Colesevelam side effects: what 1,030 FDA adverse event reports show
Drug class
Bile acid sequestrant
Who reports
1,030 reports · 73% serious · 33 with death outcome · 60% 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 16 strongest signals
What the badges mean
- 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. 17 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 | 50 | 91.4 69.7–119.9ROR 96.0 · χ² 4,364 / p <1e-300 | 88.0 EB05 69.4 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 74.6 · ♀ 0% (drug 60%) | no trial data cached |
| Pneumothorax | 50 | 64.3 49.0–84.3ROR 67.5 · χ² 3,045 / p <1e-300 | 62.6 EB05 49.4 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 50.8 · ♀ 0% (drug 60%) | no trial data cached |
| Eosinophilia | 50 | 58.3 44.5–76.4ROR 61.2 · χ² 2,754 / p <1e-300 | 56.9 EB05 44.9 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 48.0 · ♀ 0% (drug 60%) | no trial data cached |
| Secretion discharge | 34 | 56.1 40.3–78.1ROR 57.9 · χ² 1,780 / p <1e-300 | 54.3 EB05 40.6 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 72.3 · ♀ 0% (drug 60%) | no trial data cached |
| Bronchospasm (airway tightening) | 30 | 42.7 30.0–60.7ROR 43.9 · χ² 1,178 / p 2e-258 | 41.5 EB05 30.5 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 37.1 · ♀ 0% (drug 60%) | no trial data cached |
| Coronary artery disease | 50 | 33.3 25.4–43.7ROR 35.0 · χ² 1,536 / p <1e-300 | 32.9 EB05 25.9 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 26.7 · ♀ 2% (drug 60%) | no trial data cached |
| Dyspnoea exertional | 53 | 28.7 22.1–37.4ROR 30.2 · χ² 1,391 / p <1e-300 | 28.4 EB05 22.6 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 28.0 · ♀ 4% (drug 60%) | no trial data cached |
| Clostridium difficile colitis | 14 | 26.8 15.9–45.1ROR 27.2 · χ² 322 / p 2e-72 | 25.9 EB05 16.3 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 21.5 | no trial data cached |
| Dysphonia | 53 | 18.4 14.2–24.0ROR 19.4 · χ² 859 / p 4e-189 | 18.3 EB05 14.5 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 27.4 · ♀ 4% (drug 60%) | no trial data cached |
| Wheezing | 49 | 16.8 12.8–22.1ROR 17.6 · χ² 716 / p 5e-158 | 16.7 EB05 13.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 18.3 · ♀ 0% (drug 60%) | no trial data cached |
| Frequent bowel movements | 21 | 15.9 10.4–24.2ROR 16.2 · χ² 278 / p 1e-62 | 15.4 EB05 10.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 16.5 | no trial data cached |
| Subdural haematoma | 10 | 14.2 7.6–26.2ROR 14.3 · χ² 109 / p 7e-26 | 12.3 EB05 6.1 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 11.2 | no trial data cached |
| Cardiac disorder | 56 | 12.1 9.4–15.6ROR 12.8 · χ² 563 / p 1e-124 | 11.9 EB05 9.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 · ♀ 10% (drug 60%) | no trial data cached |
| Atrial fibrillation | 55 | 11.5 8.9–14.8ROR 12.1 · χ² 517 / p 1e-114 | 11.2 EB05 8.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 · ♀ 4% (drug 60%) | no trial data cached |
| Chest discomfort | 55 | 11.0 8.5–14.2ROR 11.5 · χ² 490 / p 6e-109 | 10.7 EB05 8.4 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.4 · ♀ 6% (drug 60%) | no trial data cached |
| Clostridium difficile infection | 10 | 9.4 5.1–17.4ROR 9.5 · χ² 67 / p 2e-16 | 7.4 EB05 4.0 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 | 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 |
|---|---|---|---|---|---|---|
