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Label Changes for:

Tracleer (bosentan) 62.5 and 125 mg Tablets

February 2009

Changes have been made to the WARNINGS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- February 2009


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

Summary of Changes to Contraindications and Warnings


  • Decreased Sperm Counts


  • Post-Marketing Experience


  • Decreased Sperm Counts
    • An open-label, single arm, multicenter, safety study evaluated the effect on testicular function of TRACLEER.....Based on these findings and preclinical data from endothelin receptor antagonists, it cannot be excluded that endothelin receptor antagonists such as TRACLEER have an adverse effect on spermatogenesis


  • What are the possible side effects of Tracleer
    • Sperm Count Reduction
      • Reduced sperm counts have been observed ....