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etodolac 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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 |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2A,ACVR2B,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,DYRK1B,EGFR,EIF2AK3,ERBB2,GRK2,IKBKB,ITK,MAP2K6,MAP3K21,MAPK7,MAPKAPK2,NTRK2,PDK1,PDK2,PDK4,PIK3CB,PIK3CG,PIM2,PRKDC,STK33,SYK,TEK,TGFBR1 | 33 | |||
| kinase-selectivity-class | ACVR2B,AXL,BRAF,CDK9,EIF2AK3,EPHB4,GRK2,MAP2K6,MAPK7,STK33,TEK,TGFBR1 | 12 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
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 | 64.84 | 13.76 | 126 | 7197 | 463483 | 90157641 |
| Interstitial lung disease | 39.14 | 13.76 | 39 | 7284 | 76366 | 90544758 |
| Hepatic function abnormal | 20.75 | 13.76 | 22 | 7301 | 46266 | 90574858 |
| Cholelithiasis | 20.14 | 13.76 | 23 | 7300 | 52483 | 90568641 |
| Injection site erythema | 19.15 | 13.76 | 31 | 7292 | 98471 | 90522653 |
| Mydriasis | 19.06 | 13.76 | 13 | 7310 | 14999 | 90606125 |
| Off label use | 18.03 | 13.76 | 39 | 7284 | 1102213 | 89518911 |
| Beta-N-acetyl-D-glucosaminidase increased | 17.74 | 13.76 | 3 | 7320 | 34 | 90621090 |
| Infusion related reaction | 17.38 | 13.76 | 6 | 7317 | 416774 | 90204350 |
| Contraindicated product administered | 16.44 | 13.76 | 3 | 7320 | 320136 | 90300988 |
| Herpes zoster | 16.02 | 13.76 | 28 | 7295 | 94616 | 90526508 |
| Autonomic nervous system imbalance | 15.85 | 13.76 | 7 | 7316 | 3443 | 90617681 |
| Organising pneumonia | 15.79 | 13.76 | 9 | 7314 | 7588 | 90613536 |
| Treatment failure | 15.28 | 13.76 | 3 | 7320 | 303925 | 90317199 |
| Cerebral infarction | 14.40 | 13.76 | 14 | 7309 | 26582 | 90594542 |
| Gastric ulcer perforation | 14.20 | 13.76 | 5 | 7318 | 1355 | 90619769 |
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 | 52.78 | 17.16 | 23 | 3580 | 10492 | 42607240 |
| Gastrointestinal haemorrhage | 44.94 | 17.16 | 48 | 3555 | 97678 | 42520054 |
| Gastric ulcer | 40.74 | 17.16 | 23 | 3580 | 18239 | 42599493 |
| Duodenal ulcer | 31.60 | 17.16 | 17 | 3586 | 12262 | 42605470 |
| Interstitial lung disease | 25.08 | 17.16 | 32 | 3571 | 78430 | 42539302 |
| Atypical femur fracture | 20.57 | 17.16 | 5 | 3598 | 353 | 42617379 |
| Angioedema | 19.72 | 17.16 | 21 | 3582 | 42456 | 42575276 |
| Blood alkaline phosphatase increased | 18.11 | 17.16 | 18 | 3585 | 33579 | 42584153 |
| Erythema multiforme | 18.11 | 17.16 | 11 | 3592 | 9966 | 42607766 |
| Metamorphopsia | 17.78 | 17.16 | 5 | 3598 | 624 | 42617108 |
| Off label use | 17.52 | 17.16 | 17 | 3586 | 638318 | 41979414 |
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 |
|---|---|---|---|---|---|---|
| Interstitial lung disease | 53.60 | 13.89 | 61 | 8853 | 139273 | 110441112 |
| Drug hypersensitivity | 51.32 | 13.89 | 113 | 8801 | 453977 | 110126408 |
| Gastric haemorrhage | 47.61 | 13.89 | 24 | 8890 | 15891 | 110564494 |
| Gastric ulcer | 40.30 | 13.89 | 30 | 8884 | 39797 | 110540588 |
| Gastrointestinal haemorrhage | 39.22 | 13.89 | 57 | 8857 | 165461 | 110414924 |
| Off label use | 27.95 | 13.89 | 49 | 8865 | 1500136 | 109080249 |
| Duodenal ulcer | 27.46 | 13.89 | 18 | 8896 | 19496 | 110560889 |
| Organising pneumonia | 17.32 | 13.89 | 12 | 8902 | 14231 | 110566154 |
| Osteonecrosis of external auditory canal | 17.06 | 13.89 | 4 | 8910 | 254 | 110580131 |
