Isosorbide mononitrate Side Effects

Some side effects of isosorbide mononitrate may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to isosorbide mononitrate: oral tablet, oral tablet extended release

Get emergency medical help if you have any of these signs of an allergic reaction while taking isosorbide mononitrate: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• fast, slow, pounding, or uneven heart rate;

• feeling like you might pass out;

• trouble breathing, blue-colored skin, tired feeling; or

• worsening angina pain.

Less serious side effects of isosorbide mononitrate may include:

• headache, mild dizziness;

• warmth, redness, or tingling under your skin;

• nausea, vomiting, constipation, diarrhea;

• pain or stiffness in joints or muscles;

• hot flashes; or

• dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to isosorbide mononitrate: oral tablet, oral tablet extended release

General

Isosorbide mononitrate is generally well-tolerated.

Nervous system

Nitrate-induced headaches are probably due to vasodilation, and may resolve spontaneously over days to weeks or respond to acetaminophen analgesia.

Nervous system side effects such as headache have occurred in up to 36% of patients. In a large multicenter trial, 1.2% of patients discontinued therapy due to headache. Up to 8% of patients experienced dizziness/vertigo symptoms.

Cardiovascular

Organic nitrates may induce a sudden drop in systemic blood pressure and enhanced vagal tone, resulting in possible inhibition of reflex tachycardia and syncope.

Cardiovascular side effects include flushing, increased heart rate, hypotension, and orthostasis. These are more likely in patients with hypovolemia or who are on antihypertensive medications. Syncope has been reported in rare cases. Due to tolerance to the antianginal effects of the drug, eccentric dosing is usually recommended. This typically means giving the drug upon wakening and again approximately seven hours later, leaving a "nitrate-free" period during the night to decrease the incidence of tolerance.

Gastrointestinal

Gastrointestinal side effects are relatively uncommon, and include nausea and constipation in 1% to 3% of patients.

Hypersensitivity

Hypersensitivity reactions, presenting as pruritus and drug rash, are reported with the organic nitrates.

Hematologic

Nitrates converted to nitrites may accelerate the oxidation of hemoglobin, resulting in abnormally high plasma concentrations of methemoglobin. While most cases of methemoglobinemia are asymptomatic, methemoglobin levels greater than 60% usually induce symptoms, particularly in the presence of underlying coronary artery disease. Treatment in symptomatic persons is methylene blue 1% solution 2 mg/kg intravenously over 10 minutes. It is recommended that affected patients be screened for NADP-methemoglobin reductase deficiency.

A rare hematologic side effect of nitrates is methemoglobinemia.

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