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Tox | Related Drugs | BioActivity |

Stem definition	Drug id	CAS RN
	1530	34580-13-7

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: HC 20-511 ketotifen ketotifen fumarate	A cycloheptathiophene blocker of histamine H1 receptors and release of inflammatory mediators. It has been proposed for the treatment of asthma, rhinitis, skin allergies, and anaphylaxis. Molecular weight: 309.43 Formula: C19H19NOS CLOGP: 3.59 LIPINSKI: 0 HAC: 2 HDO: 0 TPSA: 20.31 ALOGS: -4.59 ROTB: 0 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

HC 20-511
ketotifen
ketotifen fumarate

A cycloheptathiophene blocker of histamine H1 receptors and release of inflammatory mediators. It has been proposed for the treatment of asthma, rhinitis, skin allergies, and anaphylaxis.

Molecular weight: 309.43
Formula: C19H19NOS
CLOGP: 3.59
LIPINSKI: 0
HAC: 2
HDO: 0
TPSA: 20.31
ALOGS: -4.59
ROTB: 0

Status: OFP

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

Drug dosage:

Dose	Unit	Route
2	mg	O

ADMET properties:

Property	Value	Reference
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.09 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Hosey CM, Chan R, Benet LZ
BA (Bioavailability)	60 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
S (Water solubility)	10 mg/mL	Bocci G, Oprea TI, Benet LZ

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Property	Description	Value	Unit	Confidence	Similarity
azlogd74	LogD at pH 7.4	1.896		High	1
caco2-efflux	Caco-2 efflux ratio (BA/AB)	0.325		High	1
caco2-intrinsic-papp	Caco-2 intrinsic apparent permeability	41.400	10^-6 cm/s	High	1
dh-clint	Dog hepatocyte intrinsic clearance	47.534	uL/min/10^6 cells	High	1
dppb	Dog plasma protein binding (% unbound)	34.780	%	High	1
fcs-ppb	Fetal calf serum protein binding (% unbound)	53.160	%	High	1
herg	hERG pIC50	5.425	pIC50	High	1
hh-clint	Human hepatocyte intrinsic clearance	2.301	uL/min/10^6 cells	High	1
hlm-clint	Human liver microsomal intrinsic clearance	6.637	uL/min/mg protein	High	1
hppb	Human plasma protein binding (% unbound)	40.890	%	High	1
kinase-safety-class	ACVR2B,AKT2,AKT3,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,ITK,JAK2,MAP3K21,MAP3K7,MAPK10,MAPK7,MAPK9,MAPKAPK2,MET,NTRK2,PDK2,PDK4,PDPK1,PIK3CB,PIM2,PRKDC,SIK2,SIK3,STK33,TEK,TTK	39
kinase-selectivity-class	AXL,CAMK2D,CDK4,MAPK7,STK33,TTK	6
mdck-mdr1-efflux	MDCK-MDR1 efflux ratio	0.615		High	1
mh-clint	Mouse hepatocyte intrinsic clearance	97.949		High	1
mppb	Mouse plasma protein binding (% unbound)	36.530		High	1
nih-mdck-mdr1-efflux	NIH MDCK-MDR1 efflux ratio	1.352		High	1
pfas-class	PFAS structural alert (1 = True, 0 = False)	0
pld-class	Phospholipidosis risk class (1 = positive, 0 = negative)	1		High	1
pppb	Pig plasma protein binding (% unbound)	54.480	%	High	1
rh-clint	Rat hepatocyte intrinsic clearance	159.221	uL/min/10^6 cells	High	1
rh-fuinc	Rat hepatocyte fraction unbound in incubation	79.480	%	High	1
rppb	Rat plasma protein binding (% unbound)	31.320	%	High	1
solubility-dd	Solubility at pH 7.4 in DMSO	872.971	uM	High	1

Approvals:

Date	Agency	Company	Orphan
July 2, 1999	FDA

FDA Adverse Event Reporting System (Female)

