Drug
Nitric Oxide
Important: Reactions below are the flagged terms from this drug’s
FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate
disproportionality in spontaneous reporting, not causation.
Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.
| Reaction | Co-reports (a) | PRR | ROR | Signal | |
|---|---|---|---|---|---|
| 1 | Device Failure | 147 | 45.9 | 47.4 | signal |
| 2 | Device Malfunction | 636 | 44.8 | 52.0 | signal |
| 3 | Pulmonary Hypertension | 151 | 34.1 | 35.2 | signal |
| 4 | Underdose | 444 | 28.7 | 31.7 | signal |
| 5 | Device Issue | 452 | 24.4 | 27.0 | signal |
| 6 | Oxygen Saturation Decreased | 270 | 22.8 | 24.2 | signal |
| 7 | Device Delivery System Issue | 122 | 22.0 | 22.6 | signal |
| 8 | No Adverse Event | 789 | 20.9 | 25.2 | signal |
| 9 | Acute Respiratory Distress Syndrome | 67 | 17.8 | 18.1 | signal |
| 10 | Hypoxia | 132 | 17.7 | 18.2 | signal |
| 11 | Pneumothorax | 59 | 17.5 | 17.7 | signal |
| 12 | Pulmonary Arterial Hypertension | 48 | 15.5 | 15.7 | signal |
| 13 | Pulmonary Congestion | 35 | 12.4 | 12.5 | signal |
| 14 | Multiple Organ Dysfunction Syndrome | 73 | 12.3 | 12.5 | signal |
| 15 | Device Occlusion | 34 | 11.5 | 11.6 | signal |
| 16 | Atelectasis | 23 | 11.1 | 11.2 | signal |
| 17 | Premature Baby | 70 | 10.9 | 11.0 | signal |
| 18 | Premature Delivery | 37 | 10.9 | 10.9 | signal |
| 19 | Cardiogenic Shock | 33 | 10.9 | 10.9 | signal |
| 20 | Respiratory Failure | 144 | 9.3 | 9.5 | signal |
| 21 | Product Use Issue | 368 | 9.2 | 10.0 | signal |
| 22 | Therapy Non-responder | 76 | 8.0 | 8.1 | signal |
| 23 | Intestinal Perforation | 19 | 7.9 | 8.0 | signal |
| 24 | Cardio-respiratory Arrest | 71 | 7.9 | 8.0 | signal |
| 25 | Pulmonary Oedema | 71 | 7.4 | 7.5 | signal |
| 26 | Drug Ineffective For Unapproved Indication | 84 | 7.1 | 7.2 | signal |
| 27 | Coagulopathy | 24 | 6.8 | 6.8 | signal |
| 28 | Disseminated Intravascular Coagulation | 20 | 6.6 | 6.7 | signal |
| 29 | Cardiac Arrest | 117 | 6.6 | 6.8 | signal |
| 30 | Shock | 27 | 5.6 | 5.6 | signal |
| 31 | Rebound Effect | 13 | 5.4 | 5.4 | signal |
| 32 | Hypophagia | 29 | 5.4 | 5.4 | signal |
| 33 | Transfusion | 12 | 5.4 | 5.4 | signal |
| 34 | Lactic Acidosis | 36 | 5.3 | 5.3 | signal |
| 35 | Caesarean Section | 13 | 5.2 | 5.2 | signal |
| 36 | Ventricular Fibrillation | 12 | 5.1 | 5.1 | signal |
| 37 | Bacteraemia | 12 | 4.8 | 4.8 | signal |
| 38 | Septic Shock | 44 | 4.8 | 4.8 | signal |
| 39 | Circulatory Collapse | 17 | 4.7 | 4.7 | signal |
| 40 | Generalised Oedema | 12 | 4.6 | 4.6 | signal |
| 41 | No Therapeutic Response | 12 | 4.5 | 4.6 | signal |
| 42 | Blood Urea Increased | 15 | 4.2 | 4.2 | signal |
| 43 | Bradycardia | 46 | 4.1 | 4.1 | signal |
