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Does Monoket (isosorbide mononitrate) cause side effects?
Nitrates are vasodilators (dilators of blood vessels). Blood returning from the body in the veins must be pumped by the heart through the lungs and into the body's arteries against the high pressure in the arteries.
In order to accomplish this, the heart's muscle must produce and use energy which requires oxygen brought to the heart by the blood. Angina is due to an inadequate flow of blood (and oxygen) to the muscle of the heart.
Nitrates correct the imbalance between the flow of blood and oxygen to the heart and the work that the heart must do by dilating the arteries and veins in the body. Dilation of the veins reduces the amount of blood that returns to the heart that must be pumped. Dilation of the arteries lowers the pressure in the arteries against which the heart must pump.
As a consequence of both effects, the heart works less and requires less blood and oxygen.
Common side effects of Monoket include
- flushing, and
- a severe drop in blood pressure when rising from a sitting position, causing dizziness, palpitations, and weakness.
Serious side effects of Monoket include methemoglobinemia (rare).
Drug interactions of Monoket include sildenafil, tadalafil, avanafil, and vardenafil, which increase the blood pressure lowering effects of Monoket and may cause excessive reductions in blood pressure.
There are no adequate studies of Monoket in pregnant women.
What are the important side effects of Monoket (isosorbide mononitrate)?
Headaches are the most common side effect of isosorbide mononitrate and usually are dose related (increase with higher doses). Flushing may occur because isosorbide mononitrate dilates (enlarges) blood vessels. Isosorbide mononitrate may cause a severe drop in blood pressure when rising from a sitting position, causing:
To reduce the risk of low blood pressure, patients should rise slowly from a sitting position.
Monoket (isosorbide mononitrate) side effects list for healthcare professionals
The following table shows the frequency of adverse reactions observed in 1% or more of subjects in 6 placebo-controlled trials, conducted in the United States and abroad. The same table shows the frequency of withdrawal for these adverse reactions. In many cases the adverse reactions were of uncertain relation to drug treatment.
Frequency Of Adverse Reactions (Discontinuations)*
|Dose||6 Placebo-Controlled Studies|
|Placebo||5 mg||10 mg||20 mg|
|Headache||6% (0%)||17% (0%)||13% (0%)||35% (5%)|
|Fatigue Upper Respiratory||2% (0%)||0% (0%)||4% (0%)||1% (0%)|
|Infection||< 1% (0%)||0% (0%)||4% (0%)||1% (0%)|
|Pain||< 1% (0%)||4% (0%)||0% (0%)||< 1% (0%)|
|Dizziness||1% (0%)||0% (0%)||0% (0%)||4% (0%)|
|Nausea Increased||< 1% (0%)||0% (0%)||0% (0%)||3% (2%)|
|Cough||< 1% (0%)||0% (0%)||2% (0%)||< 1% (0%)|
|Rash Abdominal||0% (0%)||2% (2%)||0% (0%)||< 1% (0%)|
|Pain Allergic||< 1% (0%)||0% (0%)||2% (0%)||0% (0%)|
|Reaction Cardiovascular||0% (0%)||0% (0%)||2% (0%)||0% (0%)|
|Disorder||0% (0%)||2% (0%)||0% (0%)||0% (0%)|
|Chest Pain||< 1% (0%)||0% (0%)||2% (0%)||< 1% (0%)|
|Diarrhea||0% (0%)||0% (0%)||2% (0%)||0% (0%)|
|Flushing Emotional||0% (0%)||0% (0%)||2% (0%)||0% (0%)|
|Lability||0% (0%)||2% (0%)||0% (0%)||0% (0%)|
|Pruritus||1% (0%)||2% (2%)||0% (0%)||0% (0%)|
|*Some individuals discontinued for multiple reasons.|
Other adverse reactions, each reported by fewer than 1% of exposed patients, and in many cases of uncertain relation to drug treatment, were:
Genitourinary: prostatic disorder.
