78/100 · Elevated
Manufactured by BluePoint Laboratories
Isosorbide Dinitrate Adverse Events: High Serious Reaction Rate
53,779 FDA adverse event reports analyzed
Last updated: 2026-05-12
ISOSORBIDE DINITRATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by BluePoint Laboratories. Based on analysis of 53,779 FDA adverse event reports, ISOSORBIDE DINITRATE has a safety score of 78 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for ISOSORBIDE DINITRATE include DYSPNOEA, NAUSEA, FATIGUE, DIZZINESS, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ISOSORBIDE DINITRATE.
Isosorbide Dinitrate has a safety concern score of 78 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 53,779 adverse event reports for this medication, which is primarily manufactured by Bluepoint Laboratories.
The most commonly reported adverse events include Dyspnoea, Nausea, Fatigue. Of classified reports, 74.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of adverse events are serious, with a high percentage of reports involving myocardial infarction and chest pain.
A significant number of reports involve cardiovascular issues, including arrhythmias and heart failure. Drug ineffectiveness and off-label use are also notable, suggesting potential misuse or suboptimal dosing.
Patients taking Isosorbide Dinitrate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Isosorbide dinitrate can interact with other drugs, potentially leading to hypotension or increased risk of adverse cardiovascular events. Warnings are issued for patients with specific conditions such as hypotension and bradycardia. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Isosorbide Dinitrate received a safety concern score of 78/100 (high concern). This is based on a 74.7% serious event ratio across 19,060 classified reports. The score accounts for 53,779 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Male: 9,444, Female: 8,458, Unknown: 20. The most frequently reported age groups are age 75 (503 reports), age 78 (444 reports), age 77 (422 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 19,060 classified reports for ISOSORBIDE DINITRATE:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Isosorbide dinitrate can interact with other drugs, potentially leading to hypotension or increased risk of adverse cardiovascular events. Warnings are issued for patients with specific conditions such as hypotension and bradycardia.
If you are taking Isosorbide Dinitrate, here are important things to know. The most commonly reported side effects include dyspnoea, nausea, fatigue, dizziness, diarrhoea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for signs of serious cardiovascular events such as chest pain or myocardial infarction. Be aware of potential drug interactions, especially with antihypertensives and beta-blockers. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA closely monitors isosorbide dinitrate, and any new or worsening symptoms should be reported to healthcare providers promptly. Regular monitoring is recommended for patients on this medication.
The FDA has received approximately 53,779 adverse event reports associated with Isosorbide Dinitrate. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Isosorbide Dinitrate include Dyspnoea, Nausea, Fatigue, Dizziness, Diarrhoea. By volume, the top reported reactions are: Dyspnoea (1,608 reports), Nausea (1,316 reports), Fatigue (1,303 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Isosorbide Dinitrate.
Out of 19,060 classified reports, 14,229 (74.7%) were classified as serious and 4,831 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Isosorbide Dinitrate break down by patient sex as follows: Male: 9,444, Female: 8,458, Unknown: 20. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Isosorbide Dinitrate adverse events are: age 75: 503 reports, age 78: 444 reports, age 77: 422 reports, age 74: 420 reports, age 80: 416 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Isosorbide Dinitrate adverse event reports is Bluepoint Laboratories. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Isosorbide Dinitrate include: Myocardial Infarction, Chest Pain, Pain, Headache, Vomiting. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Isosorbide Dinitrate to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Isosorbide Dinitrate has a safety concern score of 78 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. The majority of adverse events are serious, with a high percentage of reports involving myocardial infarction and chest pain.
Key safety signals identified in Isosorbide Dinitrate's adverse event data include: High incidence of myocardial infarction and chest pain.. Significant number of serious reactions, including death and renal failure.. Common gastrointestinal issues like nausea and diarrhea.. Frequent reports of dizziness and fatigue.. Multiple cases of drug ineffectiveness and off-label use.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Isosorbide dinitrate can interact with other drugs, potentially leading to hypotension or increased risk of adverse cardiovascular events. Warnings are issued for patients with specific conditions such as hypotension and bradycardia. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Isosorbide Dinitrate.
Monitor for signs of serious cardiovascular events such as chest pain or myocardial infarction. Be aware of potential drug interactions, especially with antihypertensives and beta-blockers.
Isosorbide Dinitrate has 53,779 adverse event reports on file with the FDA. A significant number of reports involve cardiovascular issues, including arrhythmias and heart failure. The volume of reports for Isosorbide Dinitrate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors isosorbide dinitrate, and any new or worsening symptoms should be reported to healthcare providers promptly. Regular monitoring is recommended for patients on this medication. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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