DEXTROMETHORPHAN HYDROBROMIDE

N/A

Manufactured by RB Health (US) LLC

6,398 FDA adverse event reports analyzed

Last updated: 2026-04-15

About DEXTROMETHORPHAN HYDROBROMIDE

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 DEXTROMETHORPHAN HYDROBROMIDE include DRUG ABUSE, DRUG INEFFECTIVE, TOXICITY TO VARIOUS AGENTS, COMPLETED SUICIDE, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DEXTROMETHORPHAN HYDROBROMIDE.

Top Adverse Reactions

DRUG ABUSE267 reports
DRUG INEFFECTIVE257 reports
TOXICITY TO VARIOUS AGENTS228 reports
COMPLETED SUICIDE177 reports
DIARRHOEA143 reports
PYREXIA128 reports
DIZZINESS126 reports
DYSPNOEA118 reports
NAUSEA108 reports
FATIGUE107 reports
DEATH106 reports
OFF LABEL USE101 reports
VOMITING96 reports
PNEUMONIA95 reports
COUGH92 reports
CONDITION AGGRAVATED91 reports
DRUG INTERACTION90 reports
OVERDOSE88 reports
INTENTIONAL OVERDOSE85 reports
HEADACHE83 reports
MALAISE81 reports
DRUG TOXICITY79 reports
INSOMNIA78 reports
SEROTONIN SYNDROME77 reports
ASTHENIA76 reports
RASH76 reports
CARDIAC ARREST75 reports
INTENTIONAL PRODUCT MISUSE75 reports
HYPERTENSION72 reports
RESPIRATORY ARREST72 reports
CONFUSIONAL STATE70 reports
EXPOSURE DURING PREGNANCY70 reports
DECREASED APPETITE67 reports
INTERSTITIAL LUNG DISEASE67 reports
WEIGHT INCREASED63 reports
ABDOMINAL PAIN UPPER61 reports
CARDIO RESPIRATORY ARREST61 reports
PRURITUS61 reports
PAIN59 reports
HYPERSENSITIVITY57 reports
DRUG HYPERSENSITIVITY56 reports
ASTHMA54 reports
LIVER DISORDER51 reports
ANXIETY50 reports
DRY MOUTH50 reports
NASOPHARYNGITIS50 reports
URTICARIA50 reports
SOMNOLENCE49 reports
ABDOMINAL PAIN48 reports
ARTHRALGIA48 reports
INFECTION48 reports
INJURY47 reports
SINUSITIS47 reports
JOINT SWELLING46 reports
SLEEP DISORDER46 reports
GENERAL PHYSICAL HEALTH DETERIORATION45 reports
ACCIDENTAL OVERDOSE43 reports
COVID 1943 reports
HYPOAESTHESIA43 reports
CHEST PAIN42 reports
ABDOMINAL DISCOMFORT41 reports
INFUSION RELATED REACTION41 reports
PLATELET COUNT DECREASED41 reports
SUICIDE ATTEMPT41 reports
C REACTIVE PROTEIN ABNORMAL40 reports
FIBROMYALGIA40 reports
FOLLICULITIS40 reports
SWELLING40 reports
FACET JOINT SYNDROME39 reports
MOBILITY DECREASED39 reports
ROAD TRAFFIC ACCIDENT39 reports
WHEEZING39 reports
ACUTE KIDNEY INJURY38 reports
CONTUSION38 reports
DUODENAL ULCER PERFORATION38 reports
OEDEMA38 reports
AGITATION37 reports
PRODUCT USE IN UNAPPROVED INDICATION37 reports
THERAPY NON RESPONDER37 reports
HEPATIC ENZYME INCREASED36 reports
HYPERHIDROSIS36 reports
INTENTIONAL DRUG MISUSE36 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE36 reports
HYPOTENSION35 reports
LOSS OF CONSCIOUSNESS35 reports
OEDEMA PERIPHERAL35 reports
PAIN IN EXTREMITY35 reports
STOMATITIS35 reports
ANAEMIA34 reports
GASTROINTESTINAL DISORDER34 reports
ILL DEFINED DISORDER34 reports
PRODUCT USE ISSUE34 reports
ADVERSE DRUG REACTION33 reports
COMA33 reports
DRUG INTOLERANCE33 reports
GLOSSODYNIA33 reports
HELICOBACTER INFECTION33 reports
FALL32 reports
GAIT DISTURBANCE32 reports
HEPATIC FUNCTION ABNORMAL32 reports

Report Outcomes

Out of 2,849 classified reports for DEXTROMETHORPHAN HYDROBROMIDE:

Serious 75.4%Non-Serious 24.6%

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

Male1,171 (50.9%)
Female1,124 (48.9%)
Unknown4 (0.2%)

Reports by Age

Age 4466 reports
Age 1960 reports
Age 4047 reports
Age 7239 reports
Age 1738 reports
Age 5038 reports
Age 6235 reports
Age 334 reports
Age 2034 reports
Age 3134 reports
Age 5834 reports
Age 7833 reports
Age 6132 reports
Age 6832 reports
Age 7032 reports
Age 4731 reports
Age 2130 reports
Age 4630 reports
Age 5930 reports
Age 6930 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?

This profile reflects 6,398 FDA FAERS reports that mention DEXTROMETHORPHAN HYDROBROMIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for DEXTROMETHORPHAN HYDROBROMIDE?

Frequently reported terms in FAERS include DRUG ABUSE, DRUG INEFFECTIVE, TOXICITY TO VARIOUS AGENTS, COMPLETED SUICIDE, DIARRHOEA, PYREXIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures DEXTROMETHORPHAN HYDROBROMIDE?

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