Brand Name

Welchol

Generic Name
Colesevelam
View Brand Information
FDA approval date: January 01, 2010
Classification: Bile Acid Sequestrant
Form: Tablet, Powder, For

What is Welchol (Colesevelam)?

Managing cholesterol or blood sugar can be a daily challenge for many people, especially those living with high cholesterol or type 2 diabetes. Diet and exercise play a key role, but sometimes they’re not enough on their own. Welchol (colesevelam) is a medication designed to help, providing an additional, well-tolerated option for lowering “bad” cholesterol and improving blood sugar control. 

Welchol belongs to a class of drugs called bile acid sequestrants (also known as bile acid-binding resins). It works primarily in the digestive tract, rather than being absorbed into the bloodstream, which makes it different from most other cholesterol or diabetes medicines. Approved by the U.S. Food and Drug Administration (FDA), Welchol has been used for many years as a safe and effective adjunct therapy for adults who need extra help achieving their cholesterol or blood sugar goals. 

What does Welchol do? 

Welchol is used to treat two main conditions: 

  • High cholesterol (hyperlipidemia): It helps reduce levels of low-density lipoprotein (LDL), often called “bad cholesterol.” 
     
  • Type 2 diabetes: It can modestly lower blood sugar levels (HbA1c) when used along with diet, exercise, and other diabetes medications. 
     

By lowering LDL cholesterol, Welchol helps reduce the risk of heart disease, heart attack, and stroke particularly in patients already managing these risks through lifestyle changes or statin therapy. When used in diabetes care, it helps improve glycemic control without increasing the risk of low blood sugar (hypoglycemia). 

Clinical studies have shown that Welchol, when added to a statin, can further reduce LDL cholesterol by about 15–20%. For patients with diabetes, studies have also demonstrated improved blood sugar control, making it a dual-purpose therapy that benefits both heart and metabolic health (FDA, 2024; Mayo Clinic, 2024). 

How does Welchol work? 

Welchol works in the intestines rather than the bloodstream, which is why it has a favorable safety profile. It binds to bile acids, natural substances produced by the liver that help digest fats. When Welchol binds to these acids, the body can no longer reabsorb them, they’re excreted instead. 

To make more bile acids, the liver uses cholesterol from the bloodstream. This process reduces circulating LDL (“bad”) cholesterol levels over time. 

In people with type 2 diabetes, Welchol also helps lower blood sugar, though the exact mechanism isn’t fully understood. Experts believe that binding bile acids affects how the body processes glucose and certain hormones involved in blood sugar regulation. 

This mechanism is clinically significant because it provides an alternative or complementary pathway for controlling cholesterol and glucose, without the systemic side effects seen in many other medications. 

Welchol side effects 

Most people tolerate Welchol well, but like any medication, it can cause side effects. Because it acts locally in the gut, most side effects are related to the digestive system and are generally mild. 

Common side effects include: 

  • Constipation 
     
  • Bloating or gas 
     
  • Indigestion 
     
  • Nausea 
     
  • Mild abdominal discomfort 

Less common but serious side effects may include: 

  • Severe constipation or bowel obstruction 
     
  • Difficulty swallowing tablets 
     
  • Allergic reactions (such as rash, itching, or swelling of the face and throat) 

Welchol is contraindicated for those with a history of bowel obstruction, severe GI motility disorders, or triglyceride levels over 500 mg/dL. It can rarely increase triglyceride levels, requiring blood monitoring.  

Unlike statins, it usually avoids muscle pain or liver issues. However, it can interfere with other medications like thyroid hormones, seizure drugs, and some vitamins; take other medications at least four hours before or after Welchol. 

Patients should contact their healthcare provider right away if they experience severe constipation, unexplained abdominal pain, or signs of an allergic reaction. 

Welchol dosage 

Welchol comes as oral tablets or powder, taken once or twice daily with meals and liquid. Dosage varies by condition. Swallow tablets whole; do not crush. Powder can be mixed with water or non-carbonated drinks for those with swallowing difficulties. 

During treatment, doctors often monitor cholesterol levels, triglycerides, and blood sugar to ensure the medication is working effectively and safely. Regular monitoring also helps detect any changes that may require dosage adjustments. 

Older adults and patients with multiple medications should follow their provider’s instructions carefully to avoid interactions or digestive side effects. 

Does Welchol have a generic version? 

