8,840 reports of this reaction
6.1% of all MESALAMINE reports
#1 most reported adverse reaction
OFF LABEL USE is the #1 most commonly reported adverse reaction for MESALAMINE, manufactured by Takeda Pharmaceuticals America, Inc.. There are 8,840 FDA adverse event reports linking MESALAMINE to OFF LABEL USE. This represents approximately 6.1% of all 145,688 adverse event reports for this drug.
Patients taking MESALAMINE 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 MESALAMINE 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 MESALAMINE:
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 8,840 FDA reports for MESALAMINE. This does not prove causation, but indicates an association observed in post-market surveillance data.
OFF LABEL USE accounts for approximately 6.1% of all adverse event reports for MESALAMINE, making it one of the most commonly reported side effect.
If you experience off label use while taking MESALAMINE, 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.