BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL

N/A

Manufactured by CVS PHARMACY

94 FDA adverse event reports analyzed

Last updated: 2026-04-15

About BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL

BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by CVS PHARMACY. The most commonly reported adverse reactions for BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL include INTENTIONAL PRODUCT MISUSE, ABNORMAL BEHAVIOUR, ACCIDENTAL OVERDOSE, SEIZURE, SOMNOLENCE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL.

Top Adverse Reactions

INTENTIONAL PRODUCT MISUSE5 reports
ABNORMAL BEHAVIOUR3 reports
ACCIDENTAL OVERDOSE3 reports
SEIZURE3 reports
SOMNOLENCE3 reports
VOMITING3 reports
ACCIDENTAL DRUG INTAKE BY CHILD2 reports
ASTHENIA2 reports
CRYING2 reports
DIZZINESS2 reports
DRUG INEFFECTIVE2 reports
DYSARTHRIA2 reports
FALL2 reports
GAIT DISTURBANCE2 reports
LETHARGY2 reports
LOSS OF CONSCIOUSNESS2 reports
MYDRIASIS2 reports
PNEUMONIA2 reports
PYREXIA2 reports
ABORTION SPONTANEOUS1 reports
ACCIDENTAL EXPOSURE TO PRODUCT1 reports
BLOOD IRON DECREASED1 reports
BLOOD PRESSURE INCREASED1 reports
BRONCHOSPASM1 reports
CROUP INFECTIOUS1 reports
DIARRHOEA1 reports
DRUG EFFECT INCOMPLETE1 reports
DRUG EFFECT PROLONGED1 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION1 reports
DYSGEUSIA1 reports
DYSPNOEA1 reports
ERYTHEMA1 reports
EXPIRED PRODUCT ADMINISTERED1 reports
EXPOSURE DURING PREGNANCY1 reports
EXTRA DOSE ADMINISTERED1 reports
EYE HAEMORRHAGE1 reports
FEELING ABNORMAL1 reports
GASTRIC DISORDER1 reports
HALLUCINATION1 reports
HALLUCINATION, VISUAL1 reports
HEADACHE1 reports
HEART RATE INCREASED1 reports
HEART RATE IRREGULAR1 reports
HYPERHIDROSIS1 reports
HYPERSOMNIA1 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION1 reports
INCORRECT DOSAGE ADMINISTERED1 reports
INTENTIONAL OVERDOSE1 reports
NASOPHARYNGITIS1 reports
NAUSEA1 reports
OCULAR HYPERAEMIA1 reports
OVERDOSE1 reports
PETIT MAL EPILEPSY1 reports
PHARYNGITIS STREPTOCOCCAL1 reports
PREMATURE BABY1 reports
PRESYNCOPE1 reports
PRODUCT COMPLAINT1 reports
PRODUCT TASTE ABNORMAL1 reports
PRODUCT USE IN UNAPPROVED INDICATION1 reports
RESPIRATORY RATE INCREASED1 reports
RESTLESSNESS1 reports
SCIATICA1 reports
TREMOR1 reports
VISION BLURRED1 reports
VITAMIN D DECREASED1 reports
WHEEZING1 reports
WHITE BLOOD CELL COUNT INCREASED1 reports

Report Outcomes

Out of 27 classified reports for BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL:

Serious 63.0%Non-Serious 37.0%

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

Male16 (61.5%)
Female10 (38.5%)

Reports by Age

Age 74 reports
Age 42 reports
Age 732 reports
Age 21 reports
Age 31 reports
Age 81 reports
Age 91 reports
Age 101 reports
Age 111 reports
Age 181 reports
Age 241 reports
Age 371 reports
Age 431 reports
Age 661 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 BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL?

This profile reflects 94 FDA FAERS reports that mention BROMPHENIRAMINE MALEATE, 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 BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL?

Frequently reported terms in FAERS include INTENTIONAL PRODUCT MISUSE, ABNORMAL BEHAVIOUR, ACCIDENTAL OVERDOSE, SEIZURE, SOMNOLENCE, VOMITING. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL?

Labeling and FAERS entries often list CVS PHARMACY in connection with BROMPHENIRAMINE MALEATE, 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.