA-approved labels for Salmeterol Xinafoate carry a boxed warning, and its subject is asthma-related death. 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 Salmeterol Xinafoate warning opens on one specific label, identified underneath it. Only one Salmeterol Xinafoate label carrying a boxed warning is currently in the FDA database, so there is no second version to compare this wording against.
WARNING: ASTHMA-RELATED DEATH Long-acting beta 2 -adrenergic agonists (LABA), such as salmeterol, the active ingredient in SEREVENT DISKUS, as monotherapy (without inhaled corticosteroids [ICS]) increase the risk of asthma-related death. Data from a large placebo-controlled U.S. trial that compared the safety of salmeterol with placebo added to usual asthma therapy showed an increase in asthma-related deaths in subjects receiving salmeterol (13 deaths out of 13,176 subjects treated for 28 weeks on salmeterol versus 3 deaths out of 13,179 subjects on placebo). Use of background ICS was not required in this study.
SALMETEROL XINAFOATE, GlaxoSmithKline LLC, label version effective 10 October 2022. Opening of the warning; 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. Salmeterol Xinafoate 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 Salmeterol Xinafoate, its label may word the asthma-related death warning differently while describing the same hazard, and this page would then show more than one version.
Salmeterol Xinafoate 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 Salmeterol Xinafoate have a black box warning?
Yes. 1 FDA-approved labels for Salmeterol Xinafoate carry a boxed warning, and its subject is asthma-related death. 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 Salmeterol Xinafoate 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 10 October 2022, the warning concerns asthma-related death. The full text is linked so the exact version can be read rather than summarised.
Does the Salmeterol Xinafoate boxed warning mean the drug is unsafe or being withdrawn?
No. It means the FDA requires the risk of asthma-related death to be communicated prominently so prescribers weigh it explicitly. Salmeterol Xinafoate 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 Salmeterol Xinafoate 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 Salmeterol Xinafoate label carrying a boxed warning is published at present, so there is no second wording to compare against.
Should I stop taking Salmeterol Xinafoate because of this warning?
This page does not answer that and cannot. The warning about asthma-related death is written for a prescriber deciding whether Salmeterol Xinafoate 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 Salmeterol Xinafoate 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.
- SALMETEROL XINAFOATE prescribing information, GlaxoSmithKline LLC, effective 10 October 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.