Pharmacologic class (EPC) · 3 drug pages

Vasodilator: adverse event reports filed with FDA

3,609 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

3,609
reports across the class: 0% of all reports; 435
reports, 12 months to June 2026: 719 in the 12 months before; 56.4%
marked serious by the reporter: 57.4% across all reports; 3
drugs with a page: brand and generic names counted separately

Vasodilator is a pharmacologic class (an FDA Established Pharmacologic Class) with 3 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 3,609 adverse event reports received by FDA, 0% of the database, from June 2004 to June 2026.

435 reports arrived in the 12 months to June 2026, down 39% from 719 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 56.4% of the class's reports are marked serious, 29.7% record death among the outcomes and 9.2% record hospitalisation, as reported.

Across the class the reactions recorded most often are no adverse event (21.3%), device malfunction (17.5%) and device issue (12.5%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
GenosylNitric oxide	brand	1,631	207	8%	No adverse event
Nitric oxide	generic	1,258	228	98.5%	Drug ineffective
InomaxNitric oxide	brand	720	0	92.2%	Product use issue

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

No adverse eventno adverse event was reported21.3%769
Device malfunctionthe device did not work properly17.5%631
Device issuea problem with the device12.5%450
Underdoseless than the intended dose12.2%442
Deaththe patient died; cause not stated by this term9.4%338
Product use issuea problem in how the product was used9.4%338
Oxygen saturation decreased6.5%235
Drug ineffectivethe medicine did not work as expected5.8%210
Product use in unapproved indicationused for a purpose not on the label5.1%184
Off label useused for a purpose or in a way not on the label5%182
Device failurethe device failed3.9%141
Condition aggravatedthe condition being treated got worse3.5%127
Device delivery system issuea problem with the delivery system3.4%121
Cardiac arrestthe heart stopped2.3%82
Respiratory failurethe lungs could not supply enough oxygen2.2%81
Pulmonary hypertensionhigh pressure in the lung arteries2%73
Covid-19COVID-19 infection1.7%60
Cardio-respiratory arrestthe heart and breathing stopped1.6%58
Exposure to toxic agent1.6%57
Drug ineffective for unapproved indication1.4%52
Drug level fluctuating1.4%51
Therapy non-responderthe treatment did not work1.4%51
Multiple organ dysfunction syndromeseveral organs failing1.4%49
Hypoxialow oxygen1.2%44
Pulmonary haemorrhage1.2%44

Solid bar: share of all class reports. Hollow bar: the median share across the 3 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death29.7%1,071

Life-threatening8.9%320

Hospitalisation (initial or prolonged)9.2%331

Disability0.8%29

Congenital anomaly0.2%9

Other serious25.7%928

Not serious43.6%1,575

Patient age

Under 213.4%484

2 to 112.2%80

12 to 171.1%39

18 to 447.5%272

45 to 646.4%231

65 to 743.6%130

75 and over3.5%127

Age not given62.2%2,246

Who reported

Physician10.8%389

Pharmacist0.4%14

Other health professional72.6%2,619

Lawyer0%1

Consumer or non-health professional12.2%439

Not given4.1%147

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Vasodilator reports

Which drugs are in the Vasodilator class on this site?

Genosyl, Nitric oxide and Inomax. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

3,609 reports through June 2026, 435 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

no adverse event (21.3%), device malfunction (17.5%), device issue (12.5%), underdose (12.2%) and death (9.4%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. 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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.