Colesevelam adverse reactions

Colesevelam adverse reactions

Clinical data
Trade names	Welchol, Cholestagel
MedlinePlus	a699050
Pregnancy category	B
Routes of administration	Oral
ATC code	C10AC04 (WHO)
Legal status
Legal status	In general: ℞ (Prescription only)
Pharmacokinetic data
Bioavailability	N/A
Metabolism	Colesevelam is not absorbed and not metabolised.
Elimination half-life	N/A (non-systemic drug)
Excretion	By intestines only, colesevelam is non-systemic.
Identifiers
CAS Number	182815-44-7 Y
PubChem CID	160051
DrugBank	DB00930 Y
ChemSpider	NA N
UNII	P4SG24WI5Q
KEGG	D03582 Y
ChEMBL	ChEMBL1201677 Y
E number	{{#property:P628}}
ECHA InfoCard	{{#property:P2566}}
NY (what is this?)  (verify)

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]

Adverse Reactions

Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in clinical studies of another drug and may not reflect the rates observed in practice.

In the lipid-lowering trials, 807 adult patients received at least one dose of WELCHOL (total exposure 199 patient-years). In the add-on combination type 2 diabetes trials, 566 patients received at least one dose of WELCHOL (total exposure 209 patient-years). In the monotherapy type 2 diabetes trial, 175 patients received at least one dose of WELCHOL and had a post baseline follow up (total exposure 69 patient-years).

In clinical trials for the reduction of LDL-C, 68% of patients receiving WELCHOL vs. 64% of patients receiving placebo reported an adverse reaction. In add-on combination clinical trials of type 2 diabetes, 60% of patients receiving WELCHOL vs. 56% of patients receiving placebo reported an adverse reaction. In monotherapy clinical trial for type 2 diabetes, 52% of patients receiving WELCHOL vs. 45% of patients receiving placebo reported an adverse reaction.

Primary Hyperlipidemia: In 7 double-blind, placebo-controlled, clinical trials, 807 patients with primary hyperlipidemia (age range 18-86 years, 50% women, 90% Caucasians, 7% Blacks, 2% Hispanics, 1% Asians) and elevated LDL-C were treated with WELCHOL 1.5 g/day to 4.5 g/day from 4 to 24 weeks.