As of 2025, Welchol (colesevelam) is available in the United States in generic form, approved by the FDA. Generic colesevelam products contain the same active ingredient, strength, dosage form, and effectiveness as the brand-name version. However, international versions may exist in other markets. 

Patients can choose between brand-name Welchol or more affordable generic versions, both offering the same safety and quality. Welchol comes in tablet and powder forms, so patients should confirm their pharmacy provides the prescribed version. 

Conclusion 

Welchol (colesevelam) is a trusted and well-established medication that supports both heart and metabolic health. By lowering LDL cholesterol and helping control blood sugar in type 2 diabetes, it offers a versatile option for patients who need more than lifestyle changes or single-drug therapy. 

Because it acts locally in the digestive system and is not absorbed into the bloodstream, Welchol is generally well tolerated, with mild side effects. Monitoring and proper medication timing ensure safe results. Success with Welchol requires consistent use, communication with your healthcare team, and ongoing lifestyle management to control cholesterol and blood sugar and protect long-term health. 

References 

  1. U.S. Food and Drug Administration (FDA). (2024). Colesevelam hydrochloride prescribing information. Retrieved from https://www.accessdata.fda.gov 
     
  1. Mayo Clinic. (2024). Colesevelam (oral route): Drug information and precautions. Retrieved from https://www.mayoclinic.org 
     
  1. MedlinePlus. (2024). Colesevelam: Uses, side effects, and interactions. National Library of Medicine. Retrieved from https://medlineplus.gov 
     
  1. National Institutes of Health (NIH). (2024). Bile acid sequestrants in cholesterol and glucose management. Retrieved from https://www.nih.gov 
     

