ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE and PRODUCT USE IN UNAPPROVED INDICATION

Overview

PRODUCT USE IN UNAPPROVED INDICATION is the #10 most commonly reported adverse reaction for ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE, manufactured by Kenvue Brands LLC. There are 76 FDA adverse event reports linking ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE to PRODUCT USE IN UNAPPROVED INDICATION. This represents approximately 2.5% of all 3,027 adverse event reports for this drug.

Patients taking ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE 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.

Reporting Frequency

PRODUCT USE IN UNAPPROVED INDICATION is a less commonly reported adverse event for ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE, but still significant enough to appear in the safety profile.

Other Side Effects of ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE

In addition to product use in unapproved indication, the following adverse reactions have been reported for ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE:

• OFF LABEL USE — 180 reports
• VOMITING — 141 reports
• DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE — 132 reports
• WRONG TECHNIQUE IN PRODUCT USAGE PROCESS — 125 reports
• INCORRECT DOSE ADMINISTERED — 123 reports
• PRODUCT USE ISSUE — 107 reports
• DRUG INEFFECTIVE — 106 reports
• PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE — 94 reports
• ACCIDENTAL EXPOSURE TO PRODUCT BY CHILD — 88 reports
• ACCIDENTAL EXPOSURE TO PRODUCT — 71 reports

Other Drugs Associated with PRODUCT USE IN UNAPPROVED INDICATION

The following drugs have also been linked to product use in unapproved indication in FDA adverse event reports:

Does ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE cause PRODUCT USE IN UNAPPROVED INDICATION?

PRODUCT USE IN UNAPPROVED INDICATION has been reported as an adverse event in 76 FDA reports for ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE. This does not prove causation, but indicates an association observed in post-market surveillance data.

How common is PRODUCT USE IN UNAPPROVED INDICATION with ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE?

PRODUCT USE IN UNAPPROVED INDICATION accounts for approximately 2.5% of all adverse event reports for ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE, making it a notable side effect.

What should I do if I experience PRODUCT USE IN UNAPPROVED INDICATION while taking ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE?

If you experience product use in unapproved indication while taking ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE 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.

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