| Cardiac disorder | 56 | 12.1 9.4–15.6ROR 12.8 · χ² 563 / p 1e-124 | 11.9 EB05 9.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 · ♀ 10% (drug 60%) | no trial data cached |
| Chest discomfort | 55 | 11.0 8.5–14.2ROR 11.5 · χ² 490 / p 6e-109 | 10.7 EB05 8.4 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.4 · ♀ 6% (drug 60%) | no trial data cached |
| Atrial fibrillation | 55 | 11.5 8.9–14.8ROR 12.1 · χ² 517 / p 1e-114 | 11.2 EB05 8.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 · ♀ 4% (drug 60%) | no trial data cached |
| Dysphonia | 53 | 18.4 14.2–24.0ROR 19.4 · χ² 859 / p 4e-189 | 18.3 EB05 14.5 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 27.4 · ♀ 4% (drug 60%) | no trial data cached |
| Dyspnoea exertional | 53 | 28.7 22.1–37.4ROR 30.2 · χ² 1,391 / p <1e-300 | 28.4 EB05 22.6 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 28.0 · ♀ 4% (drug 60%) | no trial data cached |
| Coronary artery disease | 50 | 33.3 25.4–43.7ROR 35.0 · χ² 1,536 / p <1e-300 | 32.9 EB05 25.9 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 26.7 · ♀ 2% (drug 60%) | no trial data cached |
| Eosinophilia | 50 | 58.3 44.5–76.4ROR 61.2 · χ² 2,754 / p <1e-300 | 56.9 EB05 44.9 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 48.0 · ♀ 0% (drug 60%) | no trial data cached |
| Pneumothorax | 50 | 64.3 49.0–84.3ROR 67.5 · χ² 3,045 / p <1e-300 | 62.6 EB05 49.4 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 50.8 · ♀ 0% (drug 60%) | no trial data cached |
| Obstructive airways disorder | 50 | 91.4 69.7–119.9ROR 96.0 · χ² 4,364 / p <1e-300 | 88.0 EB05 69.4 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 74.6 · ♀ 0% (drug 60%) | no trial data cached |
| Wheezing | 49 | 16.8 12.8–22.1ROR 17.6 · χ² 716 / p 5e-158 | 16.7 EB05 13.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 18.3 · ♀ 0% (drug 60%) | no trial data cached |
| Secretion discharge | 34 | 56.1 40.3–78.1ROR 57.9 · χ² 1,780 / p <1e-300 | 54.3 EB05 40.6 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 72.3 · ♀ 0% (drug 60%) | no trial data cached |
| Bronchospasm (airway tightening) | 30 | 42.7 30.0–60.7ROR 43.9 · χ² 1,178 / p 2e-258 | 41.5 EB05 30.5 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 37.1 · ♀ 0% (drug 60%) | no trial data cached |
| Frequent bowel movements | 21 | 15.9 10.4–24.2ROR 16.2 · χ² 278 / p 1e-62 | 15.4 EB05 10.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 16.5 | no trial data cached |
| Clostridium difficile colitis | 14 | 26.8 15.9–45.1ROR 27.2 · χ² 322 / p 2e-72 | 25.9 EB05 16.3 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 21.5 | no trial data cached |
| Clostridium difficile infection | 10 | 9.4 5.1–17.4ROR 9.5 · χ² 67 / p 2e-16 | 7.4 EB05 4.0 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 | 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.
- Obstructive airways disorder — n=50, PRR 91.4
- Pneumothorax — n=50, PRR 64.3
- Eosinophilia — n=50, PRR 58.3
- Secretion discharge — n=34, PRR 56.1
- Bronchospasm — n=30, PRR 42.7
- Coronary artery disease — n=50, PRR 33.3
- Dyspnoea exertional — n=53, PRR 28.7
- Dysphonia — n=53, PRR 18.4
- Wheezing — n=49, PRR 16.8
- Frequent bowel movements — n=21, PRR 15.9
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 cardiac disorder, chest discomfort, atrial fibrillation, dysphonia, dyspnoea exertional, 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, 33 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.