What the label lists and what reports show
Nitric oxide side effects
Nitric oxide's FDA label: “The most common adverse reaction is hypotension ( 6 ).” FAERS holds 4,473 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is device malfunction (636 reports).
- Generic listed
Check it at the source: the nitric oxide FDA label on DailyMed (effective December 11, 2025, VERO BIOTECH, INC.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reaction is hypotension ( 6 ).
From the label: adverse reactions, continuedThe 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) ] The most common adverse reaction is hypotension ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Vero Biotech at 1-877-337-4118 and http://www.vero-biotech.com/ or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 gas for inhalation, 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 gas for inhalation and placebo-treated groups. …
Source: FDA drug label, VERO BIOTECH, INC., effective December 11, 2025 (SPL set c9560c54-9e28-4039-a4e5-5000c41c6c85), via openFDA; the full label on DailyMed
What do FAERS reports show?
4,473 reports list nitric oxide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,320 are coded as a death and 712 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 14 reactions below, 4 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Nitric oxide: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions