Isordil Titradose Side Effects

Generic Name: isosorbide dinitrate

Please note - some side effects for Isordil Titradose 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 Isordil Titradose - for the Consumer

Isordil Titradose

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 Isordil Titradose:

Dizziness; flushing of the face and neck; headache; lightheadedness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fainting; frequent, continuing, or severe chest pain; nausea; rapid or slow heartbeat; vomiting.

Isordil Titradose Side Effects - for the Professional

Isordil Titradose

Adverse reactions to isosorbide dinitrate are generally dose-related, and almost all of these reactions are the result of isosorbide dinitrate'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.

Extremely rarely, ordinary doses of organic nitrates have caused methemoglobinemia in normal-seeming patients. Methemoglobinemia is so infrequent at these doses that further discussion of its diagnosis and treatment is deferred.

Data are not available to allow estimation of the frequency of adverse reactions during treatment with Isordil® Titradose® tablets.

Side Effects by Body System

Nervous system

Headache is probably due to vasodilation and may respond to acetaminophen analgesia.

A case of isosorbide dinitrate-associated transient ischemic attack has been reported, supposedly due to an arterial "steal phenomenon" secondary to drug-induced vasodilation.

A case of visual hallucinations, suicidal ideation, and depression associated with isosorbide dinitrate has been reported, even upon blind rechallenge of the drug.

Nervous system side effects have included headache and dizziness.

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, hypotension, diaphoresis, weakness, sinus bradycardia, and unusual case reports of AV heart block. Unusual cases of edema have also been reported. Frequent dosing, high dosages, and long-acting preparations giving constant 24-hour nitroglycerin levels can result in tolerance to the drug. The risk of tolerance is significantly decreased by withholding the drug, so called "nitrate-free" intervals. Rebound symptoms may occur during this time.

Gastrointestinal

Gastrointestinal side effects include mild nausea and constipation.

Hypersensitivity

Hypersensitivity reactions including rare cases of pruritus and drug rash have been reported.

Hematologic

In vitro data show decreased platelet aggregation when exposed to isosorbide dinitrate.

Nitrates, after conversion 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 (dyspnea, chest pain), 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.

Hematologic side effects are rare and include methemoglobinemia and a case of isosorbide dinitrate-induced hemolytic anemia in a patient with underlying glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Renal

Renal side effects of isosorbide dinitrate (ISDN) are described in nonazotemic patients with liver cirrhosis. ISDN can cause a reduction of glomerular filtration rate and free water clearance associated with significant increases in plasma renin and aldosterone in patients with liver cirrhosis. The changes are most remarkable in patients with ascites.

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