5,813 reports of this reaction
3.2% of all TACROLIMUS EXTENDED RELEASE CAPSULES reports
#3 most reported adverse reaction
PRODUCT USE IN UNAPPROVED INDICATION is the #3 most commonly reported adverse reaction for TACROLIMUS EXTENDED RELEASE CAPSULES, manufactured by Astellas Pharma US, Inc.. There are 5,813 FDA adverse event reports linking TACROLIMUS EXTENDED RELEASE CAPSULES to PRODUCT USE IN UNAPPROVED INDICATION. This represents approximately 3.2% of all 181,869 adverse event reports for this drug.
TACROLIMUS EXTENDED RELEASE CAPSULES has an overall safety score of 92 out of 100. Patients taking TACROLIMUS EXTENDED RELEASE CAPSULES 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 TACROLIMUS EXTENDED RELEASE CAPSULES 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 TACROLIMUS EXTENDED RELEASE CAPSULES:
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 5,813 FDA reports for TACROLIMUS EXTENDED RELEASE CAPSULES. This does not prove causation, but indicates an association observed in post-market surveillance data.
PRODUCT USE IN UNAPPROVED INDICATION accounts for approximately 3.2% of all adverse event reports for TACROLIMUS EXTENDED RELEASE CAPSULES, making it one of the most commonly reported side effect.
If you experience product use in unapproved indication while taking TACROLIMUS EXTENDED RELEASE CAPSULES, 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.