Nitro-Bid Side Effects

Generic Name: nitroglycerin

Please note - some side effects for Nitro-Bid 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).

Side Effects of Nitro-Bid - for the Consumer

Nitro-Bid Ointment

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Nitro-Bid Ointment:

Dizziness, lightheadedness, or fainting when sitting up or standing; flushing of face and neck; headache; nausea; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; dry mouth; fainting; flushing; heavy sweating; irregular heartbeat; new or worsening chest pain; pale skin; pounding in the chest; rapid heartbeat; severe dizziness or headache; severe or persistent nausea or vomiting; shortness of breath; slow heartbeat; swelling of the hands, ankles, or feet; unusual weakness.

Nitro-Bid Side Effects - for the Professional

Nitro-Bid

Adverse reactions to nitroglycerin are generally dose-related, and almost all of these reactions are the result of nitroglycerin's activity as a vasodilator. Headache, which may be severe, is the most commonly reported side effect. Headache may be recurrent with each daily dose, especially at higher doses. Transient episodes of lightheadedness, occasionally related to blood pressure changes, may also occur. Hypotension occurs infrequently, but in some patients it may be severe enough to warrant discontinuation of therapy. Syncope, crescendo angina, and rebound hypertension have been reported but are uncommon.

Allergic reactions to nitroglycerin are also uncommon, and the great majority of those reported have been cases of contact dermatitis or fixed drug eruptions in patients receiving nitroglycerin in ointments or patches. There have been a few reports of genuine anaphylactoid reactions, and these reactions can probably occur in patients receiving nitroglycerin by any route.

Extremely rarely, ordinary doses of organic nitrates have caused methemoglobinemia in normal-seeming patients; for further discussion of its diagnosis and treatment see OVERDOSAGE.

Data are not available to allow estimation of the frequency of adverse reactions during treatment with nitroglycerin ointment.

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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