Yes. 137 FDA-approved labels for Celecoxib carry a boxed warning, and its subject is risk of serious cardiovascular and gastro-intestinal events cardiovascular thrombotic events. 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 Celecoxib warning opens on one specific label, identified underneath it. Of the 25 Celecoxib labels sampled, 15 carried materially different wordings and this was the most common, used by 5 of them.
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTRO-INTESTINAL EVENTS Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction, and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use [ see Warnings and Precautions (5.1) ]. Celecoxib is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [ see Contraindications (4) and Warnings and Precautions (5.1) ].
CELECOXIB, A-S Medication Solutions, label version effective 24 August 2023. 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 Celecoxib labels sampled for this page, 15 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 15 versions. Only the sentences do, which is why a refill from a different manufacturer can carry warning text that reads differently without anything about Celecoxib or its risks having changed.
Celecoxib is dispensed under 137 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 Celecoxib have a black box warning?
Yes. 137 FDA-approved labels for Celecoxib carry a boxed warning, and its subject is risk of serious cardiovascular and gastro-intestinal events cardiovascular thrombotic events. 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 Celecoxib 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 24 August 2023, the warning concerns risk of serious cardiovascular and gastro-intestinal events cardiovascular thrombotic events. The full text is linked so the exact version can be read rather than summarised.
Does the Celecoxib boxed warning mean the drug is unsafe or being withdrawn?
No. It means the FDA requires the risk of risk of serious cardiovascular and gastro-intestinal events cardiovascular thrombotic events to be communicated prominently so prescribers weigh it explicitly. Celecoxib remains FDA-approved and is dispensed under 137 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 Celecoxib labels sampled here, 15 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 Celecoxib because of this warning?
This page does not answer that and cannot. The warning about risk of serious cardiovascular and gastro-intestinal events cardiovascular thrombotic events is written for a prescriber deciding whether Celecoxib 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 Celecoxib label, linked below by its DailyMed set identifier so the exact version can be opened rather than taken on trust. The figure of 137 labels, and the count of 15 distinct wordings among 25 sampled, were computed from the openFDA labelling API on 30 August 2026.
- CELECOXIB prescribing information, A-S Medication Solutions, effective 24 August 2023.
- 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.