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U.S. Department of Health and Human Services

Safety

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Inomax (nitric oxide) for Inhalation

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

 

Summary View

 

WARNINGS AND PRECAUTIONS

Heart Failure
  • In patients with pre-existing left ventricular dysfunction, inhaled nitric oxide may increase pulmonary capillary wedge pressure leading to pulmonary edema.
  • Patients who had pre-existing left ventricular dysfunction treated with inhaled nitric oxide, even for
    short durations, experienced serious adverse events (e.g., pulmonary edema).