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sulindac 🐶 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 | 2534 | 38194-50-2 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A sulfinylindene derivative prodrug whose sulfinyl moiety is converted in vivo to an active NSAID analgesic. Specifically, the prodrug is converted by liver enzymes to a sulfide which is excreted in the bile and then reabsorbed from the intestine. This helps to maintain constant blood levels with reduced gastrointestinal side effects.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.40 | g | O |
| 0.40 | g | P |
| 0.40 | g | R |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 2 | Benet LZ, Broccatelli F, Oprea TI |
| S (Water solubility) | 0.00 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) | 16.03 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 88 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 0.356 | Moderate | 0.72 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 6.966 | Moderate | 0.72 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 7.464 | 10^-6 cm/s | Moderate | 0.72 |
| dh-clint | Dog hepatocyte intrinsic clearance | 4.603 | uL/min/10^6 cells | Moderate | 0.72 |
| dppb | Dog plasma protein binding (% unbound) | 1.680 | % | Moderate | 0.72 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 5.020 | % | Moderate | 0.72 |
| herg | hERG pIC50 | 4.448 | pIC50 | Moderate | 0.72 |
| hh-clint | Human hepatocyte intrinsic clearance | 3.006 | uL/min/10^6 cells | Moderate | 0.72 |
| hlm-clint | Human liver microsomal intrinsic clearance | 3.327 | uL/min/mg protein | Moderate | 0.72 |
| hppb | Human plasma protein binding (% unbound) | 1.400 | % | Moderate | 0.72 |
| kinase-safety-class | ACVR2B,AURKA,AXL,BRAF,BTK,CAMK2D,CDK5,CDK9,DYRK1B,EGFR,EIF2AK3,ERBB2,GRK2,ITK,MAP2K6,MAPK10,MAPK7,PDK1,PDK2,PDK4,PIK3CA,PIK3CB,PIK3CD,PIK3CG,PRKDC,TEK,TGFBR1 | 27 | |||
| kinase-selectivity-class | ACVR2B,AXL,BRAF,CDK9,EIF2AK3,GRK2,MAP2K6,MAPK7,PRKDC,STK33,TEK,TGFBR1,TTK,ZAP70 | 14 | |||
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 4.055 | Moderate | 0.72 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 7.311 | Moderate | 0.72 | |
| mppb | Mouse plasma protein binding (% unbound) | 2.330 | Moderate | 0.72 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 3.342 | Moderate | 0.72 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pld-class | Phospholipidosis risk class (1 = positive, 0 = negative) | 0 | High | 1 | |
| pppb | Pig plasma protein binding (% unbound) | 2.940 | % | Moderate | 0.72 |
| rh-clint | Rat hepatocyte intrinsic clearance | 4.808 | uL/min/10^6 cells | Moderate | 0.72 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 67.480 | % | Moderate | 0.72 |
| rppb | Rat plasma protein binding (% unbound) | 0.790 | % | Moderate | 0.72 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 901.571 | uM | Moderate | 0.72 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Sept. 27, 1978 | FDA | MERCK |
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 | 102.06 | 19.50 | 95 | 2644 | 463514 | 90162194 |
| Hangover | 66.46 | 19.50 | 15 | 2724 | 2174 | 90623534 |
| Musculoskeletal discomfort | 46.29 | 19.50 | 19 | 2720 | 20972 | 90604736 |
| Musculoskeletal chest pain | 37.57 | 19.50 | 17 | 2722 | 23733 | 90601975 |
| Skin disorder | 33.32 | 19.50 | 18 | 2721 | 36688 | 90589020 |
| Accidental exposure to product | 28.29 | 19.50 | 17 | 2722 | 42349 | 90583359 |
| Neck pain | 28.08 | 19.50 | 25 | 2714 | 113938 | 90511770 |
| Inflammatory pain | 25.47 | 19.50 | 6 | 2733 | 1047 | 90624661 |
| Crystal nephropathy | 24.94 | 19.50 | 6 | 2733 | 1145 | 90624563 |
| Psoriasis | 20.90 | 19.50 | 24 | 2715 | 147730 | 90477978 |
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 | 31.22 | 22.64 | 11 | 976 | 10504 | 42609844 |
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 | 74.60 | 18.94 | 77 | 3042 | 454013 | 110132167 |
| Hangover | 65.50 | 18.94 | 15 | 3104 | 2487 | 110583693 |
| Musculoskeletal discomfort | 45.45 | 18.94 | 19 | 3100 | 23519 | 110562661 |
