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Drug ReportsDextromethorphan
Delsym, Nuedexta(dextromethorphan)
/ Dextromethorphan /, Auvelity, Bromfed-dm, Dextromethorphan /, Mucinex, Nuedexta (dextromethorphan) is a small molecule pharmaceutical. Dextromethorphan was first approved as Promethazine hydrochloride and dextromethorphan hydrobromide on 1984-04-02. It is used to treat cough in the USA. It has been approved in Europe to treat neurobehavioral manifestations.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
nervous system diseasesD009422
signs and symptoms pathological conditionsD013568
behavior and behavior mechanismsD001520
Trade Name
FDA
EMA
Delsym, Dextromethorphan polistirex
Combinations
Auvelity, Bromfed-dm, Brompheniramine maleate, pseudoephedrine dextromethorphan, Dextromethorphan quinidine, Guaifenesin dextromethorphan, Mucinex, Nuedexta, Promethazine, Promethazine dextromethorphan, Promethazine w/ dextromethorphan (discontinued: Bromanate, Bromfed-dm, Brompheniramine maleate, pseudoephedrine dextromethorphan, Dimetane-dx, Pherazine, Promethazine dextromethorphan)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Dextromethorphan hydrobromide
+
Promethazine hydrochloride
Tradename
Company
Number
Date
Products
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEANI PharmaceuticalsN-011265 RX1984-04-02
1 products, RLD
Brompheniramine maleate
+
Dextromethorphan hydrobromide
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
DIMETANE-DXA.H. Robins CompanyN-019279 DISCN1984-08-24
1 products, RLD
Hide discontinued
Dextromethorphan hydrobromide
+
Quinidine sulfate
Tradename
Company
Number
Date
Products
NUEDEXTAAvanir PharmaceuticalsN-021879 RX2010-10-29
1 products, RLD, RS
Dextromethorphan hydrobromide
+
Guaifenesin
Tradename
Company
Number
Date
Products
MUCINEX DMRB HealthN-021620 OTC2004-04-29
2 products, RLD
Bupropion hydrochloride
+
Dextromethorphan hydrobromide
Tradename
Company
Number
Date
Products
AUVELITYAxsome TherapeuticsN-215430 RX2022-08-18
1 products, RLD, RS
Dextromethorphan polistirex
Tradename
Company
Number
Date
Products
DELSYMRB HealthN-018658 OTC1982-10-08
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
auvelityNew Drug Application2024-06-28
childrens delsymC2002632024-06-28
childrens delsym cough plus chest congestion dm and delsym cough plus cold night timeOTC monograph final2023-02-27
delsymNew Drug Application2024-04-19
delsym (dextromethorphan)New Drug Application2024-04-08
delsym coughOTC monograph final2023-04-06
delsym nighttime coughOTC monograph final2023-02-27
mucinexNew Drug Application2024-07-25
mucinex childrensOTC monograph final2022-01-31
mucinex childrens mighty chews coughC2002632024-07-18
Show 13 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
sinusitisEFO_0007486D012852J32
asthmaEFO_0000270D001249J45
coughHP_0012735D003371R05
common coldEFO_0007214D003139J00
allergic rhinitis perennialEFO_1001417D012221J30.89
urticariaEFO_0005531D014581L50
vasomotor rhinitisEFO_0007533D012223J30.0
whooping coughEFO_0000650D014917A37.0
bronchitis—D001991J40
pharyngitis—D010612R07.0
Show 14 more
Agency Specific
FDA
EMA
Expiration
Code
BUPROPION HYDROCHLORIDE / DEXTROMETHORPHAN HYDROBROMIDE, AUVELITY, AXSOME
2025-08-18NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Bupropion Hydrochloride / Dextromethorphan Hydrobromide, Auvelity, Axsome
107800642040-01-07U-3419
109258422040-01-07U-3419
109401242040-01-07U-3419
109669422040-01-07U-3419
107800662034-11-09U-3419
91682342034-11-05U-3419
91989052034-11-05U-3419
92050832034-11-05U-3419
92380322034-11-05U-3419
92780952034-11-05U-3419
93144622034-11-05U-3419
93705132034-11-05U-3419
93754292034-11-05U-3419
94088152034-11-05U-3419
94211762034-11-05U-3419
94570232034-11-05U-3419
94570252034-11-05U-3419
94747312034-11-05U-3419
94864502034-11-05U-3419
97005282034-11-05U-3419
97005532034-11-05U-3419
97071912034-11-05U-3419
97639322034-11-05U-3419
98615952034-11-05U-3419
98678192034-11-05U-3419
99685682034-11-05U-3419
100585182034-11-05U-3419
100648572034-11-05U-3419
100807272034-11-05U-3419
100925602034-11-05U-3419
