Welchol Side Effects

Please note - some side effects for Welchol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Welchol - for the Consumer

Welchol

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Welchol:

Constipation; indigestion; muscle aches; nausea; sore throat; stomach pain or discomfort; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); choking; difficulty swallowing; severe constipation; severe or persistent dizziness or headache; severe stomach pain with or without nausea and vomiting.

Welchol Side Effects - for the Professional

Welchol

In clinical trials, the most common (incidence ≥2% and greater than placebo) adverse reactions with Welchol included constipation, dyspepsia, and nausea. In the diabetes trials, the overall incidence of hypoglycemia was 3.0% in Welchol-treated patients and 2.3% in placebo-treated patients(6.1).

Postmarketing reports with concomitant Welchol administration include:

• Increased seizure activity or decreased phenytoin levels in patients receiving phenytoin. Administer phenytoin 4 hours prior to Welchol.
• Reduced International Normalized Ratio (INR) in patients receiving warfarin. Monitor INR.
• Elevated thyroid-stimulating hormone (TSH) in patients receiving thyroid hormone replacement therapy. Administer thyroid hormones 4 hours prior to Welchol.

Other postmarketing reports include bowel obstruction, dysphagia, esophageal obstruction, fecal impaction, hypertriglyceridemia, pancreatitis, and increased transaminases (5.5 ,6.2, 7, 12.3).

Side Effects by Body System

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.

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