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

Stem definition	Drug id	CAS RN
	1170	83799-24-0

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: fexofenadine terfenadine carboxylate fexofenadine hydrochloride fexofenadine HCl	a second generation antihistamine; metabolite of the antihistaminic drug terfenadine; ; RN refers to HCl Molecular weight: 501.67 Formula: C32H39NO4 CLOGP: 1.96 LIPINSKI: 1 HAC: 5 HDO: 3 TPSA: 81 ALOGS: -5.28 ROTB: 10 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

fexofenadine
terfenadine carboxylate
fexofenadine hydrochloride
fexofenadine HCl

a second generation antihistamine; metabolite of the antihistaminic drug terfenadine; ; RN refers to HCl

Molecular weight: 501.67
Formula: C32H39NO4
CLOGP: 1.96
LIPINSKI: 1
HAC: 5
HDO: 3
TPSA: 81
ALOGS: -5.28
ROTB: 10

Status: OFP

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

Drug dosage:

Dose	Unit	Route
0.12	g	O

ADMET properties:

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Property	Value	Reference
BA (Bioavailability)	70 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
MRTD (Maximum Recommended Therapeutic Daily Dose)	5.13 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
S (Water solubility)	3.60 mg/mL	Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	25 %	Benet LZ, Broccatelli F, Oprea TI

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Approvals:

Date	Agency	Company	Orphan
July 25, 1996	FDA	SANOFI AVENTIS US

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
Urticaria	140.11	10.93	298	35750	165504	63287470
Dermatitis atopic	128.87	10.93	76	35972	9648	63443326
Pruritus	108.58	10.93	449	35599	361004	63091970
Contraindicated product administered	106.05	10.93	4	36044	217644	63235330
Synovitis	92.58	10.93	3	36045	186915	63266059
Seasonal allergy	88.27	10.93	82	35966	20868	63432106
Angioedema	79.44	10.93	116	35932	47849	63405125
Lip swelling	79.34	10.93	93	35955	30970	63422004
Asthma	74.78	10.93	199	35849	127362	63325612
Systemic lupus erythematosus	72.75	10.93	15	36033	208903	63244071

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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
Pruritus	51.12	13.61	148	13793	141833	34801157
Dermatitis atopic	43.70	13.61	27	13914	5320	34937670
Toxicity to various agents	41.68	13.61	14	13927	200348	34742642
Sinusitis	37.95	13.61	63	13878	41339	34901651
Urticaria	37.27	13.61	79	13862	62298	34880692
Lip swelling	36.06	13.61	38	13903	16042	34926948
Anaphylactic reaction	34.91	13.61	53	13888	32248	34910742
Alopecia areata	32.07	13.61	9	13932	229	34942761
Skin texture abnormal	29.03	13.61	6	13935	38	34942952
Rash	28.76	13.61	169	13772	222583	34720407

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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
Urticaria	163.93	11.10	312	38893	184889	79520294
Pruritus	141.73	11.10	471	38734	394177	79311006
Lip swelling	112.79	11.10	119	39086	40792	79664391
Dermatitis atopic	110.03	11.10	66	39139	9990	79695193
Toxicity to various agents	100.16	11.10	41	39164	421499	79283684
Pharyngeal swelling	75.09	11.10	47	39158	7672	79697511
General physical health deterioration	73.52	11.10	22	39183	275216	79429967
Rash	68.88	11.10	503	38702	577855	79127328
Swelling face	64.16	11.10	121	39084	71091	79634092
Anaphylactic reaction	61.90	11.10	131	39074	83612	79621571

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	R06AX26	RESPIRATORY SYSTEM ANTIHISTAMINES FOR SYSTEMIC USE ANTIHISTAMINES FOR SYSTEMIC USE Other antihistamines for systemic use
CHEBI has role	CHEBI:37955	H1 receptor antagonists
CHEBI has role	CHEBI:50857	anti-allergic drugs
FDA EPC	N0000175587	Histamine-1 Receptor Antagonist
FDA MoA	N0000000190	Histamine H1 Receptor Antagonists
MeSH PA	D018926	Anti-Allergic Agents
MeSH PA	D018494	Histamine Agents
MeSH PA	D006633	Histamine Antagonists
MeSH PA	D006634	Histamine H1 Antagonists
MeSH PA	D039563	Histamine H1 Antagonists, Non-Sedating

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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
Allergic rhinitis	indication	61582004
Sneezing	indication	76067001
Chronic idiopathic urticaria	indication	302162004
Seasonal allergic rhinitis	indication	367498001
Allergic conjunctivitis	indication	473460002	DOID:11204
Alopecia areata	off-label use	68225006	DOID:986
Urticaria	off-label use	126485001
Hyperthyroidism	contraindication	34486009	DOID:7998
Hypertensive disorder	contraindication	38341003	DOID:10763
Coronary arteriosclerosis	contraindication	53741008	DOID:3393

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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	4.66	acidic
pKa2	8.85	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Histamine H1 receptor	GPCR	P35367	HRH1_HUMAN	ANTAGONIST	Ki	8	WOMBAT-PK	CHEMBL
Potassium voltage-gated channel subfamily H member 2	Ion channel	Q12809	KCNH2_HUMAN		IC50	4.67	CHEMBL
Multidrug resistance protein 1	Transporter	P08183	MDR1_HUMAN		Km	5.70	WOMBAT-PK
Solute carrier organic anion transporter family member 1A2	Transporter	P46721	SO1A2_HUMAN		Km	5.70	WOMBAT-PK

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External reference:

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ID	Source
006063	NDDF
006064	NDDF
108650005	SNOMEDCT_US
108653007	SNOMEDCT_US
153439-40-8	SECONDARY_CAS_RN
236474	RXNORM
3348	PUBCHEM_CID
372522002	SNOMEDCT_US
4021012	VANDF
4024052	VUID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Allergy Relief	HUMAN OTC DRUG LABEL	1	0363-8010	TABLET, COATED	180 mg	ORAL	ANDA	15 sections
Allergy Relief	HUMAN OTC DRUG LABEL	1	0363-8010	TABLET, COATED	180 mg	ORAL	ANDA	15 sections
Allergy Relief	HUMAN OTC DRUG LABEL	1	0363-8010	TABLET, COATED	180 mg	ORAL	ANDA	15 sections
basic care allergy	HUMAN OTC DRUG LABEL	1	0113-7425	TABLET, FILM COATED	60 mg	ORAL	ANDA	15 sections
basic care allergy	HUMAN OTC DRUG LABEL	1	0113-7571	TABLET, FILM COATED	180 mg	ORAL	ANDA	15 sections
Dye Free Wal Fexchildrens allergy	HUMAN OTC DRUG LABEL	1	0363-9230	SUSPENSION	30 mg	ORAL	ANDA	15 sections
Dye Free Wal Fexchildrens allergy	HUMAN OTC DRUG LABEL	1	0363-9230	SUSPENSION	30 mg	ORAL	ANDA	15 sections
Dye Free Wal Fexchildrens allergy	HUMAN OTC DRUG LABEL	1	0363-9230	SUSPENSION	30 mg	ORAL	ANDA	15 sections
Fexofenadine HCl and Pseudoephedrine HCI	HUMAN OTC DRUG LABEL	2	0363-1606	TABLET, EXTENDED RELEASE	60 mg	ORAL	ANDA	16 sections
Fexofenadine HCl and Pseudoephedrine HCl	HUMAN OTC DRUG LABEL	2	0363-0049	TABLET, EXTENDED RELEASE	180 mg	ORAL	ANDA	15 sections

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