DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE

N/A

Manufactured by RB Health (US) LLC

298 FDA adverse event reports analyzed

Last updated: 2026-04-15

About DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE

DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND 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, AND PHENYLEPHRINE HYDROCHLORIDE include DIZZINESS, DYSPNOEA, DRUG INEFFECTIVE, INSOMNIA, VOMITING. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE.

Top Adverse Reactions

DIZZINESS15 reports
DYSPNOEA14 reports
DRUG INEFFECTIVE12 reports
INSOMNIA9 reports
VOMITING9 reports
NAUSEA7 reports
ANXIETY6 reports
FEELING ABNORMAL6 reports
HEART RATE INCREASED6 reports
NERVOUSNESS6 reports
BLOOD GLUCOSE INCREASED5 reports
DIARRHOEA5 reports
EPISTAXIS5 reports
LOSS OF CONSCIOUSNESS5 reports
MALAISE5 reports
URTICARIA5 reports
BLOOD PRESSURE INCREASED4 reports
DRUG INTERACTION4 reports
HALLUCINATION, VISUAL4 reports
HEADACHE4 reports
HYPERHIDROSIS4 reports
HYPERSENSITIVITY4 reports
HYPERTENSION4 reports
VISION BLURRED4 reports
CARDIAC FLUTTER3 reports
CONDITION AGGRAVATED3 reports
DEPRESSION3 reports
DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE3 reports
EXPIRED PRODUCT ADMINISTERED3 reports
FALL3 reports
HALLUCINATION3 reports
PAIN3 reports
PALPITATIONS3 reports
PNEUMONIA3 reports
PRODUCT USE IN UNAPPROVED INDICATION3 reports
PYREXIA3 reports
RESTLESSNESS3 reports
SOMNOLENCE3 reports
THROAT TIGHTNESS3 reports
TREMOR3 reports
VERTIGO3 reports
WHEEZING3 reports
ABDOMINAL DISCOMFORT2 reports
ABDOMINAL PAIN2 reports
ABDOMINAL PAIN UPPER2 reports
ACCIDENTAL OVERDOSE2 reports
ANAPHYLACTIC REACTION2 reports
ANAPHYLACTIC SHOCK2 reports
ASTHENIA2 reports
ASTHMA2 reports
BACK PAIN2 reports
BLOOD URINE PRESENT2 reports
BRONCHITIS2 reports
CHEST PAIN2 reports
CONFUSIONAL STATE2 reports
CRYING2 reports
DIABETES MELLITUS2 reports
DIPLOPIA2 reports
DYSPEPSIA2 reports
EAR INFECTION2 reports
EATING DISORDER2 reports
ERYTHEMA2 reports
GAIT DISTURBANCE2 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION2 reports
INCOHERENT2 reports
INCORRECT PRODUCT ADMINISTRATION DURATION2 reports
MIGRAINE2 reports
OVERDOSE2 reports
PANIC ATTACK2 reports
PARANOIA2 reports
PERIPHERAL SWELLING2 reports
PRODUCT COMPLAINT2 reports
RASH2 reports
SLEEP TERROR2 reports
UNDERDOSE2 reports
UNEVALUABLE EVENT2 reports
ABNORMAL BEHAVIOUR1 reports
ABNORMAL DREAMS1 reports
ADVERSE DRUG REACTION1 reports
AGEUSIA1 reports
ANALGESIC DRUG LEVEL INCREASED1 reports
ARRHYTHMIA1 reports
ARTHRALGIA1 reports
BLADDER PAIN1 reports
BLINDNESS TRANSIENT1 reports
BLOOD ELECTROLYTES DECREASED1 reports
BLOOD GLUCOSE DECREASED1 reports
BLOOD POTASSIUM DECREASED1 reports
BODY TEMPERATURE DECREASED1 reports
BURNING SENSATION1 reports
CATAPLEXY1 reports
CHILLS1 reports
CHOKING1 reports
CHROMATURIA1 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE1 reports
COELIAC DISEASE1 reports
COMA1 reports
CONTRAINDICATED DRUG ADMINISTERED1 reports
CONTRAINDICATED PRODUCT ADMINISTERED1 reports
CONTUSION1 reports

Report Outcomes

Out of 127 classified reports for DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE:

Serious 77.2%Non-Serious 22.8%

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

Female82 (65.1%)
Male44 (34.9%)

Reports by Age

Age 65 reports
Age 474 reports
Age 724 reports
Age 33 reports
Age 93 reports
Age 303 reports
Age 373 reports
Age 533 reports
Age 643 reports
Age 783 reports
Age 803 reports
Age 42 reports
Age 52 reports
Age 72 reports
Age 312 reports
Age 422 reports
Age 522 reports
Age 552 reports
Age 562 reports
Age 622 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, AND PHENYLEPHRINE HYDROCHLORIDE?

This profile reflects 298 FDA FAERS reports that mention DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND 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, AND PHENYLEPHRINE HYDROCHLORIDE?

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

Who manufactures DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE?

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