430 reports of this reaction
2.4% of all DRONEDARONE reports
#8 most reported adverse reaction
OFF LABEL USE is the #8 most commonly reported adverse reaction for DRONEDARONE, manufactured by Sanofi-Aventis U.S. LLC. There are 430 FDA adverse event reports linking DRONEDARONE to OFF LABEL USE. This represents approximately 2.4% of all 17,724 adverse event reports for this drug.
Patients taking DRONEDARONE 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 DRONEDARONE, but still significant enough to appear in the safety profile.
In addition to off label use, the following adverse reactions have been reported for DRONEDARONE:
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 430 FDA reports for DRONEDARONE. This does not prove causation, but indicates an association observed in post-market surveillance data.
OFF LABEL USE accounts for approximately 2.4% of all adverse event reports for DRONEDARONE, making it a notable side effect.
If you experience off label use while taking DRONEDARONE, 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.