Prescription medicine
Colesevelam First approved as Welchol
Colesevelam (Welchol) is a prescription medicine with an FDA approval on record since 2000. FDA's NDC Directory lists it from 15 generic labelers, and pharmacies paid $0.262 per colesevelam 625 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the colesevelam FDA label on DailyMed (effective December 28, 2023, A-S Medication Solutions); the NDA 21141 record on Drugs@FDA; every colesevelam label on DailyMed.
Highlights of the record
FDA label of December 28, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageColesevelam hydrochloride is a bile acid sequestrant indicated as an adjunct to diet and exercise to: reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia ( 1.1 ).
Forms and strengths
- 3.75 g
- 625 mg
Film-coated tablet; tablet; powder for suspension; for suspension.
On the market
- Earliest approval on file
- May 26, 2000 Welchol, Cosette; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 18 first May 16, 2018; 11 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 15 of which 15 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.262 per tablet Colesevelam 625 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2013 0 Class I among all firms' recalls; latest March 13, 2025; 1 more by firms not listed as its makers
- FAERS reports
- 2,013 through July 30, 2026
What is colesevelam used for?
From the label: indications and usageColesevelam hydrochloride is a bile acid sequestrant indicated as an adjunct to diet and exercise to: reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia ( 1.1 ). reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH), unable to reach LDL-C target levels despite an adequate trial of diet and lifestyle modification ( 1.1 ). improve glycemic control in adults with type 2 diabetes mellitus ( 1.2 ). Limitations of Use ( 1.3 ): Do not use for treatment of type 1 diabetes or for diabetic ketoacidosis. […]
Conditions named in the indications of colesevelam's FDA labels, with every medicine labeled for each:
From other colesevelam labelsType 2 diabetes: … th heterozygous familial hypercholesterolemia (HeFH), unable to reach LDL-C target levels despite an adequate trial of diet and lifestyle modification ( 1.1 ). improve glycemic control in adults with type 2 diabetes mellitus ( 1.2 […]
FDA pharmacologic class: Bile Acid Sequestrant.
Source: FDA drug label (COLESEVELAM HYDROCHLORIDE), NDA021176 (Cosette), as published by A-S Medication Solutions, effective December 28, 2023 (SPL set 0127afae-8d8d-43f2-97f9-4f99f6947e81), via openFDA; the full label on DailyMed
Is there a generic for colesevelam (Welchol)?
The FDA approved the first generic colesevelam on May 16, 2018. 18 generic applications are approved; 11 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists colesevelam from 15 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2000 earliest approval on file
- 2018 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for colesevelam (Welchol)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.262 per Colesevelam 625 mg tablet, down 2% from $0.266 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Colesevelam 625 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Colesevelam 625 mg tablet | Generic | $0.262 per tablet | $7.85 | -2% |
| Colesevelam HCl 3.75 g packet | Generic | $2.70 per packet | n/a | +1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has colesevelam been recalled?
The FDA's Enforcement Report lists 2 recalls naming colesevelam since 2013: 0 Class I (the most serious), 2 Class II, 0 Class III; 1 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of colesevelam and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| March 13, 2025 | Class II | Glenmark Pharmaceuticals Inc., USA | CGMP Deviations |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling:Label Mixup; COLESEVELAM HCL Tablet, 625 mg may be potentially mislabeled as lamoTRIgine Tablet, 50 mg (1/2 of 100 mg), NDC 13668004701, Pedigree … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the colesevelam label say about other medicines?
The colesevelam label names 11 other medicines in its interaction, contraindication or warning sections. The labels of 19 other medicines name colesevelam. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cyclosporine | drug interactions | Drugs with a Narrow Therapeutic Index Clinical Impact: Concomitant use with colesevelam hydrochloride may decrease the exposure of the narrow therapeutic index drug. In vivo drug interactions studies showed a decrease in exposure of cyclosporine when coadministered with colesevelam hydrochloride. Intervention: Administer the narrow therapeutic index drug at least 4 hours prior to colesevelam hydrochloride. Monitor drug levels when appropriate. Examples: Cyclosporine |
| Glimepiride | drug interactions | Sulfonylureas Clinical Impact: In vivo drug interactions studies showed a decrease in sulfonylureas when coadministered with colesevelam hydrochloride. Intervention: Administer sulfonylureas 4 hours prior to colesevelam hydrochloride. Examples: Glimepiride, glipizide, and glyburide |
| Glipizide | drug interactions | Sulfonylureas Clinical Impact: In vivo drug interactions studies showed a decrease in sulfonylureas when coadministered with colesevelam hydrochloride. Intervention: Administer sulfonylureas 4 hours prior to colesevelam hydrochloride. Examples: Glimepiride, glipizide, and glyburide |
| Glyburide | drug interactions | Sulfonylureas Clinical Impact: In vivo drug interactions studies showed a decrease in sulfonylureas when coadministered with colesevelam hydrochloride. Intervention: Administer sulfonylureas 4 hours prior to colesevelam hydrochloride. Examples: Glimepiride, glipizide, and glyburide |
| Levothyroxine | drug interactions | Thyroid Hormone Replacement Therapy Clinical Impact: In vivo drug interactions studies showed a decrease in exposure of levothyroxine when coadministered with colesevelam hydrochloride. There have been postmarketing reports of elevated thyroid-stimulating hormone (TSH) in patients receiving … Intervention: Administer thyroid hormone replacement therapy 4 hours prior to colesevelam hydrochloride. |
| Metformin | drug interactions | Metformin Extended Release (ER) Clinical Impact: In vivo drug interactions studies showed an increase in metformin extended release (ER) when coadministered with colesevelam hydrochloride. Intervention: Monitor patients' glycemic control. |
| Norethindrone | drug interactions | Oral Contraceptives Containing Ethinyl Estradiol and Norethindrone Clinical Impact: In vivo drug interactions studies showed a decrease in exposure of ethinyl estradiol and norethindrone when coadministered with colesevelam hydrochloride. Intervention: Administer oral contraceptives containing ethinyl estradiol and norethindrone 4 hours prior to colesevelam hydrochloride. |
| Olmesartan | drug interactions | Olmesartan Medoxomil Clinical Impact: In vivo drug interactions studies showed a decrease in olmesartan medoxomil when coadministered with colesevelam hydrochloride. Intervention: Administer olmesartan medoxomil 4 hours prior to colesevelam hydrochloride. |
| Phenytoin | drug interactions | Phenytoin Clinical Impact: There have been postmarketing reports of increased seizure activity or decreased phenytoin levels in patients receiving phenytoin. Intervention: Administer phenytoin 4 hours prior to colesevelam hydrochloride. |
| Pioglitazone | warnings and precautions | In trials in patients with type 2 diabetes, greater increases in TG levels occurred when colesevelam hydrochloride was used as monotherapy (median increase 9.7% compared to placebo) and when colesevelam hydrochloride was used in combination with pioglitazone (median increase 11% compared to placebo in combination with … |
| Warfarin | drug interactions | For patients on warfarin, monitor International Normalized Ratio (INR) frequently during initiation then periodically ( 7.1 ). |
Other labels that name colesevelam
Source: FDA drug label (COLESEVELAM HYDROCHLORIDE), NDA021176 (Cosette), as published by A-S Medication Solutions, effective December 28, 2023 (SPL set 0127afae-8d8d-43f2-97f9-4f99f6947e81), via openFDA; the full label on DailyMed
What do FAERS reports show for colesevelam?
The FDA Adverse Event Reporting System holds 2,013 reports that list colesevelam among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 48 are coded as a death and 513 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as colesevelam?
15 other medicines are given the same way (oral) and in the same FDA class as colesevelam or labeled mainly for the same use (high cholesterol), the same class first. High cholesterol lists all 25 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Cholestyramine | High cholesterol | 15 labelers | $0.834 per packet Cholestyramine packet | No current entry |
| Colestipol | High cholesterol | 8 labelers | $0.658 per tablet 1 g tablet | No current entry |
| Atorvastatin | High cholesterol | 61 labelers | $0.0228 per tablet 10 mg tablet | No current entry |
| Fenofibrate | High cholesterol | 54 labelers | $0.103 per tablet 160 mg tablet | No current entry |
| Lovastatin | High cholesterol | 19 labelers | $0.0436 per tablet 20 mg tablet | No current entry |
| Gemfibrozil | High cholesterol | 27 labelers | $0.104 per tablet 600 mg tablet | A presentation being discontinued |
| Pitavastatin | High cholesterol | 12 labelers | $0.954 per tablet 2 mg tablet | No current entry |
| Ezetimibe | High cholesterol | 23 labelers | $0.0667 per tablet 10 mg tablet | No current entry |
Every medicine labeled for the same conditions as colesevelam
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does colesevelam compare with medicines for the same use?
2 side-by-side pages set colesevelam beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to colesevelam
- 15 medicines for the same use
- Other bile acid sequestrants
- the pharmacologic class, with prices and generics
- Colesevelam side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other