3,306 reports of this reaction
5.5% of all DARATUMUMAB reports
#2 most reported adverse reaction
OFF LABEL USE is the #2 most commonly reported adverse reaction for DARATUMUMAB, manufactured by Janssen Biotech, Inc.. There are 3,306 FDA adverse event reports linking DARATUMUMAB to OFF LABEL USE. This represents approximately 5.5% of all 59,976 adverse event reports for this drug.
Patients taking DARATUMUMAB 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 moderately reported among DARATUMUMAB users, representing a notable but not dominant share of adverse events.
In addition to off label use, the following adverse reactions have been reported for DARATUMUMAB:
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 3,306 FDA reports for DARATUMUMAB. This does not prove causation, but indicates an association observed in post-market surveillance data.
OFF LABEL USE accounts for approximately 5.5% of all adverse event reports for DARATUMUMAB, making it one of the most commonly reported side effect.
If you experience off label use while taking DARATUMUMAB, 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.