ephedrine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
sympathomimetics	1024	299-42-3

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: ephedrine sulphate ephedrine ephedrin ephedrine sulfate ephedrine hydrochloride ephedrine HCl	A phenethylamine found in EPHEDRA SINICA. PSEUDOEPHEDRINE is an isomer. It is an alpha- and beta-adrenergic agonist that may also enhance release of norepinephrine. It has been used for asthma, heart failure, rhinitis, and urinary incontinence, and for its central nervous system stimulatory effects in the treatment of narcolepsy and depression. It has become less extensively used with the advent of more selective agonists. Molecular weight: 165.24 Formula: C10H15NO CLOGP: 0.89 LIPINSKI: 0 HAC: 2 HDO: 2 TPSA: 32.26 ALOGS: -1.30 ROTB: 3 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

ephedrine sulphate
ephedrine
ephedrin
ephedrine sulfate
ephedrine hydrochloride
ephedrine HCl

A phenethylamine found in EPHEDRA SINICA. PSEUDOEPHEDRINE is an isomer. It is an alpha- and beta-adrenergic agonist that may also enhance release of norepinephrine. It has been used for asthma, heart failure, rhinitis, and urinary incontinence, and for its central nervous system stimulatory effects in the treatment of narcolepsy and depression. It has become less extensively used with the advent of more selective agonists.

Molecular weight: 165.24
Formula: C10H15NO
CLOGP: 0.89
LIPINSKI: 0
HAC: 2
HDO: 2
TPSA: 32.26
ALOGS: -1.30
ROTB: 3

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
50	mg	P
8	mg	N
50	mg	O

ADMET properties:

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Property	Value	Reference
S (Water solubility)	56.18 mg/mL	Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Bocci G, Oprea TI, Benet LZ

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Approvals:

Date	Agency	Company	Orphan
None	FDA

FDA Adverse Event Reporting System (Female)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Bradycardia	125.93	32.45	55	1819	73172	63413976
Hypotension	94.94	32.45	72	1802	272532	63214616
Exposure during pregnancy	94.47	32.45	58	1816	155489	63331659
Anterior spinal artery syndrome	85.09	32.45	12	1862	113	63487035
Maternal exposure during delivery	84.28	32.45	17	1857	1483	63485665
Anaphylactic shock	68.94	32.45	26	1848	23607	63463541
Spinal cord injury	67.68	32.45	13	1861	880	63486268
Mental status changes postoperative	56.99	32.45	9	1865	191	63486957
Cardio-respiratory arrest	56.89	32.45	30	1844	59929	63427219
Live birth	56.42	32.45	23	1851	25607	63461541

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FDA Adverse Event Reporting System (Male)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Anaphylactic shock	96.51	34.81	32	1272	15909	34939718
Toxicity to various agents	59.10	34.81	53	1251	200309	34755318
Hypertonia neonatal	47.27	34.81	9	1295	458	34955169
Anaphylactic reaction	46.22	34.81	23	1281	32278	34923349
Locked-in syndrome	45.31	34.81	8	1296	267	34955360
Hyperthermia malignant	43.12	34.81	11	1293	2166	34953461
Agitation neonatal	39.62	34.81	9	1295	1087	34954540
Embolic stroke	39.58	34.81	12	1292	4442	34951185
Hypotension	38.32	34.81	44	1260	221605	34734022
Eosinophilia	35.51	34.81	18	1286	26204	34929423

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FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Anaphylactic shock	158.32	29.12	58	3131	35938	79705261
Hypotension	88.86	29.12	98	3091	440219	79300980
Maternal exposure during delivery	80.94	29.12	17	3172	1329	79739870
Anterior spinal artery syndrome	79.90	29.12	12	3177	130	79741069
Eosinophilia	67.64	29.12	34	3155	45311	79695888
Anaphylactic reaction	62.77	29.12	40	3149	83703	79657496
Metal poisoning	60.76	29.12	9	3180	88	79741111
Bradycardia	60.21	29.12	47	3142	135510	79605689
Spinal cord injury	58.91	29.12	13	3176	1282	79739917
Cardio-respiratory arrest	53.39	29.12	40	3149	108470	79632729

