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Welchol (Colesevelam Hydrochloride) - Side Effects and Adverse Reactions

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ADVERSE REACTIONS

WelChol® treatment-emergent adverse events that occurred in greater than 2% of patients in an integrated safety analysis are presented in Table 4.

Table 4: Frequent (>2%) Treatment-Emergent Adverse Events By Treatment Category
BODY SYSTEM/ ADVERSE EVENT PLACEBO
(N=258) % 		WELCHOL® ONLY
(N=807) %
Body as a Whole
Infection 13 10
Headache 8 6
Pain 7 5
Back Pain 6 3
Abdominal Pain 5 5
Flu Syndrome 3 3
Accidental Injury 3 4
Asthenia 2 4
Digestive System
Flatulence 14 12
Constipation 7 11
Diarrhea 7 5
Nausea 4 4
Dyspepsia 3 8
Respiratory System
Sinusitis 4 2
Rhinitis 3 3
Cough Increased 2 2
Pharyngitis 2 3
Musculoskeletal System
Myalgia 0 2

Page last updated: 2006-08-08

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