3,656 reports of this reaction
2.0% of all BACLOFEN reports
#8 most reported adverse reaction
OFF LABEL USE is the #8 most commonly reported adverse reaction for BACLOFEN, manufactured by MAIA Pharmaceuticals, Inc.. There are 3,656 FDA adverse event reports linking BACLOFEN to OFF LABEL USE. This represents approximately 2.0% of all 183,365 adverse event reports for this drug.
Patients taking BACLOFEN who experience off label use should discuss this symptom with their healthcare provider to determine whether it may be related to their medication and what alternatives may be available.
OFF LABEL USE is a less commonly reported adverse event for BACLOFEN, but still significant enough to appear in the safety profile.
In addition to off label use, the following adverse reactions have been reported for BACLOFEN:
The following drugs have also been linked to off label use in FDA adverse event reports:
OFF LABEL USE has been reported as an adverse event in 3,656 FDA reports for BACLOFEN. This does not prove causation, but indicates an association observed in post-market surveillance data.
OFF LABEL USE accounts for approximately 2.0% of all adverse event reports for BACLOFEN, making it a notable side effect.
If you experience off label use while taking BACLOFEN, 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.