100925612034-11-05U-3419
101053272034-11-05U-3419
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102518792034-11-05U-3419
104636342034-11-05U-3419
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107994972034-11-05U-3419
108067102034-11-05U-3419
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108746632034-11-05U-3419
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109330342034-11-05U-3419
109459732034-11-05U-3419
109669412034-11-05U-3419
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110203892034-11-05U-3419
110586482034-11-05U-3419
110903002034-11-05U-3419
110969372034-11-05U-3419
111233432034-11-05U-3419
111298262034-11-05U-3419
111413882034-11-05U-3419
111414162034-11-05U-3419
111478082034-11-05U-3419
111855152034-11-05U-3419
111917392034-11-05DPU-3419
111978392034-11-05DPU-3419
112072812034-11-05U-3419
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113642332034-11-05U-3419
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114198672034-11-05U-3419
114263702034-11-05U-3419
114264012034-11-05U-3419
114330672034-11-05DPU-3419
114396362034-11-05U-3419
114784682034-11-05U-3419
114977212034-11-05U-3419
115109182034-11-05U-3419
115175422034-11-05U-3419
115175432034-11-05U-3419
115240072034-11-05U-3419
115240082034-11-05U-3419
115344142034-11-05DPU-3419
115410212034-11-05U-3419
115410482034-11-05U-3419
115966272034-11-05U-3419
116177282034-11-05U-3419
116177472034-11-05U-3563
85693282033-10-29DPU-3419
Dextromethorphan Hydrobromide / Quinidine Sulfate, Nuedexta, Avanir Pharms
76592822026-08-13U-1093
82274842023-07-17U-1093
ATC Codes
N: Nervous system drugs
— N07: Other nervous system drugs in atc
— N07X: Other nervous system drugs in atc
— N07XX: Other nervous system drugs in atc
— N07XX59: Dextromethorphan, combinations
R: Respiratory system drugs
— R05: Cough and cold preparations
— R05D: Cough suppressants, excl. combinations with expectorants
— R05DA: Opium alkaloids and derivatives, cough suppressants
— R05DA09: Dextromethorphan
HCPCS
No data
Clinical
Clinical Trials
775 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PainD010146EFO_0003843R52162018131477
Postoperative painD010149—G89.185611351268
Healthy volunteers/patients———551—3766
Opioid-related disordersD009293EFO_0005611F1111131391759
InfectionsD007239EFO_0000544—36913938
Chronic painD059350HP_0012532—3388425
CoughD003371HP_0012735R055384424
NeoplasmsD009369—C809542423
SyndromeD013577———663823
Acute painD059787—R525462320
Show 153 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Psychomotor agitationD011595———26—19
Cocaine-related disordersD019970—F14432——8
SclerosisD012598———33——6
Treatment-resistant depressive disorderD061218——141——6
LymphomaD008223—C85.9222—16
Amyotrophic lateral sclerosisD000690HP_0007354G12.21132——5
LeukemiaD007938—C95221—15
Parkinson diseaseD010300EFO_0002508G20—21—25
Diabetic neuropathiesD003929EFO_1000783—122——5
Multiple myelomaD009101—C90.0112—15
Show 64 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ObesityD009765EFO_0001073E66.911——34
DiarrheaD003967HP_0002014R19.7—1——34
TuberculosisD014376EFO_0000774A15-A1921——13
Breast neoplasmsD001943EFO_0003869C5011——23
FibromyalgiaD005356EFO_0005687M79.121———3
Prostatic neoplasmsD011471—C6131———3
Spinal cord injuriesD013119EFO_1001919——2——13
Irritable bowel syndromeD043183EFO_0000555K58—1——23
Non-hodgkin lymphomaD008228—C85.922———3
EmergenciesD004630———1——23
Show 103 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Drug interactionsD004347——10———414
MelanomaD008545——2————2
Food-drug interactionsD018565——2————2
Cognitive dysfunctionD060825HP_0001268G31.841———12
Non-small-cell lung carcinomaD002289——2————2
Squamous cell carcinoma of head and neckD000077195——1———12
Renal insufficiencyD051437HP_0000083N192————2
Liver diseasesD008107HP_0002910K70-K772————2
Hepatic insufficiencyD048550——2————2
HepacivirusD016174——1————1
Show 37 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ApneaD001049HP_0002104R06.81————22
PneumoniaD011014EFO_0003106—————22
Emergence deliriumD000071257——————22
Whooping coughD014917EFO_0000650A37.0————22
Pregnancy rateD018873——————22