| 44 | Post Procedural Haemorrhage | 10 | 4.0 | 4.0 | signal |
| 45 | Product Use In Unapproved Indication | 208 | 4.0 | 4.1 | signal |
| 46 | Heart Rate Decreased | 30 | 4.0 | 4.0 | signal |
| 47 | Respiratory Distress | 22 | 3.7 | 3.8 | signal |
| 48 | Foetal Exposure During Pregnancy | 61 | 3.5 | 3.6 | signal |
| 49 | Multi-organ Failure | 13 | 3.5 | 3.5 | signal |
| 50 | Blood Pressure Decreased | 49 | 3.5 | 3.5 | signal |
| 51 | Cerebral Haemorrhage | 26 | 3.4 | 3.4 | signal |
| 52 | Hypotension | 140 | 3.3 | 3.4 | signal |
| 53 | Fluid Overload | 10 | 3.2 | 3.2 | signal |
| 54 | Ventricular Extrasystoles | 7 | 3.2 | 3.2 | signal |
| 55 | Covid-19 Pneumonia | 8 | 3.2 | 3.2 | signal |
| 56 | Tachypnoea | 9 | 3.1 | 3.1 | signal |
| 57 | Ventricular Tachycardia | 11 | 3.1 | 3.1 | signal |
| 58 | Maternal Exposure During Pregnancy | 56 | 3.0 | 3.0 | signal |
| 59 | Cyanosis | 10 | 3.0 | 3.0 | signal |
| 60 | Supraventricular Tachycardia | 6 | 2.9 | 2.9 | signal |
| 61 | Pallor | 17 | 2.9 | 2.9 | signal |
| 62 | Thrombotic Microangiopathy | 6 | 2.9 | 2.9 | signal |
| 63 | Condition Aggravated | 186 | 2.9 | 3.0 | signal |
| 64 | Hepatomegaly | 6 | 2.8 | 2.9 | signal |
| 65 | Metabolic Acidosis | 19 | 2.8 | 2.8 | signal |
| 66 | Exposure During Pregnancy | 37 | 2.8 | 2.8 | signal |
| 67 | Emphysema | 6 | 2.8 | 2.8 | signal |
| 68 | Intentional Overdose | 37 | 2.7 | 2.7 | signal |
| 69 | Haemoptysis | 15 | 2.5 | 2.5 | signal |
| 70 | Pulmonary Fibrosis | 10 | 2.5 | 2.5 | signal |
| 71 | Device Related Infection | 8 | 2.4 | 2.4 | signal |
| 72 | Pneumocystis Jirovecii Pneumonia | 5 | 2.3 | 2.3 | no signal |
| 73 | Hyperbilirubinaemia | 5 | 2.3 | 2.3 | no signal |
| 74 | Drug Level Increased | 8 | 2.3 | 2.3 | signal |
| 75 | Post Procedural Complication | 9 | 2.2 | 2.2 | signal |
| 76 | Cardiac Failure | 37 | 2.2 | 2.2 | signal |
| 77 | Death | 383 | 2.1 | 2.2 | signal |
| 78 | Myocarditis | 5 | 2.1 | 2.1 | no signal |
| 79 | Haemorrhage Intracranial | 6 | 1.9 | 1.9 | no signal |
| 80 | Mydriasis | 5 | 1.8 | 1.8 | no signal |
| 81 | Complication Associated With Device | 5 | 1.8 | 1.8 | no signal |
| 82 | Cerebral Infarction | 9 | 1.7 | 1.7 | no signal |
| 83 | Interstitial Lung Disease | 17 | 1.6 | 1.7 | no signal |
| 84 | Genital Haemorrhage | 4 | 1.4 | 1.4 | no signal |
| 85 | Device Leakage | 9 | 1.0 | 1.0 | no signal |
| 86 | Drug Effective For Unapproved Indication | 6 | 1.0 | 1.0 | no signal |
| 87 | Drug Withdrawal Syndrome Neonatal | 3 | 0.9 | 0.9 | no signal |
| 88 | Drug Exposure During Pregnancy | 5 | 0.7 | 0.7 | no signal |
| 89 | Wrong Technique In Device Usage Process | 6 | 0.6 | 0.6 | no signal |
| 90 | Completed Suicide | 9 | 0.5 | 0.5 | no signal |
| 91 | Device Breakage | 4 | 0.5 | 0.5 | no signal |