6,119 reports of this reaction
2.7% of all TACROLIMUS reports
#4 most reported adverse reaction
PRODUCT USE IN UNAPPROVED INDICATION is the #4 most commonly reported adverse reaction for TACROLIMUS, manufactured by Astellas Pharma US, Inc.. There are 6,119 FDA adverse event reports linking TACROLIMUS to PRODUCT USE IN UNAPPROVED INDICATION. This represents approximately 2.7% 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 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 a less commonly reported adverse event for TACROLIMUS, but still significant enough to appear in the safety profile.
In addition to product use in unapproved indication, the following adverse reactions have been reported for TACROLIMUS:
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 6,119 FDA reports for TACROLIMUS. This does not prove causation, but indicates an association observed in post-market surveillance data.
PRODUCT USE IN UNAPPROVED INDICATION accounts for approximately 2.7% of all adverse event reports for TACROLIMUS, making it a notable side effect.
If you experience product use in unapproved indication 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.