Dextromethorphan
/api/v1/drug/dextromethorphanMechanism of action
Sourced from openFDAMechanism-of-action classes: Monoamine Oxidase Inhibitors; Serotonin Uptake Inhibitors; Sigma-1 Receptor Agonists; Uncompetitive NMDA Receptor Antagonists.
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 openFDADirections 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 openFDALiver 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
Literature
Recent PubMed references pinned to Dextromethorphan as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.
- Dextromethorphan Modulates the Osteogenic-Adipogenic Balance in Rat Bone Marrow Mesenchymal Stem Cells.Cells · 2026 · Lin JH, Luo YP, Ting PC, et al.PMID 42274588DOI 10.3390/cells15110995
- Augmentation of clozapine with dextromethorphan in treatment-resistant schizophrenia: A randomized, group sequential adaptive design, controlled clinical trial.Asian journal of psychiatry · 2026 · Hegde NC, Mishra BR, Mohapatra D, et al.PMID 41780197DOI 10.1016/j.ajp.2026.104919
- Neuroprotective, cognitive, and immunomodulatory effects of Valproic acid combined with dextromethorphan in bipolar disorder.Journal of psychiatric research · 2026 · Huang CC, Tzeng NS, Chang YH, et al.PMID 41774971DOI 10.1016/j.jpsychires.2026.02.038
- Clinical Characteristics of Over-The-Counter Drug Misusers in Psychiatric Practice in Japan: Comparison Between Codeine Misusers and Dextromethorphan Misusers.Neuropsychopharmacology reports · 2026 · Tanibuchi Y, Omiya S, Usami T, et al.PMID 41705596DOI 10.1002/npr2.70100
- Caffeine potentiates the dependence induced by central nervous system depressants contained in over-the-counter medications in mice.The Journal of toxicological sciences · 2026 · Yonemura-Hirata A, Kaizaki-Mitsumoto A, Numazawa S, et al.PMID 41621858DOI 10.2131/jts.51.131
- Mechanistic Insights into the Cardiotoxic Effects of Dextromethorphan and Its Metabolite Dextrorphan in Zebrafish Using Network Toxicology and Molecular Dynamics.Environmental science & technology · 2026 · Cao Z, Liang Z, Zhang JG, et al.PMID 41614983DOI 10.1021/acs.est.5c16284
- Efficacy and safety of dextromethorphan/quinidine in treating pseudobulbar affect in neurological disorders: A systematic review and dose-classified network meta-analysis.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2026 · Muneer MA, Tariq I, Zulfiqar E, et al.PMID 41530593DOI 10.1007/s10072-025-08640-7
- Cough Syrup Tragedies and the Commercial Determinants of Health.Indian pediatrics · 2026 · Dasgupta R, Shah DPMID 41499032DOI 10.1007/s13312-025-00243-x
Clinical trials
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.
- A Study of Psychedelics in Healthy Older Adults With Low Well-beingRecruiting · Phase 1 · Interventional · 80 enrolled · Jennifer MitchellNCT07386730updated 2026-06-08
- Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Alzheimer's Disease DementiaRecruiting · Phase 2 · Phase 3 · Interventional · 300 enrolled · Exciva GmbHNCT07284472updated 2026-06-05
- Evaluating the Pharmacokinetics of Oregano and Potential Oregano-drug Interactions Using a Drug Cocktail ApproachRecruiting · Early phase 1 · Interventional · 16 enrolled · Washington State UniversityNCT06693960updated 2026-06-04
- Study of Dextromethorphan in OCD and Related DisordersRecruiting · Phase 2 · Interventional · 60 enrolled · Stanford UniversityNCT04899687updated 2026-05-20
- Synaptic Mechanisms of Intermittent Theta Burst Stimulation for Major Depressive DisorderNot yet recruiting · Phase 1 · Phase 2 · Interventional · 100 enrolled · Mclean HospitalNCT07593222updated 2026-05-18
- Nintedanib With or Without Dextromethorphan in Patients With Idiopathic Pulmonary Fibrosis (IPF)Not yet recruiting · Phase 2 · Interventional · 60 enrolled · First Affiliated Hospital of Wenzhou Medical UniversityNCT07583589updated 2026-05-13
- Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Residual SchizophreniaCompleted · Phase 2 · Interventional · 145 enrolled · Otsuka Pharmaceutical Development & Commercialization, Inc.NCT02477670updated 2026-05-13
- Safety, Tolerability and Efficacy of AVP-786 for the Treatment of DisinhibitionTerminated · Phase 2 · Interventional · 1 enrolled · Otsuka Pharmaceutical Development & Commercialization, Inc.NCT02534038updated 2026-05-13
- Efficacy of Dextromethorphan-Bupropion Versus SSRIs in the Treatment of Major Depressive DisorderCompleted · Interventional · 80 enrolled · Asad Ullah JanNCT06957223updated 2026-05-07
- Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg BupropionCompleted · Phase 1 · Phase 2 · Interventional · 18 enrolled · Virginia Commonwealth UniversityNCT05976646updated 2026-05-06
Pharmacogenomics
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.
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.