Pharmacologic class (EPC) · 5 drug pages

Nitrate vasodilator: adverse event reports filed with FDA

11,960 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.

11,960
reports across the class: 0.1% of all reports; 627
reports, 12 months to June 2026: 847 in the 12 months before; 85.3%
marked serious by the reporter: 57.4% across all reports; 5
drugs with a page: brand and generic names counted separately

Nitrate vasodilator is a pharmacologic class (an FDA Established Pharmacologic Class) with 5 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 11,960 adverse event reports received by FDA, 0.1% of the database, from January 2004 to June 2026.

627 reports arrived in the 12 months to June 2026, down 26% from 847 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 85.3% of the class's reports are marked serious, 14.9% record death among the outcomes and 45.7% record hospitalisation, as reported.

Across the class the reactions recorded most often are headache (15.3%), dizziness (14.9%) and dyspnoea (14.5%). 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
Nitroglycerin	generic	6,041	356	85.5%	Drug ineffective
Isosorbide mononitrate	generic	3,171	174	91.6%	Dizziness
Isosorbide dinitrate	generic	1,322	59	93.9%	Dizziness
NitrostatNitroglycerin	brand	823	1	49.3%	Drug ineffective
IsosorbideIsosorbide dinitrate	brand	603	37	80.4%	Headache

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

Headachehead pain15.3%1,832
Dizzinesslight-headedness or unsteadiness14.9%1,777
Dyspnoeashortness of breath14.5%1,738
Painpain, site not specified13.9%1,660
Malaisegeneral feeling of being unwell13%1,554
Drug ineffectivethe medicine did not work as expected12.9%1,546
Hypotensionlow blood pressure12.9%1,540
Nauseafeeling sick12.7%1,515
Fatiguetiredness12.6%1,502
Pyrexiafever12%1,435
Diarrhoealoose or frequent stools11.2%1,345
Cognitive disorderproblems with thinking or memory11.2%1,340
Off label useused for a purpose or in a way not on the label11.2%1,339
Chest painchest pain11.1%1,328
Falla fall10.4%1,247
Pruritusitching10.4%1,247
Abdominal pain upperupper stomach pain10.3%1,233
Vomitingbeing sick10.1%1,213
Insomniadifficulty sleeping9.7%1,159
Myocardial infarctionheart attack9.4%1,120
Arthralgiajoint pain9.2%1,096
Tachycardiafast heart rate8.8%1,053
Tinnitusringing in the ears8.7%1,041
Hyperhidrosisexcessive sweating8.3%994
Blindnessloss of sight8.3%988

Solid bar: share of all class reports. Hollow bar: the median share across the 5 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death14.9%1,780

Life-threatening10.5%1,260

Hospitalisation (initial or prolonged)45.7%5,466

Disability5.3%632

Congenital anomaly0.9%109

Other serious58.8%7,030

Not serious14.7%1,759

Patient age

Under 20.2%27

2 to 110.1%8

12 to 170.3%34

18 to 445.1%607

45 to 6421.9%2,624

65 to 7417.4%2,082

75 and over28.9%3,460

Age not given26.1%3,118

Who reported

Physician24.6%2,946

Pharmacist8.3%998

Other health professional36.8%4,399

Lawyer0.3%39

Consumer or non-health professional25%2,994

Not given4.9%584

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 Nitrate vasodilator reports

Which drugs are in the Nitrate vasodilator class on this site?

Nitroglycerin, Isosorbide mononitrate, Isosorbide dinitrate, Nitrostat and Isosorbide. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

11,960 reports through June 2026, 627 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?

headache (15.3%), dizziness (14.9%), dyspnoea (14.5%), pain (13.9%) and malaise (13%).

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.