Ephedrine
Akovaz, Corphedra, Emerphed, 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
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 |
|---|---|---|---|---|
| REZIPRES | Dr Reddys Laboratories | N-213536 PEND | 2021-06-14 | 3 products, RLD |
Ephedrine sulfate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| EPHEDRINE SULFATE | Akorn | N-208609 RX | 2017-03-01 | 1 products |
| EPHEDRINE SULFATE | Endo | N-213994 RX | 2020-10-16 | 2 products, RLD, RS |
| AKOVAZ | Exela Pharma Sciences | N-208289 RX | 2016-04-29 | 2 products, RLD, RS |
| EMERPHED | Nexus Biopharma | N-213407 RX | 2020-04-17 | 2 products, RLD, RS |
| CORPHEDRA | Par Pharmaceutical | N-208943 RX | 2017-01-27 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| akovaz | New Drug Application | 2021-04-01 |
| corphedra | New Drug Application | 2019-12-05 |
| emerphed | New Drug Application | 2023-03-01 |
| ephedrine sulfate | ANDA | 2023-03-31 |
| rezipres | New Drug Application | 2021-08-01 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| asthma | EFO_0000270 | D001249 | J45 |
| bronchial spasm | — | D001986 | — |
| orthostatic hypotension | — | D007024 | I95.1 |
| rhinitis | EFO_0008521 | D012220 | J31 |
Agency Specific
FDA
EMA
No data
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
104 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypotension | D007022 | EFO_0005251 | I95 | — | 3 | 3 | 6 | 11 | 21 |
| Spinal anesthesia | D000775 | — | — | — | 4 | 3 | 7 | ||
| Pre-eclampsia | D011225 | EFO_0000668 | O14 | — | — | 1 | 1 | 4 | 6 |
| Cesarean section | D002585 | — | 1 | — | 1 | 3 | 5 | ||
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | 3 | — | 3 |
| Allergic rhinitis | D065631 | J30.9 | — | — | 1 | 2 | — | 3 | |
| Bradycardia | D001919 | HP_0001662 | R00.1 | — | — | — | 2 | — | 2 |
| Bronchitis | D001991 | J40 | — | — | — | 1 | 1 | 2 | |
| Cholelithiasis | D002769 | EFO_0004799 | K80 | — | — | — | 1 | — | 1 |
| Low cardiac output | D002303 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Obesity | D009765 | EFO_0001073 | E66.9 | — | 1 | 1 | — | 4 | 6 |
| Anesthesia | D000758 | — | — | 1 | — | 1 | 2 | ||
| Inflammation | D007249 | — | — | 1 | — | — | 1 | ||
| Cough | D003371 | HP_0012735 | R05 | — | — | 1 | — | — | 1 |
| Rhinitis | D012220 | EFO_0008521 | J31 | — | — | 1 | — | — | 1 |
| Rapid sequence induction and intubation | D000079603 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sinusitis | D012852 | EFO_0007486 | J32 | — | 1 | — | — | 2 | 3 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 1 | — | — | 1 | 2 |
| Pain | D010146 | EFO_0003843 | R52 | 1 | 1 | — | — | — | 1 |
| Congenital myasthenic syndromes | D020294 | Orphanet_590 | G70.2 | 1 | 1 | — | — | — | 1 |
| Vomiting | D014839 | HP_0002013 | R11.1 | — | 1 | — | — | — | 1 |
| Nausea | D009325 | HP_0002018 | R11.0 | — | 1 | — | — | — | 1 |
| Enuresis | D004775 | R32 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 9 | — | — | — | 5 | 14 | ||
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | 2 | — | — | — | — | 2 |
| Headache | D006261 | HP_0002315 | R51 | 1 | — | — | — | — | 1 |
| Fever | D005334 | HP_0001945 | R50.9 | 1 | — | — | — | — | 1 |
| Acute pain | D059787 | R52 | 1 | — | — | — | — | 1 | |
| Back pain | D001416 | HP_0003418 | M54 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hip fractures | D006620 | EFO_0003964 | S72.00 | — | — | — | — | 2 | 2 |
| Blood pressure | D001794 | EFO_0004325 | — | — | — | — | 2 | 2 | |
| Carotid endarterectomy | D016894 | — | — | — | — | 2 | 2 | ||
| Morbid obesity | D009767 | EFO_0001074 | — | — | — | — | 1 | 1 | |
| Compression fractures | D050815 | — | — | — | — | 1 | 1 | ||
| Allergic rhinitis seasonal | D006255 | EFO_0003956 | J30 | — | — | — | — | 1 | 1 |
| Pregnancy rate | D018873 | — | — | — | — | 1 | 1 | ||
| Body temperature changes | D001832 | HP_0004370 | — | — | — | — | 1 | 1 | |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | — | — | 1 | 1 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | EPHEDRINE |
| 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 class | sympathomimetics |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CN[C@@H](C)[C@H](O)c1ccccc1 |
Identifiers
| PDB | — |
| CAS-ID | 299-42-3 |
| RxCUI | 3966 |
| ChEMBL ID | CHEMBL211456 |
| ChEBI ID | 15407 |
| PubChem CID | 9294 |
| DrugBank | DB01364 |
| 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
Clinical Variant
No data
Financial
Akovaz - Avadel Pharmaceuticals
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 11,622 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3 adverse events reported
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