ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE

N/A

Manufactured by The Procter & Gamble Manufacturing Company

2,034 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by The Procter & Gamble Manufacturing Company. The most commonly reported adverse reactions for ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE include COVID-19, DISEASE RECURRENCE, NAUSEA, NASOPHARYNGITIS, DIZZINESS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE.

Top Adverse Reactions

COVID 19129 reports
DISEASE RECURRENCE107 reports
NAUSEA71 reports
NASOPHARYNGITIS65 reports
DIZZINESS58 reports
FATIGUE56 reports
DIARRHOEA54 reports
DRUG INEFFECTIVE54 reports
COUGH50 reports
HEADACHE46 reports
VOMITING43 reports
DYSPNOEA37 reports
OROPHARYNGEAL PAIN33 reports
PNEUMONIA32 reports
PYREXIA30 reports
DYSGEUSIA29 reports
PAIN27 reports
PRODUCT USE IN UNAPPROVED INDICATION27 reports
ANXIETY26 reports
FEELING ABNORMAL26 reports
OVERDOSE24 reports
MALAISE23 reports
RASH22 reports
SOMNOLENCE22 reports
INSOMNIA21 reports
NASAL CONGESTION21 reports
OFF LABEL USE21 reports
PRURITUS21 reports
URTICARIA21 reports
ABDOMINAL PAIN UPPER20 reports
BLOOD PRESSURE INCREASED19 reports
CHILLS19 reports
HYPERHIDROSIS18 reports
LOSS OF CONSCIOUSNESS18 reports
RHINORRHOEA18 reports
CONDITION AGGRAVATED17 reports
FALL17 reports
SINUSITIS17 reports
HALLUCINATION16 reports
HEART RATE INCREASED16 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION16 reports
URINARY TRACT INFECTION16 reports
ACUTE KIDNEY INJURY15 reports
ARTHRALGIA15 reports
CONFUSIONAL STATE15 reports
PRODUCT DOSE OMISSION ISSUE15 reports
WEIGHT DECREASED15 reports
ABDOMINAL DISCOMFORT14 reports
BACK PAIN14 reports
BRONCHITIS14 reports
CHEST PAIN14 reports
DRUG INTERACTION14 reports
HYPERTENSION14 reports
TOXICITY TO VARIOUS AGENTS14 reports
DRUG HYPERSENSITIVITY13 reports
INFLUENZA13 reports
ASTHENIA12 reports
CHEST DISCOMFORT12 reports
DECREASED APPETITE12 reports
ERYTHEMA12 reports
ILLNESS12 reports
PRODUCTIVE COUGH12 reports
SEIZURE12 reports
TREMOR12 reports
WEIGHT INCREASED12 reports
CONSTIPATION11 reports
HYPERSENSITIVITY11 reports
INCORRECT DOSE ADMINISTERED11 reports
PRODUCT USE ISSUE11 reports
SYNCOPE11 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS11 reports
ABDOMINAL PAIN10 reports
CHRONIC KIDNEY DISEASE10 reports
HYPOAESTHESIA10 reports
INFECTION10 reports
MUSCLE SPASMS10 reports
DRUG ADMINISTRATION ERROR9 reports
EPISTAXIS9 reports
LETHARGY9 reports
MEMORY IMPAIRMENT9 reports
MYALGIA9 reports
PAIN IN EXTREMITY9 reports
COMPLETED SUICIDE8 reports
DEHYDRATION8 reports
FLUSHING8 reports
PERIPHERAL SWELLING8 reports
PRODUCT ADMINISTRATION ERROR8 reports
PRODUCT ADMINISTRATION INTERRUPTED8 reports
SWELLING FACE8 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE8 reports
CHOKING7 reports
DEPRESSION7 reports
EXPIRED PRODUCT ADMINISTERED7 reports
INFLUENZA LIKE ILLNESS7 reports
PALPITATIONS7 reports
RESPIRATORY TRACT CONGESTION7 reports
SARS COV 2 TEST POSITIVE7 reports
TASTE DISORDER7 reports
THROAT IRRITATION7 reports
UPPER RESPIRATORY TRACT INFECTION7 reports

Report Outcomes

Out of 888 classified reports for ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE:

Serious 40.3%Non-Serious 59.7%

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

Female543 (67.2%)
Male265 (32.8%)

Reports by Age

Age 2720 reports
Age 3116 reports
Age 3415 reports
Age 4015 reports
Age 4515 reports
Age 5014 reports
Age 5814 reports
Age 5914 reports
Age 6014 reports
Age 6414 reports
Age 5113 reports
Age 5413 reports
Age 6613 reports
Age 3012 reports
Age 3912 reports
Age 4312 reports
Age 4812 reports
Age 2811 reports
Age 3211 reports
Age 4911 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, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE?

This profile reflects 2,034 FDA FAERS reports that mention ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, 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, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE?

Frequently reported terms in FAERS include COVID-19, DISEASE RECURRENCE, NAUSEA, NASOPHARYNGITIS, DIZZINESS, FATIGUE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE?

Labeling and FAERS entries often list The Procter & Gamble Manufacturing Company in connection with ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, 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.