| Mydriasis | 16.62 | 13.89 | 14 | 8900 | 22143 | 110558242 |
| Beta-N-acetyl-D-glucosaminidase increased | 16.30 | 13.89 | 3 | 8911 | 57 | 110580328 |
| Drug intolerance | 15 | 13.89 | 7 | 8907 | 406505 | 110173880 |
| Infusion related reaction | 14.96 | 13.89 | 6 | 8908 | 381156 | 110199229 |
| Atypical femur fracture | 14.67 | 13.89 | 8 | 8906 | 6211 | 110574174 |
| Pneumonia bacterial | 14.57 | 13.89 | 14 | 8900 | 26247 | 110554138 |
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 drug |
| CHEBI has role | CHEBI:35480 | analgesic |
| CHEBI has role | CHEBI:35481 | non-narcotic analgesic |
| CHEBI has role | CHEBI:35493 | antipyretic |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:35842 | antirheumatic drug |
| CHEBI has role | CHEBI:50629 | cyclooxygenase 2 inhibitor |
| MeSH PA | D000700 | Analgesics |
| MeSH PA | D000893 | Anti-Inflammatory Agents |
| MeSH PA | D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| MeSH PA | D004791 | Enzyme Inhibitors |
| MeSH PA | D016861 | Cyclooxygenase Inhibitors |
| MeSH PA | D018501 | Antirheumatic Agents |
| MeSH PA | D018689 | Sensory System Agents |
| MeSH PA | D018712 | Analgesics, Non-Narcotic |
| MeSH PA | D052246 | Cyclooxygenase 2 Inhibitors |
| FDA EPC | N0000175722 | Nonsteroidal Anti-inflammatory Drug |
Related Drugs by ATC class:
M01AB Acetic acid derivatives and related substances 16 drugs
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 |
| 2M36281008 | INXIGHT DRUGS |
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 | 28 sections |
| Etodolac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-1122 | TABLET, FILM COATED, EXTENDED RELEASE | 400 mg | ORAL | ANDA | 28 sections |
| Etodolac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-7172 | TABLET, FILM COATED, EXTENDED RELEASE | 500 mg | ORAL | ANDA | 28 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 | 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 | 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 |
| Etodolac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43063-671 | TABLET, FILM COATED | 500 mg | ORAL | ANDA | 29 sections |
| Etodolac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43063-671 | TABLET, FILM COATED | 500 mg | ORAL | ANDA | 29 sections |
| Etodolac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43063-856 | TABLET, FILM COATED | 400 mg | ORAL | ANDA | 29 sections |
| Etodolac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43353-749 | TABLET, FILM COATED | 500 mg | ORAL | ANDA | 30 sections |
| Etodolac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43353-752 | TABLET, FILM COATED | 400 mg | ORAL | ANDA | 30 sections |
| Etodolac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43353-753 | CAPSULE | 300 mg | ORAL | ANDA | 30 sections |
| Etodolac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 43353-918 | CAPSULE | 200 mg | ORAL | ANDA | 30 sections |
| Etodolac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 45865-206 | TABLET, FILM COATED | 500 mg | ORAL | ANDA | 29 sections |
| Etodolac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50090-0592 | TABLET, FILM COATED | 400 mg | ORAL | ANDA | 27 sections |
| Etodolac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50090-0613 | CAPSULE | 300 mg | ORAL | ANDA | 26 sections |