Noxivent Side Effects Center

Last updated on RxList: 5/26/2020
Noxivent Side Effects Center

What Is Noxivent?

Noxivent 101 Gas (nitric oxide) is a vasodilator indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (greater than 34 weeks' gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.

What Are Side Effects of Noxivent?

Common side effects of Noxivent include:

Dosage for Noxivent

The recommended dose of Noxivent is 20 ppm, maintained for up to 14 days or until the underlying oxygen desaturation has resolved.

Noxivent In Children

The safety and efficacy of Noxivent for inhalation has been demonstrated in term and near-term neonates with hypoxic respiratory failure associated with evidence of pulmonary hypertension. Additional studies conducted in premature neonates for the prevention of bronchopulmonary dysplasia have not demonstrated substantial evidence of efficacy. No information about its effectiveness in other age populations is available.

What Drugs, Substances, or Supplements Interact with Noxivent?

Noxivent may interact with other medicines.

Tell your doctor all medications and supplements you use.

Noxivent During Pregnancy and Breastfeeding

Noxivent is not intended for use in adults so it is unlikely to be used during pregnancy or while breastfeeding.

Additional Information

Our Noxivent 101 Gas (nitric oxide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Conception: The Amazing Journey from Egg to Embryo See Slideshow
Noxivent Professional Information

SIDE EFFECTS

The following adverse reactions are discussed elsewhere in the label:

  • Hypoxemia [see WARNINGS AND PRECAUTIONS]
  • Worsening Heart Failure [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from the clinical studies does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. Controlled studies have included 325 patients on nitric oxide doses of 5 to 80 ppm and 251 patients on placebo. Total mortality in the pooled trials was 11% on placebo and 9% on nitric oxide, a result adequate to exclude nitric oxide mortality being more than 40% worse than placebo. In both the NINOS and CINRGI studies, the duration of hospitalization was similar in nitric oxide and placebo-treated groups.

From all controlled studies, at least 6 months of follow-up is available for 278 patients who received nitric oxide and 212 patients who received placebo. Among these patients, there was no evidence of an adverse effect of treatment on the need for rehospitalization, special medical services, pulmonary disease, or neurological sequelae. 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. In CINRGI, the only adverse reaction (>2% higher incidence on nitric oxide than on placebo) was hypotension (14% vs. 11%).

Post-Marketing Experience

Post marketing reports of accidental exposure to nitric oxide for inhalation in hospital staff has been associated with chest discomfort, dizziness, dry throat, dyspnea, and headache.

Read the entire FDA prescribing information for Noxivent (Nitric Oxide Gas)

© Noxivent Patient Information is supplied by Cerner Multum, Inc. and Noxivent Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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