Label Changes for:
Sporanox (itraconazole) oral solution and capsules
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
- Gastrointestinal disorders: Pancreatitis
PATIENT PACKAGE INSERT
WHAT ARE THE POSSIBLE SIDE EFFECTS OF SPORANOX
- Call your doctor right away..fever, inflammation of the pancreas