GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE

N/A

Manufactured by RB Health (US) LLC

13,133 FDA adverse event reports analyzed

Last updated: 2026-04-15

About GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE 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 GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE include DRUG INEFFECTIVE, DIZZINESS, DIARRHOEA, ACCIDENTAL OVERDOSE, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE.

Top Adverse Reactions

DRUG INEFFECTIVE921 reports
DIZZINESS833 reports
DIARRHOEA621 reports
ACCIDENTAL OVERDOSE524 reports
NAUSEA501 reports
OVERDOSE381 reports
PRODUCT USE IN UNAPPROVED INDICATION345 reports
SOMNOLENCE292 reports
FEELING ABNORMAL283 reports
VOMITING279 reports
HEADACHE273 reports
DYSPNOEA272 reports
FATIGUE270 reports
INSOMNIA261 reports
COUGH211 reports
INCORRECT PRODUCT ADMINISTRATION DURATION199 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS177 reports
ASTHENIA174 reports
BLOOD PRESSURE INCREASED171 reports
ANXIETY169 reports
EXPIRED PRODUCT ADMINISTERED165 reports
DRUG EFFECTIVE FOR UNAPPROVED INDICATION159 reports
INCORRECT DRUG ADMINISTRATION DURATION155 reports
ABDOMINAL PAIN UPPER154 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION153 reports
MALAISE153 reports
CONDITION AGGRAVATED147 reports
NO ADVERSE EVENT144 reports
PALPITATIONS123 reports
CONFUSIONAL STATE120 reports
PAIN115 reports
HALLUCINATION114 reports
PNEUMONIA104 reports
ABDOMINAL DISCOMFORT103 reports
HYPERTENSION103 reports
PRURITUS103 reports
COVID 19102 reports
RASH102 reports
HEART RATE INCREASED100 reports
TREMOR96 reports
FALL93 reports
LOSS OF CONSCIOUSNESS88 reports
PRODUCT USE ISSUE88 reports
PRODUCT SIZE ISSUE84 reports
EPISTAXIS83 reports
NASOPHARYNGITIS80 reports
OFF LABEL USE78 reports
HYPERHIDROSIS77 reports
CHEST PAIN74 reports
VISION BLURRED74 reports
SINUSITIS72 reports
URTICARIA71 reports
HYPERSENSITIVITY70 reports
CONSTIPATION69 reports
NERVOUSNESS69 reports
HYPOAESTHESIA68 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION67 reports
PARAESTHESIA67 reports
BACK PAIN64 reports
DRY MOUTH64 reports
GAIT DISTURBANCE64 reports
PYREXIA63 reports
ARTHRALGIA59 reports
DEHYDRATION58 reports
BRONCHITIS57 reports
CHEST DISCOMFORT57 reports
DISEASE RECURRENCE57 reports
DISORIENTATION57 reports
PAIN IN EXTREMITY57 reports
PRODUCT USE COMPLAINT57 reports
SYNCOPE57 reports
ILLNESS56 reports
DRUG ABUSE55 reports
OROPHARYNGEAL PAIN55 reports
URINARY TRACT INFECTION55 reports
WEIGHT DECREASED54 reports
DEATH53 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION51 reports
MUSCLE SPASMS51 reports
PRODUCTIVE COUGH49 reports
DYSPHAGIA48 reports
HYPOTENSION48 reports
UNEVALUABLE EVENT47 reports
DECREASED APPETITE46 reports
BURNING SENSATION45 reports
FEELING JITTERY44 reports
PRODUCT DOSE OMISSION ISSUE44 reports
BALANCE DISORDER42 reports
INFLUENZA42 reports
ABDOMINAL PAIN41 reports
DEPRESSION41 reports
RETCHING41 reports
ASTHMA40 reports
ERYTHEMA40 reports
EUPHORIC MOOD40 reports
FEELING HOT39 reports
HAEMOPTYSIS38 reports
INTENTIONAL OVERDOSE38 reports
RHINORRHOEA38 reports
DYSPEPSIA37 reports

Report Outcomes

Out of 6,959 classified reports for GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE:

Serious 26.1%Non-Serious 73.9%

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

Female4,405 (66.2%)
Male2,244 (33.7%)
Unknown3 (0.0%)

Reports by Age

Age 62117 reports
Age 70114 reports
Age 65111 reports
Age 68111 reports
Age 78109 reports
Age 69107 reports
Age 77100 reports
Age 7297 reports
Age 6494 reports
Age 7494 reports
Age 7594 reports
Age 6093 reports
Age 7192 reports
Age 8090 reports
Age 7689 reports
Age 6787 reports
Age 6385 reports
Age 8281 reports
Age 6679 reports
Age 7378 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 GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE?

This profile reflects 13,133 FDA FAERS reports that mention GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, DIZZINESS, DIARRHOEA, ACCIDENTAL OVERDOSE, NAUSEA, OVERDOSE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE?

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