ISOSORBIDE DINITRATE

Isosorbide Dinitrate Adverse Events Reported to the FDA Over Time

How are Isosorbide Dinitrate adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Isosorbide Dinitrate, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Isosorbide Dinitrate is flagged as the suspect drug causing the adverse event.

Most Common Isosorbide Dinitrate Adverse Events Reported to the FDA

What are the most common Isosorbide Dinitrate adverse events reported to the FDA?

Hypotension	47 (3.21%)
Dizziness	43 (2.94%)
Loss Of Consciousness	42 (2.87%)
Syncope	29 (1.98%)
Completed Suicide	27 (1.85%)
Angina Pectoris	25 (1.71%)
Drug Ineffective	19 (1.3%)
Fall	19 (1.3%)
Chest Pain	17 (1.16%)
Product Quality Issue	16 (1.09%)
Asthenia	15 (1.03%)
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Diarrhoea	15 (1.03%)
Drug Interaction	15 (1.03%)
Dyspnoea	15 (1.03%)
Headache	15 (1.03%)
Cardiac Failure	14 (.96%)
Vomiting	14 (.96%)
Dehydration	12 (.82%)
Myocardial Infarction	12 (.82%)
Suicide Attempt	11 (.75%)
Tachycardia	11 (.75%)
Cardio-respiratory Arrest	10 (.68%)
Medication Error	10 (.68%)
Nausea	10 (.68%)
Pyrexia	10 (.68%)
Rash	10 (.68%)
Blood Glucose Increased	9 (.62%)
Multiple Drug Overdose	9 (.62%)
Pulmonary Oedema	9 (.62%)
Renal Failure	9 (.62%)
Somnolence	9 (.62%)
Blood Pressure Decreased	8 (.55%)
Heart Rate Increased	8 (.55%)
Incorrect Dose Administered	8 (.55%)
Myocardial Ischaemia	8 (.55%)
Pruritus	8 (.55%)
Renal Impairment	8 (.55%)
Ventricular Extrasystoles	8 (.55%)
Arteriospasm Coronary	7 (.48%)
Arthralgia	7 (.48%)
Blood Pressure Increased	7 (.48%)
Bradycardia	7 (.48%)
Chest Discomfort	7 (.48%)
Condition Aggravated	7 (.48%)
Disease Progression	7 (.48%)
Electrocardiogram St Segment Elevat...	7 (.48%)
Hypertension	7 (.48%)
Multiple Drug Overdose Intentional	7 (.48%)
Acute Myocardial Infarction	6 (.41%)
Alanine Aminotransferase Increased	6 (.41%)
Aspartate Aminotransferase Increase...	6 (.41%)
Blood Potassium Decreased	6 (.41%)
Cardiac Arrest	6 (.41%)
Cardiac Disorder	6 (.41%)
Cerebrovascular Accident	6 (.41%)
Circulatory Collapse	6 (.41%)
Coronary Artery Occlusion	6 (.41%)
Drug Eruption	6 (.41%)
Fatigue	6 (.41%)
Haemoglobin Decreased	6 (.41%)
Overdose	6 (.41%)
Pancytopenia	6 (.41%)
Pneumonia	6 (.41%)
Post Procedural Complication	6 (.41%)
Sensory Disturbance	6 (.41%)
Thrombocytopenia	6 (.41%)
Vertigo	6 (.41%)
Abdominal Pain Upper	5 (.34%)
Anaphylactic Shock	5 (.34%)
Cerebral Haemorrhage	5 (.34%)
Haemolytic Anaemia	5 (.34%)
Hyperglycaemia	5 (.34%)
Insomnia	5 (.34%)
Neutropenia	5 (.34%)
Orthostatic Hypotension	5 (.34%)
Renal Failure Acute	5 (.34%)
Shock	5 (.34%)
Toxic Skin Eruption	5 (.34%)
Acute Coronary Syndrome	4 (.27%)
Angina Unstable	4 (.27%)
Anorexia	4 (.27%)
Atrioventricular Block Complete	4 (.27%)
Blood Creatinine Increased	4 (.27%)
Dialysis	4 (.27%)
Drug Level Increased	4 (.27%)
Gait Disturbance	4 (.27%)
Heart Rate Decreased	4 (.27%)
Hyperkalaemia	4 (.27%)
Lactic Acidosis	4 (.27%)
Lower Respiratory Tract Infection	4 (.27%)
Pain In Extremity	4 (.27%)
Red Blood Cell Count Decreased	4 (.27%)
Sick Sinus Syndrome	4 (.27%)
Treatment Noncompliance	4 (.27%)
Ventricular Tachycardia	4 (.27%)
Acidosis	3 (.21%)
Anaemia Haemolytic Autoimmune	3 (.21%)
Balance Disorder	3 (.21%)
Blood Lactate Dehydrogenase Increas...	3 (.21%)
Blood Pressure Fluctuation	3 (.21%)
Cardiac Failure Congestive	3 (.21%)

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This graph shows the top adverse events submitted to the FDA for Isosorbide Dinitrate, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Isosorbide Dinitrate is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Isosorbide Dinitrate

What are the most common Isosorbide Dinitrate adverse events reported to the FDA?

