ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE

N/A

Manufactured by Kenvue Brands LLC

51 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE

ACETAMINOPHEN 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 AND PHENYLEPHRINE HYDROCHLORIDE include FOETAL EXPOSURE DURING PREGNANCY, INCORRECT DOSE ADMINISTERED, AUTISM SPECTRUM DISORDER, BLOOD PRESSURE INCREASED, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE.

Top Adverse Reactions

FOETAL EXPOSURE DURING PREGNANCY4 reports
INCORRECT DOSE ADMINISTERED4 reports
AUTISM SPECTRUM DISORDER2 reports
BLOOD PRESSURE INCREASED2 reports
HEADACHE2 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION2 reports
OFF LABEL USE2 reports
PRODUCT USE IN UNAPPROVED INDICATION2 reports
BLOOD URINE PRESENT1 reports
CARDIAC ARREST1 reports
CEREBROVASCULAR ACCIDENT1 reports
CIRCULATORY COLLAPSE1 reports
COUGH1 reports
DRUG ADMINISTRATION ERROR1 reports
DRUG INEFFECTIVE1 reports
DYSPEPSIA1 reports
DYSPNOEA1 reports
EAR DISCOMFORT1 reports
EXPIRED PRODUCT ADMINISTERED1 reports
EXPOSURE DURING PREGNANCY1 reports
EXPOSURE VIA BREAST MILK1 reports
GASTRIC ULCER1 reports
GASTROINTESTINAL HAEMORRHAGE1 reports
HEPATOMEGALY1 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION1 reports
JAUNDICE NEONATAL1 reports
LIP SWELLING1 reports
MATERNAL EXPOSURE DURING PREGNANCY1 reports
PERIPHERAL SWELLING1 reports
POSTNATAL GROWTH RESTRICTION1 reports
PRE ECLAMPSIA1 reports
PRODUCT LABEL ISSUE1 reports
PRODUCT TASTE ABNORMAL1 reports
PROLONGED LABOUR1 reports
PRURITUS1 reports
RHABDOMYOLYSIS1 reports
SINUS PAIN1 reports
THROAT IRRITATION1 reports
URINARY TRACT OBSTRUCTION1 reports

Report Outcomes

Out of 21 classified reports for ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE:

Serious 71.4%Non-Serious 28.6%

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

Female9 (56.3%)
Male7 (43.8%)

Reports by Age

Age 31 reports
Age 41 reports
Age 51 reports
Age 121 reports
Age 151 reports
Age 331 reports
Age 521 reports
Age 551 reports
Age 581 reports
Age 621 reports
Age 721 reports
Age 791 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 AND PHENYLEPHRINE HYDROCHLORIDE?

This profile reflects 51 FDA FAERS reports that mention ACETAMINOPHEN 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 AND PHENYLEPHRINE HYDROCHLORIDE?

Frequently reported terms in FAERS include FOETAL EXPOSURE DURING PREGNANCY, INCORRECT DOSE ADMINISTERED, AUTISM SPECTRUM DISORDER, BLOOD PRESSURE INCREASED, HEADACHE, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE?

Labeling and FAERS entries often list Kenvue Brands LLC in connection with ACETAMINOPHEN 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.