FDA label
What is colesevelam used for?
The FDA-approved uses of colesevelam, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for colesevelam hydrochloride (tablet, film coated) lists 2 uses: Primary Hyperlipidemia; Type 2 Diabetes Mellitus.
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Colesevelam Hydrochloride, tablet, film coated
Indications and Usage, quoted from the label by Macleods Pharmaceuticals Limited (ANDA204893). Cross-references to other label sections are left out.
Primary Hyperlipidemia
Colesevelam hydrochloride tablets are indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia.
Colesevelam hydrochloride tablets are 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.
Type 2 Diabetes Mellitus
Colesevelam hydrochloride tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use
- Colesevelam hydrochloride tablets should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis.
Source: DailyMed label, set id c2075dd1-e33c-4438-95f8-1897f0e1f61a, version 1, effective May 5, 2025. NDC 33342-197, one of 16 listings for this product.
Colesevelam Hydrochloride, tablet
Indications and Usage, quoted from the label by Bionpharma Inc. (ANDA208670). Cross-references to other label sections are left out.
Primary Hyperlipidemia
Colesevelam hydrochloride tablets are indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia.
Colesevelam hydrochloride tablets are indicated to reduce LDL-C levels in boys and post-menarchal girls, 10 years 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.
Type 2 Diabetes Mellitus
Colesevelam hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
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.
Source: DailyMed label, set id 4aa52225-9214-59dc-e063-6294a90a5f75, version 1, effective February 12, 2026. NDC 69452-493, one of 7 listings for this product.
Colesevelam Hydrochloride, powder, for suspension
Indications and Usage, quoted from the label by Glenmark Pharmaceuticals Inc.,USA (ANDA202190). Cross-references to other label sections are left out.
Primary Hyperlipidemia
Colesevelam hydrochloride for oral suspension 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 for oral suspension 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.
Type 2 Diabetes Mellitus
Colesevelam hydrochloride for oral suspension is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use
- Colesevelam hydrochloride for oral suspension should not be used for the treatment of type 1 diabetes or for the treatment of diabetic ketoacidosis.
- Colesevelam hydrochloride for oral suspension has not been studied in Fredrickson Type I, III, IV, and V dyslipidemias.
Source: DailyMed label, set id 2e736dd4-bb64-4f93-9821-7c24ea7d38ec, version 10, effective January 28, 2026. NDC 68462-620, one of 4 listings for this product.
Questions
What is colesevelam used for?
The FDA label for colesevelam hydrochloride (tablet, film coated) lists 2 uses: Primary Hyperlipidemia; Type 2 Diabetes Mellitus.
What drug class is colesevelam?
FDA lists colesevelam in the Bile Acid Sequestrant established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.