Neurological	149 (10.19%)
Coronary Artery	81 (5.54%)
Cardiac Arrhythmias	73 (4.99%)
Decreased And Nonspecific Blood Pre...	68 (4.65%)
Medication Errors	57 (3.9%)
Epidermal And Dermal Conditions	53 (3.63%)
Cardiac And Vascular Investigations	52 (3.56%)
Suicidal And Self-injurious Behavio...	40 (2.74%)
Therapeutic And Nontherapeutic Effe...	39 (2.67%)
Gastrointestinal Signs	35 (2.39%)
Respiratory	35 (2.39%)
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Injuries	30 (2.05%)
Renal Disorders	28 (1.92%)
Heart Failures	25 (1.71%)
Hematology Investigations	20 (1.37%)
Infections - Pathogen Unspecified	20 (1.37%)
Gastrointestinal Motility And Defec...	19 (1.3%)
Lower Respiratory Tract Disorders	19 (1.3%)
Product Quality Issues	18 (1.23%)
Electrolyte And Fluid Balance Condi...	17 (1.16%)
Hepatic And Hepatobiliary	17 (1.16%)
Hepatobiliary	17 (1.16%)
Central Nervous System Vascular	16 (1.09%)
Headaches	16 (1.09%)
Vision	13 (.89%)
Allergic Conditions	12 (.82%)
Gastrointestinal Hemorrhages	12 (.82%)
Acid-base	11 (.75%)
Renal And Urinary Tract Investigati...	11 (.75%)
Body Temperature Conditions	10 (.68%)
Enzyme	10 (.68%)
Metabolic, Nutritional And Blood Ga...	10 (.68%)
Musculoskeletal And Connective Tiss...	10 (.68%)
Water, Electrolyte And Mineral	10 (.68%)
Anemias Nonhemolytic And Marrow Dep...	9 (.62%)
Procedural And Device Related Injur...	9 (.62%)
Cardiac Disorder Signs	8 (.55%)
Deliria	8 (.55%)
Hematological And Lymphoid Tissue T...	8 (.55%)
Hemolyses And Related Conditions	8 (.55%)
Joint	8 (.55%)
Lifestyle Issues	8 (.55%)
White Blood Cell	8 (.55%)
Appetite And General Nutritional	7 (.48%)
Glucose Metabolism Disorders	7 (.48%)
Platelet	7 (.48%)
Toxicology And Therapeutic Drug Mon...	7 (.48%)
Vascular Hypertensive	7 (.48%)
Chemical Injury And Poisoning	6 (.41%)
Gallbladder	6 (.41%)
Inner Ear And Viiith Cranial Nerve	6 (.41%)
Sleep Disorders	6 (.41%)
Angiedema And Urticaria	5 (.34%)
Bone And Joint Injuries	5 (.34%)
Gastrointestinal Conditions	5 (.34%)
Mental Impairment	5 (.34%)
Myocardial	5 (.34%)
Physical Examination Topics	5 (.34%)
Embolism And Thrombosis	4 (.27%)
Gastrointestinal Ulceration And Per...	4 (.27%)
Gastrointestinal Vascular Condition...	4 (.27%)
Muscle	4 (.27%)
Nephropathies	4 (.27%)
Urinary Tract Signs	4 (.27%)
Abdominal Hernias And Other Abdomin...	3 (.21%)
Administration Site Reactions	3 (.21%)
Arteriosclerosis, Stenosis, Vascula...	3 (.21%)
Bone Disorders	3 (.21%)
Depressed Mood Disorders	3 (.21%)
Disturbances In Thinking	3 (.21%)
Economic And Housing Issues	3 (.21%)
Fatal Outcomes	3 (.21%)
Gastrointestinal Inflammatory Condi...	3 (.21%)
Gastrointestinal Neoplasms Malignan...	3 (.21%)
Hearing	3 (.21%)
Ocular Neuromuscular	3 (.21%)
Protein And Chemistry Analyses	3 (.21%)
Psychiatric	3 (.21%)
Seizures	3 (.21%)
Skin Appendage Conditions	3 (.21%)
Tongue Conditions	3 (.21%)
Upper Respiratory Tract Disorders	3 (.21%)
Anal And Rectal Conditions	2 (.14%)
Aural	2 (.14%)
Bronchial Disorders	2 (.14%)
Cardiac Valve	2 (.14%)
Coagulopathies And Bleeding Diathes...	2 (.14%)
Eye	2 (.14%)
Glaucoma And Ocular Hypertension	2 (.14%)
Hypothalamus And Pituitary Gland	2 (.14%)
Investigations, Imaging And Histopa...	2 (.14%)
Lipid Metabolism	2 (.14%)
Mood Disorders	2 (.14%)
Psychiatric And Behavioural Symptom...	2 (.14%)
Pulmonary Vascular	2 (.14%)
Therapeutic Procedures And Supporti...	2 (.14%)
Vascular	2 (.14%)
Vascular Hemorrhagic	2 (.14%)
Vascular Therapeutic Procedures	2 (.14%)
Viral Infectious	2 (.14%)
Aneurysms And Artery Dissections	1 (.07%)

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This graph shows the top categories of adverse events submitted to the FDA for Isosorbide Dinitrate, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Isosorbide Dinitrate is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.