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Brand Information

Welchol (colesevelam hydrochloride)
1DOSAGE FORMS AND STRENGTHS
  • Tablets: 625 mg tablets are off-white, oval, film-coated and imprinted with "Sankyo" and "C01" on one side.
  • For Oral Suspension: 3.75 gram packet containing a white to pale yellow powder with yellow granules.
2CONTRAINDICATIONS
WELCHOL is contraindicated in patients with:
  • Serum TG concentrations >500 mg/dL
  • History of hypertriglyceridemia-induced pancreatitis
  • A history of bowel obstruction
3ADVERSE REACTIONS
The following important adverse reactions are described below and elsewhere in the labeling:
  • Hypertriglyceridemia and Pancreatitis
  • Gastrointestinal Obstruction
  • Vitamin K or Fat-Soluble Vitamin Deficiencies
3.1Clinical 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.
3.2Post-marketing Experience
The following additional adverse reactions have been identified during post-approval use of WELCHOL. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Adverse Reactions Resulting from Drug Interactions [see Increased seizure activity or decreased phenytoin levels in patients receiving phenytoin, reduced International Normalized Ratio (INR) in patients receiving warfarin therapy, and elevated thyroid-stimulating hormone (TSH) in patients receiving thyroid hormone replacement therapy
Gastrointestinal: Bowel obstruction (in patients with a history of bowel obstruction or resection), dysphagia or esophageal obstruction (occasionally requiring medical intervention), fecal impaction, pancreatitis, abdominal distension, exacerbation of hemorrhoids, and increased transaminases
Laboratory Abnormalities: Hypertriglyceridemia
4OVERDOSAGE
WELCHOL is not absorbed and the risk of systemic toxicity is low. Excessive doses of WELCHOL may cause more severe local gastrointestinal effects (e.g., constipation).
5DESCRIPTION
WELCHOL (colesevelam hydrochloride) is a non-absorbed, polymeric, lipid-lowering and glucose-lowering agent for oral administration. Colesevelam hydrochloride is a high-capacity bile acid-binding molecule.
Colesevelam hydrochloride is poly(allylamine hydrochloride) cross-linked with epichlorohydrin and alkylated with 1-bromodecane and (6-bromohexyl)-trimethylammonium bromide. The chemical name (IUPAC) of colesevelam hydrochloride is allylamine polymer with 1-chloro-2,3-epoxypropane, [6-(allylamino)-hexyl]trimethylammonium chloride and N-allyldecylamine, hydrochloride. The chemical structure of colesevelam hydrochloride is represented by the following formula:
Chemical Structure
wherein (a) represents allyl amine monomer units that have not been alkylated by either of the 1-bromodecane or (6-bromohexyl)-trimethylammonium bromide alkylating agents or cross-linked by epichlorohydrin; (b) represents allyl amine units that have undergone cross-linking with epichlorohydrin; (c) represents allyl amine units that have been alkylated with a decyl group; (d) represents allyl amine units that have been alkylated with a (6-trimethylammonium) hexyl group, and m represents a number ≥100 to indicate an extended polymer network. A small amount of the amines are dialkylated and are not depicted in the formula above. No regular order of the groups is implied by the structure; cross-linking and alkylation are expected to occur randomly along the polymer chains. A large amount of the amines are protonated. The polymer is depicted in the hydrochloride form; a small amount of the halides are bromide. Colesevelam hydrochloride is hydrophilic and insoluble in water.
WELCHOL tablets are off-white, oval, film-coated, solid tablets each containing 625 mg colesevelam hydrochloride. In addition, each tablet contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose, silicon dioxide, HPMC (hydroxypropyl methylcellulose), and acetylated monoglyceride. The tablets are imprinted using a water-soluble black ink (<5 calories per 6 tablets).
WELCHOL for oral suspension is a citrus-flavored, white to pale yellow powder containing yellow granules packaged in a packet containing 3.75 gram colesevelam hydrochloride. In addition, each packet contains the following inactive ingredients: lemon flavor, orange flavor, propylene glycol alginate, simethicone, aspartame, citric acid, medium chain triglycerides, and magnesium trisilicate (<5 calories per 3.75 gram single-dose packet). PHENYLKETONURICS: WELCHOL for oral suspension contains 27 mg phenylalanine per 3.75 gram dose.
6HOW SUPPLIED/STORAGE AND HANDLING
WELCHOL 625 mg tablets are supplied as off-white, solid tablets imprinted with the word "Sankyo" and "C01" on one side and are available as follows:
  • Bottles of 180 – NDC 65597-701-18
WELCHOL 3.75 gram packets for oral suspension contain a white to pale yellow powder containing yellow granules and are available as follows:
  • Cartons of 30 packets – NDC 65597-902-30
7PRINCIPAL DISPLAY PANEL
NDC 65597-701-18
PRINCIPAL DISPLAY PANEL NDC 65597-701-18 TABLETS Welchol (colesevelam HCI) 180 TABLETS 625 mg
8PRINCIPAL DISPLAY PANEL - 3.75 g Packet Label
TEAR HERE
Sugar-Free
This packet is contained within the
Welchol™
3.75 g
Citrus Flavor
Each packet contains 3.75 grams of
Rx only
Keep Out of Reach of Children.
PRINCIPAL DISPLAY PANEL - 3.75 g Packet Label
9PRINCIPAL DISPLAY PANEL - 3.75 g Packet Carton
Keep Out of Reach of Children.
NDC 65597-902-30
30 packets
Welchol™
3.75 g
Each packet contains 3.75 grams of colesevelam hydrochloride.
Rx only
Dosing and use: see package insert.
PRINCIPAL DISPLAY PANEL - 3.75 g Packet Carton
10PRINCIPAL DISPLAY PANEL - 3.75 g Bar Package Carton - 209-30
NDC 65587-209-30
Welchol
3.75 g
30 CHEWABLE BARS
RX ONLY
EACH BAR CONTAINS 3.75 g
CHILD-RESISTANT WRAPPERS
CONTAINS MEDICATION
DOSING AND USE:
NOTE TO PHARMACISTS:
CHOCOLATE FLAVOR
PRINCIPAL DISPLAY PANEL - 3.75 g Bar Package Carton - 209-30
11PRINCIPAL DISPLAY PANEL - 3.75 g Bar Package Carton - 210-30
NDC 65587-210-30
Welchol
3.75 g
30 CHEWABLE BARS
RX ONLY
EACH BAR CONTAINS 3.75 g
CHILD-RESISTANT WRAPPERS
CONTAINS MEDICATION
DOSING AND USE:
NOTE TO PHARMACISTS:
STRAWBERRY FLAVOR
PRINCIPAL DISPLAY PANEL - 3.75 g Bar Package Carton - 210-30
12PRINCIPAL DISPLAY PANEL - 3.75 g Bar Package Carton - 208-30
NDC 65587-208-30
Welchol
3.75 g
30 CHEWABLE BARS
RX ONLY
EACH BAR CONTAINS 3.75 g
CHILD-RESISTANT WRAPPERS
CONTAINS MEDICATION
DOSING AND USE:
NOTE TO PHARMACISTS:
CARAMEL FLAVOR
PRINCIPAL DISPLAY PANEL - 3.75 g Bar Package Carton - 208-30