Isosorbide dinitrate adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Isosorbide dinitrate
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Generic name
Class: Nitrate vasodilator
Also reported as: Isosorbide Dinitrate Er, Isosorbide Dinitrate Tablets Usp

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

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 has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

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.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

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

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From February 2004 to June 2026, FDA received 1,322 adverse event reports that name Isosorbide dinitrate. In these reports the drug is a suspect or interacting product.

In the same period, 7,225 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 59 reports in the 12 months to June 2026 and 77 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 59 (under 0.1%) name Isosorbide dinitrate. Reports from consumers or other non-health professionals were 21% of the reports that name Isosorbide dinitrate and 45.8% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Isosorbide dinitrate is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 30 reports that name Isosorbide dinitrate.
In January to March 2026, FDA received 3.
In April to June 2025, FDA received 18.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 249 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 1,311 of the 1,322 reports (99.2%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 249 terms.

Reaction terms in the reports that name Isosorbide dinitrate, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,322 reports
Dizzinesslight-headedness or unsteadiness	403	30.5%
Pruritusitching	401	30.3%
Dyspnoeashortness of breath	400	30.3%
Diarrhoealoose or frequent stools	396	30%
Malaisegeneral feeling of being unwell	393	29.7%
Subarachnoid haemorrhage	391	29.6%
Vomitingbeing sick	385	29.1%
Fatiguetiredness	384	29%
Dehydration	382	28.9%
Pyrexiafever	381	28.8%
Abdominal discomfortstomach discomfort	379	28.7%
Chest pain	379	28.7%
Headachehead pain	379	28.7%
Palpitationsawareness of the heartbeat	377	28.5%
Insomniadifficulty sleeping	376	28.4%
Visual impairmentreduced vision	376	28.4%
Pericarditisinflammation of the sac around the heart	375	28.4%
Back pain	374	28.3%
Amnesiamemory loss	373	28.2%
Hyperhidrosisexcessive sweating	373	28.2%
Tachycardiafast heart rate	373	28.2%
Heart rate increaseda fast heart rate reading	372	28.1%
Atrial tachycardia	371	28.1%
Cardiospasm	371	28.1%
Cognitive disorderproblems with thinking or memory	371	28.1%
Muscular weaknessmuscle weakness	371	28.1%
Nauseafeeling sick	371	28.1%
Feeling abnormalfeeling odd or not right	370	28%
Hallucinationseeing or hearing things that are not there	370	28%
Ventricular tachycardiaa fast rhythm from the lower heart chambers	370	28%
Lip swellingswollen lips	369	27.9%
Memory impairmentmemory problems	369	27.9%
Myocardial infarctionheart attack	369	27.9%
Anxiety	368	27.8%
Arthralgiajoint pain	368	27.8%
Disturbance in attentiondifficulty concentrating	368	27.8%
Angioedemadeep swelling of skin or mucous membranes	367	27.8%
Covid-19COVID-19 infection	367	27.8%
Migraine	367	27.8%
Carotid artery occlusion	366	27.7%
Diplopiadouble vision	366	27.7%
Pruritus genital	366	27.7%
Transient ischaemic attack	366	27.7%
Vasculitisinflammation of blood vessels	366	27.7%
Blindnessloss of sight	365	27.6%
Muscle twitching	365	27.6%
Peripheral swellingswelling of the arms or legs	365	27.6%
Sleep terror	365	27.6%
Dry skin	364	27.5%
Alopeciahair loss	363	27.5%

Download all 249 terms of Isosorbide dinitrate (CSV)

The counts add to more than 1,322 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Isosorbide dinitrate with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Isosorbide dinitrate (this page)	Generic name	1,322
Isosorbide	Brand name	603

Sum of the separately reported names: 1,925. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Isosorbide dinitrate, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	30	30	5	6	17	0	0	10	0
2005	26	26	6	3	13	0	0	8	0
2006	23	23	6	3	12	0	0	5	0
2007	13	11	0	1	8	0	0	4	2
2008	62	57	9	5	24	1	0	29	5
2009	24	23	3	5	12	1	0	15	1
2010	30	28	4	3	20	0	0	7	2
2011	48	47	3	1	26	0	0	22	1
2012	37	34	8	4	18	2	0	14	3
2013	59	57	2	7	16	0	0	40	2
2014	61	59	38	2	22	1	0	15	2
2015	21	19	3	0	6	0	0	13	2
2016	41	33	7	5	14	5	0	13	8
2017	23	14	4	1	3	0	0	8	9
2018	42	35	2	9	18	0	0	25	7
2019	52	44	3	1	30	1	0	41	8
2020	51	47	7	19	36	1	0	34	4
2021	62	58	24	16	34	0	0	38	4
2022	42	36	12	3	24	1	0	28	6
2023	328	325	23	109	117	97	11	300	3
2024	87	83	3	15	38	14	0	65	4
2025	93	86	9	12	50	23	1	74	7
2026	67	66	8	15	23	14	2	62	1

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Isosorbide dinitrate, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Isosorbide dinitrate, by the year in which FDA received them
Year	Reports
2004	23
2005	29
2006	22
2007	13
2008	62
2009	25
2010	32
2011	50
2012	39
2013	62
2014	64
2015	29
2016	33
2017	27
2018	66
2019	54
2020	71
2021	56
2022	52
2023	329
2024	93
2025	58
2026	33

Reports that name Isosorbide dinitrate, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Isosorbide dinitrate
Age	Reports	Share
Under 2	0	0%
2 to 11	1	0.1%
12 to 17	3	0.2%
18 to 44	91	6.9%
45 to 64	360	27.2%
65 to 74	224	16.9%
75 and over	356	26.9%
Age not given	287	21.7%

Sex of the patient in the reports that name Isosorbide dinitrate
Sex	Reports	Share
Female	543	41.1%
Male	595	45%
Unknown or not given	184	13.9%

Type of reporter in the reports that name Isosorbide dinitrate
Reporter	Reports	Share
Physician	425	32.1%
Pharmacist	110	8.3%
Other health professional	413	31.2%
Lawyer	1	0.1%
Consumer or non-health professional	277	21%
Not given	96	7.3%

Age and sex are as the report gives them. The reporter is the primary source in the report. 27% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Isosorbide dinitrate record
Indication as recorded (MedDRA)	Reports	Share
Angina pectoris	65	4.9%
Coronary artery disease	38	2.9%
Hypertension	35	2.6%
Myocardial ischaemia	15	1.1%
Cardiac failure	10	0.8%
Ill-defined disorder	10	0.8%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,322 reports.

Pages near this one

Isosorbide same ingredient
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These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for Isosorbide dinitrateThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Isosorbide dinitrate: adverse event reports that FDA received. https://reportedreactions.com/drug/isosorbide-dinitrate/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Isosorbide dinitrate as a suspect or interacting product. The 7,225 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Isosorbide dinitrate was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Isosorbide dinitrate?

No. It is a count of what people reported to FDA: 1,322 reports from February 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Physician (32.1%), other health professional (31.2%) and consumer or non-health professional (21%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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