| Musculoskeletal chest pain | 32.51 | 18.94 | 16 | 3103 | 28831 | 110557349 |
| Skin disorder | 29.17 | 18.94 | 17 | 3102 | 42896 | 110543284 |
| Accidental exposure to product | 26.77 | 18.94 | 17 | 3102 | 49991 | 110536189 |
| Gastric haemorrhage | 24.66 | 18.94 | 11 | 3108 | 15904 | 110570276 |
| Neck pain | 24.02 | 18.94 | 23 | 3096 | 123107 | 110463073 |
| Inflammatory pain | 23.57 | 18.94 | 6 | 3113 | 1547 | 110584633 |
| Crystal nephropathy | 22.51 | 18.94 | 6 | 3113 | 1850 | 110584330 |
| Pain in extremity | 19.94 | 18.94 | 43 | 3076 | 487075 | 110099105 |
| Psoriasis | 19.79 | 18.94 | 22 | 3097 | 139971 | 110446209 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | M01AB02 | 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 |
| MeSH PA | D000700 | Analgesics |
| MeSH PA | D000893 | Anti-Inflammatory Agents |
| MeSH PA | D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| MeSH PA | D000970 | Antineoplastic Agents |
| 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 |
| FDA EPC | N0000175722 | Nonsteroidal Anti-inflammatory Drug |
| 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:35544 | EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:50266 | prodrug |
| CHEBI has role | CHEBI:66993 | tocolytic agent |
| CHEBI has role | CHEBI:68495 | apoptosis inducer |
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 |
|---|---|---|---|
| Ankylosing spondylitis | indication | 9631008 | DOID:7147 |
| Tendinitis | indication | 34840004 | DOID:971 |
| Articular gout | indication | 48440001 | DOID:13189 |
| Rheumatoid arthritis | indication | 69896004 | DOID:7148 |
| Bursitis | indication | 84017003 | DOID:2965 |
| Osteoarthritis | indication | 396275006 | |
| Alcoholism | contraindication | 7200002 | |
| Peptic ulcer | contraindication | 13200003 | DOID:750 |
| Asthenia | contraindication | 13791008 | |
| 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 |
| Gastrointestinal perforation | contraindication | 51875005 | |
| Systemic lupus erythematosus | contraindication | 55464009 | DOID:9074 |
| Blood coagulation disorder | contraindication | 64779008 | DOID:1247 |
| Gastrointestinal hemorrhage | contraindication | 74474003 | |
| Kidney disease | contraindication | 90708001 | DOID:557 |
| Kidney stone | contraindication | 95570007 | |
| Disorder of connective tissue | contraindication | 105969002 | DOID:65 |
| Coronary artery bypass graft | contraindication | 232717009 | |
| Disease of liver | contraindication | 235856003 | DOID:409 |
| Edema | contraindication | 267038008 | |
| Anemia | contraindication | 271737000 | DOID:2355 |
| Pregnancy, function | contraindication | 289908002 | |
| Cardiovascular event risk | contraindication | 395112001 | |
| Breastfeeding (mother) | contraindication | 413712001 | |
| Smokes tobacco daily | contraindication | 449868002 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 4.33 | 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 | 4.25 | WOMBAT-PK | CHEMBL | |||
| Prostaglandin G/H synthase 1 | Enzyme | INHIBITOR | IC50 | 5.92 | IUPHAR | ||||
| Glycine receptor subunit alpha-1 | Ion channel | EC50 | 6.42 | CHEMBL | |||||
| Aldose reductase | Enzyme | IC50 | 6.43 | CHEMBL | |||||
| Peroxisome proliferator-activated receptor gamma | Nuclear hormone receptor | EC50 | 4.64 | CHEMBL | |||||
| Retinoic acid receptor RXR-alpha | Nuclear hormone receptor | IC50 | 4.08 | CHEMBL | |||||
| 72 kDa type IV collagenase | Enzyme | WOMBAT-PK | |||||||
| Lactoylglutathione lyase | Enzyme | Ki | 4.11 | CHEMBL | |||||
| Aldo-keto reductase family 1 member B10 | Enzyme | IC50 | 6.46 | CHEMBL | |||||
| Prostaglandin E synthase | Enzyme | IC50 | 4.10 | CHEMBL | |||||
| Complement C5 | Secreted | Kd | 6.24 | CHEMBL | |||||
| Aldose reductase | Enzyme | IC50 | 6.36 | DRUG MATRIX | |||||
| Prostaglandin G/H synthase 1 | Enzyme | IC50 | 4.80 | CHEMBL | |||||
| Bile salt export pump | Transporter | IC50 | 4.06 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4017957 | VUID |
| N0000146307 | NUI |
| D00120 | KEGG_DRUG |
