Label Changes for:

Welchol (colesevelam HCL) Tablets and Welchol (colesevelam HCl) for Oral Suspension

January 2012

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

January 2012

ADVERSE REACTIONS

6.2 Post-Marketing Experience

Gastrointestinal Adverse Reactions

  • ..... dysphagia (tablet and oral suspension formulations).....

 

 

September 2010

 

DRUG INTERACTION

  • cyclosporine

 

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