pharmacopeia

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Monoamine Oxidase Inhibitors; Serotonin Uptake Inhibitors; Sigma-1 Receptor Agonists; Uncompetitive NMDA Receptor Antagonists.

Monoamine OxidaseSerotonin UptakeSigma-1 ReceptorUncompetitive NMDA Receptor

Indications

Sourced from openFDA
  • Uses temporarily relieves these symptoms due to a cold minor aches and pains headache nasal and sinus congestion sore throat cough due to minor throat and bronchial irritation temporarily reduces feverICD-10: R05.9, R50.9, R51.9

Dosage & administration

Sourced from openFDA

Directions do not take more than directed (see overdose warning ) do not take more than 6 doses (180 mL) in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. mL= milliliter keep dosing cup with product adults and children 12 years and over 30 mL every 4 hours chlldren under 12 years of age: do not use

Warnings & precautions

Sourced from openFDA

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may inclide: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease) or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have liver disease heart disease diabetes high blood pressure thyroid disease trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Approval history

Sourced from openFDA
  • Dec 3, 1957NDANDA011265Ani Pharms
  • Oct 8, 1982NDANDA018658Rb Hlth
  • Jan 4, 1985ANDAANDA088864Pharmobedient
  • Apr 29, 2004NDANDA021620Rb Hlth
  • Feb 14, 2006ANDAANDA040649Pai Holdings
  • Oct 29, 2010NDANDA021879Avanir Pharms
  • Aug 18, 2022NDANDA215430Axsome
  • Dec 22, 2025NDANDA217338Rb Hlth

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
57,639 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective5,78110%
  2. 2Dizziness3,4996.1%
  3. 3Diarrhoea3,3215.8%
  4. 4Nausea3,2505.6%
  5. 5Dyspnoea3,0405.3%
  6. 6Fatigue3,0085.2%
  7. 7Headache2,5794.5%
  8. 8Cough2,3584.1%
  9. 9Vomiting2,0763.6%
  10. 10Pneumonia2,0573.6%
  11. 11Off Label Use1,9703.4%
  12. 12Pain1,8463.2%
  13. 13Insomnia1,7133.0%
  14. 14Malaise1,6062.8%
  15. 15Asthenia1,5832.7%

Literature

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Recent PubMed references pinned to Dextromethorphan as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 211 ClinicalTrials.gov registrations naming Dextromethorphan as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Dextromethorphan. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

  • CYP2D6CPIC B/C (provisional)ClinPGx 1B

Frequently asked questions

How does Dextromethorphan work?
Mechanism-of-action classes: Monoamine Oxidase Inhibitors; Serotonin Uptake Inhibitors; Sigma-1 Receptor Agonists; Uncompetitive NMDA Receptor Antagonists.
What is Dextromethorphan used for?
According to FDA labeling, Dextromethorphan carries indications including: Uses temporarily relieves these symptoms due to a cold minor aches and pains headache nasal and sinus congestion sore throat cough due to minor throat and bronchial irritation temporarily reduces fever. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Dextromethorphan?
Dextromethorphan is classified as Opium alkaloids and derivatives, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, Monoamine Oxidase Inhibitors, Serotonin Uptake Inhibitors, Sigma-1 Receptor Agonists, Uncompetitive NMDA Receptor Antagonists, Decreased Medullary Respiratory Drive.
What are the brand names for Dextromethorphan?
Dextromethorphan is marketed under brand names including Auvelity, Babee Cof, Bromfed DM, Buckley's Cough Suppressant, Cepacol Sore Throat Plus Cough, Cepastat Sore Throat & Cough, Chloraseptic Sore Throat + Cough, Creomulsion.
Note. Data for dextromethorphan is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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