Drug · FAERS side-effect profile with label screen
Nitric Oxide side effects: what 4,473 FDA adverse event reports show
Drug class
Vasodilator
FDA label (Established Pharmacologic Class)
Brand names
Genosyl
openFDA label
Who reports
4,473 reports · 63% serious · 1,320 with death outcome · 47% female
openFDA FAERS counts, all years, deduplication not applied
Used for
GENOSYL ® is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>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.
FDA label, Indications and Usage
What it is
GENOSYL (nitric oxide) is administered by inhalation. Nitric oxide is a pulmonary vasodilator. Nitric oxide is generated from liquid dinitrogen tetroxide (N 2 O 4 ) by the Cassette in the GENOSYL Delivery System.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 2Labeled (related wording) 2Likely indication confounding 3Reporting / coding artifact 10Lab value / disease marker 1Not in label — unassessed 22
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 51 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Device failure | 147 | 45.9 39.1–53.8ROR 47.4 · χ² 6,348 / p <1e-300 | 45.2 EB05 39.4 · IC025 +5.0 3/3 methods agree | Reporting / coding artifact | serious PRR 31.7 · 91% clinician | no trial data cached |
| Device malfunction | 636 | 44.8 41.7–48.2ROR 52.0 · χ² 27,010 / p <1e-300 | 44.3 EB05 41.5 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | serious PRR 10.5 · 91% clinician | no trial data cached |
| Pulmonary hypertension | 151 | 34.1 29.1–39.9ROR 35.2 · χ² 4,787 / p <1e-300 | 33.7 EB05 29.4 · IC025 +4.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 30.7 · 97% clinician | no trial data cached |
| Underdose | 444 | 28.7 26.2–31.3ROR 31.7 · χ² 11,791 / p <1e-300 | 28.5 EB05 26.3 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious PRR 9.5 | no trial data cached |
| Device issue | 452 | 24.4 22.4–26.6ROR 27.0 · χ² 10,112 / p <1e-300 | 24.3 EB05 22.4 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious PRR 15.5 | no trial data cached |
| Oxygen saturation decreased | 270 | 22.8 20.3–25.6ROR 24.2 · χ² 5,590 / p <1e-300 | 22.6 EB05 20.5 · IC025 +4.2 3/3 methods agree | Lab value / disease marker | serious PRR 19.4 · 90% clinician | no trial data cached |
| Device delivery system issue | 122 | 22.0 18.4–26.2ROR 22.6 · χ² 2,414 / p <1e-300 | 21.8 EB05 18.8 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious n=19 · 100% clinician | no trial data cached |
| No adverse event | 789 | 20.9 19.7–22.3ROR 25.2 · χ² 15,024 / p <1e-300 | 20.8 EB05 19.7 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 1.6 · 99% clinician | no trial data cached |
| Acute respiratory distress syndrome | 67 | 17.8 14.0–22.6ROR 18.1 · χ² 1,044 / p 3e-229 | 17.7 EB05 14.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 16.1 · ♀ 79% (drug 47%) · 92% clinician | no trial data cached |
| Hypoxia (low oxygen) | 132 | 17.7 15.0–21.0ROR 18.2 · χ² 2,060 / p <1e-300 | 17.6 EB05 15.2 · IC025 +3.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 16.2 · 93% clinician | no trial data cached |
| Pneumothorax | 59 | 17.5 13.6–22.6ROR 17.7 · χ² 899 / p 7e-198 | 17.3 EB05 13.9 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 15.9 · 100% clinician | no trial data cached |
| Pulmonary arterial hypertension | 48 | 15.5 11.7–20.5ROR 15.7 · χ² 635 / p 2e-140 | 15.3 EB05 11.9 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 14.4 · 94% clinician | no trial data cached |
| Pulmonary congestion | 35 | 12.4 8.9–17.3ROR 12.5 · χ² 356 / p 1e-79 | 12.0 EB05 8.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 13.1 · 97% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 73 | 12.3 9.8–15.4ROR 12.5 · χ² 745 / p 2e-164 | 12.1 EB05 9.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 11.1 · 96% clinician | no trial data cached |
| Device occlusion | 34 | 11.5 8.2–16.1ROR 11.6 · χ² 314 / p 1e-70 | 11.0 EB05 8.0 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious n=12 | no trial data cached |
