Label Changes for:

Sporanox (itraconazole) oral solution and capsules

July 2010

Changes have been made to the ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – July 2010

ADVERSE REACTIONS

Post-marketing experience
  • Gastrointestinal disorders: Pancreatitis

PATIENT PACKAGE INSERT

WHAT ARE THE POSSIBLE SIDE EFFECTS OF SPORANOX
  • Call your doctor right away..fever, inflammation of the pancreas
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