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

Stem definitionDrug idCAS RN
4405 182815-43-6

Description:

MoleculeDescription

Synonyms:

  • cholestagel
  • colesevelam
  • colesevelam hydrochloride
  • WELCHOL
  • colesevelam HCl
An allylamine derivative that binds BILE ACIDS in the intestine and is used as an ANTICHOLESTEREMIC AGENT in the treatment of HYPERCHOLESTEROLEMIA and HYPERLIPIDEMIAS.
  • Molecular weight:
  • Formula: C12H26Cl5N2O(C5H12N)a(C15H32N)c(C14H32ClN2)d
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
3.75 g O

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
May 26, 2000 FDA DAIICHI SANKYO

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
No adverse event 554.10 16.37 216 8276 67766 90552189
Off label use 195.48 16.37 359 8133 1101893 89518062
Product administration error 112.00 16.37 53 8439 26370 90593585
Incorrect dose administered 79.54 16.37 63 8429 78867 90541088
Myalgia 69.85 16.37 84 8408 175041 90444914
Diarrhoea 59.78 16.37 208 8284 938982 89680973
Constipation 44.87 16.37 88 8404 280307 90339648
Anembryonic gestation 36.86 16.37 9 8483 583 90619372
Functional gastrointestinal disorder 33.87 16.37 14 8478 5048 90614907
Low density lipoprotein increased 33.58 16.37 16 8476 8069 90611886
Flatulence 29.32 16.37 27 8465 41340 90578615
Muscle spasms 28.75 16.37 69 8423 251814 90368141
Dysphagia 26.72 16.37 42 8450 112236 90507719
Bile acid malabsorption 26.31 16.37 6 8486 289 90619666
Product dose omission issue 26.17 16.37 73 8419 291614 90328341
Therapeutic response unexpected 23.17 16.37 18 8474 21862 90598093
Clostridium difficile colitis 22.04 16.37 19 8473 26687 90593268
Abdominal pain 21.90 16.37 84 8408 395637 90224318
Lipids increased 21.32 16.37 7 8485 1325 90618630
Maternal exposure during pregnancy 21.26 16.37 4 8488 360059 90259896
Contraindicated product administered 20.13 16.37 3 8489 320136 90299819
Monoclonal immunoglobulin increased 19.25 16.37 5 8487 416 90619539
Infusion related reaction 18.43 16.37 8 8484 416772 90203183
Feeling abnormal 17.15 16.37 44 8448 167191 90452764
Treatment failure 16.66 16.37 4 8488 303924 90316031

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Fractional exhaled nitric oxide increased 276.46 23.88 58 4796 1551 42614930
Myoglobin blood increased 233.63 23.88 59 4795 3623 42612858
Sensation of foreign body 229.77 23.88 58 4796 3555 42612926
Plantar fasciitis 223.86 23.88 55 4799 3015 42613466
Brain natriuretic peptide increased 198.04 23.88 59 4795 6711 42609770
No adverse event 179.92 23.88 88 4766 38933 42577548
Exostosis 155.70 23.88 47 4807 5584 42610897
Obstructive airways disorder 126.62 23.88 60 4794 24699 42591782
Dysphonia 124.59 23.88 62 4792 28388 42588093
Secretion discharge 121.90 23.88 42 4812 7593 42608888
Eosinophilia 110.48 23.88 60 4794 32839 42583642
Muscle spasms 104.69 23.88 83 4771 85961 42530520
Dyspnoea exertional 99.15 23.88 65 4789 50083 42566398
Cardiac disorder 98.15 23.88 64 4790 48868 42567613
Coronary artery disease 95.08 23.88 65 4789 53655 42562826
Chest discomfort 94.15 23.88 69 4785 63547 42552934
Pneumothorax 93.37 23.88 48 4806 23495 42592986
Cerebrovascular accident 81.95 23.88 76 4778 97084 42519397
Nasopharyngitis 81.27 23.88 71 4783 83925 42532556
Wheezing 80.09 23.88 59 4795 54722 42561759
Increased upper airway secretion 69.19 23.88 21 4833 2535 42613946
Atrial fibrillation 67.23 23.88 81 4773 139512 42476969
Foreign body in throat 51.01 23.88 12 4842 544 42615937
Cough 43.67 23.88 75 4779 178028 42438453
Off label use 38.91 23.88 159 4695 638176 41978305
Product administration error 31.93 23.88 22 4832 18321 42598160
Bronchospasm 31.16 23.88 19 4835 12866 42603615
Pancreatitis 31.01 23.88 31 4823 43237 42573244
Myalgia 25.53 23.88 42 4812 96038 42520443

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
No adverse event 266.50 16.74 129 9390 73710 110506070
Fractional exhaled nitric oxide increased 123.23 16.74 25 9494 751 110579029
Cerebrovascular accident 94.36 16.74 96 9423 181188 110398592
Myoglobin blood increased 85.37 16.74 26 9493 4206 110575574
Myalgia 76.64 16.74 95 9424 222286 110357494
Plantar fasciitis 76.52 16.74 25 9494 5076 110574704
Sensation of foreign body 69.21 16.74 26 9493 7949 110571831
Off label use 67.06 16.74 280 9239 1499905 109079875
Product administration error 64.26 16.74 40 9479 37177 110542603
Increased upper airway secretion 64.03 16.74 22 9497 5210 110574570
Brain natriuretic peptide increased 60.64 16.74 26 9493 11183 110568597
Foreign body in throat 56.53 16.74 14 9505 1049 110578731
Muscle spasms 54.68 16.74 91 9428 278066 110301714
Anembryonic gestation 40.40 16.74 9 9510 425 110579355
Coronary artery disease 39.13 16.74 39 9480 71651 110508129
Diarrhoea 38.28 16.74 196 9323 1139309 109440471
Incorrect dose administered 35.20 16.74 44 9475 103597 110476183
Pneumothorax 35.06 16.74 27 9492 35258 110544522
Bile acid malabsorption 34.27 16.74 8 9511 466 110579314
Cardiac disorder 33.59 16.74 37 9482 76243 110503537
Obstructive airways disorder 30.68 16.74 28 9491 46121 110533659
Low density lipoprotein increased 30.66 16.74 16 9503 10650 110569130
Functional gastrointestinal disorder 29.36 16.74 13 9506 6036 110573744
Myocardial infarction 28.93 16.74 56 9463 192027 110387753
Exostosis 28.84 16.74 27 9492 45929 110533851
Chest discomfort 27.81 16.74 52 9467 173796 110405984
Flatulence 27.78 16.74 28 9491 52121 110527659
Bronchospasm 27.58 16.74 22 9497 30217 110549563
Dysphagia 27.18 16.74 48 9471 153552 110426228
Atrial fibrillation 26.47 16.74 60 9459 229582 110350198
Constipation 26.34 16.74 79 9440 357707 110222073
Dyspnoea exertional 25.92 16.74 38 9481 104022 110475758
Dysphonia 25.40 16.74 32 9487 75897 110503883
Eosinophilia 23.62 16.74 27 9492 57909 110521871
Blood creatine phosphokinase increased 23.19 16.74 30 9489 73047 110506733
Pancreatitis 23.07 16.74 34 9485 93499 110486281
Toxicity to various agents 21.99 16.74 7 9512 480548 110099232
Product dose omission issue 19.96 16.74 67 9452 321715 110258065
Influenza like illness 17.43 16.74 29 9490 88383 110491397
Blood triglycerides increased 16.85 16.74 15 9504 23911 110555869

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C10AC04 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, PLAIN
Bile acid sequestrants
FDA MoA N0000175365 Bile-acid Binding Activity
MeSH PA D000924 Anticholesteremic Agents
MeSH PA D000960 Hypolipidemic Agents
MeSH PA D000963 Antimetabolites
MeSH PA D057847 Lipid Regulating Agents
FDA EPC N0000180292 Bile Acid Sequestrant
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:35821 anticholesteremic drug
CHEBI has role CHEBI:35526 hypoglycemic agent
CHEBI has role CHEBI:35610 antineoplastic agent

Related Drugs by ATC class:

C10AC Bile acid sequestrants 3 drugs
cholestyraminecolestipolcolextran

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

DiseaseRelationSNOMED_IDDOID
Hypercholesterolemia indication 13644009
Type 2 Diabetes Mellitus Treatment Adjunct indication
Dysphasia contraindication 20301004
Vitamin D deficiency contraindication 34713006
Vitamin K deficiency contraindication 52675005 DOID:11249
Vitamin E deficiency contraindication 54137008
Vitamin A deficiency contraindication 72000004
Intestinal obstruction contraindication 81060008 DOID:8437
Chronic idiopathic constipation contraindication 82934008
Gastrointestinal obstruction contraindication 126765001
Gastroparesis contraindication 235675006
Esophageal dysmotility contraindication 266434009 DOID:9192
Hypertriglyceridemia contraindication 302870006
Operation on gastrointestinal tract contraindication 386621005
Gastrointestinal hypomotility contraindication 421807004
Predisposition To Hypertriglyceridemia contraindication
Esophageal Obstruction contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

IDSource
D03582 KEGG_DRUG
4021227 VUID
N0000148671 NUI
182815-44-7 SECONDARY_CAS_RN
4021227 VANDF
4029706 VANDF
C0541155 UMLSCUI
CHEBI:59594 CHEBI
CHEMBL6068331 ChEMBL_ID
CHEMBL1201473 ChEMBL_ID
DB00930 DRUGBANK_ID
7621 INN_ID
1XU104G55N UNII
141625 RXNORM
15635 MMSL
26906 MMSL
280036 MMSL
37702 MMSL
d04695 MMSL
008852 NDDF
008853 NDDF
127965004 SNOMEDCT_US
441851004 SNOMEDCT_US
442510005 SNOMEDCT_US
D000069472 MESH_DESCRIPTOR_UI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Colesevelam Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0115-1320 TABLET, FILM COATED 625 mg ORAL ANDA 26 sections
Colesevelam hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0115-1864 FOR SUSPENSION 3.75 g ORAL ANDA 26 sections
Welchol HUMAN PRESCRIPTION DRUG LABEL 1 0713-0879 TABLET, FILM COATED 625 mg ORAL NDA 31 sections
Welchol HUMAN PRESCRIPTION DRUG LABEL 1 0713-0880 FOR SUSPENSION 3.75 g ORAL NDA 31 sections
COLESEVELAM HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0713-0935 FOR SUSPENSION 3.75 g ORAL NDA 31 sections
COLESEVELAM HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 0713-0936 TABLET, FILM COATED 625 mg ORAL NDA 31 sections
Welchol HUMAN PRESCRIPTION DRUG LABEL 1 21695-779 FOR SUSPENSION 3.75 g ORAL NDA 28 sections
Welchol HUMAN PRESCRIPTION DRUG LABEL 1 21695-781 TABLET, FILM COATED 625 mg ORAL NDA 28 sections
Colesevelam hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 27808-190 TABLET 625 mg ORAL ANDA 24 sections
Colesevelam Hydrochloride Human Prescription Drug Label 1 33342-197 TABLET, FILM COATED 625 mg ORAL ANDA 27 sections
Colesevelam Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 43598-230 TABLET 625 mg ORAL ANDA 28 sections
Colesevelam HCL Human Prescription Drug Label 1 50090-4371 TABLET, FILM COATED 625 mg ORAL ANDA 28 sections
COLESEVELAM HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 50090-6994 TABLET, FILM COATED 625 mg ORAL NDA 30 sections
COLESEVELAM HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 50090-6995 TABLET, FILM COATED 625 mg ORAL NDA 30 sections
colesevelam hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 50090-7459 TABLET, FILM COATED 625 mg ORAL ANDA 25 sections
colesevelam hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 50090-7460 TABLET, FILM COATED 625 mg ORAL ANDA 25 sections
Colesevelam hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 50090-7604 TABLET 625 mg ORAL ANDA 24 sections
Colesevelam hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 50090-7605 TABLET 625 mg ORAL ANDA 24 sections
Colesevelam HCL Human Prescription Drug Label 1 50090-7811 TABLET, FILM COATED 625 mg ORAL ANDA 27 sections
COLESEVELAM HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 51407-336 TABLET 625 mg ORAL ANDA 24 sections
Welchol HUMAN PRESCRIPTION DRUG LABEL 1 54868-4474 TABLET, FILM COATED 625 mg ORAL NDA 29 sections
Welchol HUMAN PRESCRIPTION DRUG LABEL 1 54868-6136 FOR SUSPENSION 3.75 g ORAL NDA 29 sections
Colesevelam Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 60687-385 TABLET, FILM COATED 625 mg ORAL ANDA 27 sections
Colesevelam HCL HUMAN PRESCRIPTION DRUG LABEL 1 63629-8767 TABLET, FILM COATED 625 mg ORAL ANDA 27 sections
Colesevelam hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 63629-8860 POWDER, FOR SUSPENSION 3.75 g ORAL ANDA 28 sections
Colesevelam HCL Human Prescription Drug Label 1 67877-506 TABLET, FILM COATED 625 mg ORAL ANDA 27 sections
Colesevelam hydrochloride Human Prescription Drug Label 1 67877-523 POWDER, FOR SUSPENSION 3.75 g ORAL ANDA 27 sections
Welchol HUMAN PRESCRIPTION DRUG LABEL 1 68151-4362 TABLET, FILM COATED 625 mg ORAL NDA 27 sections
Colesevelam HUMAN PRESCRIPTION DRUG LABEL 1 68382-619 TABLET, FILM COATED 625 mg ORAL ANDA 25 sections
Colesevelam HUMAN PRESCRIPTION DRUG LABEL 1 68382-619 TABLET, FILM COATED 625 mg ORAL ANDA 25 sections