Colesevelam Side Effects

Some side effects of colesevelam may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to colesevelam: oral powder for reconstitution, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking colesevelam: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using colesevelam and call your doctor at once if you have severe constipation or stomach pain.

Less serious side effects of colesevelam may include:

• mild constipation;

• nausea, vomiting, upset stomach, gas, indigestion;

• feeling weak or tired;

• headache;

• muscle pain; or

• runny nose, sore throat, flu symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to colesevelam: oral powder for reconstitution, oral tablet

Cardiovascular

Cardiovascular side effects including hypertension, myocardial infarction, aortic stenosis, and bradycardia have been reported in 3% of patients.

Gastrointestinal

Gastrointestinal side effects have included flatulence (12%), constipation (8.7% to 11%), dyspepsia (3.9% to 8%), diarrhea (5%), and nausea (3% to 4%). Bowel obstruction (in patients with a history of bowel obstruction or resection), dysphagia or esophageal obstruction (occasionally requiring medical intervention), fecal impaction, pancreatitis, abdominal distension, exacerbation of hemorrhoids, and increased transaminases have been reported in postmarketing experience.

Immunologic

Immunologic side effects have included infection (10%).

General

In the lipid-lowering trials, 807 patients received at least one dose of colesevelam therapy (total exposure 199 patient-years). In the type 2 diabetes trials, 566 patients received at least one dose of colesevelam therapy (total exposure 209 patient years). In clinical trials for the reduction of LDL-C, 68% of patients receiving colesevelam therapy versus 64% of patients receiving placebo reported an adverse event. In clinical trials of type 2 diabetes, 60% of patients receiving colesevelam therapy versus 56% of patients receiving placebo reported an adverse event.

Respiratory

Respiratory side effects have included nasopharyngitis (4%), pharyngitis (3%), rhinitis (3%), sinusitis (2%), and increased cough (2%).

Musculoskeletal

Musculoskeletal side effects have included myalgia (2%).

Metabolic

Metabolic side effects have included hypoglycemia (3%). Hypertriglyceridemia has been reported in postmarketing experience.

Nervous system

Nervous system side effects have included headache (6%), pain (6%), and back pain (3%).

Other

Other side effects have included abdominal pain (5%), accidental injury (4%), asthenia (4%), and flu syndrome (3%).

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