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U.S. Department of Health and Human Services

Safety

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Welchol (colsevelam) tablets and oral suspension

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

 

July 2012 

Summary View

ADVERSE REACTIONS

DRUG INTERACTIONS

Drugs that do not interact with colesevelam based on in vitro or in vivo testing

  • enalapril
  • atenolol
  • aspirin
  • rosiglitazone
  • sitagliptin
  • phenytoin
  • olmesartan

Drugs with a known interaction with colesevelam: Decrease in exposure of coadministered drug

  • glimepiride

Drugs with a known interaction with colesevelam: Increase in exposure of coadministered drug

  • Metformin ER

Drug(s) with postmarketing reports consistent with potential drug-drug interactions when coadministered with Welchol

  • phenytoin 

 

January 2012

Summary View

ADVERSE REACTIONS

6.2 Post-Marketing Experience

Gastrointestinal Adverse Reactions

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

 

September 2010

Summary View

 

DRUG INTERACTION

  • cyclosporine