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Label Changes for:

Avapro (irbesartan) Tablets

December 2011

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

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2011



Drug Interactions
  • Concomitant use of potassium-sparing diuretics, potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium.



Post-Marketing Experience
  • Thrombocytopenia
  • Impaired renal function, including cases of renal failure, has been reported.
  • Cases of increased CPK and rhabdomyolysis have been reported in patients receiving angiotensin II receptor blocker.