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Drug ReportsEphedrine
Ephedrine
Akovaz, Corphedra, Emerphed, Ephedrine, Rezipres (ephedrine) is a small molecule pharmaceutical. Ephedrine was first approved as Akovaz on 2016-04-29. It is used to treat asthma, bronchial spasm, orthostatic hypotension, and rhinitis in the USA. The pharmaceutical is active against beta-2 adrenergic receptor.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
respiratory tract diseasesD012140
otorhinolaryngologic diseasesD010038
nervous system diseasesD009422
cardiovascular diseasesD002318
immune system diseasesD007154
Trade Name
FDA
EMA
Akovaz, Corphedra, Emerphed, Rezipres (generic drugs available since 2017-08-23)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ephedrine hydrochloride
Tradename
Company
Number
Date
Products
REZIPRESDr Reddys LaboratoriesN-213536 PEND2021-06-14
3 products, RLD
Ephedrine sulfate
Tradename
Company
Number
Date
Products
EPHEDRINE SULFATEAkornN-208609 RX2017-03-01
1 products
EPHEDRINE SULFATEEndoN-213994 RX2020-10-16
2 products, RLD, RS
AKOVAZExela Pharma SciencesN-208289 RX2016-04-29
2 products, RLD, RS
EMERPHEDNexus BiopharmaN-213407 RX2020-04-17
2 products, RLD, RS
CORPHEDRAPar PharmaceuticalN-208943 RX2017-01-27
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
akovazNew Drug Application2020-11-27
bronkaidOTC monograph final2020-06-11
corphedraNew Drug Application2018-10-17
emerphedNew Drug Application2022-09-30
ephed asthmaOTC monograph final2019-03-28
ephed plusOTC monograph final2019-04-02
ephed plus liquidOTC monograph final2019-04-02
ephedrine hydrochlorideC2002632023-12-14
ephedrine sulfateANDA2023-10-30
primateneOTC monograph final2021-01-25
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Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Ephedrine Sulfate, Emerphed, Nexus Pharms
110902782040-05-16U-3183
112414002040-05-16U-3183
114647522040-05-16DP
114784362040-05-16U-3183
115713982040-05-16U-3183
Ephedrine Sulfate, Ephedrine Sulfate, Endo Ventures
108698452040-01-22DP
ATC Codes
A: Alimentary tract and metabolism drugs
— A08: Antiobesity preparations, excl. diet products
— A08A: Antiobesity preparations, excl. diet products
— A08AA: Centrally acting antiobesity products
— A08AA56: Ephedrine, combinations
C: Cardiovascular system drugs
— C01: Cardiac therapy drugs
— C01C: Cardiac stimulants excl. cardiac glycosides
— C01CA: Adrenergic and dopaminergic cardiac stimulants
— C01CA26: Ephedrine
R: Respiratory system drugs
— R01: Nasal preparations
— R01A: Decongestants and other nasal preparations for topical use
— R01AA: Sympathomimetics, plain
— R01AA03: Ephedrine
— R01AB: Sympathomimetics, combinations excl. corticosteroids
— R01AB05: Ephedrine
— R03: Drugs for obstructive airway diseases
— R03C: Adrenergics for systemic use
— R03CA: Alpha- and beta-adrenoreceptor agonist, systemic drugs
— R03CA02: Ephedrine
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01F: Mydriatics and cycloplegics
— S01FB: Sympathomimetics excl. antiglaucoma preparations
— S01FB02: Ephedrine
HCPCS
No data
Clinical
Clinical Trials
254 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypotensionD007022EFO_0005251I95—3482134
Allergic rhinitisD065631—J30.9—314412
Spinal anesthesiaD000775———114511
Allergic rhinitis seasonalD006255EFO_0003956J301231310
AnesthesiaD000758————12710
Common coldD003139EFO_0007214J001—32—6
Pre-eclampsiaD011225EFO_0000668O14——1146
Cesarean sectionD002585———1—236
PregnancyD011247EFO_0002950Z33.1———415
Respiratory tract infectionsD012141—J06.91—21—4
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ObesityD009765EFO_0001073E66.9111—58
RhinitisD012220EFO_0008521J311—4—16
CoughD003371HP_0012735R05—12——3
Allergic rhinitis perennialD012221EFO_1001417J30.89——2—13
Vasomotor rhinitisD012223EFO_0007533J30.0——2—13
Postoperative nausea and vomitingD020250EFO_0004888———1—12
InflammationD007249MP_0001845———2——2
Obstetrical anesthesiaD000773———11——2
AnalgesiaD000698————1—12
PharyngitisD010612—R07.0——1——1
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hiv infectionsD015658EFO_0000764B20—1——12
Lacrimal duct obstructionD007767——11———1
PainD010146EFO_0003843R5211———1
Congenital myasthenic syndromesD020294Orphanet_590G70.211———1
VomitingD014839HP_0002013R11.1—1———1
NauseaD009325HP_0002018R11.0—1———1
EnuresisD004775—R32—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———15———722
Pure autonomic failureD054970——2————2
HypersensitivityD006967HP_0012393T78.402————2
HypertensionD006973EFO_0000537I101———12
Shy-drager syndromeD012791EFO_1001050—2————2
Orthostatic hypotensionD007024—I95.11————1
FeverD005334HP_0001945R50.91————1
Acute painD059787—R521————1
Back painD001416HP_0003418M541————1
Multiple system atrophyD019578——1————1
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Carotid stenosisD016893——————22
Hip fracturesD006620EFO_0003964S72.00————22
Nasal obstructionD015508HP_0001742—————22
Carotid endarterectomyD016894——————22
HysterectomyD007044EFO_0003881—————11
Acute cholecystitisD041881EFO_1001289K81.0————11
CholecystitisD002764HP_0001082K81————11
Morbid obesityD009767EFO_0001074—————11
Compression fracturesD050815——————11
Male breast neoplasmsD018567——————11
Show 33 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameEphedrine
INN—
Description
(-)-ephedrine is a phenethylamine alkaloid that is 2-phenylethanamine substituted by a methyl group at the amino nitrogen and a methyl and a hydroxy group at position 2 and 1 respectively. It has a role as a nasal decongestant, a sympathomimetic agent, a vasoconstrictor agent, a xenobiotic, an environmental contaminant, a plant metabolite and a bacterial metabolite. It is a member of phenylethanolamines and a phenethylamine alkaloid. It is a conjugate base of a (-)-ephedrinium.
Classification
Small molecule
Drug classsympathomimetics
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CN[C@@H](C)[C@H](O)c1ccccc1
Identifiers
PDB—
CAS-ID299-42-3
RxCUI—
ChEMBL IDCHEMBL211456
ChEBI ID15407
PubChem CID9294
DrugBankDB01364
UNII ID—
Target
Agency Approved
ADRB2
ADRB2
Organism
Homo sapiens
Gene name
ADRB2
Gene synonyms
ADRB2R, B2AR
NCBI Gene ID
Protein name
beta-2 adrenergic receptor
Protein synonyms
adrenergic, beta-2-, receptor, surface, adrenoceptor beta 2 surface, Beta-2 adrenoceptor, Beta-2 adrenoreceptor, catecholamine receptor
Uniprot ID
Mouse ortholog
Adrb2 (11555)
beta-2 adrenergic receptor (Q8BH38)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Akovaz – Avadel Pharmaceuticals
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Estimated US medical usage
Ephedrine
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Guaifenesin
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Ephedrine
+
Hydroxyzine
+
Theophylline
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 12,717 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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19,153 adverse events reported
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