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U.S. Department of Health and Human Services


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Rifater (rifampin, isoniazid and pyrazinamide) Tablets December 2008

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. Read about the new physician labeling format.


Summary View


Sections Modified

Summary of Changes to Contraindications and Warnings


  • Rifampin


  • Adverse Reactions Reported for Individual Components
    • Other


  • Rifampin
    • Rifampin has been shown to produce liver dysfunction. Fatalities associated with.....