ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE

N/A

Manufactured by The Procter & Gamble Manufacturing Company

1,750 FDA adverse event reports analyzed

Last updated: 2026-04-15

About ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE

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

Top Adverse Reactions

COVID 19126 reports
DISEASE RECURRENCE105 reports
NASOPHARYNGITIS63 reports
NAUSEA59 reports
FATIGUE56 reports
DRUG INEFFECTIVE48 reports
COUGH46 reports
DIARRHOEA46 reports
VOMITING41 reports
DIZZINESS40 reports
HEADACHE35 reports
DYSPNOEA30 reports
DYSGEUSIA28 reports
OROPHARYNGEAL PAIN28 reports
PNEUMONIA25 reports
PYREXIA25 reports
ANXIETY24 reports
MALAISE23 reports
PAIN23 reports
FEELING ABNORMAL22 reports
PRODUCT USE IN UNAPPROVED INDICATION22 reports
INSOMNIA20 reports
OFF LABEL USE20 reports
SOMNOLENCE20 reports
RASH19 reports
ABDOMINAL PAIN UPPER17 reports
NASAL CONGESTION17 reports
OVERDOSE17 reports
CONDITION AGGRAVATED16 reports
ACUTE KIDNEY INJURY15 reports
CHILLS15 reports
DRUG INTERACTION15 reports
PRURITUS15 reports
RHINORRHOEA15 reports
URINARY TRACT INFECTION15 reports
URTICARIA15 reports
WEIGHT DECREASED15 reports
BLOOD PRESSURE INCREASED14 reports
TOXICITY TO VARIOUS AGENTS14 reports
ARTHRALGIA13 reports
BACK PAIN13 reports
CHEST PAIN13 reports
SINUSITIS13 reports
BRONCHITIS12 reports
HYPERHIDROSIS12 reports
HYPERTENSION12 reports
PRODUCT DOSE OMISSION ISSUE12 reports
ABDOMINAL DISCOMFORT11 reports
ASTHENIA11 reports
CONFUSIONAL STATE11 reports
DECREASED APPETITE11 reports
ERYTHEMA11 reports
FALL11 reports
HEART RATE INCREASED11 reports
TREMOR11 reports
WEIGHT INCREASED11 reports
CHRONIC KIDNEY DISEASE10 reports
HYPOAESTHESIA10 reports
ILLNESS10 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION10 reports
INFLUENZA10 reports
PAIN IN EXTREMITY10 reports
ABDOMINAL PAIN9 reports
CHEST DISCOMFORT9 reports
CONSTIPATION9 reports
DEPRESSION9 reports
HYPERSENSITIVITY9 reports
LOSS OF CONSCIOUSNESS9 reports
MYALGIA9 reports
PRODUCT USE ISSUE9 reports
PRODUCTIVE COUGH9 reports
SEIZURE9 reports
DEHYDRATION8 reports
DRUG HYPERSENSITIVITY8 reports
INCORRECT DOSE ADMINISTERED8 reports
PRODUCT ADMINISTRATION INTERRUPTED8 reports
SYNCOPE8 reports
ALOPECIA7 reports
COMPLETED SUICIDE7 reports
HYPOTENSION7 reports
INFLUENZA LIKE ILLNESS7 reports
IRRITABILITY7 reports
LETHARGY7 reports
MEMORY IMPAIRMENT7 reports
MUSCLE SPASMS7 reports
PALPITATIONS7 reports
RESPIRATORY TRACT CONGESTION7 reports
SARS COV 2 TEST POSITIVE7 reports
SURGERY7 reports
TASTE DISORDER7 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE7 reports
ABDOMINAL DISTENSION6 reports
ALCOHOL INTERACTION6 reports
ANOSMIA6 reports
ASPARTATE AMINOTRANSFERASE INCREASED6 reports
ASTHMA6 reports
DRY SKIN6 reports
EPISTAXIS6 reports
GAIT DISTURBANCE6 reports
HALLUCINATION6 reports

Report Outcomes

Out of 760 classified reports for ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE:

Serious 36.4%Non-Serious 63.6%

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

Female484 (68.8%)
Male219 (31.2%)

Reports by Age

Age 2719 reports
Age 3116 reports
Age 3416 reports
Age 4515 reports
Age 4013 reports
Age 5013 reports
Age 5113 reports
Age 6413 reports
Age 3012 reports
Age 4312 reports
Age 4912 reports
Age 5412 reports
Age 6612 reports
Age 2811 reports
Age 6011 reports
Age 3210 reports
Age 3310 reports
Age 3510 reports
Age 3910 reports
Age 4810 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 PHENYLEPHRINE HYDROCHLORIDE?

This profile reflects 1,750 FDA FAERS reports that mention ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, 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, AND PHENYLEPHRINE HYDROCHLORIDE?

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

Who manufactures ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE?

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