14,225 reports of this reaction
6.4% of all TACROLIMUS reports
#1 most reported adverse reaction
OFF LABEL USE is the #1 most commonly reported adverse reaction for TACROLIMUS, manufactured by Astellas Pharma US, Inc.. There are 14,225 FDA adverse event reports linking TACROLIMUS to OFF LABEL USE. This represents approximately 6.4% of all 222,557 adverse event reports for this drug.
TACROLIMUS has an overall safety score of 90 out of 100. Patients taking TACROLIMUS 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 TACROLIMUS 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 TACROLIMUS:
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 14,225 FDA reports for TACROLIMUS. This does not prove causation, but indicates an association observed in post-market surveillance data.
OFF LABEL USE accounts for approximately 6.4% of all adverse event reports for TACROLIMUS, making it one of the most commonly reported side effect.
If you experience off label use while taking TACROLIMUS, 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.