Yes. 47 FDA-approved labels for Warfarin carry a boxed warning, and its subject is bleeding risk. 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 Warfarin warning opens on one specific label, identified underneath it. Of the 25 Warfarin labels sampled, 4 carried materially different wordings and this was the most common, used by 14 of them.
WARNING: BLEEDING RISK Warfarin sodium can cause major or fatal bleeding [see Warnings and Precautions ( 5.1 )] . Perform regular monitoring of INR in all treated patients [see Dosage and Administration ( 2.1 )] . Drugs, dietary changes, and other factors affect INR levels achieved with warfarin sodium therapy [see Drug Interactions ( 7 )] . Instruct patients about prevention measures to minimize risk of bleeding and to report signs and symptoms of bleeding [see Patient Counseling Information ( 17 )] . WARNING: BLEEDING RISK See full prescribing information for complete boxed warning. Warfarin sodium can cause major or fatal bleeding.
WARFARIN SODIUM, Teva Pharmaceuticals USA, Inc., label version effective 17 June 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 Warfarin labels sampled for this page, 4 carried materially different wordings of the same warning, and the version quoted above was used by 14 of them.
The hazard does not change between those 4 versions. Only the sentences do, which is why a refill from a different manufacturer can carry warning text that reads differently without anything about Warfarin or its risks having changed.
Warfarin is dispensed under 47 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 Warfarin have a black box warning?
Yes. 47 FDA-approved labels for Warfarin carry a boxed warning, and its subject is bleeding risk. 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 Warfarin 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 17 June 2025, the warning concerns bleeding risk. The full text is linked so the exact version can be read rather than summarised.
Does the Warfarin boxed warning mean the drug is unsafe or being withdrawn?
No. It means the FDA requires the risk of bleeding risk to be communicated prominently so prescribers weigh it explicitly. Warfarin remains FDA-approved and is dispensed under 47 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 Warfarin labels sampled here, 4 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 Warfarin because of this warning?
This page does not answer that and cannot. The warning about bleeding risk is written for a prescriber deciding whether Warfarin 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 Warfarin label, linked below by its DailyMed set identifier so the exact version can be opened rather than taken on trust. The figure of 47 labels, and the count of 4 distinct wordings among 25 sampled, were computed from the openFDA labelling API on 30 August 2026.
- WARFARIN SODIUM prescribing information, Teva Pharmaceuticals USA, Inc., effective 17 June 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.