Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Colesevelam hydrochloride
Drug ID BADD_D00519
Description Colesevelam is a bile acid sequestrant. Colesevelam is used with exercise and diet changes (restriction of cholesterol and fat intake) to reduce the amount of cholesterol and certain fatty substances in the blood. It works by binding bile acids in the intestine. Bile acids are made when cholesterol is broken down in the body. Removing these bile acids helps to lower blood cholesterol.
Indications and Usage For use, alone or in combination with an HMG-CoA reductase inhibitor, as adjunctive therapy to diet and exercise for the reduction of elevated LDL cholesterol in patients with primary hypercholesterolemia (Fredrickson Type IIa).
Marketing Status approved
ATC Code C10AC04
DrugBank ID DB00930
KEGG ID D03582
MeSH ID D000069472
PubChem ID 60208760
TTD Drug ID D01YVT
NDC Product Code 68462-433; 0713-0880; 0713-0936; 59651-080; 66406-0106; 51407-336; 68462-620; 45941-3050; 0115-1864; 63629-8860; 65597-701; 67877-523; 66499-0022; 51660-995; 0713-0935; 27808-190; 69452-158; 65597-902; 0713-0879; 75834-152; 43598-230; 60687-385; 76339-153; 0115-1320; 42291-147; 51660-996
UNII P4SG24WI5Q
Synonyms Colesevelam Hydrochloride | Hydrochloride, Colesevelam | Colesevelam HCl | HCl, Colesevelam | CholestaGel | Welchol | Colesevelam | GT 31104 | 31104, GT | GT-31104 | GT31-104 | GT31 104 | GT31104
Chemical Information
Molecular Formula C31H67Cl3N4O
CAS Registry Number 182815-44-7
SMILES [H+].CCCCCCCCCCNCC=C.C[N+](C)(C)CCCCCCNCC=C.C=CCN.C1C(O1)CCl.[Cl-].[Cl-]
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Abnormal faeces07.01.03.001---
Aortic valve stenosis02.07.03.004---
Asthenia08.01.01.001---
Back pain15.03.04.005--
Blister12.01.06.002; 23.03.01.001---
Blood creatine phosphokinase increased13.04.01.001--
Blood triglycerides increased13.12.03.001---
Bradycardia02.03.02.002---
Constipation07.02.02.001--
Cough22.02.03.001--
Dermatitis23.03.04.002---
Dermatitis bullous23.03.01.002--
Diabetes mellitus05.06.01.001; 14.06.01.001---
Diarrhoea07.02.01.001--
Drug interaction08.06.03.001---
Dyspepsia07.01.02.001--
Dysphagia07.01.06.003--
Fatigue08.01.01.002--
Flatulence07.01.04.002--
Gastrointestinal disorder07.11.01.001---
Gastrointestinal pain07.01.05.005--
Haemorrhoids07.15.03.001; 24.10.02.002--
Headache17.14.01.001--
Hypersensitivity10.01.03.003--
Hypertension24.08.02.001--
Hypertriglyceridaemia14.08.02.001--
Hypoglycaemia05.06.03.001; 14.06.03.001--
Infection11.01.08.002---
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