Yes. 26 FDA-approved labels for Rivaroxaban carry a boxed warning, and its subject is premature discontinuation of xarelto increases the risk of thrombotic events, (b) spinal/epidural hematoma warning. 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 Rivaroxaban warning opens on one specific label, identified underneath it. Of the 25 Rivaroxaban labels sampled, 15 carried materially different wordings, and this was the most common, used by 5 of them.
WARNING: (A) PREMATURE DISCONTINUATION OF XARELTO INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA WARNING: (A) PREMATURE DISCONTINUATION OF XARELTO INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA See full prescribing information for complete boxed warning. (A) Premature discontinuation of XARELTO increases the risk of thrombotic events Premature discontinuation of any oral anticoagulant, including XARELTO, increases the risk of thrombotic events. To reduce this risk, consider coverage with another anticoagulant if XARELTO is discontinued for a reason other than pathological bleeding or completion of a course of therapy.
RIVAROXABAN, Aphena Pharma Solutions - Tennessee, LLC, label version effective 17 February 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 Rivaroxaban 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 Rivaroxaban or its risks having changed.
Rivaroxaban is dispensed under 26 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 Rivaroxaban have a black box warning?
Yes. 26 FDA-approved labels for Rivaroxaban carry a boxed warning, and its subject is premature discontinuation of xarelto increases the risk of thrombotic events, (b) spinal/epidural hematoma warning. 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 Rivaroxaban 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 February 2023, the warning concerns premature discontinuation of xarelto increases the risk of thrombotic events, (b) spinal/epidural hematoma warning. The full text is linked so the exact version can be read rather than summarised.
Does the Rivaroxaban boxed warning mean the drug is unsafe or being withdrawn?
No. It means the FDA requires the risk of premature discontinuation of xarelto increases the risk of thrombotic events, (b) spinal/epidural hematoma warning to be communicated prominently so prescribers weigh it explicitly. Rivaroxaban remains FDA-approved and is dispensed under 26 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 Rivaroxaban 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 Rivaroxaban because of this warning?
This page does not answer that and cannot. The warning about premature discontinuation of xarelto increases the risk of thrombotic events, (b) spinal/epidural hematoma warning is written for a prescriber deciding whether Rivaroxaban 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 Rivaroxaban label, linked below by its DailyMed set identifier so the exact version can be opened rather than taken on trust. The figure of 26 labels, and the count of 15 distinct wordings among 25 sampled, were computed from the openFDA labelling API on 30 August 2026.
- RIVAROXABAN prescribing information, Aphena Pharma Solutions - Tennessee, LLC, effective 17 February 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.