Drug · FAERS side-effect profile with label screen
Colestipol side effects: what 2,595 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Colestipol Hydrochloride (Colestid)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
2,595 reports · 57% serious · 111 with death outcome · 69% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Since no drug is innocuous, strict attention should be paid to the indications and contraindications, particularly when selecting drugs for chronic long-term use. COLESTID Granules and FLAVORED COLESTID Granules are indicated as adjunctive therapy to d.
FDA label, Indications and Usage
What it is
DESCRIPTION COLESTID Granules and FLAVORED COLESTID Granules contain colestipol hydrochloride, which is a lipid lowering agent for oral use. Colestipol hydrochloride is an insoluble, high mole.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 2Labeled (related wording) 2Likely indication confounding 2Reporting / coding artifact 5Lab value / disease marker 6Not in label — unassessed 23
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 138 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Product physical issue | 89 | 36.2 29.5–44.4ROR 37.4 · χ² 2,998 / p <1e-300 | 35.8 EB05 29.9 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious n=9 | no trial data cached |
| Product use complaint | 58 | 30.3 23.5–39.1ROR 31.0 · χ² 1,608 / p <1e-300 | 29.9 EB05 24.0 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious n=11 · 77% consumer | no trial data cached |
| Poor quality product administered | 31 | 24.5 17.3–34.8ROR 24.8 · χ² 675 / p 5e-149 | 24.1 EB05 17.8 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=4 | no trial data cached |
| Fistula | 29 | 20.8 14.5–29.9ROR 21.0 · χ² 526 / p 1e-116 | 20.5 EB05 14.9 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 22.0 · ♀ 93% (drug 69%) | no trial data cached |
| Weight fluctuation | 24 | 18.6 12.5–27.7ROR 18.8 · χ² 382 / p 2e-85 | 18.3 EB05 12.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=22 · ♀ 29% (drug 69%) · 79% consumer | no trial data cached |
| Choking | 36 | 15.0 10.8–20.7ROR 15.2 · χ² 455 / p 3e-101 | 14.7 EB05 11.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 12.7 · 76% consumer | no trial data cached |
| Nerve compression | 15 | 13.1 7.9–21.8ROR 13.2 · χ² 156 / p 4e-36 | 12.0 EB05 7.1 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 17.8 | no trial data cached |
| Frequent bowel movements | 42 | 12.6 9.3–17.0ROR 12.8 · χ² 437 / p 2e-97 | 12.3 EB05 9.3 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 15.8 | no trial data cached |
| Incontinence | 15 | 11.4 6.9–18.9ROR 11.5 · χ² 132 / p 6e-31 | 10.1 EB05 6.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 13.4 | no trial data cached |
| Irritable bowel syndrome | 30 | 11.3 7.9–16.2ROR 11.5 · χ² 272 / p 2e-61 | 10.7 EB05 7.6 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 13.0 · ♀ 96% (drug 69%) | no trial data cached |
| Small intestinal obstruction | 17 | 11.2 7.0–18.0ROR 11.3 · χ² 148 / p 3e-34 | 10.0 EB05 6.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 11.3 | no trial data cached |
| Respiratory tract congestion | 21 | 10.7 7.0–16.3ROR 10.7 · χ² 174 / p 5e-40 | 9.7 EB05 6.4 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 17.6 · ♀ 100% (drug 69%) | no trial data cached |
| Intestinal obstruction | 48 | 10.3 7.8–13.7ROR 10.5 · χ² 396 / p 2e-88 | 9.9 EB05 7.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 10.3 | no trial data cached |
| Haemorrhoids | 24 | 9.9 6.7–14.8ROR 10.0 · χ² 183 / p 4e-42 | 9.0 EB05 6.2 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.8 · ♀ 90% (drug 69%) | no trial data cached |
| Body temperature decreased | 12 | 9.8 5.5–17.2ROR 9.8 · χ² 86 / p 1e-20 | 8.0 EB05 4.6 · IC025 +1.9 3/3 methods agree | Lab value / disease marker | serious PRR 10.9 | no trial data cached |
