Label Changes for:
Welchol (colesevelam HCl) Tablets and Oral Suspension
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)
Drugs that do not interact with colesevelam based on in vitro or in vivo testing
Drugs with a known interaction with colesevelam: Decrease in exposure of coadministered drug
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
6.2 Post-Marketing Experience
Gastrointestinal Adverse Reactions
- ..... dysphagia (tablet and oral suspension formulations).....