colesevelam Side Effects
Also known as: Welchol
Analysis of 952 adverse event reports submitted to the FDA from 2006 to 2025.
Total Reports
952
Death-Related
32
3.4% of reports
Hospitalizations
277
29.1% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 32 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 10 |
| ASTHENIA | 4 |
| DIARRHOEA | 4 |
| FATIGUE | 4 |
| ACUTE KIDNEY INJURY | 3 |
| ANAEMIA | 3 |
| DEHYDRATION | 3 |
| DEPRESSION | 3 |
| DISEASE RECURRENCE | 3 |
| DYSPNOEA | 3 |
| GASTROINTESTINAL HAEMORRHAGE | 3 |
| HYPOTENSION | 3 |
| MYOCARDIAL INFARCTION | 3 |
| RENAL FAILURE | 3 |
| SEPSIS | 3 |
| VOLVULUS | 3 |
| ABDOMINAL PAIN | 2 |
| ATRIAL FIBRILLATION | 2 |
| CHRONIC KIDNEY DISEASE | 2 |
| CRYSTAL DEPOSIT INTESTINE | 2 |
Reactions in Hospitalization Reports
Top reactions in 277 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| DIARRHOEA | 32 |
| ABDOMINAL PAIN | 28 |
| NAUSEA | 23 |
| DRUG INEFFECTIVE | 22 |
| PNEUMONIA | 19 |
| WEIGHT DECREASED | 18 |
| OFF LABEL USE | 16 |
| ASTHENIA | 14 |
| FATIGUE | 14 |
| VOMITING | 14 |
| CROHN^S DISEASE | 13 |
| DRUG INTERACTION | 13 |
| DEHYDRATION | 12 |
| FALL | 12 |
| BILE ACID MALABSORPTION | 11 |
| CEREBROVASCULAR ACCIDENT | 11 |
| DYSPNOEA | 11 |
| PAIN | 11 |
| CLOSTRIDIUM DIFFICILE COLITIS | 10 |
| FUNCTIONAL GASTROINTESTINAL DISORDER | 10 |
Nearby — Related Medications
What the FAERS Data Reveals About colesevelam Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 952 voluntary reports linked to colesevelam and its brand equivalents (Welchol), spanning 2006 through 2025. Of those, 32 (3.4%) listed death as an outcome and 277 (29.1%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 60% were female and 40% male; age distribution skews toward 45-64, with 230 reports in that bracket. The single most reported reaction is diarrhoea with 121 submissions, followed by dyspnoea and off label use.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.