19 reports of this reaction
2.0% of all PHENOBARBITAL SODIUM reports
#5 most reported adverse reaction
PRODUCT USE IN UNAPPROVED INDICATION is the #5 most commonly reported adverse reaction for PHENOBARBITAL SODIUM, manufactured by BPI Labs LLC. There are 19 FDA adverse event reports linking PHENOBARBITAL SODIUM to PRODUCT USE IN UNAPPROVED INDICATION. This represents approximately 2.0% of all 956 adverse event reports for this drug.
Patients taking PHENOBARBITAL SODIUM 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 PHENOBARBITAL SODIUM, 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 PHENOBARBITAL SODIUM:
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 19 FDA reports for PHENOBARBITAL SODIUM. 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 PHENOBARBITAL SODIUM, making it a notable side effect.
If you experience product use in unapproved indication while taking PHENOBARBITAL SODIUM, 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.