5,811 reports of this reaction
3.2% of all TACROLIMUS OINTMENT 0.1% reports
#3 most reported adverse reaction
PRODUCT USE IN UNAPPROVED INDICATION is the #3 most commonly reported adverse reaction for TACROLIMUS OINTMENT 0.1%, manufactured by Encube Ethicals, Inc.. There are 5,811 FDA adverse event reports linking TACROLIMUS OINTMENT 0.1% to PRODUCT USE IN UNAPPROVED INDICATION. This represents approximately 3.2% of all 181,625 adverse event reports for this drug.
TACROLIMUS OINTMENT 0.1% has an overall safety score of 92 out of 100. Patients taking TACROLIMUS OINTMENT 0.1% 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 OINTMENT 0.1% 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 OINTMENT 0.1%:
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 5,811 FDA reports for TACROLIMUS OINTMENT 0.1%. 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 OINTMENT 0.1%, making it one of the most commonly reported side effect.
If you experience product use in unapproved indication while taking TACROLIMUS OINTMENT 0.1%, 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.