Cholestyramine Resin: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: March 22, 2025🚩 Report this page

Cholestyramine Resin

Bile Acid Sequestrants

Sold as OLESTYR · PMS-CHOLESTYRAMINE · CHOLESTYRAMINE-ODAN · JAMP-CHOLESTYRAMINE

CA Health Canada

Drug class: Bile Acid Sequestrants
Availability: See label
Routes: Oral
Markets covered: 1
Products on record: 7

Overview

Cholestyramine Resin 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
CA Canada	Health Canada	7	March 22, 2025

CACanada· Health Canada

7 products

Uses

CAOfficial regulatory label· revised March 22, 2025[1]

OLESTYR (cholestyramine resin) is indicated in adults:  As adjunctive therapy to diet and exercise for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low -density lipoproteins).
Such reduction of serum cholesterol may reduce the risks of atherosclerotic coronary artery disease and myocardial infarction.  For lowering elevated cholesterol in patients with combined hypercholesterolemia and hypertriglyceridemia.
OLESTYR is not indicated where hypertriglyceridemia is the abnormality of most concern.  As a symptomatic control of bile acid induced diarrhea due to short bowel syndrome.  For the relief of pruritus associated with partial biliary obstruction.
3 Pediatrics). 1 Adverse Reaction Overview).

Sources & citations

[1]Health Canada (DPD) · 00890960 · revised March 22, 2025

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.

Side effects & warnings

CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[1]

5 Post-Market Adverse Reactions). When used as a cholesterol lowering agent, predisposing factors for most complaints of constipation [*] are high dose and increased age (more than 60 years old). Most instances of constipation are mild, transient, and controlled with conventional therapy.
Some patients require a temporary decrease in dosage or discontinuation of therapy. [*] The percentage of complaints that are associated with these predisposing factors is unknown. 2 Clinical Trial Adverse Reactions The clinical trial data on which the original indication was authorized is not available.
5 Post-Market Adverse Reactions The following table presents a listing of post-market adverse reactions with their frequency of occurrence in patients treated with cholestyramine. OLESTYR (cholestyramine resin) Page 11 of 27 Adverse Reactions Categorized by System Organ Class Very Common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Rare (≥ 1/10,000 to < 1/1,000) Blood and lymphatic system disorders Bleeding tendencies due to hypoprothrombinaemia (Vitamin K deficiency)  Vitamin A and vitamin D deficiencies  Night blindness  Gastrointestinal disorders Constipation  Abdominal discomfort  Flatulence  Nausea  Vomiting  Diarrhea  Heartburn  Dyspepsia  Steatorrhea  Intestinal obstruction  Metabolism and nutrition disorders Anorexia  Musculoskeletal and connective tissue disorders Osteoporosis  Skin and subcutaneous tissue disorders Rash and irritation of skin, tongue and perianal area  The frequency of the following post-market adverse reactions is unknown.
OLESTYR (cholestyramine resin) Page 12 of 27  Gastrointestinal: gastrointestinal-rectal bleeding, black stools, hemorrhoidal bleeding, bleeding from known duodenal ulcer, dysphagia, hiccups, ulcer attack, sour taste, pancreatitis, rectal pain, diverticulitis, eructation  Hematologic: decreased or increased prothrombin time, ecchymosis, anemia, dental bleeding  Hypersensitivity: asthma, wheezing, shortness of breath  Monitoring and Laboratory Tests: liver function abnormalities  Musculoskeletal: backache, muscle and joint pain, arthritis  Neurologic: headache, anxiety, vertigo, dizziness, fatigue, tinnitus, syncope, drowsiness, femoral nerve pain, paresthesia  Ophthalmologic: uveitis  Renal: hematuria, dysuria, burnt odour of urine, diuresis  Other: weight loss, weight gain, increased libido, swollen glands, edema, dental caries.

CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[1]

Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. General Before instituting therapy with OLESTYR, an attempt should be made to control serum cholesterol by appropriate dietary regimen, weight reduction, and the treatment of any underlying disorder such as hypothyroidism, diabetes mellitus, nephrotic syndrome, Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients oral Cholestyramine resin for oral suspension / 4g per 5g dose (light powder, orange flavour) Aspartame (each 5g contains 50 mg phenylalanine), Citric Acid Anhydrous, Colloidal Silicon Dioxide, FD&C Yellow #6, Natural Orange Flavour, Propylene Glycol Alginate oral Cholestyramine resin for oral suspension / 4g per 5g dose (light powder, lemon-lime flavour) Aspartame (each 5g contains 50 mg phenylalanine), Citric Acid Anhydrous, Colloidal Silicon Dioxide, D&C Yellow #10, Natural Lemon-Lime Flavour, Propylene Glycol Alginate oral Cholestyramine resin for oral suspension / 4g per 9g dose (regular powder, orange flavour) Citric Acid Anhydrous, Colloidal Silicon Dioxide, D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6, Orange Flavour, Propylene Glycol Alginate, Sucrose OLESTYR (cholestyramine resin) Page 8 of 27 dysproteinemias and obstructive liver disease which might be the cause of hypercholesterolemia.
In addition, the current medications of the patient should be reviewed for their potential to increase serum LDL-C or total cholesterol. A favorable trend in cholesterol reduction should occur during the first month of cholestyramine therapy.
The therapy should be continued to sustain cholesterol reduction. Carcinogenesis and Mutagenesis Please see section 16 NON-CLINICAL TOXICOLOGY, Carcinogenicity / Genotoxicity. Driving and Operating Machinery OLESTYR has not been shown to impair the patient’s ability to drive or use machines .
Endocrine and Metabolism There is a possibility that prolonged use of cholestyramine resin, since it is a chloride form of anion exchange resin, may produce hyperchloremic acidosis. This would especially be true in younger and smaller patients where the relative dosage may be higher.
Because cholestyramine binds bile acids, it may interfere with normal fat digestion and absorption and thus may prevent absorption of fat-soluble vitamins such as A, D and K. When OLESTYR is given for long periods of time, concomitant supplementation of water-miscible parenteral forms of vitamins A and D should be considered.

This is not medical advice. Consult a qualified healthcare professional.

Overview

Regulatory status by market

CACanada· Health Canada

Drugs in the same class

Sources & citations