NitroMist Side Effects

Please note - some side effects for NitroMist may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

NitroMist Side Effects - for the Professional

NitroMist

Most common adverse reactions are headache, flushing, hypotension, and syncope (6).

Side Effects by Body System

Nervous system

Nervous system side effects commonly include headaches and lightheadedness in 2 to 50% of patients, which may be severe, but may become less intense after 2 weeks of therapy. Some intravenous preparations of nitroglycerin contain alcohol. Rare cases of alcohol intoxication have been reported in some patients after prolonged, high dose administration of intravenous nitroglycerin.

Headaches are the result of intracranial vasodilation and increased intracranial pressure. Rare cases of increased intracranial pressure, resulting in papilledema, diplopia, 6th cranial nerve palsy, and decreased mental status have been reported.

Rare cases of Wernicke's encephalopathy have been reported, thought to be due to the ethyl alcohol and propylene glycol vehicle used in some intravenous preparations of nitroglycerin.

A case of ageusia associated with transdermal nitroglycerin has been reported.

Cardiovascular

In a review of 17 cases of hypotensive bradycardia following nitroglycerin administration, no reliable factors to predict this side effect were found. The mechanism is thought to be vasovagal; atropine is an effective countermeasure. There is evidence that right ventricular (RV) dysfunction, particularly in the event of RV myocardial infarction (MI), may predispose patients to develop hypotension during nitroglycerin administration. These patients are extremely sensitive to changes in preload and may have preexisting bradycardia. Therefore, caution is recommended if nitroglycerin is necessary in patients with RV or inferior wall MI.

Rare cases of A-V block, including complete heart block, thought to be vasovagally-mediated after nitroglycerin administration, have been reported.

Nitroglycerin may aggravate angina associated with hypertrophic cardiomyopathy.

Nitroglycerin may induce vasodilation in poorly ventilated areas of the lung, which may result in hypoxemia.

In some cases, coronary artery stenoses have appeared paradoxically worsened angiographically after administration of nitroglycerin. The mechanism by which nitroglycerin may induce myocardial ischemia is not known. It may cause coronary artery vasodilation and a local "steal phenomenon" or it may cause a greater degree of venous pooling than coronary artery dilation, resulting in an imbalance of myocardial perfusion.

Nitroglycerin transdermal patches should be removed prior to DC cardioversion. Cases of electrical arcing from the paddles to the aluminum patch backing have been reported.

Some intravenous preparations of nitroglycerin, such as Tridil, contain 100 mEq/L potassium (K+), which may cause hyperkalemia and an increased risk of arrhythmias. When using such preparations, monitor the serum K+ and heart rhythm closely.

Cardiovascular side effects include bradycardia, hypotension, or syncope in less than 5% of patients. Hypotension associated with intravenous nitroglycerin is reported in up to 18% of patients, but may be more likely in cases of right ventricular or inferior wall infarction. Nitroglycerin may induce reflex tachycardia in less than 1% of patients.

Rarely, myocardial ischemia or pedal edema have been associated with nitroglycerin.

Rare cases of increased arteriolar-alveolar (Aa) O2 differences have been reported. It is recommended that nitroglycerin be given with caution to patients with pneumonia and preexisting lung disease.

Tolerance to the cardiovascular effects of nitrates has been reported.

Gastrointestinal

Gastrointestinal complaints of mild nausea occur in less than 1% after orally-ingested nitroglycerin.

Hematologic

An unusual hematologic side effect is the development of methemoglobinemia, almost exclusively reported after doses greater than 30 mcg/kg/min were given for several days. Nitroglycerin may prolong bleeding times via a prostacyclin mechanism.

Methemoglobinemia may be asymptomatic, but should be suspected if the patient's blood appears dark to gross examination or if the patient appears cyanotic. Patients with ischemic heart disease may experience angina pectoris. The diagnosis is confirmed by measurement of arterial methemoglobin concentration, and therapy consist of withdrawal of nitroglycerin, if possible, oxygen therapy, and 1 to 2 mg/kg of 1% methylene blue intravenously over 10 minutes. If the response is inadequate, methylene blue may be repeated in 1 hour.

Dermatologic

Dermatologic reactions have occasionally been associated with transdermal patches. Cases of mild and severe contact dermatitis manifest as erythema, pruritus, and burning have been reported, as well as rare cases of lichen planus. Hypersensitivity rashes have rarely been associated with orally administered nitroglycerin.

The cause of some cases of dermatitis may not be nitroglycerin, per se, but another material used in the patch itself.

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