Colesevelam
Bile Acid Sequestrants
Sold as Cholestagel
- Drug class
- Bile Acid Sequestrants
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 3
- Products on record
- 27
- FDA reports (12 mo)
- 235
Overview
Colesevelam is an active pharmaceutical ingredient in the Bile Acid Sequestrants group (C10AC). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 22 | May 15, 2026 |
| US United States | FDA | 4 | July 17, 2025 |
| EU European Union | EMA | 1 | June 3, 2025 |
GBUnited Kingdom· MHRA
22 products
Uses
Colesevelam hydrochloride co-administered with a 3-hydroxy-3-methyl-glutaryl- coenzyme A (HMG-CoA) reductase inhibitor (statin) is indicated as adjunctive therapy to diet to provide an additive reduction in low-density lipoprotein cholesterol (LDL-C) levels in adult patients with primary hypercholesterolaemia who are not adequately controlled with a statin alone.
Colesevelam hydrochloride as monotherapy is indicated as adjunctive therapy to diet for reduction of elevated total-cholesterol and LDL-C in adult patients with primary hypercholesterolaemia, in whom a statin is considered inappropriate or is not well- tolerated.
1). 2
How to take
USUnited States· FDA
4 products
Uses
1 ). 1 ). 2 ). 3 ): Do not use for treatment of type 1 diabetes or for diabetic ketoacidosis. 1 Primary Hyperlipidemia Colesevelam hydrochloride is indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia.
Colesevelam hydrochloride is indicated to reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH) who are unable to reach LDL-C target levels despite an adequate trial of dietary therapy and lifestyle modification.
2 Type 2 Diabetes Mellitus Colesevelam hydrochloride is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus . 3 Limitations of Use Colesevelam hydrochloride should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis.
Colesevelam hydrochloride has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias.
EUEuropean Union· EMA
1 product
Uses
Cholestagel co-administered with a 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase inhibitor (statin) is indicated as adjunctive therapy to diet to provide an additive reduction in low-density lipoprotein cholesterol (LDL-C) levels in adult patients with primary hypercholesterolaemia who are not adequately controlled with a statin alone.
Cholestagel as monotherapy is indicated as adjunctive therapy to diet for reduction of elevated total-cholesterol and LDL-C in adult patients with primary hypercholesterolaemia, in whom a statin is considered inappropriate or is not well-tolerated.
1).
How to take
Drug interactions
Known interactions involving Colesevelam. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL559120004 · revised October 24, 2025
- [2]FDA DailyMed · 0127afae-8d8d-43… · revised December 28, 2023 [PDF]
- [3]European Medicines Agency · EMEA/H/C/000512 · revised June 3, 2025
- [4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.