DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE

N/A

Manufactured by RB Health (US) LLC

524 FDA adverse event reports analyzed

Last updated: 2026-04-15

About DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE

DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by RB Health (US) LLC. The most commonly reported adverse reactions for DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE include DIZZINESS, DYSPNOEA, PAIN, CHRONIC KIDNEY DISEASE, DRUG INEFFECTIVE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE.

Top Adverse Reactions

DIZZINESS24 reports
DYSPNOEA20 reports
PAIN14 reports
CHRONIC KIDNEY DISEASE13 reports
DRUG INEFFECTIVE13 reports
DIARRHOEA12 reports
HEADACHE12 reports
NAUSEA11 reports
INSOMNIA10 reports
FATIGUE9 reports
CONDITION AGGRAVATED8 reports
COUGH8 reports
PYREXIA8 reports
RENAL FAILURE8 reports
VOMITING8 reports
ANXIETY7 reports
BLOOD PRESSURE INCREASED7 reports
FALL7 reports
HYPERHIDROSIS7 reports
HYPERSENSITIVITY7 reports
LOSS OF CONSCIOUSNESS7 reports
ABDOMINAL PAIN UPPER6 reports
BLOOD GLUCOSE INCREASED6 reports
CHEST PAIN6 reports
CONFUSIONAL STATE6 reports
DEATH6 reports
DEPRESSION6 reports
HEART RATE INCREASED6 reports
MALAISE6 reports
VISION BLURRED6 reports
ACUTE KIDNEY INJURY5 reports
BACK PAIN5 reports
FEELING ABNORMAL5 reports
HYPERTENSION5 reports
NERVOUSNESS5 reports
PAIN IN EXTREMITY5 reports
RASH5 reports
URTICARIA5 reports
VERTIGO5 reports
ADVERSE DRUG REACTION4 reports
ASTHENIA4 reports
ASTHMA4 reports
CONSTIPATION4 reports
DIPLOPIA4 reports
EMOTIONAL DISTRESS4 reports
EPISTAXIS4 reports
ERYTHEMA4 reports
HALLUCINATION4 reports
HALLUCINATION, VISUAL4 reports
NASOPHARYNGITIS4 reports
NEPHROGENIC ANAEMIA4 reports
OFF LABEL USE4 reports
PALPITATIONS4 reports
PERIPHERAL SWELLING4 reports
PRODUCT USE IN UNAPPROVED INDICATION4 reports
RASH MACULAR4 reports
SOMNOLENCE4 reports
THROAT TIGHTNESS4 reports
TREMOR4 reports
TUBULOINTERSTITIAL NEPHRITIS4 reports
UNEVALUABLE EVENT4 reports
ABDOMINAL DISCOMFORT3 reports
ABDOMINAL PAIN3 reports
BLOOD URINE PRESENT3 reports
BRONCHITIS3 reports
BURNING SENSATION3 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE3 reports
COVID 193 reports
DECREASED APPETITE3 reports
DEHYDRATION3 reports
DRUG DOSE OMISSION3 reports
DRUG HYPERSENSITIVITY3 reports
DRUG INTERACTION3 reports
DYSARTHRIA3 reports
DYSPEPSIA3 reports
DYSPHONIA3 reports
DYSURIA3 reports
END STAGE RENAL DISEASE3 reports
EXPIRED PRODUCT ADMINISTERED3 reports
HOT FLUSH3 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION3 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION3 reports
INCORRECT DOSE ADMINISTERED3 reports
INJECTION SITE PAIN3 reports
MEMORY IMPAIRMENT3 reports
MIGRAINE3 reports
MUSCLE SPASMS3 reports
MUSCULOSKELETAL PAIN3 reports
MYALGIA3 reports
NASAL CONGESTION3 reports
NECK PAIN3 reports
OROPHARYNGEAL PAIN3 reports
PNEUMONIA3 reports
PRODUCT DOSE OMISSION3 reports
RECTAL HAEMORRHAGE3 reports
RESTLESSNESS3 reports
SURGERY3 reports
SWELLING FACE3 reports
SYNCOPE3 reports
URINARY TRACT INFECTION3 reports

Report Outcomes

Out of 203 classified reports for DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE:

Serious 72.4%Non-Serious 27.6%

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

Female121 (61.1%)
Male77 (38.9%)

Reports by Age

Age 528 reports
Age 575 reports
Age 645 reports
Age 665 reports
Age 474 reports
Age 584 reports
Age 674 reports
Age 694 reports
Age 724 reports
Age 784 reports
Age 303 reports
Age 373 reports
Age 443 reports
Age 533 reports
Age 553 reports
Age 563 reports
Age 603 reports
Age 623 reports
Age 633 reports
Age 653 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 DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE?

This profile reflects 524 FDA FAERS reports that mention DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE?

Frequently reported terms in FAERS include DIZZINESS, DYSPNOEA, PAIN, CHRONIC KIDNEY DISEASE, DRUG INEFFECTIVE, DIARRHOEA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE?

Labeling and FAERS entries often list RB Health (US) LLC in connection with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, 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.