ACETAMINOPHEN, DEXTROMETHORPHAN HBR

N/A

Manufactured by The Procter & Gamble Manufacturing Company

1,934 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ACETAMINOPHEN, DEXTROMETHORPHAN HBR

ACETAMINOPHEN, DEXTROMETHORPHAN HBR 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 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.

Top Adverse Reactions

COVID 19127 reports
DISEASE RECURRENCE105 reports
NASOPHARYNGITIS67 reports
NAUSEA67 reports
DRUG INEFFECTIVE66 reports
FATIGUE59 reports
COUGH47 reports
DIARRHOEA47 reports
DIZZINESS47 reports
VOMITING46 reports
HEADACHE39 reports
PNEUMONIA35 reports
DYSPNOEA33 reports
DYSGEUSIA32 reports
ANXIETY30 reports
FEELING ABNORMAL28 reports
PYREXIA28 reports
OROPHARYNGEAL PAIN27 reports
PAIN27 reports
PRODUCT USE IN UNAPPROVED INDICATION27 reports
MALAISE24 reports
INSOMNIA21 reports
OFF LABEL USE21 reports
RASH21 reports
ABDOMINAL PAIN UPPER20 reports
OVERDOSE20 reports
SOMNOLENCE20 reports
CHILLS19 reports
NASAL CONGESTION19 reports
WEIGHT DECREASED19 reports
CONDITION AGGRAVATED18 reports
DRUG INTERACTION16 reports
TOXICITY TO VARIOUS AGENTS16 reports
URINARY TRACT INFECTION16 reports
ACUTE KIDNEY INJURY15 reports
ASTHENIA15 reports
BLOOD PRESSURE INCREASED15 reports
BRONCHITIS15 reports
HYPERTENSION15 reports
INFLUENZA15 reports
PRURITUS15 reports
RECALLED PRODUCT ADMINISTERED15 reports
RHINORRHOEA15 reports
URTICARIA15 reports
ARTHRALGIA14 reports
CONFUSIONAL STATE14 reports
PRODUCT DOSE OMISSION ISSUE14 reports
SINUSITIS14 reports
BACK PAIN13 reports
DECREASED APPETITE13 reports
HEART RATE INCREASED13 reports
HYPERHIDROSIS13 reports
ILLNESS13 reports
ABDOMINAL DISCOMFORT12 reports
CHEST PAIN12 reports
FALL12 reports
TREMOR12 reports
MYALGIA11 reports
WEIGHT INCREASED11 reports
CHRONIC KIDNEY DISEASE10 reports
DRUG HYPERSENSITIVITY10 reports
ERYTHEMA10 reports
HALLUCINATION10 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION10 reports
LOSS OF CONSCIOUSNESS10 reports
MUSCLE SPASMS10 reports
SEIZURE10 reports
ABDOMINAL PAIN9 reports
CHEST DISCOMFORT9 reports
CONSTIPATION9 reports
DEPRESSION9 reports
INCORRECT DOSE ADMINISTERED9 reports
PRODUCT USE ISSUE9 reports
PRODUCTIVE COUGH9 reports
ALOPECIA8 reports
BLOOD GLUCOSE INCREASED8 reports
EPISTAXIS8 reports
HYPERSENSITIVITY8 reports
HYPOAESTHESIA8 reports
HYPOTENSION8 reports
INFLUENZA LIKE ILLNESS8 reports
LETHARGY8 reports
PAIN IN EXTREMITY8 reports
PRODUCT ADMINISTRATION INTERRUPTED8 reports
RENAL FAILURE8 reports
SYNCOPE8 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE8 reports
THERAPEUTIC RESPONSE UNEXPECTED8 reports
ALANINE AMINOTRANSFERASE INCREASED7 reports
ASPARTATE AMINOTRANSFERASE INCREASED7 reports
ASTHMA7 reports
COMPLETED SUICIDE7 reports
DEHYDRATION7 reports
IRRITABILITY7 reports
PALPITATIONS7 reports
RESPIRATORY TRACT CONGESTION7 reports
SARS COV 2 TEST POSITIVE7 reports
SNEEZING7 reports
SURGERY7 reports
TASTE DISORDER7 reports

Report Outcomes

Out of 860 classified reports for ACETAMINOPHEN, DEXTROMETHORPHAN HBR:

Serious 37.8%Non-Serious 62.2%

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

Female522 (68.6%)
Male235 (30.9%)
Unknown4 (0.5%)

Reports by Age

Age 2723 reports
Age 3117 reports
Age 3416 reports
Age 4516 reports
Age 4015 reports
Age 5114 reports
Age 6414 reports
Age 3313 reports
Age 3913 reports
Age 4313 reports
Age 5013 reports
Age 5413 reports
Age 3012 reports
Age 3212 reports
Age 6012 reports
Age 6612 reports
Age 2811 reports
Age 4911 reports
Age 5811 reports
Age 5911 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?

This profile reflects 1,934 FDA FAERS reports that mention ACETAMINOPHEN, DEXTROMETHORPHAN HBR. 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?

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?

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