Brompheniramine - PharmaKB

Brompheniramine

/ /, Bromfed-dm, Dimetane, Dimetane-ten (brompheniramine) is a small molecule pharmaceutical. Brompheniramine was first approved as Dimetane-ten on 1982-01-01. It is used to treat allergic rhinitis perennial, common cold, urticaria, and vasomotor rhinitis in the USA.

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
infections	D007239
respiratory tract diseases	D012140
otorhinolaryngologic diseases	D010038
skin and connective tissue diseases	D017437
immune system diseases	D007154

Trade Name

FDA

EMA

Combinations

Bromfed-dm, Brompheniramine maleate, pseudoephedrine dextromethorphan (discontinued: Bromanate, Bromfed-dm, Brompheniramine maleate, pseudoephedrine dextromethorphan, Dimetane-dx, Efidac 24 pseudoephedrine hydrochloride/brompheniramine)

Drug Products

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EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Brompheniramine maleate

Tradename	Company	Number	Date	Products
DIMETANE-TEN	Wyeth	N-011418 DISCN	1982-01-01	1 products
DIMETANE	Wyeth	N-010799 DISCN	1982-01-01	3 products

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Brompheniramine maleate

Dextromethorphan hydrobromide

Pseudoephedrine hydrochloride

Tradename	Company	Number	Date	Products
DIMETANE-DX	A.H. Robins Company	N-019279 DISCN	1984-08-24	1 products, RLD

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Brompheniramine maleate

Pseudoephedrine hydrochloride

Tradename	Company	Number	Date	Products
EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE	Alza	N-019672 DISCN	1996-03-29	1 products

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Labels

FDA

EMA

Brand Name	Status	Last Update
altipres-b	C200263	2024-12-26
atuss da	OTC monograph final	2021-11-02
balahist	OTC monograph final	2013-11-11
basic care childrens cold and cough	C200263	2024-11-17
bio dtuss	C200263	2024-12-20
bio t pres-b	OTC monograph final	2012-12-18
brom tapp	OTC monograph final	2018-04-30
brom tapp dm	OTC monograph final	2018-04-30
bromfed	ANDA	2015-09-01
bromfed dm	ANDA	2021-01-11

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Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
common cold	EFO_0007214	D003139	J00
allergic rhinitis perennial	EFO_1001417	D012221	J30.89
urticaria	EFO_0005531	D014581	L50
vasomotor rhinitis	EFO_0007533	D012223	J30.0
sinusitis	EFO_0007486	D012852	J32
asthma	EFO_0000270	D001249	J45
cough	—	D003371	R05

Agency Specific

FDA

EMA

No data

Patent Expiration

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ATC Codes

R: Respiratory system drugs

— R06: Antihistamines for systemic use

— R06A: Antihistamines for systemic use

— R06AB: Substituted alkylamines, systemic antihistamines

— R06AB01: Brompheniramine

— R06AB51: Brompheniramine, combinations

HCPCS

Code	Description
J0945	Injection, brompheniramine maleate, per 10 mg

Clinical

Clinical Trials

17 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Opioid-related disorders	D009293	EFO_0005611	F11	—	1	6	1	—	8

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Inflammation	D007249	MP_0001845	—	—	—	3	—	—	3
Rhinitis	D012220	EFO_0008521	J31	—	—	3	—	—	3
Substance-related disorders	D019966	EFO_0003890	F13	—	—	1	—	—	1
Cough	D003371	—	R05	—	—	1	—	—	1
Common cold	D003139	EFO_0007214	J00	—	—	1	—	—	1

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Chronic pain	D059350	—	—	—	1	—	—	—	1
Substance withdrawal syndrome	D013375	EFO_0005800	—	1	1	—	—	—	1
Neonatal abstinence syndrome	D009357	EFO_0005799	P96.1	1	1	—	—	—	1
Neoplasms	D009369	—	C80	—	1	—	—	—	1
Head and neck neoplasms	D006258	—	—	—	1	—	—	—	1
Mouth neoplasms	D009062	EFO_0003868	C06.9	—	1	—	—	—	1
Pharyngeal neoplasms	D010610	—	C14.0	—	1	—	—	—	1
Laryngeal neoplasms	D007822	EFO_0003817	C32	—	1	—	—	—	1
Alzheimer disease	D000544	EFO_0000249	F03	—	1	—	—	—	1

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hypersensitivity	D006967	EFO_0003785	T78.40	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Exercise	D015444	EFO_0000483	—	—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Brompheniramine
INN	brompheniramine
Description	Brompheniramine is pheniramine in which the hydrogen at position 4 of the phenyl substituent is substituted by bromine. A histamine H1 receptor antagonist, brompheniramine is used (commonly as its maleate salt) for the symptomatic relief of allergic conditions, including rhinitis and conjunctivitis. It has a role as a H1-receptor antagonist and an anti-allergic agent. It is a member of pyridines and an organobromine compound.
Classification	Small molecule
Drug class	—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CN(C)CCC(c1ccc(Br)cc1)c1ccccn1

Identifiers

PDB	—
CAS-ID	86-22-6
RxCUI	—
ChEMBL ID	CHEMBL811
ChEBI ID	3183
PubChem CID	6834
DrugBank	DB00835
UNII ID	H57G17P2FN (ChemIDplus, GSRS)

Target

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Variants

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Estimated US medical usage

Brompheniramine

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Brompheniramine

Carbetapentane

Phenylephrine

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Brompheniramine

Phenylephrine

Codeine

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Brompheniramine

Codeine

Phenylpropanolamine

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Brompheniramine

Phenylephrine

Dihydrocodeine

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Brompheniramine

Phenylephrine

Diphenhydramine

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Brompheniramine

Phenylephrine

Hydrocodone

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Brompheniramine

Phenylephrine

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Brompheniramine

Phenylpropanolamine

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Brompheniramine

Pseudoephedrine

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Trends

PubMed Central

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Additional graphs summarizing 3,308 documents

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Safety

Black-box Warning

No Black-box warning

Adverse Events

Top Adverse Reactions

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760 adverse events reported

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