Medical Editor: John P. Cunha, DO, FACOEP
- headache, and
The recommended starting dose of Imdur Tablets is 30 mg (given as a single 30 mg tablet or as 1/2 of a 60 mg tablet) or 60 mg (given as a single tablet) once daily. After several days, the dosage may be increased to 120 mg (given as a single 120 mg tablet or as two 60 mg tablets) once daily. Imdur may interact with sildenafil, other vasodilators, alcohol, calcium channel blockers, and organic nitrates. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Imdur; it is unknown how it may affect a fetus. It is unknown if Imdur passes into breast milk. Consult your doctor before breastfeeding.
Our Imdur (isosorbide mononitrate) Extended Release Tablets Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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 IMDUR 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 IMDUR treatment be initiated at low doses for several days before being increased to desired levels.
FREQUENCY AND ADVERSE EVENTS (DISCONTINUED)*
|Three Controlled North American Studies|
|Dose||Placebo||30 mg||60 mg||120 mg†||240 mg†|
|Headache||15% (0%)||38% (5%)||51% (8%)||42% (5%)||57% (8%)|
|Dizziness||4% (0%)||8% (0%)||11% (1%)||9% (2%)||9% (2%)|
|*Some individuals discontinued for multiple reasons.
†Patients were started on 60 mg and titrated to their final dose.
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 IMDUR 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.
Gastrointestinal System Disorders: Abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gastric ulcer, gastritis, glossitis, hemorrhagic gastric ulcer, hemorrhoids, loose stools, melena, nausea, vomiting.
Red Blood Cell Disorder: Hypochromic anemia.
Resistance Mechanism Disorders: Bacterial infection, moniliasis, viral infection.
In addition, the following spontaneous adverse event has been reported during the marketing of isosorbide mononitrate: syncope.
Read the entire FDA prescribing information for Imdur (isosorbide mononitrate)