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What the label lists and what reports show

Cholestyramine side effects

Cholestyramine's FDA label: “The most common adverse reaction is constipation.” FAERS holds 12,024 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is diarrhoea (1,697 reports).

  • Generic listed

Check it at the source: the cholestyramine FDA label on DailyMed (effective August 20, 2026, AiPing Pharmaceutical, Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The most common adverse reaction is constipation.

From the label: adverse reactions, continued

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, 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 cholestyramine resin 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 a cholestyramine for oral suspension product. One patient diagnosed as acute abdominal symptom complex was found to have a “pasty mass” in the transverse colon on x-ray.

Source: FDA drug label, AiPing Pharmaceutical, Inc., effective August 20, 2026 (SPL set 214ea05f-de81-4026-9df9-4ce3820668ee), via openFDA; the full label on DailyMed

What do FAERS reports show?

12,024 reports list cholestyramine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 834 are coded as a death and 4,058 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. Of the 20 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Diarrhoea (named in the label)1,697
  • Off Label Use (a use or a product term, not a reaction)1,111
  • Drug Ineffective (a use or a product term, not a reaction)946
  • Fatigue (named in the label)905
  • Nausea (named in the label)823
  • Arthralgia633
  • Headache (named in the label)573
  • Abdominal Pain547
  • Vomiting (named in the label)528
  • Dyspnoea517
  • Weight Decreased516
  • Pain486
  • Asthenia468
  • Constipation (named in the label)409
  • Malaise403
  • Pneumonia388
  • Dizziness (named in the label)387
  • Cough382
  • Pruritus (a use or a product term, not a reaction)380
  • Fall365
  • Crohn^S Disease360
  • Condition Aggravated (a use or a product term, not a reaction)357
  • Death (an outcome recorded in the report)353
  • Rash (named in the label)326
  • Pain In Extremity325

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Cholestyramine: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions