BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE

N/A

Manufactured by Foundation Consumer Brands

662 FDA adverse event reports analyzed

Last updated: 2026-04-15

About BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE

BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Foundation Consumer Brands. The most commonly reported adverse reactions for BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE include CEREBROVASCULAR ACCIDENT, HAEMORRHAGIC STROKE, CONVULSION, DRUG HYPERSENSITIVITY, INJURY. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE.

Top Adverse Reactions

CEREBROVASCULAR ACCIDENT123 reports
HAEMORRHAGIC STROKE31 reports
CONVULSION23 reports
DRUG HYPERSENSITIVITY16 reports
INJURY16 reports
HEMIPARESIS15 reports
HEADACHE13 reports
ANEURYSM12 reports
HYPERTENSION12 reports
AMNESIA11 reports
CEREBRAL HAEMORRHAGE11 reports
SUBARACHNOID HAEMORRHAGE11 reports
DIZZINESS10 reports
LOSS OF CONSCIOUSNESS10 reports
MYOCARDIAL INFARCTION10 reports
CEREBRAL INFARCTION9 reports
INTRACRANIAL ANEURYSM9 reports
BLOOD PRESSURE INCREASED8 reports
PAIN8 reports
FALL7 reports
ASTHENIA6 reports
CONFUSIONAL STATE6 reports
DRUG INEFFECTIVE6 reports
HEMIPLEGIA6 reports
INTRAVENTRICULAR HAEMORRHAGE6 reports
NASOPHARYNGITIS6 reports
APHASIA5 reports
CHEST PAIN5 reports
COMA5 reports
COUGH5 reports
ERYTHEMA5 reports
FACIAL PALSY5 reports
HYDROCEPHALUS5 reports
MALAISE5 reports
NAUSEA5 reports
NERVOUS SYSTEM DISORDER5 reports
POLYTRAUMATISM5 reports
ABNORMAL BEHAVIOUR4 reports
ACCIDENTAL OVERDOSE4 reports
ACUTE KIDNEY INJURY4 reports
ANGER4 reports
BRAIN OEDEMA4 reports
CEREBRAL HAEMATOMA4 reports
DEPRESSION4 reports
DYSPNOEA4 reports
HEART RATE INCREASED4 reports
HYPOAESTHESIA4 reports
INCORRECT DOSE ADMINISTERED4 reports
INFLUENZA4 reports
INSOMNIA4 reports
ISCHAEMIC STROKE4 reports
MENTAL DISORDER4 reports
OVERDOSE4 reports
PARALYSIS4 reports
ROAD TRAFFIC ACCIDENT4 reports
SOMNOLENCE4 reports
SPEECH DISORDER4 reports
SYNCOPE4 reports
TRANSIENT ISCHAEMIC ATTACK4 reports
VISUAL DISTURBANCE4 reports
VOMITING4 reports
ABDOMINAL PAIN3 reports
AGGRESSION3 reports
AGITATION3 reports
ANGINA PECTORIS3 reports
BLINDNESS3 reports
BLOOD CREATINE PHOSPHOKINASE INCREASED3 reports
BRAIN NATRIURETIC PEPTIDE INCREASED3 reports
BRAIN NEOPLASM3 reports
BRONCHITIS ACUTE3 reports
CHRONIC KIDNEY DISEASE3 reports
COGNITIVE DISORDER3 reports
DISORIENTATION3 reports
DYSARTHRIA3 reports
DYSKINESIA3 reports
FATIGUE3 reports
FEELING ABNORMAL3 reports
HALLUCINATION3 reports
HEAD INJURY3 reports
INCOHERENT3 reports
INTRACRANIAL PRESSURE INCREASED3 reports
LACUNAR INFARCTION3 reports
PYREXIA3 reports
RASH3 reports
RENAL FAILURE3 reports
RUPTURED CEREBRAL ANEURYSM3 reports
SEPSIS3 reports
SINUSITIS3 reports
TACHYCARDIA3 reports
TREMOR3 reports
VENTRICULAR HYPERTROPHY3 reports
VISION BLURRED3 reports
VISUAL FIELD DEFECT3 reports
ACUTE RESPIRATORY FAILURE2 reports
ALPHA HAEMOLYTIC STREPTOCOCCAL INFECTION2 reports
APPLICATION SITE RASH2 reports
ARTERIOVENOUS MALFORMATION2 reports
ASTHMA2 reports
ATELECTASIS2 reports
BACK INJURY2 reports

Report Outcomes

Out of 319 classified reports for BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE:

Serious 81.2%Non-Serious 18.8%

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

Female177 (57.5%)
Male130 (42.2%)
Unknown1 (0.3%)

Reports by Age

Age 4212 reports
Age 5011 reports
Age 569 reports
Age 418 reports
Age 478 reports
Age 76 reports
Age 366 reports
Age 486 reports
Age 546 reports
Age 35 reports
Age 45 reports
Age 115 reports
Age 385 reports
Age 54 reports
Age 64 reports
Age 84 reports
Age 134 reports
Age 184 reports
Age 324 reports
Age 394 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 HYDROBROMIDE?

This profile reflects 662 FDA FAERS reports that mention BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE. 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 HYDROBROMIDE?

Frequently reported terms in FAERS include CEREBROVASCULAR ACCIDENT, HAEMORRHAGIC STROKE, CONVULSION, DRUG HYPERSENSITIVITY, INJURY, HEMIPARESIS. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE?

Labeling and FAERS entries often list Foundation Consumer Brands in connection with BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE. 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.