DEXTROMETHORPHAN

N/A

Manufactured by RB Health (US) LLC

14,865 FDA adverse event reports analyzed

Last updated: 2026-04-14

About DEXTROMETHORPHAN

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

Top Adverse Reactions

DRUG INEFFECTIVE1,313 reports
DRUG ABUSE713 reports
TOXICITY TO VARIOUS AGENTS679 reports
OVERDOSE594 reports
DIZZINESS435 reports
ACCIDENTAL OVERDOSE404 reports
DIARRHOEA394 reports
COMPLETED SUICIDE333 reports
DEATH321 reports
COUGH307 reports
NAUSEA281 reports
NO ADVERSE EVENT246 reports
DYSPNOEA233 reports
FATIGUE230 reports
VOMITING228 reports
DRUG INTERACTION223 reports
HEADACHE215 reports
SOMNOLENCE207 reports
INSOMNIA196 reports
PNEUMONIA190 reports
INTENTIONAL OVERDOSE180 reports
OFF LABEL USE178 reports
ANXIETY167 reports
FEELING ABNORMAL166 reports
MALAISE165 reports
CONDITION AGGRAVATED154 reports
SEROTONIN SYNDROME147 reports
ASTHENIA144 reports
CARDIO RESPIRATORY ARREST142 reports
ABDOMINAL PAIN UPPER139 reports
CONFUSIONAL STATE137 reports
TREMOR136 reports
PYREXIA131 reports
HYPERTENSION124 reports
HALLUCINATION121 reports
PAIN117 reports
AGITATION110 reports
CARDIAC ARREST110 reports
PRURITUS107 reports
DEPRESSION104 reports
RASH104 reports
PRODUCT USE IN UNAPPROVED INDICATION102 reports
FALL95 reports
ABDOMINAL DISCOMFORT94 reports
ARTHRALGIA94 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION94 reports
TACHYCARDIA94 reports
ACCIDENTAL EXPOSURE TO PRODUCT BY CHILD92 reports
NASOPHARYNGITIS90 reports
RESPIRATORY ARREST90 reports
HYPOAESTHESIA87 reports
HYPERSENSITIVITY85 reports
ABDOMINAL PAIN83 reports
DECREASED APPETITE83 reports
INTENTIONAL PRODUCT MISUSE83 reports
URTICARIA83 reports
BLOOD PRESSURE INCREASED82 reports
HYPOTENSION81 reports
LOSS OF CONSCIOUSNESS81 reports
SLEEP DISORDER80 reports
WHEEZING80 reports
COMA79 reports
DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE79 reports
SINUSITIS78 reports
SUICIDE ATTEMPT77 reports
GAIT DISTURBANCE76 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE76 reports
PRODUCTIVE COUGH75 reports
HYPERHIDROSIS73 reports
ASTHMA72 reports
MYDRIASIS71 reports
PRODUCT USE ISSUE71 reports
POISONING70 reports
WEIGHT INCREASED69 reports
DRUG HYPERSENSITIVITY68 reports
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION68 reports
COVID 1964 reports
DEPRESSED LEVEL OF CONSCIOUSNESS64 reports
ACUTE KIDNEY INJURY63 reports
CHEST DISCOMFORT63 reports
CONSTIPATION63 reports
CHEST PAIN62 reports
MUSCLE SPASMS62 reports
PARAESTHESIA61 reports
DRY MOUTH60 reports
HEART RATE INCREASED60 reports
VISION BLURRED60 reports
PAIN IN EXTREMITY59 reports
PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE59 reports
CHRONIC OBSTRUCTIVE PULMONARY DISEASE58 reports
NASAL CONGESTION56 reports
EXPIRED PRODUCT ADMINISTERED55 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES54 reports
DISORIENTATION53 reports
DYSPEPSIA53 reports
CONTUSION52 reports
LETHARGY52 reports
DRUG TOXICITY51 reports
RHINORRHOEA51 reports
AGGRESSION50 reports

Report Outcomes

Out of 7,478 classified reports for DEXTROMETHORPHAN:

Serious 52.0%Non-Serious 48.0%

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

Female4,020 (57.4%)
Male2,982 (42.6%)
Unknown3 (0.0%)

Reports by Age

Age 4163 reports
Age 5129 reports
Age 6109 reports
Age 53107 reports
Age 67107 reports
Age 17106 reports
Age 61102 reports
Age 2195 reports
Age 6094 reports
Age 389 reports
Age 1889 reports
Age 5689 reports
Age 2086 reports
Age 3283 reports
Age 5283 reports
Age 6882 reports
Age 778 reports
Age 3377 reports
Age 4777 reports
Age 6577 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?

This profile reflects 14,865 FDA FAERS reports that mention DEXTROMETHORPHAN. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for DEXTROMETHORPHAN?

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

Who manufactures DEXTROMETHORPHAN?

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