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	A08AA56	ALIMENTARY TRACT AND METABOLISM ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS Centrally acting antiobesity products
ATC	C01CA26	CARDIOVASCULAR SYSTEM CARDIAC THERAPY CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES Adrenergic and dopaminergic agents
ATC	R01AA03	RESPIRATORY SYSTEM NASAL PREPARATIONS DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE Sympathomimetics, plain
ATC	R01AB05	RESPIRATORY SYSTEM NASAL PREPARATIONS DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE Sympathomimetics, combinations excl. corticosteroids
ATC	R03CA02	RESPIRATORY SYSTEM DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES ADRENERGICS FOR SYSTEMIC USE Alpha- and beta-adrenoreceptor agonists
ATC	S01FB02	SENSORY ORGANS OPHTHALMOLOGICALS MYDRIATICS AND CYCLOPLEGICS Sympathomimetics excl. antiglaucoma preparations
CHEBI has role	CHEBI:35524	sympathomimetic
CHEBI has role	CHEBI:35703	Xenobiotic
CHEBI has role	CHEBI:76924	plant metabolites
CHEBI has role	CHEBI:77715	nasal decongestants

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Drug Use | Suggest Off label Use Form| |View source of the data|

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Disease	Relation	SNOMED_ID	DOID
Bronchospasm	indication	4386001
Sinus headache	indication	4969004
Vasomotor rhinitis	indication	8229003	DOID:4730
Bronchitis	indication	32398004	DOID:6132
Allergic rhinitis	indication	61582004
Nasal discharge	indication	64531003
Nasal congestion	indication	68235000
Rhinitis	indication	70076002	DOID:4483
Sneezing	indication	76067001
Common cold	indication	82272006	DOID:10459

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	9.22	Basic

Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
25MG/5ML (5MG/ML)	EMERPHED	NEXUS	N213407	Feb. 28, 2023	RX	SOLUTION	INTRAVENOUS	11571398	May 16, 2040	USE OF EPHEDRINE SULFATE FOR TREATING HYPOTENSION
50MG/10ML (5MG/ML)	EMERPHED	NEXUS	N213407	April 17, 2020	RX	SOLUTION	INTRAVENOUS	11090278	May 16, 2040	USE OF EPHEDRINE SULFATE FOR TREATING HYPOTENSION
50MG/10ML (5MG/ML)	EMERPHED	NEXUS	N213407	April 17, 2020	RX	SOLUTION	INTRAVENOUS	11241400	May 16, 2040	USE OF EPHEDRINE SULFATE FOR TREATING HYPOTENSION
50MG/10ML (5MG/ML)	EMERPHED	NEXUS	N213407	April 17, 2020	RX	SOLUTION	INTRAVENOUS	11478436	May 16, 2040	USE OF EPHEDRINE SULFATE FOR TREATING HYPOTENSION
50MG/10ML (5MG/ML)	EMERPHED	NEXUS	N213407	April 17, 2020	RX	SOLUTION	INTRAVENOUS	11571398	May 16, 2040	USE OF EPHEDRINE SULFATE FOR TREATING HYPOTENSION

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Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Beta-2 adrenergic receptor	GPCR	P07550	ADRB2_HUMAN	AGONIST	Ki	5.60		IUPHAR	IUPHAR

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External reference:

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ID	Source
001820	NDDF
001821	NDDF
001822	NDDF
134-72-5	SECONDARY_CAS_RN
3438	MMSL
387327006	SNOMEDCT_US
387358007	SNOMEDCT_US
3966	RXNORM
4017462	VUID
4017462	VANDF

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Bronchial Asthma Relief	HUMAN OTC DRUG LABEL	2	0363-2529	TABLET	12.50 mg	ORAL	OTC monograph final	15 sections
Corphedra	HUMAN PRESCRIPTION DRUG LABEL	1	42023-196	INJECTION, SOLUTION	50 mg	INTRAVENOUS	NDA	24 sections
Corphedra	HUMAN PRESCRIPTION DRUG LABEL	1	42023-196	INJECTION, SOLUTION	50 mg	INTRAVENOUS	NDA	24 sections
Corphedra	HUMAN PRESCRIPTION DRUG LABEL	1	42023-233	INJECTION, SOLUTION	500 mg	INTRAVENOUS	NDA	24 sections
Emerphed	HUMAN PRESCRIPTION DRUG LABEL	1	14789-250	INJECTION	5 mg	INTRAVENOUS	NDA	25 sections
Emerphed	HUMAN PRESCRIPTION DRUG LABEL	1	14789-250	INJECTION	5 mg	INTRAVENOUS	NDA	25 sections
Emerphed	HUMAN PRESCRIPTION DRUG LABEL	1	14789-251	INJECTION	5 mg	INTRAVENOUS	NDA	26 sections
Emerphed	HUMAN PRESCRIPTION DRUG LABEL	1	14789-252	INJECTION	5 mg	INTRAVENOUS	NDA	26 sections
Ephedrine Hydrochloride	HUMAN OTC DRUG LABEL	1	0363-9812	TABLET	12.50 mg	ORAL	OTC monograph final	18 sections
Ephedrine Sulfate	HUMAN OTC DRUG LABEL	1	0363-5789	TABLET, FILM COATED	25 mg	ORAL	OTC monograph final	18 sections

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