| Clostridium difficile infection | 26 | 9.7 6.6–14.2ROR 9.8 · χ² 194 / p 2e-44 | 8.9 EB05 6.2 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 · ♀ 96% (drug 69%) | no trial data cached |
| Cholecystectomy | 13 | 9.2 5.4–15.9ROR 9.3 · χ² 87 / p 5e-21 | 7.7 EB05 4.5 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 | no trial data cached |
| Red blood cell sedimentation rate increased | 12 | 8.7 5.0–15.4ROR 8.8 · χ² 75 / p 3e-18 | 7.1 EB05 4.1 · IC025 +1.8 3/3 methods agree | Lab value / disease marker | serious PRR 9.9 | no trial data cached |
| Seasonal allergy | 15 | 8.6 5.2–14.2ROR 8.6 · χ² 93 / p 3e-22 | 7.2 EB05 4.5 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Abscess | 16 | 8.1 5.0–13.2ROR 8.1 · χ² 93 / p 3e-22 | 6.9 EB05 4.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 | no trial data cached |
| Blood calcium decreased | 11 | 7.9 4.4–14.2ROR 7.9 · χ² 59 / p 7e-15 | 6.3 EB05 3.6 · IC025 +1.6 3/3 methods agree | Lab value / disease marker | serious PRR 9.9 | no trial data cached |
| Poor venous access | 10 | 7.8 4.2–14.5ROR 7.8 · χ² 53 / p 2e-13 | 6.1 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Pharyngitis | 12 | 7.8 4.4–13.7ROR 7.8 · χ² 64 / p 6e-16 | 6.3 EB05 3.7 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 | no trial data cached |
| Gastrointestinal pain | 10 | 7.4 4.0–13.7ROR 7.4 · χ² 49 / p 1e-12 | 5.8 EB05 3.3 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.9 | no trial data cached |
| Blood pressure systolic increased | 17 | 7.0 4.4–11.2ROR 7.0 · χ² 82 / p 8e-20 | 6.0 EB05 3.9 · IC025 +1.8 3/3 methods agree | Lab value / disease marker | serious PRR 7.7 | no trial data cached |
| Device failure | 13 | 6.9 4.0–11.9ROR 6.9 · χ² 60 / p 5e-15 | 5.7 EB05 3.5 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 11.8 | no trial data cached |
| Hiatus hernia | 11 | 6.8 3.8–12.3ROR 6.9 · χ² 49 / p 1e-12 | 5.5 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Blood triglycerides increased | 15 | 6.8 4.1–11.3ROR 6.9 · χ² 69 / p 5e-17 | 5.8 EB05 3.7 · IC025 +1.7 3/3 methods agree | Likely indication confounding term in indications | serious PRR 10.1 | no trial data cached |
| Ear pain | 16 | 6.6 4.1–10.8ROR 6.7 · χ² 71 / p 2e-17 | 5.7 EB05 3.7 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.4 | no trial data cached |
| Flatulence (gas) | 46 | 6.6 4.9–8.7ROR 6.7 · χ² 212 / p 3e-48 | 6.2 EB05 4.8 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.3 | no trial data cached |
| Nephrolithiasis (kidney stones) | 37 | 6.5 4.7–9.0ROR 6.6 · χ² 168 / p 1e-38 | 6.1 EB05 4.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 | no trial data cached |
| Intentional product use issue | 69 | 6.3 5.0–8.0ROR 6.5 · χ² 305 / p 1e-68 | 6.1 EB05 5.0 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 8.4 | no trial data cached |
| Gallbladder disorder | 14 | 6.3 3.7–10.6ROR 6.3 · χ² 57 / p 2e-14 | 5.3 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Heart rate decreased | 26 | 5.9 4.1–8.7ROR 6.0 · χ² 102 / p 3e-24 | 5.4 EB05 3.9 · IC025 +1.8 3/3 methods agree | Lab value / disease marker | serious PRR 7.2 | no trial data cached |
| Blood cholesterol increased | 34 | 5.9 4.2–8.2ROR 5.9 · χ² 133 / p 4e-31 | 5.5 EB05 4.1 · IC025 +1.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 5.8 | no trial data cached |
| Colitis | 27 | 5.8 4.0–8.4ROR 5.8 · χ² 102 / p 2e-24 | 5.3 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 · ♀ 92% (drug 69%) | no trial data cached |
| Haematocrit decreased | 14 | 5.7 3.4–9.5ROR 5.7 · χ² 49 / p 1e-12 | 4.8 EB05 3.1 · IC025 +1.4 3/3 methods agree | Lab value / disease marker | serious PRR 5.9 | no trial data cached |
| Rectal haemorrhage | 30 | 5.6 3.9–8.0ROR 5.7 · χ² 109 / p 7e-26 | 5.2 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Brain fog | 10 | 5.5 3.0–10.3ROR 5.5 · χ² 33 / p 5e-9 | 4.5 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 | no trial data cached |
