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.
