ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE and OFF LABEL USE

Overview

OFF LABEL USE is the #1 most commonly reported adverse reaction for ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE, manufactured by Kenvue Brands LLC. There are 180 FDA adverse event reports linking ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE to OFF LABEL USE. This represents approximately 5.9% of all 3,027 adverse event reports for this drug.

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

Reporting Frequency

OFF LABEL USE 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 off label use, the following adverse reactions have been reported for ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE:

• 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
• PRODUCT USE IN UNAPPROVED INDICATION — 76 reports
• ACCIDENTAL EXPOSURE TO PRODUCT — 71 reports

Other Drugs Associated with OFF LABEL USE

The following drugs have also been linked to off label use in FDA adverse event reports:

Does ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE cause OFF LABEL USE?

OFF LABEL USE has been reported as an adverse event in 180 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 OFF LABEL USE with ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE?

OFF LABEL USE accounts for approximately 5.9% of all adverse event reports for ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE, making it one of the most commonly reported side effect.

What should I do if I experience OFF LABEL USE while taking ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE?

If you experience off label use 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.

Related Pages