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Label Changes for:

Dexilant (former Kapidex) (dexlansoprazole) delayed release capsules

March 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) – March 2010


Postmarketing Experience
  • Immune System Disorders: anaphylactic shock (requiring emergency intervention), Stevens-Johnsons syndrome, toxic epidermal necrolysis (some fatal)