Imdurisosorbide mononitrate
According to the FDA label: Isosorbide Mononitrate Tablets USP are indicated for the prevention and treatment of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.
20,264 adverse event reports submitted to the FDA (2002–2026)
Top Reported Adverse Events
The most frequently reported events in association with Imdur in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
Show these terms with plain-language definitions
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Dyspnoea 1,523 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Dizziness 1,420 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →Diarrhoea 1,273 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Fatigue 1,271 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Nausea 1,246 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Chest Pain 1,193 reports
Pain or discomfort in the chest. Chest pain has many causes, but it is always worth taking seriously and discussing with a doctor.
Full definition in the glossary → See all drugs reporting this event →Myocardial Infarction 1,035 reports
The medical term for a heart attack.
Full definition in the glossary →Headache 1,029 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Vomiting 954 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Hypotension 914 reports
Malaise 906 reports
A general feeling of being unwell or uncomfortable, without a specific symptom.
Full definition in the glossary →Acute Kidney Injury 899 reports
A sudden drop in how well the kidneys are working. It is often temporary and can have many causes.
Full definition in the glossary →Off Label Use 874 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Pain 859 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Fall 835 reports
A report that the person fell down. Falls are tracked because they can signal issues like dizziness, weakness, or balance problems.
Full definition in the glossary →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Male | 10,097 |
| Female | 8,628 |
| Unknown | 21 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 33 |
| 18-34 | 143 |
| 35-49 | 701 |
| 50-64 | 3,188 |
| 65-74 | 4,367 |
| 75+ | 6,599 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Imdur. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 9,768 |
| Hospitalization | 9,727 |
| Non-Serious | 3,197 |
| Death | 2,572 |
| Life-Threatening | 1,532 |
| Disability | 943 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Imdur. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2002 | 2 |
| 2003 | 3 |
| 2004 | 456 |
| 2005 | 538 |
| 2006 | 517 |
| 2007 | 396 |
| 2008 | 615 |
| 2009 | 518 |
| 2010 | 455 |
| 2011 | 661 |
| 2012 | 821 |
| 2013 | 533 |
| 2014 | 858 |
| 2015 | 1,022 |
| 2016 | 1,162 |
| 2017 | 1,198 |
| 2018 | 1,477 |
| 2019 | 1,416 |
| 2020 | 1,179 |
| 2021 | 974 |
| 2022 | 1,265 |
| 2023 | 1,527 |
| 2024 | 1,149 |
| 2025 | 1,246 |
| 2026 (partial) | 276 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Imdur
In FDA adverse event reports that mention Imdur, these medications appeared most often in the same report.
- Aspirin (7,704 reports)
- Furosemide (6,098 reports)
- Clopidogrel (4,443 reports)
- Omeprazole (4,095 reports)
- Metoprolol (3,545 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026