Colesevelam Hydrochloride side effects: what 968 FDA adverse event reports show
Drug class
Bile acid sequestrant
Who reports
968 reports · 66% serious · 14 with death outcome · 55% female
Used for
Colesevelam hydrochloride is a bile acid sequestrant indicated as an adjunct to diet and exercise to: reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia ( 1.1 ). reduce LDL-C levels in boys and postmenarch.
What it is
Colesevelam hydrochloride is a non-absorbed, polymeric, lipid-lowering and glucose-lowering agent for oral administration. Colesevelam hydrochloride is a high-capacity bile acid-binding molecule.
Boxed warning
None in the current label
Causality screen of the 19 strongest signals
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.
- 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. 12 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Obstructive airways disorder | 110 | 215.4 180.4–257.1ROR 242.8 · χ² 23,038 / p <1e-300 | 205.7 EB05 175.4 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious PRR 193.6 · ♀ 0% (drug 55%) | no trial data cached |
| Secretion discharge | 88 | 155.2 127.1–189.6ROR 170.6 · χ² 13,242 / p <1e-300 | 149.2 EB05 124.8 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious PRR 220.9 · ♀ 0% (drug 55%) | no trial data cached |
| Eosinophilia | 110 | 137.1 114.9–163.6ROR 154.5 · χ² 14,644 / p <1e-300 | 133.1 EB05 113.5 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 124.5 · ♀ 0% (drug 55%) | no trial data cached |
| Pneumothorax | 91 | 124.9 102.7–152.0ROR 137.8 · χ² 11,009 / p <1e-300 | 121.1 EB05 101.6 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 109.2 · ♀ 1% (drug 55%) | no trial data cached |
| Coronary artery disease | 112 | 79.7 67.0–94.9ROR 90.0 · χ² 8,608 / p <1e-300 | 78.4 EB05 67.0 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 70.5 · ♀ 2% (drug 55%) | no trial data cached |
| Dyspnoea exertional | 110 | 63.6 53.3–75.9ROR 71.6 · χ² 6,708 / p <1e-300 | 62.8 EB05 53.5 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 69.9 · ♀ 1% (drug 55%) | no trial data cached |
| Bronchospasm (airway tightening) | 39 | 59.1 43.4–80.4ROR 61.5 · χ² 2,166 / p <1e-300 | 57.4 EB05 43.8 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 55.4 · ♀ 3% (drug 55%) | no trial data cached |
| Dysphonia | 111 | 41.2 34.6–49.1ROR 46.4 · χ² 4,317 / p <1e-300 | 40.8 EB05 34.9 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 67.8 · ♀ 0% (drug 55%) | no trial data cached |
| Wheezing | 109 | 39.9 33.5–47.7ROR 44.9 · χ² 4,103 / p <1e-300 | 39.6 EB05 33.8 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 48.0 · ♀ 0% (drug 55%) | no trial data cached |
| Atrial fibrillation | 116 | 25.8 21.7–30.6ROR 29.1 · χ² 2,746 / p <1e-300 | 25.6 EB05 22.0 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 23.2 · ♀ 3% (drug 55%) | no trial data cached |
| Cardiac disorder | 108 | 24.9 20.9–29.8ROR 27.9 · χ² 2,463 / p <1e-300 | 24.8 EB05 21.1 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 25.1 · ♀ 2% (drug 55%) | no trial data cached |
| Chest discomfort | 115 | 24.4 20.6–29.0ROR 27.6 · χ² 2,570 / p <1e-300 | 24.3 EB05 20.8 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 31.6 · ♀ 4% (drug 55%) | no trial data cached |
| Sleep apnoea syndrome | 15 | 17.0 10.3–28.1ROR 17.2 · χ² 210 / p 7e-48 | 16.3 EB05 9.9 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 17.6 | no trial data cached |
| Muscle spasms | 130 | 15.3 13.1–18.0ROR 17.6 · χ² 1,742 / p <1e-300 | 15.3 EB05 13.2 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 23.5 · ♀ 15% (drug 55%) | no trial data cached |
| Nasopharyngitis (common cold) | 126 | 14.8 12.5–17.4ROR 16.8 · χ² 1,617 / p <1e-300 | 14.7 EB05 12.7 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 27.4 · ♀ 8% (drug 55%) | no trial data cached |
| Cough | 138 | 10.7 9.1–12.5ROR 12.3 · χ² 1,216 / p 8e-267 | 10.6 EB05 9.1 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 15.5 · ♀ 16% (drug 55%) | no trial data cached |
| Cerebrovascular accident (stroke) | 83 | 10.6 8.6–13.0ROR 11.5 · χ² 715 / p 9e-158 | 10.4 EB05 8.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 · ♀ 7% (drug 55%) | no trial data cached |
| Frequent bowel movements | 12 | 9.7 5.5–16.9ROR 9.8 · χ² 85 / p 2e-20 | 7.9 EB05 4.5 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 10.8 | no trial data cached |
