ISOSORBIDE MONONITRATE

Isosorbide Mononitrate Adverse Events Reported to the FDA Over Time

How are Isosorbide Mononitrate adverse event reports trending over time?

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

Most Common Isosorbide Mononitrate Adverse Events Reported to the FDA

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

Product Quality Issue	326 (5.3%)
Dizziness	176 (2.86%)
Hypotension	176 (2.86%)
Chest Pain	99 (1.61%)
Headache	99 (1.61%)
Dyspnoea	98 (1.59%)
Fall	85 (1.38%)
Myocardial Infarction	84 (1.37%)
Syncope	75 (1.22%)
Asthenia	73 (1.19%)
Loss Of Consciousness	72 (1.17%)
	Show More
Nausea	70 (1.14%)
Diarrhoea	68 (1.11%)
Bradycardia	66 (1.07%)
Renal Failure Acute	62 (1.01%)
Blood Pressure Decreased	51 (.83%)
Fatigue	51 (.83%)
Hypertension	48 (.78%)
Vomiting	46 (.75%)
Cardiac Failure Congestive	41 (.67%)
Cardiovascular Disorder	40 (.65%)
Coronary Artery Disease	38 (.62%)
Atrial Fibrillation	36 (.59%)
Hyperkalaemia	36 (.59%)
Shock	35 (.57%)
Drug Interaction	34 (.55%)
Palpitations	34 (.55%)
Renal Failure	34 (.55%)
Somnolence	34 (.55%)
Electrocardiogram Qrs Complex Prolo...	33 (.54%)
Dehydration	32 (.52%)
Chronic Obstructive Pulmonary Disea...	31 (.5%)
Dialysis	31 (.5%)
Angina Pectoris	30 (.49%)
Cerebrovascular Accident	30 (.49%)
Drug Ineffective	30 (.49%)
Death	29 (.47%)
Emphysema	29 (.47%)
Overdose	29 (.47%)
Condition Aggravated	28 (.46%)
Cardiac Failure	27 (.44%)
Pain In Extremity	26 (.42%)
Pneumonia	26 (.42%)
Amnesia	25 (.41%)
Malaise	25 (.41%)
Orthostatic Hypotension	25 (.41%)
Gait Disturbance	24 (.39%)
Pain	24 (.39%)
Ventricular Hypertrophy	24 (.39%)
Vision Blurred	24 (.39%)
Anorexia	23 (.37%)
Hyperhidrosis	23 (.37%)
Acute Myocardial Infarction	22 (.36%)
Arrhythmia	22 (.36%)
Cardiac Arrest	22 (.36%)
Confusional State	22 (.36%)
Oedema Peripheral	22 (.36%)
Abdominal Pain	21 (.34%)
Bedridden	21 (.34%)
Blood Creatinine Increased	21 (.34%)
Cerebral Haematoma	21 (.34%)
Chest Discomfort	21 (.34%)
Muscle Spasms	21 (.34%)
Cardiac Disorder	20 (.33%)
Heart Rate Decreased	20 (.33%)
Incorrect Dose Administered	20 (.33%)
Unresponsive To Stimuli	20 (.33%)
Anxiety	19 (.31%)
Dysarthria	19 (.31%)
Glucose Urine Present	19 (.31%)
Hemianopia Homonymous	19 (.31%)
Proteinuria	19 (.31%)
Abnormal Dreams	18 (.29%)
Hypokalaemia	18 (.29%)
Blood Glucose Increased	17 (.28%)
Blood Pressure Increased	17 (.28%)
Coma	17 (.28%)
Cough	17 (.28%)
Haemoglobin Decreased	17 (.28%)
Heart Rate Increased	17 (.28%)
Presyncope	17 (.28%)
Pyrexia	17 (.28%)
Weight Increased	17 (.28%)
Blood Urea Increased	16 (.26%)
Constipation	16 (.26%)
Head Injury	16 (.26%)
Multiple Drug Overdose	16 (.26%)
Suicide Attempt	16 (.26%)
Urinary Tract Infection	16 (.26%)
Feeling Abnormal	15 (.24%)
Haemorrhagic Stroke	15 (.24%)
Hypoaesthesia	15 (.24%)
Paraesthesia	15 (.24%)
Tachycardia	15 (.24%)
Blood Creatine Phosphokinase Increa...	14 (.23%)
Complex Partial Seizures	14 (.23%)
Disorientation	14 (.23%)
Liver Disorder	14 (.23%)
Myocardial Ischaemia	14 (.23%)
Rash	14 (.23%)
Respiratory Failure	14 (.23%)

Share/Embed Graph Export Data

This graph shows the top adverse events submitted to the FDA for Isosorbide Mononitrate, 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 Mononitrate 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 Mononitrate

