Nitric Oxide: uses, dosing, side effects & brands
Nitric Oxide is a vasodilator sold in the U.S. under one brand, for newborn respiratory distress syndrome. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Vasodilator
- Treats
- Newborn Respiratory Distress Syndrome
- Available as
- Gas
- Sold as
- Noxivent
- Prescription?
- Prescription only
- Generic available?
- Yes
How nitric oxide is dosed
From the FDA label for Noxivent (application ANDA207141). Other nitric oxide products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
The recommended dose is 20 ppm, maintained for up to 14 days or until the underlying oxygen desaturation has resolved ( 2.1 ). Doses greater than 20 ppm are not recommended ( 2.1 , 5.2 ) Administration: • Avoid abrupt discontinuation ( 2.2 , 5.1 ). 2. DOSAGE AND ADMINISTRATION 2.1 Dosage Term and near-term neonates with hypoxic respiratory failure The recommended dose of Noxivent™ is 20 ppm. Maintain treatment up to 14 days or until the underlying oxygen desaturation has resolved and the neonate is ready to be weaned from Noxivent™ therapy. Doses greater than 20 ppm are not recommended [see Warnings and Precautions (5.2) ]. 2.2 Administration Nitric Oxide Delivery Systems Noxivent™ must be administered using a calibrated FDA-cleared Nitric Oxide Delivery System (NODS). There are various FDA-cleared NODS; refer to the NODS labeling to determine which NODS to use with this drug product and for needed information on training and technical support for users of this drug product with the NODS. Do not use Noxivent with Inomax DSIR Plus and DSIP MRI NODS. Do not use Noxivent in the MPI suite. Keep available a backup battery power supply and an independent reserve nitric oxide delivery system to address power and system failures. Monitoring Measure methemoglobin within 4-8 hours after initiation of treatment with Noxivent™ and periodically throughout treatment [see Warnings and…
Nitric Oxide side effects
The most common adverse reaction is hypotension. ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Linde, Inc. at 1-800-772-9247 and www.linde.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6. ADVERSE REACTIONS The following adverse reactions are discussed elsewhere in the label; Hypoxemia [see Warnings and Precautions (5.2 )] Worsening Heart Failure [see Warnings and Precautions (5.4 )] 6.1 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…
Who shouldn’t take nitric oxide
Neonates dependent on right-to-left shunting of blood ( 4 ). 4. CONTRAINDICATIONS Noxivent™ is contraindicated in neonates dependent on right-to-left shunting of blood.
Nitric Oxide drug interactions
Nitric oxide donor compounds may increase the risk of developing methemoglobinemia ( 7 ). Revised: 08/2023 7. DRUG INTERACTIONS 7.1 Nitric Oxide Donor Agents Nitric oxide donor agents such as prilocaine, sodium nitroprusside and nitroglycerine may increase the risk of developing methemoglobinemia.
Every nitric oxide product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Noxivent.
What people report to the FDA about nitric oxide
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 2,068 reports naming nitric oxide, and the FDA flagged 96% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- pulmonary hypertension123 reports
- hypotension119 reports
- respiratory failure115 reports
- hypoxia106 reports
- oxygen saturation decreased79 reports
- pulmonary oedema62 reports
- foetal exposure during pregnancy60 reports
- right ventricular failure60 reports
Read these as a signal, not a rate. A report does not mean nitric oxide caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is nitric oxide?
Noxivent™ (nitric oxide gas) is a drug administered by inhalation. Nitric oxide, the active substance in Noxivent™, is a pulmonary vasodilator. Noxivent™ is a gaseous blend of nitric oxide and nitrogen (0.08% and 99.92%, respectively for 800 ppm; 0.01% and 99.99%, respectively for 100 ppm). Noxivent™ is supplied in aluminum cylinders as a compressed gas under high pressure (2000 pounds per square inch gauge [psig]).
What kind of drug is nitric oxide?
The FDA classifies nitric oxide as a vasodilator. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take nitric oxide with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run nitric oxide against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does nitric oxide come in?
Across the brands we track, nitric oxide is currently marketed as gas, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic nitric oxide?
Yes. Our catalog lists 1 generic nitric oxide product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Nitric Oxide: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/nitric-oxide
- MLA
- “Nitric Oxide: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/nitric-oxide.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for nitric oxide on DailyMed (NIH) ↗.