3,833 reports of this reaction
10.3% of all ACETAMINOPHEN, ASPIRIN, AND CAFFEINE reports
#2 most reported adverse reaction
PRODUCT USE IN UNAPPROVED INDICATION is the #2 most commonly reported adverse reaction for ACETAMINOPHEN, ASPIRIN, AND CAFFEINE, manufactured by Haleon US Holdings LLC. There are 3,833 FDA adverse event reports linking ACETAMINOPHEN, ASPIRIN, AND CAFFEINE to PRODUCT USE IN UNAPPROVED INDICATION. This represents approximately 10.3% of all 37,042 adverse event reports for this drug.
Patients taking ACETAMINOPHEN, ASPIRIN, AND CAFFEINE 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 frequently reported adverse event for ACETAMINOPHEN, ASPIRIN, AND CAFFEINE, accounting for a significant proportion of all reports.
In addition to product use in unapproved indication, the following adverse reactions have been reported for ACETAMINOPHEN, ASPIRIN, AND CAFFEINE:
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 3,833 FDA reports for ACETAMINOPHEN, ASPIRIN, AND CAFFEINE. This does not prove causation, but indicates an association observed in post-market surveillance data.
PRODUCT USE IN UNAPPROVED INDICATION accounts for approximately 10.3% of all adverse event reports for ACETAMINOPHEN, ASPIRIN, AND CAFFEINE, making it one of the most commonly reported side effect.
If you experience product use in unapproved indication while taking ACETAMINOPHEN, ASPIRIN, AND CAFFEINE, 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.