664 reports of this reaction
2.3% of all AMIODARONE HYDROCHLORIDE reports
#6 most reported adverse reaction
PRODUCT USE IN UNAPPROVED INDICATION is the #6 most commonly reported adverse reaction for AMIODARONE HYDROCHLORIDE, manufactured by Upsher-Smith Laboratories, LLC. There are 664 FDA adverse event reports linking AMIODARONE HYDROCHLORIDE to PRODUCT USE IN UNAPPROVED INDICATION. This represents approximately 2.3% of all 29,334 adverse event reports for this drug.
Patients taking AMIODARONE HYDROCHLORIDE 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 AMIODARONE HYDROCHLORIDE, 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 AMIODARONE HYDROCHLORIDE:
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 664 FDA reports for AMIODARONE HYDROCHLORIDE. This does not prove causation, but indicates an association observed in post-market surveillance data.
PRODUCT USE IN UNAPPROVED INDICATION accounts for approximately 2.3% of all adverse event reports for AMIODARONE HYDROCHLORIDE, making it a notable side effect.
If you experience product use in unapproved indication while taking AMIODARONE HYDROCHLORIDE, 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.