ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL

N/A

Manufactured by The Procter & Gamble Manufacturing Company

1,997 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL

ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL 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 HBR, PHENYLEPHRINE HCL include COVID-19, DISEASE RECURRENCE, NASOPHARYNGITIS, NAUSEA, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL.

Top Adverse Reactions

COVID 19129 reports
DISEASE RECURRENCE106 reports
NASOPHARYNGITIS72 reports
NAUSEA69 reports
DRUG INEFFECTIVE66 reports
FATIGUE64 reports
COUGH48 reports
DIZZINESS48 reports
DIARRHOEA47 reports
VOMITING46 reports
HEADACHE39 reports
DYSPNOEA35 reports
FEELING ABNORMAL32 reports
PNEUMONIA32 reports
DYSGEUSIA31 reports
ANXIETY29 reports
OROPHARYNGEAL PAIN29 reports
MALAISE28 reports
PYREXIA28 reports
PAIN27 reports
PRODUCT USE IN UNAPPROVED INDICATION25 reports
WEIGHT DECREASED24 reports
INSOMNIA23 reports
RASH23 reports
ABDOMINAL PAIN UPPER21 reports
OFF LABEL USE21 reports
BLOOD PRESSURE INCREASED20 reports
SOMNOLENCE20 reports
OVERDOSE19 reports
PRODUCT DOSE OMISSION ISSUE19 reports
CHILLS18 reports
NASAL CONGESTION18 reports
PRURITUS18 reports
URINARY TRACT INFECTION18 reports
CONDITION AGGRAVATED17 reports
ILLNESS17 reports
DRUG INTERACTION16 reports
HYPERTENSION16 reports
TOXICITY TO VARIOUS AGENTS16 reports
URTICARIA16 reports
ACUTE KIDNEY INJURY15 reports
ASTHENIA15 reports
BRONCHITIS15 reports
DECREASED APPETITE15 reports
INFLUENZA15 reports
RHINORRHOEA15 reports
ARTHRALGIA14 reports
BACK PAIN14 reports
FALL14 reports
ABDOMINAL DISCOMFORT13 reports
CONFUSIONAL STATE13 reports
HEART RATE INCREASED13 reports
HYPERHIDROSIS13 reports
SINUSITIS13 reports
TREMOR13 reports
CHEST PAIN12 reports
DRUG HYPERSENSITIVITY12 reports
WEIGHT INCREASED12 reports
CHEST DISCOMFORT11 reports
ERYTHEMA11 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION11 reports
LOSS OF CONSCIOUSNESS11 reports
MYALGIA11 reports
SURGERY11 reports
CHRONIC KIDNEY DISEASE10 reports
CONSTIPATION10 reports
HYPERSENSITIVITY10 reports
PRODUCT ADMINISTRATION INTERRUPTED10 reports
ABDOMINAL PAIN9 reports
DEPRESSION9 reports
HALLUCINATION9 reports
HYPOAESTHESIA9 reports
INCORRECT DOSE ADMINISTERED9 reports
MUSCLE SPASMS9 reports
PRODUCT USE ISSUE9 reports
PRODUCTIVE COUGH9 reports
SEIZURE9 reports
SYNCOPE9 reports
ASTHMA8 reports
BLOOD GLUCOSE INCREASED8 reports
EPISTAXIS8 reports
HYPOTENSION8 reports
INFLUENZA LIKE ILLNESS8 reports
LETHARGY8 reports
PAIN IN EXTREMITY8 reports
PALPITATIONS8 reports
PERIPHERAL SWELLING8 reports
RENAL FAILURE8 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE8 reports
ALANINE AMINOTRANSFERASE INCREASED7 reports
ALOPECIA7 reports
ASPARTATE AMINOTRANSFERASE INCREASED7 reports
COMPLETED SUICIDE7 reports
DEHYDRATION7 reports
DRUG DOSE OMISSION7 reports
HOSPITALISATION7 reports
IRRITABILITY7 reports
MEMORY IMPAIRMENT7 reports
RESPIRATORY TRACT CONGESTION7 reports
SARS COV 2 TEST POSITIVE7 reports

Report Outcomes

Out of 890 classified reports for ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL:

Serious 38.4%Non-Serious 61.6%

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

Female551 (68.4%)
Male250 (31.1%)
Unknown4 (0.5%)

Reports by Age

Age 2722 reports
Age 6418 reports
Age 3117 reports
Age 4517 reports
Age 5416 reports
Age 3415 reports
Age 4015 reports
Age 4314 reports
Age 5914 reports
Age 5013 reports
Age 5113 reports
Age 5713 reports
Age 6013 reports
Age 3012 reports
Age 3312 reports
Age 3912 reports
Age 5812 reports
Age 6612 reports
Age 2811 reports
Age 3211 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 HBR, PHENYLEPHRINE HCL?

This profile reflects 1,997 FDA FAERS reports that mention ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL?

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

Who manufactures ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL?

Labeling and FAERS entries often list The Procter & Gamble Manufacturing Company in connection with ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL. 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.