36,010 reports of this reaction
4.6% of all DUPILUMAB reports
#3 most reported adverse reaction
PRODUCT USE IN UNAPPROVED INDICATION is the #3 most commonly reported adverse reaction for DUPILUMAB, manufactured by sanofi-aventis U.S. LLC. There are 36,010 FDA adverse event reports linking DUPILUMAB to PRODUCT USE IN UNAPPROVED INDICATION. This represents approximately 4.6% of all 782,562 adverse event reports for this drug.
Patients taking DUPILUMAB who experience product use in unapproved indication should discuss this symptom with their healthcare provider to determine whether it may be related to their medication and what alternatives may be available.
PRODUCT USE IN UNAPPROVED INDICATION is moderately reported among DUPILUMAB users, representing a notable but not dominant share of adverse events.
In addition to product use in unapproved indication, the following adverse reactions have been reported for DUPILUMAB:
The following drugs have also been linked to product use in unapproved indication in FDA adverse event reports:
PRODUCT USE IN UNAPPROVED INDICATION has been reported as an adverse event in 36,010 FDA reports for DUPILUMAB. This does not prove causation, but indicates an association observed in post-market surveillance data.
PRODUCT USE IN UNAPPROVED INDICATION accounts for approximately 4.6% of all adverse event reports for DUPILUMAB, making it one of the most commonly reported side effect.
If you experience product use in unapproved indication while taking DUPILUMAB, 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.