| Atelectasis | 23 | 11.1 7.4–16.8ROR 11.2 · χ² 202 / p 4e-46 | 10.3 EB05 6.9 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 · 95% clinician | no trial data cached |
| Premature baby | 70 | 10.9 8.6–13.7ROR 11.0 · χ² 618 / p 8e-137 | 10.6 EB05 8.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 · 97% clinician | no trial data cached |
| Premature delivery | 37 | 10.9 7.9–15.0ROR 10.9 · χ² 321 / p 4e-72 | 10.4 EB05 7.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 · ♀ 100% (drug 47%) · 97% clinician | no trial data cached |
| Cardiogenic shock | 33 | 10.9 7.7–15.3ROR 10.9 · χ² 285 / p 3e-64 | 10.3 EB05 7.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 · 94% clinician | no trial data cached |
| Respiratory failure | 144 | 9.3 7.9–10.9ROR 9.5 · χ² 1,055 / p 9e-232 | 9.1 EB05 7.9 · IC025 +2.9 3/3 methods agree | Likely indication confounding term in indications | serious PRR 8.4 · 94% clinician | no trial data cached |
| Product use issue | 368 | 9.2 8.4–10.2ROR 10.0 · χ² 2,716 / p <1e-300 | 9.2 EB05 8.4 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 18.4 · 96% clinician | no trial data cached |
| Therapy non-responder | 76 | 8.0 6.4–10.0ROR 8.1 · χ² 459 / p 4e-102 | 7.7 EB05 6.3 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 11.7 · 96% clinician | no trial data cached |
| Intestinal perforation | 19 | 7.9 5.1–12.4ROR 8.0 · χ² 108 / p 1e-25 | 6.9 EB05 4.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 | no trial data cached |
| Cardio-respiratory arrest | 71 | 7.9 6.3–10.0ROR 8.0 · χ² 422 / p 4e-94 | 7.6 EB05 6.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 · 97% clinician | no trial data cached |
| Pulmonary oedema | 71 | 7.4 5.9–9.4ROR 7.5 · χ² 389 / p 6e-87 | 7.1 EB05 5.8 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.8 · 96% clinician | no trial data cached |
| Drug ineffective for unapproved indication | 84 | 7.1 5.7–8.7ROR 7.2 · χ² 432 / p 2e-96 | 6.8 EB05 5.7 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 13.7 · 92% clinician | no trial data cached |
| Coagulopathy | 24 | 6.8 4.5–10.1ROR 6.8 · χ² 112 / p 1e-26 | 6.1 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 · 100% clinician | no trial data cached |
| Disseminated intravascular coagulation | 20 | 6.6 4.3–10.3ROR 6.7 · χ² 90 / p 1e-21 | 5.9 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 · 95% clinician | no trial data cached |
| Cardiac arrest (heart stopping) | 117 | 6.6 5.5–7.9ROR 6.8 · χ² 555 / p 6e-123 | 6.5 EB05 5.5 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.0 · 95% clinician | no trial data cached |
| Shock | 27 | 5.6 3.8–8.1ROR 5.6 · χ² 96 / p 5e-23 | 5.1 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 · 93% clinician | no trial data cached |
| Rebound effect | 13 | 5.4 3.1–9.3ROR 5.4 · χ² 42 / p 4e-11 | 4.6 EB05 2.9 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.0 | no trial data cached |
| Hypophagia | 29 | 5.4 3.7–7.7ROR 5.4 · χ² 99 / p 2e-23 | 5.0 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · ♀ 100% (drug 47%) · 93% clinician | no trial data cached |
| Transfusion | 12 | 5.4 3.0–9.4ROR 5.4 · χ² 38 / p 3e-10 | 4.5 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Lactic acidosis | 36 | 5.3 3.8–7.3ROR 5.3 · χ² 120 / p 3e-28 | 4.9 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 · ♀ 97% (drug 47%) · 91% clinician | no trial data cached |
| Caesarean section | 13 | 5.2 3.0–8.9ROR 5.2 · χ² 40 / p 1e-10 | 4.4 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Ventricular fibrillation | 12 | 5.1 2.9–8.9ROR 5.1 · χ² 35 / p 2e-9 | 4.3 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Bacteraemia | 12 | 4.8 2.7–8.4ROR 4.8 · χ² 32 / p 7e-9 | 4.1 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Septic shock | 44 | 4.8 3.6–6.4ROR 4.8 · χ² 128 / p 6e-30 | 4.6 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Circulatory collapse | 17 | 4.7 2.9–7.5ROR 4.7 · χ² 45 / p 8e-12 | 4.2 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Generalised oedema | 12 | 4.6 2.6–8.0ROR 4.6 · χ² 30 / p 2e-8 | 4.0 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| No adverse event | 789 | 20.9 19.7–22.3ROR 25.2 · χ² 15,024 / p <1e-300 | 20.8 EB05 19.7 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 1.6 · 99% clinician | no trial data cached |