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
Treatment failure	907.86	22.96	452	6772	303476	90317747
Perfume sensitivity	113.22	22.96	24	7200	971	90620252
Urticaria	112.07	22.96	131	7093	312603	90308620
Mastocytosis	102.75	22.96	22	7202	934	90620289
Anaphylactic reaction	91.79	22.96	67	7157	87457	90533766
Mast cell activation syndrome	86.42	22.96	21	7203	1573	90619650
Angioedema	68.76	22.96	50	7174	64826	90556397
Muscle tension dysphonia	62.69	22.96	12	7212	287	90620936
Dysphoria	62.20	22.96	22	7202	6132	90615091
Skin warm	57.42	22.96	22	7202	7665	90613558
Pruritus	57.02	22.96	130	7094	541395	90079828
Dysphemia	55.36	22.96	17	7207	3053	90618170
Mechanical urticaria	54.28	22.96	12	7212	592	90620631
Haemorrhagic diathesis	52.99	22.96	19	7205	5505	90615718
Appetite disorder	50.36	22.96	21	7203	9112	90612111
Skin reaction	50.06	22.96	26	7198	18527	90602696
Arthritis infective	46.17	22.96	19	7205	7973	90613250
Immunisation reaction	45.73	22.96	11	7213	789	90620434
Lymphadenitis	42.61	22.96	15	7209	4122	90617101
Lipohypertrophy	41.41	22.96	10	7214	729	90620494
Photophobia	41.33	22.96	24	7200	21245	90599978
Food intolerance	39.62	22.96	14	7210	3888	90617335
Thinking abnormal	39.18	22.96	19	7205	11713	90609510
Erythema	38.49	22.96	67	7157	229179	90392044
Vaccination complication	37.84	22.96	10	7214	1049	90620174
Dysphagia	36.72	22.96	45	7179	112233	90508990
Scratch	36.05	22.96	17	7207	9849	90611374
Conjunctivitis allergic	35.57	22.96	10	7214	1322	90619901
Oral pruritus	35.43	22.96	12	7212	2939	90618284
Visual impairment	35.37	22.96	48	7176	132317	90488906
Restrictive pulmonary disease	33.94	22.96	11	7213	2351	90618872
Tenderness	33.77	22.96	23	7201	26845	90594378
Oropharyngeal discomfort	33.51	22.96	15	7209	7720	90613503
Wound complication	33.33	22.96	13	7211	4750	90616473
Skin plaque	32.84	22.96	16	7208	9959	90611264
Dry eye	32.69	22.96	31	7193	57900	90563323
Sneezing	31.58	22.96	23	7201	29846	90591377
Eye inflammation	30.15	22.96	14	7210	7837	90613386
Oral pain	29.73	22.96	23	7201	32660	90588563
Subcutaneous abscess	29.11	22.96	13	7211	6653	90614570
Blood pressure increased	28.46	22.96	54	7170	197163	90424060
Product availability issue	27.80	22.96	13	7211	7391	90613832
Pharyngeal swelling	24.17	22.96	13	7211	9931	90611292
Bone pain	23.83	22.96	27	7197	61956	90559267
Ear pain	23.67	22.96	26	7198	57676	90563547
Rhinorrhoea	23.54	22.96	32	7192	88284	90532939
Skin disorder	23.34	22.96	21	7203	36685	90584538
Osteoporotic fracture	23.15	22.96	10	7214	4726	90616497
Muscle tightness	23.07	22.96	14	7210	13425	90607798

FDA Adverse Event Reporting System (Male)

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
Treatment failure	516.51	26.65	173	2142	62451	42556569
Mast cell activation syndrome	53.04	26.65	10	2305	328	42618692
Tendon disorder	51.24	26.65	15	2300	3374	42615646
Exostosis	47.68	26.65	16	2299	5615	42613405
Foot fracture	46.19	26.65	16	2299	6175	42612845
Ankle fracture	45.89	26.65	15	2300	4851	42614169
Foot deformity	45.29	26.65	15	2300	5053	42613967
Anaphylactic reaction	44.18	26.65	28	2287	42715	42576305
Application site eczema	38.29	26.65	5	2310	11	42619009
Vasospasm	36.26	26.65	8	2307	578	42618442
Application site oedema	35.50	26.65	5	2310	23	42618997
Episcleritis	31.58	26.65	6	2309	205	42618815
Lower respiratory tract infection viral	31.54	26.65	7	2308	520	42618500
Lower respiratory tract infection bacterial	31.06	26.65	7	2308	557	42618463
Synovitis	29.03	26.65	15	2300	15552	42603468

FDA Adverse Event Reporting System (Geriatric)

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	122.62	19.44	132	7829	318725	110262613
Perfume sensitivity	113.45	19.44	24	7937	1067	110580271
Mastocytosis	108.03	19.44	22	7939	810	110580528
Anaphylactic reaction	99.25	19.44	75	7886	114225	110467113
Mast cell activation syndrome	79.02	19.44	19	7942	1509	110579829
Pruritus	78.93	19.44	146	7815	581414	109999924
Mechanical urticaria	67.39	19.44	14	7947	569	110580769
Dysphoria	67.34	19.44	23	7938	6405	110574933
Muscle tension dysphonia	57.89	19.44	11	7950	281	110581057
Appetite disorder	51.06	19.44	21	7940	9748	110571590
Skin reaction	49.35	19.44	26	7935	21118	110560220
Skin warm	48.91	19.44	20	7941	9150	110572188
Dysphemia	48.44	19.44	16	7945	4021	110577317
Immunisation reaction	46.72	19.44	11	7950	798	110580540
Haemorrhagic diathesis	45.66	19.44	18	7943	7490	110573848
Dry eye	42.70	19.44	34	7927	55759	110525579
Thinking abnormal	42.24	19.44	21	7940	15119	110566219
Arthritis infective	39.96	19.44	18	7943	10411	110570927
Angioedema	39.88	19.44	42	7919	98458	110482880
Lipohypertrophy	39.36	19.44	10	7951	996	110580342
Application site eczema	38.32	19.44	5	7956	7	110581331
Scratch	36.20	19.44	18	7943	12961	110568377
Visual impairment	35.47	19.44	46	7915	134382	110446956
Food intolerance	35.26	19.44	13	7948	4514	110576824
Oral pruritus	35.24	19.44	12	7949	3308	110578030
Photophobia	34.29	19.44	22	7939	25749	110555589
Tendon disorder	33.89	19.44	15	7946	8322	110573016
Blood pressure increased	32.58	19.44	63	7898	258310	110323028
Tenderness	31.63	19.44	22	7939	29415	110551923
Restrictive pulmonary disease	31.57	19.44	11	7950	3248	110578090
Product availability issue	31.45	19.44	14	7947	7876	110573462
Oropharyngeal discomfort	30.83	19.44	15	7946	10312	110571026
Vaccination complication	30.82	19.44	8	7953	867	110580471
Skin plaque	30.79	19.44	16	7945	12629	110568709
Vasospasm	30.37	19.44	9	7952	1587	110579751
Erythema	29.61	19.44	65	7896	291382	110289956
Dysphagia	29.29	19.44	45	7916	153555	110427783
Application site oedema	28.90	19.44	5	7956	74	110581264
Dacryostenosis acquired	27.75	19.44	7	7954	677	110580661
Sneezing	27.75	19.44	21	7940	31963	110549375
Oral pain	26.91	19.44	22	7939	37422	110543916
Asthma	26.76	19.44	57	7904	250234	110331104
Food allergy	26.46	19.44	17	7944	19931	110561407
Eye inflammation	26.41	19.44	13	7948	9158	110572180
Ear pain	25.75	19.44	25	7936	53201	110528137
Acute kidney injury	25.70	19.44	7	7954	635423	109945915
Eye pruritus	25.13	19.44	20	7941	32755	110548583
Inappropriate schedule of product administration	24.86	19.44	49	7912	203588	110377750
Lower respiratory tract infection bacterial	24.55	19.44	7	7954	1078	110580260
Episcleritis	23.48	19.44	7	7954	1259	110580079
Muscle tightness	23.17	19.44	14	7947	14748	110566590
Osteoporotic fracture	22.98	19.44	10	7951	5327	110576011
Lower respiratory tract infection viral	22.59	19.44	7	7954	1434	110579904
Allergic eosinophilia	22.39	19.44	4	7957	72	110581266
Skin disorder	22.36	19.44	21	7940	42892	110538446
pH body fluid increased	22.28	19.44	4	7957	74	110581264
Ankle fracture	21.73	19.44	15	7946	19804	110561534
Injection site pruritus	20.99	19.44	22	7939	51236	110530102
Rhinorrhoea	20.87	19.44	31	7930	102635	110478703
Cardiac valve sclerosis	20.87	19.44	4	7957	107	110581231
Foot fracture	20.47	19.44	16	7945	25530	110555808
Hereditary angioedema	20.24	19.44	10	7951	7104	110574234
Gastrointestinal submucosal tumour	20.00	19.44	4	7957	134	110581204
Bone pain	19.90	19.44	24	7937	65109	110516229
Dry skin	19.76	19.44	31	7930	107622	110473716

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	R06AX17	RESPIRATORY SYSTEM ANTIHISTAMINES FOR SYSTEMIC USE ANTIHISTAMINES FOR SYSTEMIC USE Other antihistamines for systemic use
ATC	S01GX08	SENSORY ORGANS OPHTHALMOLOGICALS DECONGESTANTS AND ANTIALLERGICS Other antiallergics
FDA MoA	N0000000190	Histamine H1 Receptor Antagonists
FDA EPC	N0000175519	Histamine-1 Receptor Inhibitor
MeSH PA	D000982	Antipruritics
MeSH PA	D003879	Dermatologic Agents
MeSH PA	D006633	Histamine Antagonists
MeSH PA	D006634	Histamine H1 Antagonists
MeSH PA	D018377	Neurotransmitter Agents
MeSH PA	D018926	Anti-Allergic Agents
CHEBI has role	CHEBI:37955	H<small><sub>1</sub></small>-receptor antagonist
CHEBI has role	CHEBI:49167	anti-asthmatic drug
CHEBI has role	CHEBI:22587	antiviral agent
CHEBI has role	CHEBI:50857	anti-allergic agent
CHEBI has role	CHEBI:66981	ophthalmology drug

Related Drugs by ATC class:

R06AX Other antihistamines for systemic use 26 drugs

acrivastine antazoline astemizole azatadine azelastine bamipine bilastine cyproheptadine deptropine desloratadine ebastine epinastine show all 26 →

S01GX Other antiallergics 12 drugs

alcaftadine azelastine bilastine cetirizine cromoglicic acid emedastine epinastine levocabastine lodoxamide nedocromil olopatadine spaglumic acid

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

Disease	Relation	SNOMED_ID	DOID
Allergic conjunctivitis	indication	473460002	DOID:11204

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	8.8	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Histamine H1 receptor	GPCR	P35367	HRH1_HUMAN	ANTAGONIST	Ki	9.51	WOMBAT-PK	CHEMBL
Muscarinic acetylcholine receptor M3	GPCR	P20309	ACM3_HUMAN		Ki	6.58	WOMBAT-PK
Muscarinic acetylcholine receptor M4	GPCR	P08173	ACM4_HUMAN		Ki	7.08	WOMBAT-PK
D(1A) dopamine receptor	GPCR	P21728	DRD1_HUMAN		Ki	6.36	DRUG MATRIX
D(2) dopamine receptor	GPCR	P14416	DRD2_HUMAN		Ki	5.76	CHEMBL
Alpha-2A adrenergic receptor	GPCR	P08913	ADA2A_HUMAN		Ki	6.09	DRUG MATRIX
Multidrug resistance protein 1	Transporter	P08183	MDR1_HUMAN				WOMBAT-PK
5-hydroxytryptamine receptor 1A	GPCR	P08908	5HT1A_HUMAN		Ki	5.84	DRUG MATRIX
5-hydroxytryptamine receptor 2A	GPCR	P28223	5HT2A_HUMAN		Ki	8.05	DRUG MATRIX
5-hydroxytryptamine receptor 2B	GPCR	P41595	5HT2B_HUMAN		Ki	7.54	DRUG MATRIX
5-hydroxytryptamine receptor 2C	GPCR	P28335	5HT2C_HUMAN		Ki	7.08	DRUG MATRIX
5-hydroxytryptamine receptor 6	GPCR	P50406	5HT6R_HUMAN		Ki	6.28	DRUG MATRIX
5-hydroxytryptamine receptor 7	GPCR	P34969	5HT7R_HUMAN		Ki	6.39	CHEMBL
Alpha-2B adrenergic receptor	GPCR	P18089	ADA2B_HUMAN		Ki	6.49	DRUG MATRIX
D(3) dopamine receptor	GPCR	P35462	DRD3_HUMAN		Ki	6.18	DRUG MATRIX
D(1B) dopamine receptor	GPCR	P21918	DRD5_HUMAN		Ki	5.58	CHEMBL
Histamine H2 receptor	GPCR	P25021	HRH2_HUMAN		Ki	5.39	DRUG MATRIX
Histamine H4 receptor	GPCR	Q9H3N8	HRH4_HUMAN		IC50	4.68	CHEMBL
Muscarinic acetylcholine receptor M1	GPCR	P11229	ACM1_HUMAN		Ki	7.02	WOMBAT-PK
Muscarinic acetylcholine receptor M2	GPCR	P08172	ACM2_HUMAN		Ki	6.36	WOMBAT-PK
5-hydroxytryptamine receptor 1B	GPCR	P28222	5HT1B_HUMAN		Ki	5.76	CHEMBL
Alpha-1D adrenergic receptor	GPCR	P25100	ADA1D_HUMAN		Ki	5.74	DRUG MATRIX
5-hydroxytryptamine receptor 3A	Ion channel	P46098	5HT3A_HUMAN		Ki	6.47	CHEMBL
Muscarinic acetylcholine receptor M5	GPCR	P08912	ACM5_HUMAN		Ki	7.73	WOMBAT-PK
Transmembrane protein 97	Enzyme	Q5BJF2	TMM97_HUMAN		Ki	6.44	CHEMBL
Histamine H1 receptor	GPCR		HRH1_CAVPO		Ki	9.51	CHEMBL
5-hydroxytryptamine receptor 1A	GPCR		5HT1A_RAT		IC50	5.60	CHEMBL

