Isosorbide mononitrate Side Effects

Brand Names: Imdur, Ismo

Please note - some side effects for 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.

Side Effects of Isosorbide mononitrate - for the Consumer

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.

Seek medical attention right away if any of these SEVERE side effects occur when using Isosorbide Mononitrate:

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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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.

Seek medical attention right away if any of these SEVERE side effects occur when using Isosorbide Mononitrate Sustained-Release Tablets:

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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Isosorbide mononitrate Side Effects - for the Professional

Isosorbide Mononitrate

The table below shows the frequencies of the adverse events that occurred in >5% of the subjects in three placebo-controlled North American studies in which patients in the active treatment arm received 30 mg, 60 mg, 120 mg, or 240 mg of Isosorbide Mononitrate as Isosorbide Mononitrate Tablets once daily. In parentheses, the same table shows the frequencies with which these adverse events were associated with the discontinuation of treatment. Overall, 8% of the patients who received 30 mg, 60 mg, 120 mg, or 240 mg of Isosorbide Mononitrate in the three placebo-controlled North American studies discontinued treatment because of adverse events. Most of these discontinued because of headache. Dizziness was rarely associated with withdrawal from these studies. Since headache appears to be a dose-related adverse effect and tends to disappear with continued treatment, it is recommended that Isosorbide Mononitrate treatment be initiated at low doses for several days before being increased to desired levels.

FREQUENCY AND ADVERSE EVENTS (DISCONTINUED)*

*Some individuals discontinued for multiple reasons.
**Patients were started on 60 mg and titrated to their final dose.
Three Controlled North American Studies
Dose	Placebo	30 mg	60 mg	120 mg**	240 mg**
Patients	96	60	102	65	65
Headache	15% (0%)	38% (5%)	51% (8%)	42% (5%)	57% (8%)
Dizziness	4% (0%)	8% (0%)	11% (1%)	9% (2%)	9% (2%)

In addition, the three North American trials were pooled with 11 controlled trials conducted in Europe. Among the 14 controlled trials, a total of 711 patients were randomized to Isosorbide Mononitrate Tablets. When the pooled data were reviewed, headache and dizziness were the only adverse events that were reported by >5% of patients. Other adverse events, each reported by ≤5% of exposed patients, and in many cases of uncertain relation to drug treatment, were:

Autonomic Nervous System Disorders: Dry mouth, hot flushes.

Body as a Whole: Asthenia, back pain, chest pain, edema, fatigue, fever, flu-like symptoms, malaise, rigors.

Cardiovascular Disorders, General: Cardiac failure, hypertension, hypotension.

Central and Peripheral Nervous System Disorders: Dizziness, headache, hypoesthesia, migraine, neuritis, paresis, paresthesia, ptosis, tremor, vertigo.

Gastrointestinal System Disorders: Abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gastric ulcer, gastritis, glossitis, hemorrhagic gastric ulcer, hemorrhoids, loose stools, melena, nausea, vomiting.

Hearing and Vestibular Disorders: Earache, tinnitus, tympanic membrane perforation.

Heart Rate and Rhythm Disorders: Arrhythmia, arrhythmia atrial, atrial fibrillation, bradycardia, bundle branch block, extrasystole, palpitation, tachycardia, ventricular tachycardia.

Liver and Biliary System Disorders: SGOT increase, SGPT increase.

Metabolic and Nutritional Disorders: Hyperuricemia, hypokalemia.

Musculoskeletal System Disorders: Arthralgia, frozen shoulder, muscle weakness, musculoskeletal pain, myalgia, myositis, tendon disorder, torticollis.

Myo-, Endo-, Pericardial, and Valve Disorders: Angina pectoris aggravated, heart murmur, heart sound abnormal, myocardial infarction, Q wave abnormality.

Platelet, Bleeding, and Clotting Disorders: Purpura, thrombocytopenia.

Psychiatric Disorders: Anxiety, concentration impaired, confusion, decreased libido, depression, impotence, insomnia, nervousness, paroniria, somnolence.

Red Blood Cell Disorder: Hypochromic anemia.

Reproductive Disorders, Female: Atrophic vaginitis, breast pain.

Resistance Mechanism Disorders: Bacterial infection, moniliasis, viral infection.

Respiratory System Disorders: Bronchitis, bronchospasm, coughing, dyspnea, increased sputum, nasal congestion, pharyngitis, pneumonia, pulmonary infiltration, rales, rhinitis, sinusitis.

Skin and Appendages Disorders: Acne, hair texture abnormal, increased sweating, pruritus, rash, skin nodule.

Urinary System Disorders: Polyuria, renal calculus, urinary tract infection.

Vascular (Extracardiac) Disorders: Flushing, intermittent claudication, leg ulcer, varicose vein.

Vision Disorders: Conjunctivitis, photophobia, vision abnormal.

In addition, the following spontaneous adverse event has been reported during the marketing of Isosorbide Mononitrate: syncope.

To report SUSPECTED ADVERSE REACTIONS, contact West-ward Pharmaceutical Corp. at 1-877-233-2001, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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Side Effects by Body System - for Healthcare Professionals

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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