ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE

N/A

Manufactured by The Procter & Gamble Manufacturing Company

3,480 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE 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, AND DOXYLAMINE SUCCINATE include COVID-19, DISEASE RECURRENCE, NASOPHARYNGITIS, FATIGUE, COUGH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE.

Top Adverse Reactions

COVID 19175 reports
DISEASE RECURRENCE136 reports
NASOPHARYNGITIS126 reports
FATIGUE104 reports
COUGH97 reports
NAUSEA96 reports
DRUG INEFFECTIVE83 reports
DIZZINESS78 reports
DIARRHOEA77 reports
VOMITING74 reports
HEADACHE73 reports
PAIN66 reports
INSOMNIA65 reports
MALAISE55 reports
DYSPNOEA54 reports
FEELING ABNORMAL54 reports
TOXICITY TO VARIOUS AGENTS48 reports
ANXIETY46 reports
PYREXIA46 reports
LOSS OF CONSCIOUSNESS43 reports
ASTHENIA40 reports
INFLUENZA39 reports
SOMNOLENCE39 reports
INTENTIONAL OVERDOSE38 reports
OVERDOSE38 reports
PNEUMONIA38 reports
FALL37 reports
RASH37 reports
RHINORRHOEA37 reports
DYSGEUSIA36 reports
OFF LABEL USE36 reports
OROPHARYNGEAL PAIN36 reports
NASAL CONGESTION34 reports
WEIGHT DECREASED31 reports
PRODUCT DOSE OMISSION ISSUE30 reports
DEPRESSION29 reports
PRURITUS29 reports
ARTHRALGIA28 reports
DRUG INTERACTION28 reports
INCORRECT DOSE ADMINISTERED28 reports
ABDOMINAL PAIN UPPER27 reports
BLOOD GLUCOSE INCREASED27 reports
CHRONIC KIDNEY DISEASE27 reports
ACUTE KIDNEY INJURY26 reports
BLOOD PRESSURE INCREASED26 reports
CHEST PAIN26 reports
ABDOMINAL DISCOMFORT25 reports
PAIN IN EXTREMITY25 reports
SUICIDE ATTEMPT25 reports
WEIGHT INCREASED25 reports
BACK PAIN24 reports
CONDITION AGGRAVATED24 reports
PRODUCT USE IN UNAPPROVED INDICATION24 reports
CONSTIPATION23 reports
SINUS TACHYCARDIA23 reports
ABDOMINAL PAIN22 reports
ALOPECIA22 reports
DRUG HYPERSENSITIVITY22 reports
ERYTHEMA22 reports
PERIPHERAL SWELLING22 reports
SEIZURE22 reports
SINUSITIS22 reports
CHILLS21 reports
HYPERHIDROSIS21 reports
DECREASED APPETITE20 reports
HYPERTENSION20 reports
TREMOR20 reports
UPPER RESPIRATORY TRACT INFECTION20 reports
URINARY TRACT INFECTION20 reports
CONFUSIONAL STATE19 reports
DRUG DOSE OMISSION19 reports
ILLNESS19 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION19 reports
INTENTIONAL PRODUCT MISUSE19 reports
LACTIC ACIDOSIS19 reports
MEMORY IMPAIRMENT19 reports
BLOOD CREATININE INCREASED18 reports
BRONCHITIS18 reports
DEATH18 reports
DEHYDRATION18 reports
MIGRAINE18 reports
PARAESTHESIA18 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS18 reports
BLOOD PRESSURE DECREASED17 reports
GAIT DISTURBANCE17 reports
HYPOAESTHESIA17 reports
MUSCLE SPASMS17 reports
RENAL FAILURE17 reports
ANION GAP INCREASED16 reports
CHEST DISCOMFORT16 reports
DRY MOUTH16 reports
HYPERSENSITIVITY16 reports
OSMOLAR GAP INCREASED15 reports
PRODUCT USE ISSUE15 reports
RESPIRATORY RATE DECREASED15 reports
ABDOMINAL DISTENSION14 reports
HALLUCINATION14 reports
HYPOTENSION14 reports
INFLUENZA LIKE ILLNESS14 reports
SYMPTOM RECURRENCE14 reports

Report Outcomes

Out of 1,424 classified reports for ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE:

Serious 45.3%Non-Serious 54.7%

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

Female839 (64.1%)
Male469 (35.9%)

Reports by Age

Age 5341 reports
Age 5425 reports
Age 6425 reports
Age 6625 reports
Age 7125 reports
Age 4222 reports
Age 4822 reports
Age 4720 reports
Age 5720 reports
Age 5920 reports
Age 6120 reports
Age 3819 reports
Age 5519 reports
Age 6919 reports
Age 3018 reports
Age 4618 reports
Age 6518 reports
Age 2517 reports
Age 3317 reports
Age 5817 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, AND DOXYLAMINE SUCCINATE?

This profile reflects 3,480 FDA FAERS reports that mention ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE. 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, AND DOXYLAMINE SUCCINATE?

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

Who manufactures ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE?

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