| Drug ineffective for unapproved indication | 38 | 5.5 4.0–7.5ROR 5.6 · χ² 136 / p 1e-31 | 5.2 EB05 3.9 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 1.6 · 79% consumer | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Diarrhoea (diarrhea) | 374 | 4.7 4.3–5.2ROR 5.3 · χ² 1,116 / p 5e-245 | 4.7 EB05 4.3 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.4 | no trial data cached |
| Product dose omission issue | 93 | 2.6 2.2–3.2ROR 2.7 · χ² 94 / p 2e-22 | 2.6 EB05 2.2 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 7.4 | no trial data cached |
| Product physical issue | 89 | 36.2 29.5–44.4ROR 37.4 · χ² 2,998 / p <1e-300 | 35.8 EB05 29.9 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious n=9 | no trial data cached |
| Intentional product use issue | 69 | 6.3 5.0–8.0ROR 6.5 · χ² 305 / p 1e-68 | 6.1 EB05 5.0 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 8.4 | no trial data cached |
| Dysphagia (difficulty swallowing) | 59 | 5.0 3.9–6.5ROR 5.1 · χ² 187 / p 7e-43 | 4.8 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Sinusitis | 58 | 4.6 3.5–5.9ROR 4.6 · χ² 158 / p 2e-36 | 4.4 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 | no trial data cached |
| Product use complaint | 58 | 30.3 23.5–39.1ROR 31.0 · χ² 1,608 / p <1e-300 | 29.9 EB05 24.0 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious n=11 · 77% consumer | no trial data cached |
| Illness | 57 | 4.6 3.5–5.9ROR 4.7 · χ² 156 / p 3e-36 | 4.4 EB05 3.5 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 7.4 · ♀ 92% (drug 69%) | no trial data cached |
| Inappropriate schedule of product administration | 53 | 2.4 1.9–3.2ROR 2.4 · χ² 43 / p 3e-11 | 2.4 EB05 1.9 · IC025 +0.8 | Reporting / coding artifact | serious PRR 5.5 | no trial data cached |
| Injection site pain (pain where injected) | 51 | 1.4 1.0–1.8ROR 1.4 · χ² 4 / p 0.017 | 1.4 EB05 1.1 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Labeled (related wording) related wording | serious PRR 1.7 | no trial data cached |
| Arthritis | 49 | 5.0 3.8–6.6ROR 5.1 · χ² 154 / p 1e-35 | 4.8 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.9 | no trial data cached |
| Intestinal obstruction | 48 | 10.3 7.8–13.7ROR 10.5 · χ² 396 / p 2e-88 | 9.9 EB05 7.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 10.3 | no trial data cached |
| Flatulence (gas) | 46 | 6.6 4.9–8.7ROR 6.7 · χ² 212 / p 3e-48 | 6.2 EB05 4.8 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.3 | no trial data cached |
| Migraine | 43 | 3.7 2.7–4.9ROR 3.7 · χ² 81 / p 1e-19 | 3.5 EB05 2.7 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.3 · ♀ 92% (drug 69%) | no trial data cached |
| Frequent bowel movements | 42 | 12.6 9.3–17.0ROR 12.8 · χ² 437 / p 2e-97 | 12.3 EB05 9.3 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 15.8 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Poor quality product administered — n=31, PRR 24.5
- Fistula — n=29, PRR 20.8
- Weight fluctuation — n=24, PRR 18.6
- Choking — n=36, PRR 15.0
- Frequent bowel movements — n=42, PRR 12.6
- Irritable bowel syndrome — n=30, PRR 11.3
- Respiratory tract congestion — n=21, PRR 10.7
- Intestinal obstruction — n=48, PRR 10.3
- Clostridium difficile infection — n=26, PRR 9.7
- Nephrolithiasis — n=37, PRR 6.5
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Colestipol?
In FDA FAERS, the most frequently co-reported reaction terms for Colestipol are diarrhoea, dysphagia, sinusitis, injection site pain, arthritis, intestinal obstruction. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Colestipol have an FDA boxed warning?
No. The FDA label retrieved for Colestipol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Colestipol causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 21b37725-fc0c-4365-a7dc-1a473d42502d, effective 20240627; matched on
openfda.generic_name.exact:"COLESTIPOL HYDROCHLORIDE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 178 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.