OpenClaim

Colesevelam Side Effects

The most commonly reported side effects of colesevelam include off label use, no adverse event, and diarrhoea, based on 10,268 FDA adverse event reports from 2004 to 2025. 4.5% of reports found the drug to be ineffective.

Colesevelam side effects

Percentages show how often each reaction appears relative to total reports for colesevelam.

1
Off Label Use14.0%1,438
2
No Adverse Event9.0%929
3
Diarrhoea7.1%727
4
Drug Ineffective4.5%467
5
Fatigue4.5%465
6
Nausea4.5%459
7
Constipation3.5%356
8
Dyspnoea3.3%342
9
Headache3.0%308
10
Muscle Spasms2.9%300
11
Pain2.8%288
12
Arthralgia2.7%278
13
Weight Decreased2.6%268
14
Cough2.5%258
15
Incorrect Dose Administered2.2%226

These are voluntary reports and do not establish that colesevelam caused these reactions.

Report severity

45.2%Serious4,643 reports
19.7%Hospitalizations2,025 reports
3.0%Fatal309 reports

Seriousness is determined by the reporter, not by OpenClaim.

Colesevelam drug interactions

Other drugs that appear in adverse event reports alongside colesevelam. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Lenalidomide6.0%620
2
Adalimumab5.2%533
3
Niacin3.8%393
4
Rosuvastatin3.5%355
5
Evolocumab2.8%287
6
Atorvastatin-calcium2.4%243
7
Alirocumab2.4%243
8
Ezetimibe2.3%238
9
Aspirin2.2%224
10
Lomitapide-mesylate2.1%218
11
Rivaroxaban1.8%185
12
Sodium-oxybate1.7%179
13
Esomeprazole1.6%168
14
Ergocalciferol1.5%153
15
Pantoprazole-sodium1.5%151

Taken alongside

1
Aspirin19.2%1,976
2
Ergocalciferol15.8%1,625
3
Levothyroxine-sodium13.6%1,401
4
Acetaminophen12.2%1,256
5
Metformin10.8%1,105
6
Omeprazole10.4%1,063
7
Metoprolol9.7%994
8
Amlodipine9.6%982
9
Ezetimibe9.0%927
10
Lisinopril8.8%906
11
Furosemide8.2%840
12
Gabapentin8.0%820
13
Atorvastatin-calcium7.3%751
14
Calcium7.1%731
15
Albuterol7.0%719

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports colesevelam side effects

58.8% of colesevelam adverse event reports involve female patients and 31.8% involve male patients. The largest age group is elderly at 50%. These figures reflect who reports side effects, not underlying risk.

Sex

Female58.8%
Male31.8%
Unknown9.5%

Age group

< 2<0.1%
2–110.2%
12–170.2%
18–6449.6%
65+49.9%

What is colesevelam used for

Conditions and purposes for which patients were taking colesevelam when the adverse event was reported.

Abdominal DiscomfortAbdominal DistensionAbdominal PainAbdominal Pain UpperAbnormal FaecesAdverse EventAlveolar ProteinosisAnal IncontinenceAnorectal DiscomfortAntidiarrhoeal Supportive CareAntiinflammatory TherapyArterial DisorderAutoimmune DisorderAbdominal DiscomfortAdverse Drug Reaction

Showing 15 of 292 indications

Colesevelam brand names and reporting trend

Colesevelam is sold under the brand name Colesevelam Hydrochloride.

Brand names

Colesevelam Hydrochloride19

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking colesevelam with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.