DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN

N/A

Manufactured by RB Health (US) LLC

8,751 FDA adverse event reports analyzed

Last updated: 2026-04-15

About DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN

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

Top Adverse Reactions

DRUG INEFFECTIVE1,293 reports
OVERDOSE436 reports
DIZZINESS397 reports
DIARRHOEA364 reports
ACCIDENTAL OVERDOSE333 reports
COUGH254 reports
NO ADVERSE EVENT238 reports
NAUSEA234 reports
SOMNOLENCE182 reports
HEADACHE181 reports
FEELING ABNORMAL175 reports
INSOMNIA171 reports
VOMITING147 reports
FATIGUE141 reports
DYSPNOEA130 reports
ABDOMINAL PAIN UPPER99 reports
HALLUCINATION98 reports
ANXIETY94 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION91 reports
DRUG ABUSE90 reports
ACCIDENTAL EXPOSURE TO PRODUCT BY CHILD89 reports
CONDITION AGGRAVATED85 reports
BLOOD PRESSURE INCREASED83 reports
ASTHENIA82 reports
DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE81 reports
MALAISE81 reports
PNEUMONIA71 reports
CONFUSIONAL STATE70 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION69 reports
RASH67 reports
EXPIRED PRODUCT ADMINISTERED65 reports
PRURITUS65 reports
OFF LABEL USE64 reports
PAIN64 reports
PRODUCT USE IN UNAPPROVED INDICATION64 reports
TREMOR64 reports
ABDOMINAL DISCOMFORT63 reports
HYPERSENSITIVITY60 reports
URTICARIA59 reports
HEART RATE INCREASED58 reports
DECREASED APPETITE54 reports
GAIT DISTURBANCE54 reports
PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE54 reports
NASOPHARYNGITIS53 reports
PYREXIA53 reports
VISION BLURRED53 reports
BLOOD GLUCOSE INCREASED49 reports
HYPERHIDROSIS49 reports
MYDRIASIS49 reports
PRODUCT USE ISSUE48 reports
CONSTIPATION47 reports
INCORRECT DRUG ADMINISTRATION DURATION47 reports
FALL46 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS46 reports
HYPOAESTHESIA45 reports
LOSS OF CONSCIOUSNESS45 reports
INCORRECT DOSE ADMINISTERED44 reports
FEELING DRUNK43 reports
HYPERTENSION42 reports
INTENTIONAL OVERDOSE42 reports
ARTHRALGIA41 reports
PALPITATIONS40 reports
DISORIENTATION37 reports
PRODUCTIVE COUGH37 reports
EUPHORIC MOOD36 reports
NERVOUSNESS36 reports
WEIGHT DECREASED36 reports
CHEST PAIN35 reports
DEPRESSION35 reports
UNEVALUABLE EVENT35 reports
DEHYDRATION34 reports
MUSCLE SPASMS34 reports
ERYTHEMA32 reports
PRODUCT COMPLAINT32 reports
PSYCHOMOTOR HYPERACTIVITY32 reports
BALANCE DISORDER31 reports
COVID 1931 reports
DEATH31 reports
DRUG EFFECTIVE FOR UNAPPROVED INDICATION31 reports
SINUSITIS31 reports
DRUG HYPERSENSITIVITY30 reports
INCORRECT PRODUCT ADMINISTRATION DURATION30 reports
ABDOMINAL PAIN29 reports
DYSARTHRIA29 reports
INFLUENZA29 reports
ABNORMAL BEHAVIOUR28 reports
DRY MOUTH28 reports
PARAESTHESIA28 reports
URINARY TRACT INFECTION28 reports
AGITATION27 reports
ILLNESS27 reports
LETHARGY27 reports
PRODUCT TASTE ABNORMAL27 reports
SYNCOPE27 reports
BRONCHITIS26 reports
CHEST DISCOMFORT26 reports
CHOKING26 reports
OROPHARYNGEAL PAIN26 reports
RHINORRHOEA26 reports
HYPOTENSION25 reports

Report Outcomes

Out of 5,052 classified reports for DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN:

Serious 24.4%Non-Serious 75.6%

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

Female3,024 (63.1%)
Male1,764 (36.8%)
Unknown4 (0.1%)

Reports by Age

Age 4145 reports
Age 5114 reports
Age 696 reports
Age 775 reports
Age 367 reports
Age 7563 reports
Age 6759 reports
Age 7258 reports
Age 6557 reports
Age 7757 reports
Age 6054 reports
Age 6353 reports
Age 6853 reports
Age 7052 reports
Age 7152 reports
Age 6151 reports
Age 6651 reports
Age 7651 reports
Age 8050 reports
Age 947 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 AND GUAIFENESIN?

This profile reflects 8,751 FDA FAERS reports that mention DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN. Reporting is voluntary and does not prove that the drug caused any listed event.

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

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

Who manufactures DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN?

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