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

Neurological	546 (8.88%)
Product Quality Issues	346 (5.63%)
Cardiac Arrhythmias	279 (4.54%)
Decreased And Nonspecific Blood Pre...	260 (4.23%)
Cardiac And Vascular Investigations	236 (3.84%)
Coronary Artery	224 (3.64%)
Respiratory	212 (3.45%)
Gastrointestinal Signs	187 (3.04%)
Injuries	161 (2.62%)
Renal Disorders	129 (2.1%)
Medication Errors	121 (1.97%)
	Show More
Central Nervous System Vascular	109 (1.77%)
Gastrointestinal Motility And Defec...	107 (1.74%)
Headaches	106 (1.72%)
Cardiac Disorder Signs	103 (1.68%)
Electrolyte And Fluid Balance Condi...	101 (1.64%)
Infections - Pathogen Unspecified	101 (1.64%)
Epidermal And Dermal Conditions	94 (1.53%)
Heart Failures	91 (1.48%)
Therapeutic And Nontherapeutic Effe...	86 (1.4%)
Renal And Urinary Tract Investigati...	74 (1.2%)
Musculoskeletal And Connective Tiss...	66 (1.07%)
Lower Respiratory Tract Disorders	64 (1.04%)
Muscle	63 (1.03%)
Myocardial	58 (.94%)
Hematology Investigations	53 (.86%)
Vascular Hypertensive	52 (.85%)
Vision	52 (.85%)
Urinary Tract Signs	49 (.8%)
Appetite And General Nutritional	45 (.73%)
Hepatic And Hepatobiliary	44 (.72%)
Seizures	43 (.7%)
Skin Appendage Conditions	42 (.68%)
Sleep Disorders	40 (.65%)
Bronchial Disorders	38 (.62%)
Lifestyle Issues	38 (.62%)
Anxiety Disorders	37 (.6%)
Deliria	37 (.6%)
Fatal Outcomes	36 (.59%)
Hematological And Lymphoid Tissue T...	36 (.59%)
Physical Examination Topics	36 (.59%)
Bone And Joint Injuries	33 (.54%)
Metabolic, Nutritional And Blood Ga...	33 (.54%)
Water, Electrolyte And Mineral	33 (.54%)
Glucose Metabolism Disorders	29 (.47%)
Enzyme	28 (.46%)
Mental Impairment	28 (.46%)
Bacterial Infectious	26 (.42%)
Joint	26 (.42%)
Eye	25 (.41%)
Suicidal And Self-injurious Behavio...	25 (.41%)
Vascular	25 (.41%)
Depressed Mood Disorders	22 (.36%)
Lipid Analyses	22 (.36%)
Anemias Nonhemolytic And Marrow Dep...	21 (.34%)
Movement Disorders	21 (.34%)
Psychiatric	21 (.34%)
Body Temperature Conditions	20 (.33%)
Cardiac Valve	20 (.33%)
Neurological Disorders Of The Eye	19 (.31%)
Inner Ear And Viiith Cranial Nerve	18 (.29%)
Procedural And Device Related Injur...	18 (.29%)
Acid-base	17 (.28%)
Bone, Calcium, Magnesium And Phosph...	17 (.28%)
Pleural	16 (.26%)
Hepatobiliary	15 (.24%)
Disturbances In Thinking	14 (.23%)
Gastrointestinal Hemorrhages	14 (.23%)
Gastrointestinal	13 (.21%)
Neurological Disorders Congenital	13 (.21%)
Upper Respiratory Tract Disorders	13 (.21%)
Arteriosclerosis, Stenosis, Vascula...	12 (.2%)
Chemical Injury And Poisoning	12 (.2%)
Cranial Nerve Disorders	11 (.18%)
Peritoneal And Retroperitoneal Cond...	11 (.18%)
Allergic Conditions	10 (.16%)
Gastrointestinal Stenosis And Obstr...	10 (.16%)
Gastrointestinal Vascular Condition...	10 (.16%)
Personality Disorders	10 (.16%)
Therapeutic Procedures And Supporti...	10 (.16%)
Anterior Eye Structural Change, Dep...	9 (.15%)
Encephalopathies	9 (.15%)
Gastrointestinal Inflammatory Condi...	9 (.15%)
Toxicology And Therapeutic Drug Mon...	9 (.15%)
Vascular Therapeutic Procedures	9 (.15%)
Protein And Chemistry Analyses	8 (.13%)
Tissue	8 (.13%)
Viral Infectious	8 (.13%)
Bile Duct	7 (.11%)
Economic And Housing Issues	7 (.11%)
Embolism And Thrombosis	7 (.11%)
Lipid Metabolism	7 (.11%)
Neurological, Special Senses And Ps...	7 (.11%)
Oral Soft Tissue Conditions	7 (.11%)
Thoracic Disorders	7 (.11%)
Vascular Hemorrhagic	7 (.11%)
White Blood Cell	7 (.11%)
Angiedema And Urticaria	6 (.1%)
Coagulopathies And Bleeding Diathes...	6 (.1%)
Gastrointestinal Ulceration And Per...	6 (.1%)
Neuromuscular	6 (.1%)

Share/Embed Graph Export Data

This graph shows the top categories of adverse events submitted to the FDA for Isosorbide Mononitrate, 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 Mononitrate 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.