| 4017957 | VANDF |
| C0038792 | UMLSCUI |
| CHEBI:9352 | CHEBI |
| SUZ | PDB_CHEM_ID |
| CHEMBL15770 | ChEMBL_ID |
| DB00605 | DRUGBANK_ID |
| D013467 | MESH_DESCRIPTOR_UI |
| 1548887 | PUBCHEM_CID |
| 5425 | IUPHAR_LIGAND_ID |
| 3791 | INN_ID |
| 184SNS8VUH | UNII |
| 10237 | RXNORM |
| 2100 | MMSL |
| 285 | MMSL |
| 5535 | MMSL |
| d00033 | MMSL |
| 002386 | NDDF |
| 387513000 | SNOMEDCT_US |
| 89505005 | SNOMEDCT_US |
| 184SNS8VUH | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Sulindac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0591-5660 | TABLET | 200 mg | ORAL | ANDA | 25 sections |
| Sulindac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0591-5661 | TABLET | 150 mg | ORAL | ANDA | 25 sections |
| SULINDAC | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0904-7334 | TABLET | 150 mg | ORAL | ANDA | 28 sections |
| SULINDAC | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0904-7335 | TABLET | 200 mg | ORAL | ANDA | 28 sections |
| Sulindac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16590-211 | TABLET | 200 mg | ORAL | ANDA | 19 sections |
| SULINDAC | HUMAN PRESCRIPTION DRUG LABEL | 1 | 24658-770 | TABLET | 150 mg | ORAL | ANDA | 25 sections |
| SULINDAC | HUMAN PRESCRIPTION DRUG LABEL | 1 | 24658-771 | TABLET | 200 mg | ORAL | ANDA | 25 sections |
| Sulindac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 33261-100 | TABLET | 200 mg | ORAL | ANDA | 19 sections |
| SULINDAC | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42806-011 | TABLET | 200 mg | ORAL | ANDA | 24 sections |
| SULINDAC | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42806-018 | TABLET | 150 mg | ORAL | ANDA | 24 sections |
| SULINDAC | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50090-0529 | TABLET | 200 mg | ORAL | ANDA | 24 sections |
| SULINDAC | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50090-2093 | TABLET | 200 mg | ORAL | ANDA | 27 sections |
| Sulindac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50090-4976 | TABLET | 200 mg | ORAL | ANDA | 24 sections |
| Sulindac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 52959-195 | TABLET | 200 mg | ORAL | ANDA | 24 sections |
| SULINDAC | HUMAN PRESCRIPTION DRUG LABEL | 1 | 53489-478 | TABLET | 150 mg | ORAL | ANDA | 28 sections |
| SULINDAC | HUMAN PRESCRIPTION DRUG LABEL | 1 | 53489-479 | TABLET | 200 mg | ORAL | ANDA | 28 sections |
| SULINDAC | HUMAN PRESCRIPTION DRUG LABEL | 1 | 53808-0302 | TABLET | 200 mg | ORAL | ANDA | 27 sections |
| Sulindac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 53808-0303 | TABLET | 200 mg | ORAL | ANDA | 22 sections |
| Sulindac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 53808-0799 | TABLET | 150 mg | ORAL | ANDA | 21 sections |
| Sulindac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 53808-0814 | TABLET | 200 mg | ORAL | ANDA | 19 sections |
| Sulindac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54738-902 | TABLET | 150 mg | ORAL | ANDA | 28 sections |
| Sulindac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54738-903 | TABLET | 200 mg | ORAL | ANDA | 28 sections |
| Sulindac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54868-0879 | TABLET | 150 mg | ORAL | ANDA | 25 sections |
| Sulindac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54868-1118 | TABLET | 200 mg | ORAL | ANDA | 25 sections |
| Sulindac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55289-930 | TABLET | 200 mg | ORAL | ANDA | 25 sections |
| Sulindac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68151-2871 | TABLET | 200 mg | ORAL | ANDA | 24 sections |
| Sulindac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68151-2872 | TABLET | 200 mg | ORAL | ANDA | 24 sections |
| SULINDAC | HUMAN PRESCRIPTION DRUG LABEL | 1 | 71205-648 | TABLET | 200 mg | ORAL | ANDA | 25 sections |
| SULINDAC | HUMAN PRESCRIPTION DRUG LABEL | 1 | 71335-0413 | TABLET | 200 mg | ORAL | ANDA | 27 sections |
| SULINDAC | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72789-373 | TABLET | 150 mg | ORAL | ANDA | 28 sections |