ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE

N/A

Manufactured by Kenvue Brands LLC

3,027 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE

ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Kenvue Brands LLC. The most commonly reported adverse reactions for ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE include OFF LABEL USE, VOMITING, DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS, INCORRECT DOSE ADMINISTERED. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE.

Top Adverse Reactions

OFF LABEL USE180 reports
VOMITING141 reports
DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE132 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS125 reports
INCORRECT DOSE ADMINISTERED123 reports
PRODUCT USE ISSUE107 reports
DRUG INEFFECTIVE106 reports
PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE94 reports
ACCIDENTAL EXPOSURE TO PRODUCT BY CHILD88 reports
PRODUCT USE IN UNAPPROVED INDICATION76 reports
ACCIDENTAL EXPOSURE TO PRODUCT71 reports
DRUG ADMINISTRATION ERROR64 reports
PYREXIA64 reports
EXPIRED PRODUCT ADMINISTERED59 reports
EXTRA DOSE ADMINISTERED57 reports
PRODUCT QUALITY ISSUE48 reports
SEIZURE42 reports
ACCIDENTAL OVERDOSE39 reports
PRODUCT PACKAGING ISSUE38 reports
FAILURE OF CHILD RESISTANT MECHANISM FOR PHARMACEUTICAL PRODUCT36 reports
PRODUCT DOSE OMISSION ISSUE35 reports
DIARRHOEA34 reports
RASH33 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION32 reports
THERAPEUTIC RESPONSE UNEXPECTED32 reports
COUGH31 reports
INTENTIONAL PRODUCT MISUSE31 reports
OVERDOSE30 reports
MALAISE27 reports
NAUSEA27 reports
WRONG DRUG ADMINISTERED27 reports
HEADACHE26 reports
URTICARIA26 reports
DEATH25 reports
FATIGUE25 reports
PNEUMONIA25 reports
ABDOMINAL PAIN UPPER24 reports
DECREASED APPETITE24 reports
HEPATIC ENZYME INCREASED21 reports
WEIGHT INCREASED21 reports
HYPERSENSITIVITY20 reports
RETCHING20 reports
EAR INFECTION19 reports
HYPERSOMNIA19 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION19 reports
INSOMNIA19 reports
PAIN19 reports
PRODUCT PHYSICAL ISSUE19 reports
ASTHENIA17 reports
ILLNESS17 reports
SOMNOLENCE17 reports
ABDOMINAL DISCOMFORT16 reports
ANXIETY16 reports
CRYING16 reports
DRUG PRESCRIBING ERROR16 reports
PRURITUS16 reports
WEIGHT DECREASED16 reports
ABNORMAL BEHAVIOUR15 reports
DRUG EFFECT INCOMPLETE15 reports
FALL15 reports
MEDICATION ERROR15 reports
SINUSITIS15 reports
TREMOR15 reports
CONSTIPATION14 reports
ACUTE HEPATIC FAILURE13 reports
INTENTIONAL PRODUCT USE ISSUE13 reports
LETHARGY13 reports
PSYCHOMOTOR HYPERACTIVITY13 reports
SUSPECTED PRODUCT CONTAMINATION13 reports
CONTUSION12 reports
INFLUENZA12 reports
NASOPHARYNGITIS12 reports
PRODUCT LABEL ISSUE12 reports
ABDOMINAL PAIN11 reports
ARTHRALGIA11 reports
AUTISM SPECTRUM DISORDER11 reports
BALANCE DISORDER11 reports
DRUG HYPERSENSITIVITY11 reports
FLATULENCE11 reports
HOSPITALISATION11 reports
PRODUCT TASTE ABNORMAL11 reports
CONDITION AGGRAVATED10 reports
COVID 1910 reports
ERYTHEMA10 reports
SEPSIS10 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE10 reports
THROAT IRRITATION10 reports
VIRAL INFECTION10 reports
ADVERSE EVENT9 reports
DIZZINESS9 reports
DRUG INTOLERANCE9 reports
DYSPHAGIA9 reports
GAIT DISTURBANCE9 reports
MUSCLE SPASMS9 reports
PRODUCT CONTAMINATION PHYSICAL9 reports
RHINORRHOEA9 reports
UNDERDOSE9 reports
ABDOMINAL DISTENSION8 reports
BACK PAIN8 reports
BLOOD GLUCOSE INCREASED8 reports

Report Outcomes

Out of 1,860 classified reports for ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE:

Serious 21.6%Non-Serious 78.4%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female838 (51.8%)
Male765 (47.3%)
Unknown16 (1.0%)

Reports by Age

Age 3101 reports
Age 4100 reports
Age 579 reports
Age 273 reports
Age 2464 reports
Age 662 reports
Age 759 reports
Age 1057 reports
Age 856 reports
Age 942 reports
Age 1140 reports
Age 1240 reports
Age 3634 reports
Age 1422 reports
Age 121 reports
Age 1317 reports
Age 1817 reports
Age 1515 reports
Age 3015 reports
Age 1611 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE?

This profile reflects 3,027 FDA FAERS reports that mention ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE?

Frequently reported terms in FAERS include OFF LABEL USE, VOMITING, DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS, INCORRECT DOSE ADMINISTERED, PRODUCT USE ISSUE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE?

Labeling and FAERS entries often list Kenvue Brands LLC in connection with ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.