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

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 604.30 16.40 215 7354 41190 63440263
Off label use 224.92 16.40 333 7236 674129 62807324
Product administration error 108.21 16.40 53 7516 22344 63459109
Incorrect dose administered 79.28 16.40 62 7507 59906 63421547
Myalgia 50.51 16.40 74 7495 146455 63334998
Diarrhoea 35.89 16.40 174 7395 715192 62766261
Anembryonic gestation 35.13 16.40 9 7560 556 63480897
Muscle spasms 35.03 16.40 65 7504 156085 63325368
Low density lipoprotein increased 33.57 16.40 16 7553 6341 63475112
Constipation 32.27 16.40 78 7491 224865 63256588
Dysphagia 25.24 16.40 41 7528 88544 63392909
Functional gastrointestinal disorder 23.35 16.40 11 7558 4248 63477205
Flatulence 22.36 16.40 24 7545 34678 63446775
Bile acid malabsorption 22.20 16.40 5 7564 178 63481275
Therapeutic response unexpected 21.79 16.40 18 7551 18741 63462712
Lipids increased 20.40 16.40 7 7562 1190 63480263
Drug hypersensitivity 17.24 16.40 78 7491 310609 63170844
Abdominal distension 16.88 16.40 34 7535 86581 63394872
Maternal exposure during pregnancy 16.77 16.40 3 7566 220059 63261394

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
No adverse event 220.27 22.62 87 3954 22840 34930050
Fractional exhaled nitric oxide increased 214.34 22.62 44 3997 1038 34951852
Plantar fasciitis 174.58 22.62 42 3999 2074 34950816
Sensation of foreign body 172.96 22.62 44 3997 2739 34950151
Myoglobin blood increased 169.35 22.62 44 3997 2979 34949911
Brain natriuretic peptide increased 146.30 22.62 45 3996 5614 34947276
Secretion discharge 123.70 22.62 40 4001 5865 34947025
Obstructive airways disorder 102.10 22.62 45 3996 15449 34937441
Exostosis 98.94 22.62 32 4009 4691 34948199
Dysphonia 93.05 22.62 48 3993 23335 34929555
Muscle spasms 85.34 22.62 70 3971 74931 34877959
Cerebrovascular accident 81.85 22.62 72 3969 84739 34868151
Eosinophilia 79.65 22.62 45 3996 26177 34926713
Cardiac disorder 72.84 22.62 51 3990 43075 34909815
Chest discomfort 70.74 22.62 55 3986 54475 34898415
Dyspnoea exertional 70.35 22.62 50 3991 43229 34909661
Coronary artery disease 67.65 22.62 51 3990 48254 34904636
Off label use 66.87 22.62 148 3893 419376 34533514
Wheezing 60.83 22.62 45 3996 41357 34911533
Nasopharyngitis 60.73 22.62 56 3985 69912 34882978
Pneumothorax 50.59 22.62 30 4011 19062 34933828
Atrial fibrillation 48.58 22.62 65 3976 122328 34830562
Product administration error 33.95 22.62 22 4019 16322 34936568
Pancreatitis 33.44 22.62 31 4010 38860 34914030
Cough 28.33 22.62 57 3984 150083 34802807
Myalgia 26.41 22.62 40 4001 84070 34868820
Sleep apnoea syndrome 25.22 22.62 20 4021 20301 34932589

