Generic name
Nitric oxide: adverse event reports filed with FDA
1,258 reports list it as a suspect or interacting product, 2004–2026. Class: Vasodilator.
- 1,258
- reports as suspect product
- 0% of all reports · about 58 a year
- 228
- reports, 12 months to June 2026
- 282 in the 12 months before
- 98.5%
- marked serious by the reporter
- 56.4% across the class
- 47.2%
- record death among outcomes, as reported
- 594 reports · not verified by FDA
1,258 adverse event reports received by FDA list nitric oxide, a generic name as a suspect or interacting product, from September 2004 to June 2026. A further 865 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 228 reports listed it, down 19% from 282 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 58 reports a year and 0% of the 20,646,523 reports in the database, and 34.9% of the reports for the vasodilator class. How many people take it is not in the data, so a count is not a rate of occurrence.
The reactions recorded most often are drug ineffective (15.4%), product use issue (14.1%) and death (13.4%). A report can list several reactions, so shares add to more than 100%; 254 different terms appear across these reports. Drug ineffective is recorded in 15.4% of these reports, a larger share than in the median vasodilator drug (1.9%).
98.5% of the reports are marked serious by the reporter (56.4% across the class); 47.2% record death among the outcomes and 24.5% record hospitalisation, as reported. 71% of the reports came from other health professionals, and the largest patient age group is under 2 (19.9%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Nitric oxide reports recording the termmedian drug in vasodilator
- Drug ineffectivethe medicine did not work as expected15.4%194
- Product use issuea problem in how the product was used14.1%177
- Deaththe patient died; cause not stated by this term13.4%168
- Condition aggravatedthe condition being treated got worse8.7%109
- Off label useused for a purpose or in a way not on the label7.1%89
- Product use in unapproved indicationused for a purpose not on the label5.5%69
- Pulmonary hypertensionhigh pressure in the lung arteries4.8%60
- Respiratory failurethe lungs could not supply enough oxygen4.8%60
- Cardiac arrestthe heart stopped3.5%44
- Multiple organ dysfunction syndromeseveral organs failing3.4%43
- Maternal exposure during pregnancythe mother took the medicine during pregnancy3.2%40
- Hypotensionlow blood pressure3.1%39
- Foetal exposure during pregnancythe unborn baby was exposed to the medicine3%38
- Premature babya baby born early2.9%37
- Patent ductus arteriosus2.7%34
- Pulmonary oedemafluid in the lungs2.6%33
- Therapy non-responderthe treatment did not work2.5%32
- Newborn persistent pulmonary hypertension2.3%29
- Hypoxialow oxygen2.2%28
- Premature delivery2.2%28
- Intraventricular haemorrhage neonatal1.9%24
- Exposure during pregnancythe medicine was taken during pregnancy1.7%21
- Sepsisa severe body-wide response to infection1.7%21
- Acute kidney injurysudden loss of kidney function1.6%20
- Neonatal disorder1.6%20
- Pneumothoraxa collapsed lung1.6%20
- Septic shockshock arising from infection1.5%19
- Bradycardiaslow heart rate1.4%18
Top 30 of 254 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 3 drugs in the vasodilator class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 3,609 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 32.4% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Pulmonary hypertension | 480 | 38.2% |
| Lung disorder | 74 | 5.9% |
| Newborn persistent pulmonary hypertension | 66 | 5.2% |
| Pulmonary arterial hypertension | 46 | 3.7% |
| Hypoxia | 39 | 3.1% |
| Acute respiratory distress syndrome | 35 | 2.8% |
The indication field is filled in by the reporter and is often blank; shares are of all 1,258 reports.
In context
| Measure | Nitric oxide | Vasodilator | All reports |
|---|---|---|---|
| Reports as suspect product | 1,258 | 3,609 | 20,646,523 |
| Share of that pool | — | 34.9% | 0% |
| Reports, latest 12 months | 228 | — | 1,332,454 |
| Marked serious | 98.5% | 56.4% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 472 | 297 | 91 |
| Hospitalisation recorded, per 1,000 reports | 245 | 92 | 213 |
| Consumer-filed share | 2% | 12.2% | 45.8% |
| Top term, share of reports | Drug ineffective 15.4% | median 1.9% | 6.3% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the vasodilator class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Genosyl | brand | 1,631 | 207 | 8% |
| Inomax | brand | 720 | 0 | 92.2% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Nitric oxide reports
How many adverse event reports has FDA received for Nitric oxide?
1,258 reports list Nitric oxide as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 228 of them arrived in the latest 12 months. Another 865 list it only as a concomitant medication.
What reactions are recorded in Nitric oxide reports?
drug ineffective (15.4%), product use issue (14.1%), death (13.4%), condition aggravated (8.7%) and off label use (7.1%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Nitric oxide was responsible.
How serious are the reports?
98.5% are marked serious by the reporter. Among the outcomes recorded, 47.2% of reports include death and 24.5% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
other health professional (71%), physician (23.8%) and not given (2.2%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Nitric oxide rising?
228 reports in the 12 months to June 2026, down 19% from 282 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Nitric oxide was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Nitric oxide?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Nitric oxide as a suspect or interacting product; reports listing it only as a concomitant medication (865) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.