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Label Changes for:

Malarone (atovaquone and proguanil hydrochloride) Tablets

December 2008

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) -- December 2008


The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.

Summary View


Sections Modified


  • Postmarketing Adverse Reactions
    • Immune System Disorders
      • vasculitis (added)
    • Gastrointestinal Disorders (new subsection)
      • stomatitis
    • Hepatobiliary Disorders
      • cholestasis (added)