Extremely rarely, ordinary doses of organic nitrates have caused methemoglobinemia in normal-seeming patients; for further discussion of its diagnosis and treatment see the prescribing information.
What drugs interact with Monoket (isosorbide mononitrate)?
Concomitant use of Monoket with phosphodiesterase inhibitors in any form is contraindicated.
Concomitant use of Monoket with riociguat, a soluble guanylate cyclase stimulator, is contraindicated.
The vasodilating effects of isosorbide mononitrate may be additive with those of other vasodilators. Alcohol, in particular, has been found to exhibit additive effects of this variety.
Marked symptomatic orthostatic hypotension has been reported when calcium channel blockers and organic nitrates were used in combination. Dose adjustments of either class of agents may be necessary.
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Related Disease Conditions
Heart disease (coronary artery disease) occurs when plaque builds up in the coronary arteries, the vessels that supply blood to the heart. Heart disease can lead to heart attack. Risk factors for heart disease include: Smoking High blood pressure High cholesterol Diabetes Family history Obesity Angina, shortness of breath, and sweating are just a few symptoms that may indicate a heart attack. Treatment of heart disease involves control of heart disease risk factors through lifestyle changes, medications, and/or stenting or bypass surgery. Heart disease can be prevented by controlling heart disease risk factors.
Angina is chest pain due to inadequate blood supply to the heart. Angina symptoms may include chest tightness, burning, squeezing, and aching. Coronary artery disease is the main cause of angina but there are other causes. Angina is diagnosed by taking the patient's medical history and performing tests such as an electrocardiogram (EKG), blood test, stress test, echocardiogram, cardiac CT scan, and heart catheterization. Treatment of angina usually includes lifestyle modification, medication, and sometimes, surgery. The risk of angina can be reduced by following a heart healthy lifestyle.
Heart Disease: Sudden Cardiac Death
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Stress and Heart Disease
The connection between stress and heart disease is not clear. Stress itself may be a risk factor, or high levels of stress may make risk factors for heart disease worse. The warning signs of stress can be physical, mental, emotional, or behavioral. Reducing stressors in an individuals life not only can lead to a more productive life, but may also decrease the risk for heart disease and causes of heart disease.
Heart Disease in Women
Heart disease in women has somewhat different symptoms, risk factors, and treatment compared to heart disease in men. Many women and health professionals are not aware of the risk factors for heart disease in women and may delay diagnosis and treatment. Lifestyle factors such as diet, exercise, tobacco use, overweight/obesity, stress, alcohol consumption, and depression influence heart disease risk in women. High blood pressure, high cholesterol, and diabetes also increase women's risk of heart disease. Electrocardiogram (EKG or ECG), stress-ECG, endothelial testing, ankle-brachial index (ABI), echocardiogram, nuclear imaging, electron beam CT, and lab tests to assess blood lipids and biomarkers of inflammation are used to diagnose heart disease. Early diagnosis and treatment of heart disease in women saves lives. Heart disease can be prevented and reversed with lifestyle changes.
Heart Disease Treatment in Women
Heart disease treatment in women should take into account female-specific guidelines that were developed by the American Heart Association. Risk factors and symptoms of heart disease in women differ from those in men. Treatment may include lifestyle modification (diet, exercise, weight management, smoking cessation, stress reduction), medications, percutaneous intervention procedure (PCI), and coronary artery bypass grafting (CABG). Heart disease is reversible with treatment.
Congenital Heart Defects
Congenital heart defects are heart problems that are present at birth. Genetics may play a role in some heart defects. Symptoms can range from nonexistent to severe and life-threatening. Fatigue, rapid breathing, and decreased blood circulation are a few possible symptoms of congenital heart defects. Many cases do not require any treatment. Procedures using catheters and surgery may be used to repair severe heart defects.
Smoking and Heart Disease
Smoking increases the risk of heart disease in women and men. Nicotine in cigarettes decrease oxygen to the heart, increases blood pressure, blood clots, and damages coronary arteries. Learn how to quit smoking today, to prolong your life.
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Medications & Supplements
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.