Isosorbide Side Effects

Please note - some side effects for Isosorbide 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 Isosorbide - for the Consumer

Isosorbide Dinitrate Extended-Release

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 Isosorbide Dinitrate Extended-Release:

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

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

Isosorbide Mononitrate

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 Isosorbide Mononitrate:

Dizziness; headache; nausea.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in vision; fainting; numbness of an arm or leg; severe stomach pain; sharp or crushing chest pain; sudden leg pain; sudden, severe headache; sudden shortness of breath; vomiting.

Isosorbide Dinitrate

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 Isosorbide Dinitrate:

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.

Isosorbide Dinitrate/Hydralazine

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 Isosorbide Dinitrate/Hydralazine:

Dizziness; headache; lightheadedness; nausea; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in the amount of urine produced; chest pain; difficult urination; fainting; fast or irregular heartbeat; fever, chills, or sore throat; joint pain; numbness or tingling of the skin; persistent fatigue or weakness; runny nose; severe or persistent headache or dizziness; vision changes.

Isosorbide Mononitrate Sustained-Release Tablets

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 Isosorbide Mononitrate Sustained-Release Tablets:

Dizziness; headache; nausea.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in vision; fainting; numbness of an arm or leg; severe stomach pain; sharp or crushing chest pain; sudden leg pain; sudden, severe headache; sudden shortness of breath; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .

Isosorbide Side Effects - for the Professional

Isosorbide

Headache is the most frequent side effect and was the cause of 2% of all dropouts from controlled-clinical trials. Headache decreased in incidence after the first few days of therapy.

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.

Other adverse reactions, each reported by fewer than 1% of exposed patients, and in many cases of uncertain relation to drug treatment, were:

Cardiovascular: acute myocardial infarction, apoplexy, arrhythmias, bradycardia, edema, hypertension, hypotension, pallor, palpitations, tachycardia.

Dermatologic: sweating.

Gastrointestinal: anorexia, dry mouth, dyspepsia, thirst, vomiting, decreased weight.

Genitourinary: prostatic disorder.

Miscellaneous: amblyopia, back pain, bitter taste, muscle cramps, neck pain, paresthesia, susurrus aurium.

Neurologic: anxiety, impaired concentration, depression, insomnia, nervousness, nightmares, restlessness, tremor, vertigo.

Respiratory: asthma, dyspnea, sinusitis.

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

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