| Myocardial infarction (heart attack) | 49 | 6.0 4.6–7.9ROR 6.3 · χ² 202 / p 3e-46 | 5.7 EB05 4.5 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 · ♀ 6% (drug 55%) | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Cough | 138 | 10.7 9.1–12.5ROR 12.3 · χ² 1,216 / p 8e-267 | 10.6 EB05 9.1 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 15.5 · ♀ 16% (drug 55%) | no trial data cached |
| Muscle spasms | 130 | 15.3 13.1–18.0ROR 17.6 · χ² 1,742 / p <1e-300 | 15.3 EB05 13.2 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 23.5 · ♀ 15% (drug 55%) | no trial data cached |
| Nasopharyngitis (common cold) | 126 | 14.8 12.5–17.4ROR 16.8 · χ² 1,617 / p <1e-300 | 14.7 EB05 12.7 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 27.4 · ♀ 8% (drug 55%) | no trial data cached |
| Atrial fibrillation | 116 | 25.8 21.7–30.6ROR 29.1 · χ² 2,746 / p <1e-300 | 25.6 EB05 22.0 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 23.2 · ♀ 3% (drug 55%) | no trial data cached |
| Chest discomfort | 115 | 24.4 20.6–29.0ROR 27.6 · χ² 2,570 / p <1e-300 | 24.3 EB05 20.8 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 31.6 · ♀ 4% (drug 55%) | no trial data cached |
| Coronary artery disease | 112 | 79.7 67.0–94.9ROR 90.0 · χ² 8,608 / p <1e-300 | 78.4 EB05 67.0 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 70.5 · ♀ 2% (drug 55%) | no trial data cached |
| Dysphonia | 111 | 41.2 34.6–49.1ROR 46.4 · χ² 4,317 / p <1e-300 | 40.8 EB05 34.9 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 67.8 · ♀ 0% (drug 55%) | no trial data cached |
| Dyspnoea exertional | 110 | 63.6 53.3–75.9ROR 71.6 · χ² 6,708 / p <1e-300 | 62.8 EB05 53.5 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 69.9 · ♀ 1% (drug 55%) | no trial data cached |
| Eosinophilia | 110 | 137.1 114.9–163.6ROR 154.5 · χ² 14,644 / p <1e-300 | 133.1 EB05 113.5 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 124.5 · ♀ 0% (drug 55%) | no trial data cached |
| Obstructive airways disorder | 110 | 215.4 180.4–257.1ROR 242.8 · χ² 23,038 / p <1e-300 | 205.7 EB05 175.4 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious PRR 193.6 · ♀ 0% (drug 55%) | no trial data cached |
| Wheezing | 109 | 39.9 33.5–47.7ROR 44.9 · χ² 4,103 / p <1e-300 | 39.6 EB05 33.8 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 48.0 · ♀ 0% (drug 55%) | no trial data cached |
| Cardiac disorder | 108 | 24.9 20.9–29.8ROR 27.9 · χ² 2,463 / p <1e-300 | 24.8 EB05 21.1 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 25.1 · ♀ 2% (drug 55%) | no trial data cached |
| Pneumothorax | 91 | 124.9 102.7–152.0ROR 137.8 · χ² 11,009 / p <1e-300 | 121.1 EB05 101.6 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 109.2 · ♀ 1% (drug 55%) | no trial data cached |
| Secretion discharge | 88 | 155.2 127.1–189.6ROR 170.6 · χ² 13,242 / p <1e-300 | 149.2 EB05 124.8 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious PRR 220.9 · ♀ 0% (drug 55%) | no trial data cached |
| Cerebrovascular accident (stroke) | 83 | 10.6 8.6–13.0ROR 11.5 · χ² 715 / p 9e-158 | 10.4 EB05 8.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 · ♀ 7% (drug 55%) | 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.
- Obstructive airways disorder — n=110, PRR 215.4
- Secretion discharge — n=88, PRR 155.2
- Eosinophilia — n=110, PRR 137.1
- Pneumothorax — n=91, PRR 124.9
- Coronary artery disease — n=112, PRR 79.7
- Dyspnoea exertional — n=110, PRR 63.6
- Bronchospasm — n=39, PRR 59.1
- Dysphonia — n=111, PRR 41.2
- Wheezing — n=109, PRR 39.9
- Atrial fibrillation — n=116, PRR 25.8
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 Colesevelam?
In FDA FAERS, the most frequently co-reported reaction terms for Colesevelam are cough, muscle spasms, nasopharyngitis, atrial fibrillation, chest discomfort, coronary artery disease. 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 Colesevelam have an FDA boxed warning?
No. The FDA label retrieved for Colesevelam has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Colesevelam 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 6a26e745-7e38-4af0-9bcc-566b2812df75, effective 20250927; matched on
openfda.generic_name.exact:"COLESEVELAM") - 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, 31 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.