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What the label lists and what reports show

Colestipol side effects

Colestipol's FDA label: “The most common adverse reactions are confined to the gastrointestinal tract.” FAERS holds 2,599 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 (374 reports).

  • Generic listed

Check it at the source: the colestipol FDA label on DailyMed (effective February 19, 2024, Zydus Pharmaceuticals USA Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The most common adverse reactions are confined to the gastrointestinal tract.

From the label: adverse reactions, continued

Gastrointestinal The most common adverse reactions are confined to the gastrointestinal tract. To achieve minimal GI disturbance with an optimal LDL-C lowering effect, a gradual increase of dosage starting with 2 grams, once or twice daily is recommended. Constipation is the major single complaint and at times is severe. Most instances of constipation are mild, transient and controlled with standard treatment. Increased fluid intake and inclusion of additional dietary fiber should be the first step; a stool softener may be added if needed. Some patients require decreased dosage or discontinuation of therapy. Hemorrhoids may be aggravated. Other, less frequent gastrointestinal complaints consist of abdominal discomfort (abdominal pain and cramping), intestinal gas (bloating and flatulence), indigestion and heartburn, diarrhea and loose stools and nausea and vomiting. Bleeding hemorrhoids and blood in the stool have been infrequently reported. Peptic ulceration, cholecystitis and cholelithiasis have been rarely reported in patients receiving COLESTID granules and are not necessarily drug related. Difficulty swallowing and transient esophageal obstruction have been rarely reported in patients taking colestipol hydrochloride tablets. …

Source: FDA drug label, Zydus Pharmaceuticals USA Inc., effective February 19, 2024 (SPL set 71f12e0d-373a-4867-b37c-f24d99c5ce95), via openFDA; the full label on DailyMed

What do FAERS reports show?

2,599 reports list colestipol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 111 are coded as a death and 654 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 21 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)374
  • Off Label Use (a use or a product term, not a reaction)280
  • Nausea (named in the label)230
  • Fatigue (named in the label)217
  • Drug Ineffective (a use or a product term, not a reaction)177
  • Headache (named in the label)142
  • Pain126
  • Vomiting (named in the label)126
  • Weight Decreased116
  • Dizziness (named in the label)112
  • Arthralgia111
  • Asthenia111
  • Dyspnoea105
  • Malaise102
  • Crohn^S Disease101
  • Abdominal Pain (named in the label)93
  • Product Dose Omission Issue (a use or a product term, not a reaction)93
  • Condition Aggravated (a use or a product term, not a reaction)91
  • Pneumonia89
  • Product Physical Issue89
  • Abdominal Pain Upper88
  • Cough80
  • Fall78
  • Constipation (named in the label)72
  • Back Pain70

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

What next?

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