487 reports of this reaction
2.0% of all TOLVAPTAN reports
#7 most reported adverse reaction
PRODUCT USE IN UNAPPROVED INDICATION is the #7 most commonly reported adverse reaction for TOLVAPTAN, manufactured by Otsuka America Pharmaceutical, Inc.. There are 487 FDA adverse event reports linking TOLVAPTAN to PRODUCT USE IN UNAPPROVED INDICATION. This represents approximately 2.0% of all 24,584 adverse event reports for this drug.
Patients taking TOLVAPTAN 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 TOLVAPTAN, 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 TOLVAPTAN:
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 487 FDA reports for TOLVAPTAN. This does not prove causation, but indicates an association observed in post-market surveillance data.
PRODUCT USE IN UNAPPROVED INDICATION accounts for approximately 2.0% of all adverse event reports for TOLVAPTAN, making it a notable side effect.
If you experience product use in unapproved indication while taking TOLVAPTAN, 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.