3,344 reports of this reaction
2.7% of all FLUOROURACIL reports
#5 most reported adverse reaction
OFF LABEL USE is the #5 most commonly reported adverse reaction for FLUOROURACIL, manufactured by Bausch Health US, LLC. There are 3,344 FDA adverse event reports linking FLUOROURACIL to OFF LABEL USE. This represents approximately 2.7% of all 124,552 adverse event reports for this drug.
Patients taking FLUOROURACIL 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 FLUOROURACIL, but still significant enough to appear in the safety profile.
In addition to off label use, the following adverse reactions have been reported for FLUOROURACIL:
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 3,344 FDA reports for FLUOROURACIL. This does not prove causation, but indicates an association observed in post-market surveillance data.
OFF LABEL USE accounts for approximately 2.7% of all adverse event reports for FLUOROURACIL, making it a notable side effect.
If you experience off label use while taking FLUOROURACIL, 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.