The most common adverse reaction is constipation. 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.

Less Frequent Adverse Reactions: Abdominal discomfort and/or pain, flatulence, nausea, vomiting, diarrhea, eructation, anorexia, and steatorrhea, bleeding tendencies due to hypoprothrombinemia (Vitamin K deficiency) as well as Vitamin A (one case of night blindness reported) and D deficiencies, hyperchloremic acidosis in children, osteoporosis, rash and irritation of the skin, tongue and perianal area. Rare reports of intestinal obstruction, including two deaths, have been reported in pediatric patients.

Occasional calcified material has been observed in the biliary tree, including calcification of the gallbladder, in patients to whom QUESTRAN has been given. However, this may be a manifestation of the liver disease and not drug related.

One patient experienced biliary colic on each of three occasions on which he took QUES-TRAN. One patient diagnosed as acute abdominal symptom complex was found to have a “pasty mass”in the transverse colon on x-ray.

Other events (not necessarily drug related) reported in patients taking QUESTRAN include: Gastrointestinal-GI-rectal bleeding, black stools, hemorrhoidal bleeding, bleeding from known duodenal ulcer, dysphagia, hiccups, ulcer attack, sour taste, pancreatitis, rectal pain, diverticulitis.

Laboratory test changes-Liver function abnormalities.

Hematologic-Prolonged prothrombin time, ecchymosis, anemia.

Hypersensitivity-Urticaria, asthma, wheezing, shortness of breath.

Musculoskeletal-Backache, muscle and joint pains, arthritis.

Neurologic-Headache, anxiety, vertigo, dizziness, fatigue, tinnitus, syncope, drowsiness, femoral nerve pain, paresthesia.

Eye-Uveitis.

Renal-Hematuria, dysuria, burnt odor to urine, diuresis.

Miscellaneous-Weight loss, weight gain, increased libido, swollen glands, edema, dental bleeding, dental caries, erosion of tooth enamel, tooth discoloration.

QUESTRAN (Cholestyramine for Oral Suspension USP) may delay or reduce the absorption of concomitant oral medication such as phenylbutazone, warfarin, thiazide diuretics (acidic), or propranolol (basic), as well as tetracycline, penicillin G, phenobarbital, thyroid and thyroxine preparations, estrogens and progestins, and digitalis. Interference with the absorption of oral phosphate supplements has been observed with another positively-charged bile acid sequestrant. QUESTRAN may interfere with the pharmacokinetics of drugs that undergo enterohepatic circulation. The discontinuance of QUESTRAN could pose a hazard to health if a potentially toxic drug such as digitalis has been titrated to a maintenance level while the patient was taking QUESTRAN.

Because cholestyramine binds bile acids, QUESTRAN may interfere with normal fat digestion and absorption and thus may prevent absorption of fat-soluble vitamins such as A, D, E and K. When QUESTRAN is given for long periods of time, concomitant supplementation with water-miscible (or parenteral) forms of fat-soluble vitamins should be considered.

SINCE QUESTRAN MAY BIND OTHER DRUGS GIVEN CONCURRENTLY, IT IS RECOMMENDED THAT PATIENTS TAKE OTHER DRUGS AT LEAST ONE HOUR BEFORE OR 4 TO 6 HOURS AFTER QUESTRAN (OR AT AS GREAT AN INTERVAL AS POSSIBLE) TO AVOID IMPEDING THEIR ABSORPTION.

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