Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Colestipol hydrochloride
Drug ID BADD_D00522
Description Bile acid sequestrants like colestipol have been in use since the 1970s.[FDA Label, F4555, F4567, L6262] And even though such an agent may very well be useful in reducing elevated cholesterol levels and decreasing the risk for atherosclerotic vascular disease due to hypercholesterolemia, colestipol is still generally only employed as an adjunct therapy and the relatively physical nature of its pharmacological activity sometimes limits its usefulness.[FDA Label, F4555, F4567, L6262] In particular, as colestipol's general mechanism of action ultimately results in the decreased absorption and enhanced secretion of bile acids and lipids in the feces, patients who take complicated medication regimens, experience constipation or biliary obstruction, etc. may not be good candidates for using the agent owing to its physical effects on the gut.[FDA Label, F4555, F4567, L6262] Alternatively, colestipol predominantly elicits its activities within the gut environment because it undergoes little absorption and metabolism.[FDA Label, F4555, F4567, L6262] The resultant lack of systemic exposure consequently means the medication generally demonstrates very few adverse effects inside the body.[FDA Label, F4555, F4567, L6262]
Indications and Usage Colestipol is indicated as adjunctive therapy to diet for the reduction of elevated serum total and low-density lipoprotein cholesterol (LDL-C) in patients with primary hypercholesterolemia (a condition that features elevated LDL-C) who do not respond adequately to dietary changes .[FDA Label,L6115,F4555] Therapy with lipid-altering agents like colestipol should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia [FDA Label, L6115, F4555]. Treatment should begin and continue with dietary therapy [FDA Label, L6115, F4555]. In general, a minimum of six months of intensive dietary therapy and counseling should be carried out prior to initiation of drug therapy such as that with colestipol [FDA Label, F4555]. Shorter periods may be considered in patients with severe elevations of LDL-C or with definite coronary heart disease [FDA Label, F4555]. Although colestipol is effective in all types of hypercholesterolemia, some regional prescribing information note in particular that it is medically most appropriate in patients with Fredrickson's type II hyperlipoproteinemia [L6115]. Nevertheless, in patients with combined hypercholesterolemia and hypertriglyceridemia, although colestipol may be helpful in reducing elevated cholesterol, it is not formally indicated where hypertriglyceridemia is the abnormality of greatest concern [F4567].
Marketing Status approved
ATC Code C10AC02
DrugBank ID DB00375
KEGG ID D02113
MeSH ID D003084
PubChem ID 3084661
TTD Drug ID D0GJ8R
NDC Product Code 11014-0125; 11014-0126; 66499-0007; 70771-1653; 58159-060; 66406-0109; 0115-5211; 0115-5212; 0115-5213; 59762-0450; 72643-019; 0115-2142; 0009-0260; 59762-0260; 70710-1467; 60687-715; 0009-0450; 62559-395; 0009-0370
UNII X7D10K905G
Synonyms Colestipol | Colestipol Hydrochloride | Hydrochloride, Colestipol | Colestipol HCl | HCl, Colestipol | U-26,597 A | U 26,597 A | U26,597 A | Colestid
Chemical Information
Molecular Formula C8H24ClN5
CAS Registry Number 4961-41-5
SMILES C(CNCCNCCNCCN)N.Cl
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Alanine aminotransferase increased13.03.04.005--
Angina pectoris24.04.04.002; 02.02.02.002--
Arthralgia15.01.02.001--
Arthritis15.01.01.001--
Aspartate aminotransferase increased13.03.04.011--
Asthenia08.01.01.001--Not Available
Back pain15.03.04.005--
Chest pain22.12.02.003; 08.01.08.002; 02.02.02.011--Not Available
Cholecystitis09.03.01.001--
Cholelithiasis09.03.01.002--Not Available
Constipation07.02.02.001--
Dermatitis23.03.04.002--Not Available
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.003--
Dyspepsia07.01.02.001--
Dysphagia07.01.06.003--
Dyspnoea02.11.05.003; 22.02.01.004--
Fatigue08.01.01.002--
Flatulence07.01.04.002--
Haematochezia24.07.02.012; 07.12.02.003--Not Available
Headache17.14.01.001--
Insomnia19.02.01.002; 17.15.03.002--
Migraine24.03.05.003; 17.14.02.001--Not Available
Musculoskeletal pain15.03.04.007--
Oesophageal obstruction07.13.02.002--
Pain in extremity15.03.04.010--
Peptic ulcer07.04.07.001--Not Available
Rash23.03.13.001--Not Available
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