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 331.65 17.22 127 7498 37065 79699698
Off label use 95.69 17.22 243 7382 906972 78829791
Cerebrovascular accident 87.39 17.22 90 7535 155202 79581561
Myalgia 66.18 17.22 85 7540 185556 79551207
Product administration error 66.15 17.22 40 7585 31806 79704957
Anembryonic gestation 39.84 17.22 9 7616 407 79736356
Incorrect dose administered 37.00 17.22 41 7584 76589 79660174
Muscle spasms 36.14 17.22 62 7563 174668 79562095
Low density lipoprotein increased 32.29 17.22 16 7609 8606 79728157
Dysphagia 28.82 17.22 46 7579 122090 79614673
Bile acid malabsorption 27.97 17.22 6 7619 213 79736550
Pancreatitis 26.93 17.22 33 7592 68542 79668221
Myocardial infarction 23.10 17.22 53 7572 184076 79552687
Diarrhoea 22.90 17.22 153 7472 880336 78856427
Blood creatine phosphokinase increased 21.54 17.22 29 7596 66061 79670702
Toxicity to various agents 21.13 17.22 7 7618 421533 79315230
Functional gastrointestinal disorder 20.91 17.22 10 7615 4980 79731783
Blood cholesterol increased 20.38 17.22 32 7593 83688 79653075
Weight decreased 19.29 17.22 76 7549 355122 79381641
Flatulence 19.15 17.22 22 7603 42702 79694061
Constipation 19.11 17.22 65 7560 282985 79453778
Product dose omission issue 18.64 17.22 59 7566 247478 79489285
Influenza like illness 18.28 17.22 28 7597 71679 79665084

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 D000963 Antimetabolites
MeSH PA D000960 Hypolipidemic Agents
MeSH PA D057847 Lipid Regulating Agents
FDA EPC N0000180292 Bile Acid Sequestrant
CHEBI has role CHEBI:35821 anticholesteremic drugs

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)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
1.875GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** WELCHOL COSETTE N022362 Oct. 2, 2009 DISCN FOR SUSPENSION ORAL Oct. 20, 2024 INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES
3.75GM/PACKET WELCHOL COSETTE N022362 Oct. 2, 2009 RX FOR SUSPENSION ORAL Oct. 20, 2024 INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES

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
CHEMBL1201473 ChEMBL_ID
CHEMBL1201677 ChEMBL_ID
DB00930 DRUGBANK_ID
7621 INN_ID
1XU104G55N UNII
160051 PUBCHEM_CID
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, COATED 625 mg ORAL ANDA 27 sections
Colesevelam Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0115-1320 TABLET, COATED 625 mg ORAL ANDA 27 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 25 sections
Colesevelam hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 27808-190 TABLET 625 mg ORAL ANDA 25 sections
Colesevelam hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 27808-190 TABLET 625 mg ORAL ANDA 25 sections
Colesevelam Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 42291-147 TABLET, COATED 625 mg ORAL ANDA 28 sections
Colesevelam Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 43598-230 TABLET 625 mg ORAL ANDA 30 sections
Colesevelam Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 43598-230 TABLET 625 mg ORAL ANDA 30 sections
Colesevelam HCL Human Prescription Drug Label 1 50090-4371 TABLET, FILM COATED 625 mg ORAL ANDA 29 sections
Colesevelam HCL Human Prescription Drug Label 1 50090-4371 TABLET, FILM COATED 625 mg ORAL ANDA 29 sections
Colesevelam Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 51407-159 TABLET 625 mg ORAL ANDA 27 sections
Colesevelam Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 51407-159 TABLET 625 mg ORAL ANDA 27 sections
Colesevelam hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 51407-336 TABLET 625 mg ORAL ANDA 25 sections
Colesevelam hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 51407-336 TABLET 625 mg ORAL ANDA 25 sections
Colesevelam hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 51660-995 POWDER, FOR SUSPENSION 3.75 g ORAL NDA 31 sections
Colesevelam hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 51660-995 POWDER, FOR SUSPENSION 3.75 g ORAL NDA 31 sections
Colesevelam hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 51660-996 TABLET, FILM COATED 625 mg ORAL NDA 31 sections
Colesevelam hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 51660-996 TABLET, FILM COATED 625 mg ORAL NDA 31 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, COATED 625 mg ORAL ANDA 28 sections
Colesevelam Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 60687-385 TABLET, COATED 625 mg ORAL ANDA 28 sections
colesevelam hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 60687-621 TABLET, FILM COATED 625 mg ORAL ANDA 28 sections