INOMAX Has a Well-Established Safety Profile
- The most common adverse reaction is hypotension
- An FDA-approved drug that selectively dilates the pulmonary vasculature2
- More than 5000 subjects have been studied in iNO trials worldwide1
- Short half-life minimizes systemic effects2,3
From all controlled studies, at least 6 months of follow-up is available for 278 patients who received INOMAX and 212 patients who received placebo. Among these patients, there was no evidence of an adverse effect of treatment or the need for rehospitalization, special medical services, pulmonary disease, or neurological sequelae.2
In the NINOS study, treatment groups were similar with respect to the incidence and severity of intracranial hemorrhage, grade IV hemorrhage, periventricular leukomalacia, cerebral infarction, seizures requiring anticonvulsant therapy, pulmonary hemorrhage, or gastrointestinal hemorrhage.2
In CINRGI, the only adverse reaction (>2% higher incidence on INOMAX than on placebo) was hypotension (14% vs 11%).2
Based upon postmarketing experience, accidental exposure to nitric oxide for inhalation in hospital staff has been associated with chest discomfort, dizziness, dry throat, dyspnea, and headache.2
Please see Full Prescribing Information.
*Data reflect the cumulative number of exposed patients across periodically updated safety reports and do not include patients in blinded clinical trials.