Torsades de pointesD016171EFO_0005307I47.21————11
Cardiovascular diseasesD002318HP_0001626—————11
Post-traumatic stress disordersD013313EFO_0001358F43.1————11
Traumatic stress disordersD040921——————11
Psychotic disordersD011618—F20.81————11
Show 67 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDextromethorphan
INNdextromethorphan
Description
Dextromethorphan is a 6-methoxy-11-methyl-1,3,4,9,10,10a-hexahydro-2H-10,4a-(epiminoethano)phenanthrene in which the sterocenters at positions 4a, 10 and 10a have S-configuration. It is a prodrug of dextrorphan and used as an antitussive drug for suppressing cough. It has a role as a NMDA receptor antagonist, a neurotoxin, a xenobiotic, an environmental contaminant, an antitussive, a prodrug and a oneirogen. It is functionally related to a dextrorphan. It is an enantiomer of a levomethorphan.
Classification
Small molecule
Drug classdeuterated compounds; narcotic antagonists/agonists (morphinan derivatives)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
COc1ccc2c(c1)[C@]13CCCC[C@@H]1[C@H](C2)N(C)CC3
Identifiers
PDB—
CAS-ID125-71-3
RxCUI—
ChEMBL IDCHEMBL52440
ChEBI ID—
PubChem CID5360696
DrugBankDB00514
UNII ID7355X3ROTS (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
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Estimated US medical usage
Dextromethorphan
+
Acetaminophen
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Dextromethorphan
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Acetaminophen
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Doxylamine
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Dextromethorphan
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Phenylephrine
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Carbinoxamine
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Dextromethorphan
+
Chlorpheniramine
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Dextromethorphan
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Dextromethorphan
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Doxylamine
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Dextromethorphan
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Guaifenesin
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Dextromethorphan
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Phenylephrine
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Guaifenesin
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Dextromethorphan
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Phenylephrine
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Dextromethorphan
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Phenylephrine
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Pyrilamine
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Dextromethorphan
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Phenylephrine
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Triprolidine
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Dextromethorphan
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Phenylpropanolamine
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Dextromethorphan
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Promethazine
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Dextromethorphan
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Pseudoephedrine
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Dextromethorphan
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Pyrilamine
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Dextromethorphan
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Quinidine
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Tabular view
Trends
PubMed Central
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Additional graphs summarizing 38,799 documents
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Safety
Black-box Warning
Black-box warning for: Auvelity
Adverse Events
Top Adverse Reactions
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378,224 adverse events reported
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