ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE and PRODUCT USE ISSUE

Overview

PRODUCT USE ISSUE is the #6 most commonly reported adverse reaction for ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE, manufactured by Kenvue Brands LLC. There are 107 FDA adverse event reports linking ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE to PRODUCT USE ISSUE. This represents approximately 3.5% of all 3,027 adverse event reports for this drug.

Patients taking ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE who experience product use issue 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 ISSUE is moderately reported among ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE users, representing a notable but not dominant share of adverse events.

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

In addition to product use issue, 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
• DRUG INEFFECTIVE — 106 reports
• PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE — 94 reports
• ACCIDENTAL EXPOSURE TO PRODUCT BY CHILD — 88 reports
• PRODUCT USE IN UNAPPROVED INDICATION — 76 reports
• ACCIDENTAL EXPOSURE TO PRODUCT — 71 reports

Other Drugs Associated with PRODUCT USE ISSUE

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

Does ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE cause PRODUCT USE ISSUE?

PRODUCT USE ISSUE has been reported as an adverse event in 107 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 ISSUE with ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE?

PRODUCT USE ISSUE accounts for approximately 3.5% 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 ISSUE while taking ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE?

If you experience product use issue 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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