Label Changes for:
Dexilant (former Kapidex) (dexlansoprazole) delayed release capsules
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) – March 2010
- Immune System Disorders: anaphylactic shock (requiring emergency intervention), Stevens-Johnsons syndrome, toxic epidermal necrolysis (some fatal)