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

Stem definition	Drug id	CAS RN
	4405	182815-43-6

Description:

Molecule	Description
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

Molecule

Description

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:

Dose	Unit	Route
3.75	g	O

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
May 26, 2000	FDA	DAIICHI SANKYO

FDA Adverse Event Reporting System (Female)

Show entries

Search:

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
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

Showing 1 to 10 of 19 entries

Previous1 2Next

FDA Adverse Event Reporting System (Male)

Show entries

Search:

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
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

Showing 1 to 10 of 27 entries

Previous1 2 3Next

FDA Adverse Event Reporting System (Geriatric)

Show entries

Search:

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
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

Showing 1 to 10 of 23 entries

Previous1 2 3Next

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Show entries

Search:

Source	Code	Description
ATC	C10AC04	CARDIOVASCULAR SYSTEM LIPID MODIFYING AGENTS LIPID MODIFYING AGENTS, PLAIN Bile acid sequestrants
CHEBI has role	CHEBI:35821	anticholesteremic drugs
FDA EPC	N0000180292	Bile Acid Sequestrant
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

Showing 1 to 8 of 8 entries

Previous1Next

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

Show entries

Search:

Disease	Relation	SNOMED_ID	DOID
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

Showing 1 to 10 of 17 entries

Previous1 2Next

🐶 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)

Show entries

Search:

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
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

Showing 1 to 2 of 2 entries

Previous1Next

Bioactivity Summary:

None

External reference:

Show entries

Search:

ID	Source
008852	NDDF
008853	NDDF
127965004	SNOMEDCT_US
141625	RXNORM
15635	MMSL
160051	PUBCHEM_CID
182815-44-7	SECONDARY_CAS_RN
1XU104G55N	UNII
26906	MMSL
280036	MMSL

Showing 1 to 10 of 26 entries

Previous1 2 3Next

Pharmaceutical products:

Show entries

Search:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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	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
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
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

Showing 1 to 10 of 30 entries

Previous1 2 3Next