External reference:

ID	Source
4021170	VUID
N0000148619	NUI
D01332	KEGG_DRUG
34580-14-8	SECONDARY_CAS_RN
4021170	VANDF
4021171	VANDF
C0022642	UMLSCUI
CHEBI:92511	CHEBI
CHEMBL534	ChEMBL_ID
CHEMBL1633	ChEMBL_ID
DB00920	DRUGBANK_ID
D007665	MESH_DESCRIPTOR_UI
3827	PUBCHEM_CID
7206	IUPHAR_LIGAND_ID
3993	INN_ID
X49220T18G	UNII
11404	RXNORM
365752	MMSL
8247	MMSL
8249	MMSL
d04580	MMSL
003742	NDDF
003743	NDDF
116098000	SNOMEDCT_US
354038002	SNOMEDCT_US
372642003	SNOMEDCT_US
X49220T18G	INXIGHT DRUGS

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Zaditor	HUMAN OTC DRUG LABEL	1	0065-4011	SOLUTION	0.25 mg	OPHTHALMIC	ANDA	13 sections
Eye Itch Relief	HUMAN OTC DRUG LABEL	1	0363-0038	SOLUTION	0.35 mg	OPHTHALMIC	NDA	10 sections
EYE ITCH RELIEF	HUMAN OTC DRUG LABEL	1	0363-0610	SOLUTION/ DROPS	0.25 mg	OPHTHALMIC	ANDA	13 sections
Ketotifen Fumarate	HUMAN OTC DRUG LABEL	1	0363-9060	SOLUTION/ DROPS	0.25 mg	OPHTHALMIC	ANDA	13 sections
Ketotifen Fumarate	HUMAN OTC DRUG LABEL	1	0536-1252	SOLUTION/ DROPS	0.25 mg	OPHTHALMIC	NDA authorized generic	12 sections
Eye Itch Relief	HUMAN OTC DRUG LABEL	1	11673-064	SOLUTION	0.25 mg	OPHTHALMIC	NDA	9 sections
LEADER EYE ITCH RELIEF DROPS	HUMAN OTC DRUG LABEL	1	11716-1163	SOLUTION/ DROPS	0.35 mg	OPHTHALMIC	OTC monograph final	10 sections
eye itch relief	HUMAN OTC DRUG LABEL	1	11822-4201	SOLUTION/ DROPS	0.35 mg	OPHTHALMIC	ANDA	13 sections
eye itch relief	HUMAN OTC DRUG LABEL	1	11822-4202	SOLUTION/ DROPS	0.35 mg	OPHTHALMIC	ANDA	13 sections
Eye Itch Releif	HUMAN OTC DRUG LABEL	1	11822-5533	SOLUTION/ DROPS	0.25 mg	OPHTHALMIC	NDA	12 sections
Ketotifen Fumarate	HUMAN OTC DRUG LABEL	1	17478-717	SOLUTION/ DROPS	0.35 mg	OPHTHALMIC	ANDA	13 sections
Eye Itch Relief	HUMAN OTC DRUG LABEL	1	21130-601	SOLUTION	0.25 mg	OPHTHALMIC	NDA	11 sections
Alaway	HUMAN OTC DRUG LABEL	1	24208-601	SOLUTION/ DROPS	0.25 mg	OPHTHALMIC	NDA	12 sections
Eye Itch Relief	HUMAN OTC DRUG LABEL	1	30142-398	SOLUTION/ DROPS	0.25 mg	OPHTHALMIC	NDA	11 sections
Eye Itch	HUMAN OTC DRUG LABEL	1	30142-702	SOLUTION/ DROPS	0.35 mg	OPHTHALMIC	ANDA	13 sections
Eye Itch Relief	HUMAN OTC DRUG LABEL	1	36800-097	SOLUTION/ DROPS	0.25 mg	OPHTHALMIC	NDA	10 sections
Eye Itch Relief	HUMAN OTC DRUG LABEL	1	37808-802	SOLUTION/ DROPS	0.35 mg	OPHTHALMIC	ANDA	13 sections
Allergy Eye Drops	HUMAN OTC DRUG LABEL	1	37808-870	SOLUTION/ DROPS	0.35 mg	OPHTHALMIC	ANDA	13 sections
Eye Itch	HUMAN OTC DRUG LABEL	1	41250-302	SOLUTION/ DROPS	0.35 mg	OPHTHALMIC	ANDA	13 sections
Itchy Eye	HUMAN OTC DRUG LABEL	1	41250-303	SOLUTION/ DROPS	0.35 mg	OPHTHALMIC	ANDA	14 sections
Equate Eye Itch Relief	HUMAN OTC DRUG LABEL	1	49035-231	SOLUTION	0.25 mg	OPHTHALMIC	NDA	9 sections
eye itch relief	HUMAN OTC DRUG LABEL	1	49348-107	SOLUTION/ DROPS	0.35 mg	OPHTHALMIC	ANDA	13 sections
Zaditor	HUMAN OTC DRUG LABEL	1	50090-1037	SOLUTION	0.35 mg	OPHTHALMIC	ANDA	14 sections
Ketotifen Fumarate	HUMAN OTC DRUG LABEL	1	50090-6472	SOLUTION/ DROPS	0.25 mg	OPHTHALMIC	NDA authorized generic	13 sections
Eye Itch Relief	HUMAN OTC DRUG LABEL	1	50090-7253	SOLUTION/ DROPS	0.25 mg	OPHTHALMIC	NDA	13 sections
Eye Itch Relief	HUMAN OTC DRUG LABEL	1	50804-601	SOLUTION/ DROPS	0.25 mg	OPHTHALMIC	NDA	12 sections
Ketotifen Fumarate	HUMAN OTC DRUG LABEL	1	59779-330	SOLUTION/ DROPS	0.35 mg	OPHTHALMIC	ANDA	14 sections
Ketotifen Fumarate	HUMAN OTC DRUG LABEL	1	59779-330	SOLUTION/ DROPS	0.35 mg	OPHTHALMIC	ANDA	14 sections
Ketotifen Fumarate	HUMAN OTC DRUG LABEL	1	59779-627	SOLUTION/ DROPS	0.35 mg	OPHTHALMIC	ANDA	13 sections
Eye Itch Relief	HUMAN OTC DRUG LABEL	1	59779-705	SOLUTION/ DROPS	0.35 mg	OPHTHALMIC	ANDA	13 sections

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ketotifen 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Description:

Drug dosage:

ADMET properties:

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Approvals:

FDA Adverse Event Reporting System (Female)

FDA Adverse Event Reporting System (Male)

FDA Adverse Event Reporting System (Geriatric)

FDA Adverse Event Reporting System (Pediatric)

Pharmacologic Action:

Related Drugs by ATC class:

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

🐶 Veterinary Drug Use

🐶 Veterinary products

Acid dissociation constants calculated using MoKa v3.0.0

Orange Book patent data (new drug applications)

Orange Book exclusivity data (new drug applications)

Bioactivity Summary:

External reference:

Pharmaceutical products: