7,808 reports of this reaction
2.6% of all RIVAROXABAN reports
#2 most reported adverse reaction
OFF LABEL USE is the #2 most commonly reported adverse reaction for RIVAROXABAN, manufactured by Janssen Pharmaceuticals, Inc.. There are 7,808 FDA adverse event reports linking RIVAROXABAN to OFF LABEL USE. This represents approximately 2.6% of all 299,230 adverse event reports for this drug.
RIVAROXABAN has an overall safety score of 88 out of 100. Patients taking RIVAROXABAN who experience off label use should discuss this symptom with their healthcare provider to determine whether it may be related to their medication and what alternatives may be available.
OFF LABEL USE is a less commonly reported adverse event for RIVAROXABAN, but still significant enough to appear in the safety profile.
In addition to off label use, the following adverse reactions have been reported for RIVAROXABAN:
The following drugs have also been linked to off label use in FDA adverse event reports:
OFF LABEL USE has been reported as an adverse event in 7,808 FDA reports for RIVAROXABAN. This does not prove causation, but indicates an association observed in post-market surveillance data.
OFF LABEL USE accounts for approximately 2.6% of all adverse event reports for RIVAROXABAN, making it one of the most commonly reported side effect.
If you experience off label use while taking RIVAROXABAN, contact your healthcare provider. They can evaluate whether the symptom is related to your medication and discuss potential adjustments to your treatment plan. Do not stop taking prescribed medication without consulting your doctor.