ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE

N/A

Manufactured by The Procter & Gamble Manufacturing Company

3,300 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE

ACETAMINOPHEN, DEXTROMETHORPHAN HBR, 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 HBR, 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 HBR, DOXYLAMINE SUCCINATE.

Top Adverse Reactions

COVID 19173 reports
DISEASE RECURRENCE135 reports
NASOPHARYNGITIS123 reports
FATIGUE101 reports
COUGH94 reports
NAUSEA89 reports
DRUG INEFFECTIVE79 reports
DIZZINESS76 reports
DIARRHOEA71 reports
HEADACHE69 reports
VOMITING68 reports
INSOMNIA62 reports
PAIN62 reports
MALAISE55 reports
DYSPNOEA52 reports
FEELING ABNORMAL52 reports
ANXIETY44 reports
PYREXIA44 reports
TOXICITY TO VARIOUS AGENTS43 reports
ASTHENIA38 reports
INFLUENZA37 reports
LOSS OF CONSCIOUSNESS37 reports
RASH37 reports
SOMNOLENCE37 reports
DYSGEUSIA36 reports
OVERDOSE36 reports
PNEUMONIA36 reports
RHINORRHOEA36 reports
NASAL CONGESTION35 reports
FALL34 reports
INTENTIONAL OVERDOSE34 reports
OFF LABEL USE34 reports
OROPHARYNGEAL PAIN34 reports
PRODUCT DOSE OMISSION ISSUE30 reports
PRURITUS30 reports
WEIGHT DECREASED29 reports
DEPRESSION28 reports
DRUG INTERACTION28 reports
ARTHRALGIA27 reports
INCORRECT DOSE ADMINISTERED27 reports
CHRONIC KIDNEY DISEASE26 reports
ACUTE KIDNEY INJURY25 reports
WEIGHT INCREASED25 reports
CHEST PAIN24 reports
PAIN IN EXTREMITY24 reports
SUICIDE ATTEMPT24 reports
ABDOMINAL PAIN UPPER23 reports
BLOOD PRESSURE INCREASED23 reports
PRODUCT USE IN UNAPPROVED INDICATION23 reports
ABDOMINAL DISCOMFORT22 reports
ALOPECIA22 reports
CONDITION AGGRAVATED22 reports
CONSTIPATION22 reports
SEIZURE22 reports
BACK PAIN21 reports
DRUG HYPERSENSITIVITY21 reports
ERYTHEMA21 reports
PERIPHERAL SWELLING21 reports
ABDOMINAL PAIN20 reports
BLOOD GLUCOSE INCREASED20 reports
SINUSITIS20 reports
URINARY TRACT INFECTION20 reports
DRUG DOSE OMISSION19 reports
HYPERHIDROSIS19 reports
HYPERTENSION19 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION19 reports
SINUS TACHYCARDIA19 reports
UPPER RESPIRATORY TRACT INFECTION19 reports
CHILLS18 reports
CONFUSIONAL STATE18 reports
DECREASED APPETITE18 reports
INTENTIONAL PRODUCT MISUSE18 reports
MEMORY IMPAIRMENT18 reports
PARAESTHESIA18 reports
TREMOR18 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS18 reports
BRONCHITIS17 reports
DEHYDRATION17 reports
HYPOAESTHESIA17 reports
MUSCLE SPASMS17 reports
DEATH16 reports
GAIT DISTURBANCE16 reports
ILLNESS16 reports
MIGRAINE16 reports
RENAL FAILURE16 reports
CHEST DISCOMFORT15 reports
DRY MOUTH15 reports
HYPERSENSITIVITY15 reports
LACTIC ACIDOSIS15 reports
BLOOD CREATININE INCREASED14 reports
BLOOD PRESSURE DECREASED14 reports
HYPOTENSION14 reports
INFLUENZA LIKE ILLNESS14 reports
PALPITATIONS14 reports
SYMPTOM RECURRENCE14 reports
URTICARIA14 reports
VISION BLURRED14 reports
ABDOMINAL DISTENSION13 reports
PRODUCT USE ISSUE13 reports
SNEEZING13 reports

Report Outcomes

Out of 1,397 classified reports for ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE:

Serious 44.8%Non-Serious 55.2%

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

Female824 (64.2%)
Male459 (35.8%)

Reports by Age

Age 5337 reports
Age 6425 reports
Age 6625 reports
Age 7125 reports
Age 5424 reports
Age 4222 reports
Age 5922 reports
Age 4821 reports
Age 5720 reports
Age 3819 reports
Age 4719 reports
Age 5519 reports
Age 6119 reports
Age 3018 reports
Age 4618 reports
Age 6518 reports
Age 2517 reports
Age 3317 reports
Age 5817 reports
Age 6917 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, DOXYLAMINE SUCCINATE?

This profile reflects 3,300 FDA FAERS reports that mention ACETAMINOPHEN, DEXTROMETHORPHAN HBR, 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 HBR, 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 HBR, DOXYLAMINE SUCCINATE?

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