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Label Changes for:

Dexilant (dexlansoprazole) delayed release capsules

June 2010

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) – June 2010

ADVERSE REACTIONS

Additional adverse reactions that were reported in a long-term uncontrolled study and were considered related: bursitis

DRUG INTERACTIONS

Tacrolimus
  • Concomitant administration of dexlansoprazole and tacrolimus may increase whole blood levels of tacrolimus, especially in transplant patients who are intermediate or poor metabolizers of CYP2C19.
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