| Device malfunction | 636 | 44.8 41.7–48.2ROR 52.0 · χ² 27,010 / p <1e-300 | 44.3 EB05 41.5 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | serious PRR 10.5 · 91% clinician | no trial data cached |
| Device issue | 452 | 24.4 22.4–26.6ROR 27.0 · χ² 10,112 / p <1e-300 | 24.3 EB05 22.4 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious PRR 15.5 | no trial data cached |
| Underdose | 444 | 28.7 26.2–31.3ROR 31.7 · χ² 11,791 / p <1e-300 | 28.5 EB05 26.3 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious PRR 9.5 | no trial data cached |
| Death | 383 | 2.1 1.9–2.3ROR 2.2 · χ² 224 / p 5e-51 | 2.1 EB05 1.9 · IC025 +0.9 | Outcome field, not a reaction | serious PRR 1.9 · 96% clinician | no trial data cached |
| Product use issue | 368 | 9.2 8.4–10.2ROR 10.0 · χ² 2,716 / p <1e-300 | 9.2 EB05 8.4 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 18.4 · 96% clinician | no trial data cached |
| Oxygen saturation decreased | 270 | 22.8 20.3–25.6ROR 24.2 · χ² 5,590 / p <1e-300 | 22.6 EB05 20.5 · IC025 +4.2 3/3 methods agree | Lab value / disease marker | serious PRR 19.4 · 90% clinician | no trial data cached |
| Product use in unapproved indication | 208 | 4.0 3.5–4.6ROR 4.1 · χ² 469 / p 3e-104 | 4.0 EB05 3.5 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 8.0 · 98% clinician | no trial data cached |
| Condition aggravated | 186 | 2.9 2.5–3.3ROR 3.0 · χ² 231 / p 2e-52 | 2.9 EB05 2.5 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 3.9 · 94% clinician | no trial data cached |
| Pulmonary hypertension | 151 | 34.1 29.1–39.9ROR 35.2 · χ² 4,787 / p <1e-300 | 33.7 EB05 29.4 · IC025 +4.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 30.7 · 97% clinician | no trial data cached |
| Device failure | 147 | 45.9 39.1–53.8ROR 47.4 · χ² 6,348 / p <1e-300 | 45.2 EB05 39.4 · IC025 +5.0 3/3 methods agree | Reporting / coding artifact | serious PRR 31.7 · 91% clinician | no trial data cached |
| Respiratory failure | 144 | 9.3 7.9–10.9ROR 9.5 · χ² 1,055 / p 9e-232 | 9.1 EB05 7.9 · IC025 +2.9 3/3 methods agree | Likely indication confounding term in indications | serious PRR 8.4 · 94% clinician | no trial data cached |
| Hypotension (low blood pressure) | 140 | 3.3 2.8–3.9ROR 3.4 · χ² 221 / p 2e-50 | 3.2 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 · 93% clinician | no trial data cached |
| Hypoxia (low oxygen) | 132 | 17.7 15.0–21.0ROR 18.2 · χ² 2,060 / p <1e-300 | 17.6 EB05 15.2 · IC025 +3.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 16.2 · 93% clinician | no trial data cached |
| Device delivery system issue | 122 | 22.0 18.4–26.2ROR 22.6 · χ² 2,414 / p <1e-300 | 21.8 EB05 18.8 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious n=19 · 100% clinician | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Acute respiratory distress syndrome — n=67, PRR 17.8
- Pneumothorax — n=59, PRR 17.5
- Pulmonary congestion — n=35, PRR 12.4
- Multiple organ dysfunction syndrome — n=73, PRR 12.3
- Atelectasis — n=23, PRR 11.1
- Premature baby — n=70, PRR 10.9
- Premature delivery — n=37, PRR 10.9
- Cardiogenic shock — n=33, PRR 10.9
- Cardio-respiratory arrest — n=71, PRR 7.9
- Coagulopathy — n=24, PRR 6.8
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Nitric Oxide?
In FDA FAERS, the most frequently co-reported reaction terms for Nitric Oxide are oxygen saturation decreased, pulmonary hypertension, respiratory failure, hypotension, hypoxia. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Nitric Oxide have an FDA boxed warning?
No. The FDA label retrieved for Nitric Oxide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Nitric Oxide causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 8e6b2a92-7915-4709-9076-3a591bf195eb, effective 20251204; matched on
openfda.generic_name.exact:"NITRIC OXIDE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 91 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.