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

Stem definition	Drug id	CAS RN
anti-inflammatory agents, ibufenac derivatives	1103	41340-25-4

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: etodolac etodine etodolic acid hypen	A non-steroidal anti-inflammatory agent and cyclooxygenase-2 (COX-2) inhibitor with potent analgesic and anti-arthritic properties. It has been shown to be effective in the treatment of OSTEOARTHRITIS; RHEUMATOID ARTHRITIS; ANKYLOSING SPONDYLITIS; and in the alleviation of postoperative pain (PAIN, POSTOPERATIVE). Molecular weight: 287.36 Formula: C17H21NO3 CLOGP: 3.43 LIPINSKI: 0 HAC: 4 HDO: 2 TPSA: 62.32 ALOGS: -3.87 ROTB: 4 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

etodolac
etodine
etodolic acid
hypen

A non-steroidal anti-inflammatory agent and cyclooxygenase-2 (COX-2) inhibitor with potent analgesic and anti-arthritic properties. It has been shown to be effective in the treatment of OSTEOARTHRITIS; RHEUMATOID ARTHRITIS; ANKYLOSING SPONDYLITIS; and in the alleviation of postoperative pain (PAIN, POSTOPERATIVE).

Molecular weight: 287.36
Formula: C17H21NO3
CLOGP: 3.43
LIPINSKI: 0
HAC: 4
HDO: 2
TPSA: 62.32
ALOGS: -3.87
ROTB: 4

Status: OFP

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

Drug dosage:

Dose	Unit	Route
0.40	g	O

ADMET properties:

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Property	Value	Reference
BA (Bioavailability)	90 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
MRTD (Maximum Recommended Therapeutic Daily Dose)	69.60 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	1 %	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.01 mg/mL	Benet LZ, Broccatelli F, Oprea TI
fu (Fraction unbound in plasma)	0.01 %	Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

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Approvals:

Date	Agency	Company	Orphan
Jan. 31, 1991	FDA	WYETH PHARMS INC

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
Drug hypersensitivity	78.33	14.94	127	6580	310560	63171755
Interstitial lung disease	37.26	14.94	39	6668	61869	63420446
Hepatic function abnormal	19.88	14.94	22	6685	37120	63445195
Cholelithiasis	18.48	14.94	23	6684	43902	63438413
Psoriasis	17.16	14.94	32	6675	86925	63395390
Beta-N-acetyl-D-glucosaminidase increased	16.93	14.94	3	6704	34	63482281

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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
Gastric haemorrhage	50.50	17.67	23	3336	10238	34943334
Gastrointestinal haemorrhage	43.82	17.67	48	3311	88429	34865143
Gastric ulcer	41.31	17.67	23	3336	15627	34937945
Duodenal ulcer	26.75	17.67	15	3344	10317	34943255
Interstitial lung disease	26.52	17.67	32	3327	65250	34888322
Atypical femur fracture	20.28	17.67	5	3354	329	34953243
Angioedema	19.72	17.67	21	3338	37353	34916219
Erythema multiforme	18.26	17.67	11	3348	8638	34944934
Metamorphopsia	18.00	17.67	5	3354	524	34953048

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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
Drug hypersensitivity	66.77	13.90	114	8068	298802	79437404
Interstitial lung disease	52.20	13.90	61	8121	112539	79623667
Gastric haemorrhage	43.42	13.90	24	8158	15026	79721180
Gastric ulcer	38.16	13.90	30	8152	33875	79702331
Gastrointestinal haemorrhage	33.77	13.90	57	8125	147662	79588544
Duodenal ulcer	21.76	13.90	16	8166	16353	79719853
Osteonecrosis of external auditory canal	17.44	13.90	4	8178	180	79736026
Beta-N-acetyl-D-glucosaminidase increased	15.43	13.90	3	8179	60	79736146
Pneumonia bacterial	15.35	13.90	14	8168	19317	79716889
Off label use	14.80	13.90	46	8136	907169	78829037

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	M01AB08	MUSCULO-SKELETAL SYSTEM ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS Acetic acid derivatives and related substances
CHEBI has role	CHEBI:35475	non-steroidal anti-inflammatory agent
CHEBI has role	CHEBI:35493	anti-pyretic
CHEBI has role	CHEBI:50629	COX-2 inhibitor
FDA CS	M0001335	Anti-Inflammatory Agents, Non-Steroidal
FDA EPC	N0000175722	Nonsteroidal Anti-inflammatory Drug
FDA MoA	N0000000160	Cyclooxygenase Inhibitors
MeSH PA	D000700	Analgesics
MeSH PA	D018712	Analgesics, Non-Narcotic
MeSH PA	D000893	Anti-Inflammatory Agents

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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
Pain	indication	22253000
Rheumatoid arthritis	indication	69896004	DOID:7148
Osteoarthritis	indication	396275006
Juvenile rheumatoid arthritis	indication	410795001
Ankylosing spondylitis	off-label use	9631008	DOID:7147
Tendinitis	off-label use	34840004	DOID:971
Bursitis	off-label use	84017003	DOID:2965
Gout	off-label use	90560007	DOID:13189
Peptic ulcer	contraindication	13200003	DOID:750
Myocardial infarction	contraindication	22298006	DOID:5844

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🐶 Veterinary Drug Use

Species	Use	Relation
Dogs	Pain and inflammation associated with osteoarthritis	Indication

🐶 Veterinary products

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Product	Applicant	Ingredients
Etogesic Sterile Injectable Solution	Boehringer lngelheim Animal Health USA Inc.	1
EtoGesic Tablets	Boehringer lngelheim Animal Health USA Inc.	1

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Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	4.95	acidic
pKa2	11.17	acidic

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])	Mechanism action	Bioact source	MoA source
Prostaglandin G/H synthase 2	Enzyme	P35354	PGH2_HUMAN	INHIBITOR	IC50	5.70		CHEMBL	CHEMBL
Prostaglandin G/H synthase 1	Enzyme	P23219	PGH1_HUMAN		IC50	5.58		DRUG MATRIX

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External reference:

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ID	Source
003587	NDDF
108510003	SNOMEDCT_US
24605	RXNORM
2M36281008	UNII
3308	PUBCHEM_CID
3715	INN_ID
386860005	SNOMEDCT_US
4019559	VUID
4019559	VANDF
4707	MMSL

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Etodolac	HUMAN PRESCRIPTION DRUG LABEL	1	0093-1118	TABLET, FILM COATED, EXTENDED RELEASE	600 mg	ORAL	ANDA	30 sections
Etodolac	HUMAN PRESCRIPTION DRUG LABEL	1	0093-1118	TABLET, FILM COATED, EXTENDED RELEASE	600 mg	ORAL	ANDA	30 sections
Etodolac	HUMAN PRESCRIPTION DRUG LABEL	1	0093-1122	TABLET, FILM COATED, EXTENDED RELEASE	400 mg	ORAL	ANDA	30 sections
Etodolac	HUMAN PRESCRIPTION DRUG LABEL	1	0093-1122	TABLET, FILM COATED, EXTENDED RELEASE	400 mg	ORAL	ANDA	30 sections
Etodolac	HUMAN PRESCRIPTION DRUG LABEL	1	0093-7172	TABLET, FILM COATED, EXTENDED RELEASE	500 mg	ORAL	ANDA	30 sections
Etodolac	HUMAN PRESCRIPTION DRUG LABEL	1	0093-7172	TABLET, FILM COATED, EXTENDED RELEASE	500 mg	ORAL	ANDA	30 sections
Etodolac	HUMAN PRESCRIPTION DRUG LABEL	1	0185-0675	TABLET, COATED	400 mg	ORAL	ANDA	26 sections
Etodolac	HUMAN PRESCRIPTION DRUG LABEL	1	0185-0675	TABLET, COATED	400 mg	ORAL	ANDA	26 sections
Etodolac	HUMAN PRESCRIPTION DRUG LABEL	1	0185-0687	TABLET, COATED	500 mg	ORAL	ANDA	26 sections
Etodolac	HUMAN PRESCRIPTION DRUG LABEL	1	0185-0687	TABLET, COATED	500 mg	ORAL	ANDA	26 sections

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