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 |
|---|---|
|
Synonyms:
|
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).
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.40 | g | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 2 | Benet LZ, Broccatelli F, Oprea TI |
| S (Water solubility) | 0.01 mg/mL | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 1 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 69.60 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 90 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
| 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 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Jan. 31, 1991 | FDA | WYETH PHARMS INC |
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 |
|---|---|---|---|---|---|---|
| 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 |
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 |
|---|---|---|---|---|---|---|
| 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 |
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 |
|---|---|---|---|---|---|---|
| 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 |
| Atypical femur fracture | 14.21 | 13.90 | 8 | 8174 | 5181 | 79731025 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | M01AB08 | MUSCULO-SKELETAL SYSTEM ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS Acetic acid derivatives and related substances |
| FDA CS | M0001335 | Anti-Inflammatory Agents, Non-Steroidal |
| FDA MoA | N0000000160 | Cyclooxygenase Inhibitors |
| 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 EPC | N0000175722 | Nonsteroidal Anti-inflammatory Drug |
| MeSH PA | D000700 | Analgesics |
| MeSH PA | D018712 | Analgesics, Non-Narcotic |
| MeSH PA | D000893 | Anti-Inflammatory Agents |
| MeSH PA | D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| MeSH PA | D018501 | Antirheumatic Agents |
| MeSH PA | D052246 | Cyclooxygenase 2 Inhibitors |
| MeSH PA | D016861 | Cyclooxygenase Inhibitors |
| MeSH PA | D004791 | Enzyme Inhibitors |
| MeSH PA | D018373 | Peripheral Nervous System Agents |
| MeSH PA | D018689 | Sensory System Agents |
Drug Use | Suggest Off label Use Form| |View source of the data|
| 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 |
| Hypertensive disorder | contraindication | 38341003 | DOID:10763 |
| Gastrointestinal ulcer | contraindication | 40845000 | |
| Chronic heart failure | contraindication | 48447003 | |
| Disorder of cardiovascular system | contraindication | 49601007 | DOID:1287 |
| Blood coagulation disorder | contraindication | 64779008 | DOID:1247 |
| Gastrointestinal hemorrhage | contraindication | 74474003 | |
| Kidney disease | contraindication | 90708001 | DOID:557 |
| Coronary artery bypass graft | contraindication | 232717009 | |
| Disease of liver | contraindication | 235856003 | DOID:409 |
| Pregnancy, function | contraindication | 289908002 | |
| Cardiovascular event risk | contraindication | 395112001 | |
| Smokes tobacco daily | contraindication | 449868002 |
🐶 Veterinary Drug Use
| Species | Use | Relation |
|---|---|---|
| Dogs | Pain and inflammation associated with osteoarthritis | Indication |
🐶 Veterinary products
| Product | Applicant | Ingredients |
|---|---|---|
| EtoGesic Tablets | Boehringer lngelheim Animal Health USA Inc. | 1 |
| Etogesic Sterile Injectable Solution | Boehringer lngelheim Animal Health USA Inc. | 1 |
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:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Prostaglandin G/H synthase 2 | Enzyme | INHIBITOR | IC50 | 5.70 | CHEMBL | CHEMBL | |||
| Prostaglandin G/H synthase 1 | Enzyme | IC50 | 5.58 | DRUG MATRIX |
External reference:
| ID | Source |
|---|---|
| 4019559 | VUID |
| N0000147659 | NUI |
| D00315 | KEGG_DRUG |
| 4019559 | VANDF |
| C0059865 | UMLSCUI |
| CHEBI:4909 | CHEBI |
| CHEMBL622 | ChEMBL_ID |
| DB00749 | DRUGBANK_ID |
| D017308 | MESH_DESCRIPTOR_UI |
| 3308 | PUBCHEM_CID |
| 7185 | IUPHAR_LIGAND_ID |
| 3715 | INN_ID |
| 2M36281008 | UNII |
| 24605 | RXNORM |
| 4707 | MMSL |
| 8937 | MMSL |
| d00851 | MMSL |
| 003587 | NDDF |
| 108510003 | SNOMEDCT_US |
| 386860005 | SNOMEDCT_US |
Pharmaceutical products:
| 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 |
| Etodolac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 10544-862 | TABLET, FILM COATED | 400 mg | ORAL | ANDA | 30 sections |
| ETODOLAC | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16590-092 | TABLET | 400 mg | ORAL | ANDA | 30 sections |
| ETODOLAC | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16590-488 | CAPSULE | 300 mg | ORAL | ANDA | 30 sections |
| Etodolac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16714-497 | TABLET, EXTENDED RELEASE | 400 mg | ORAL | ANDA | 28 sections |
| Etodolac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16714-498 | TABLET, EXTENDED RELEASE | 500 mg | ORAL | ANDA | 28 sections |
| Etodolac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16714-499 | TABLET, EXTENDED RELEASE | 600 mg | ORAL | ANDA | 28 sections |
| Etodolac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 21695-049 | CAPSULE, GELATIN COATED | 300 mg | ORAL | ANDA | 27 sections |
| Etodolac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 21695-050 | TABLET, FILM COATED | 400 mg | ORAL | ANDA | 30 sections |
| Etodolac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 33261-043 | TABLET, FILM COATED | 400 mg | ORAL | ANDA | 28 sections |
| Etodolac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 33261-044 | TABLET, FILM COATED | 500 mg | ORAL | ANDA | 28 sections |
| Etodolac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 35356-711 | TABLET, FILM COATED | 400 mg | ORAL | ANDA | 30 sections |
| Etodolac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42254-052 | TABLET, FILM COATED | 400 mg | ORAL | ANDA | 28 sections |
| Etodolac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42254-121 | CAPSULE | 300 mg | ORAL | ANDA | 14 sections |
| Etodolac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42291-404 | CAPSULE | 200 mg | ORAL | ANDA | 26 sections |
| Etodolac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42291-405 | CAPSULE | 300 mg | ORAL | ANDA | 26 sections |
| ETODOLAC | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42549-511 | TABLET, FILM COATED | 400 mg | ORAL | ANDA | 30 sections |
| Etodolac | Human Prescription Drug Label | 1 | 42799-111 | TABLET, FILM COATED | 400 mg | ORAL | ANDA | 25 sections |
| Etodolac | Human Prescription Drug Label | 1 | 42799-112 | TABLET, FILM COATED | 500 mg | ORAL | ANDA | 25 sections |
| Etodolac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43063-578 | TABLET, FILM COATED | 400 mg | ORAL | ANDA | 29 sections |
| Etodolac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43063-578 | TABLET, FILM COATED | 400 mg | ORAL | ANDA | 29 sections |