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U.S. Department of Health and Human Services


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Avapro (irbesartan) Tablets

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


May 2014

Summary View


Dual Blockade of the Renin-Angiotensin System (RAS)

  • ...text was added as the second paragraph...In most patients no benefit has been associated with using two RAS inhibitors concomitantly. In general, avoid combined use of RAS inhibitors.
  • Lithium: Increases in serum lithium concentrations and lithium toxicity have been reported with concomitant use of irbesartan or thiazide diuretics. Monitor lithium levels in patients receiving Avapro and lithium. 


December 2011

Summary View



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.