Isosorbide dinitrate is a nitrate vasodilator indicated for the prevention of angina pectoris due to coronary artery disease. It is available as tablets for oral use. MedsAcross supplies Isosorbide dinitrate for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
Isosorbide Dinitrate tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.
Source: US FDA prescribing information
As noted under CLINICAL PHARMACOLOGY, multiple-dose studies with ISDN and other nitrates have shown that maintenance of continuous 24-hour plasma levels results in refractory tolerance. Every dosing regimen for Isosorbide Dinitrate tablets must provide a daily dose-free interval to minimize the development of this tolerance. With immediate-release ISDN, it appears that one daily dose-free interval must be at least 14 hours long. As also noted under CLINICAL PHARMACOLOGY, the effects of the second and later doses have been smaller and shorter-lasting than the effects of the first. Large controlled studies with other nitrates suggest that no dosing regimen with Isosorbide Dinitrate tablets should be expected to provide more than about 12 hours of continuous anti-anginal efficacy per day.
Source: US FDA prescribing information
Isosorbide Dinitrate is contraindicated in patients who are allergic to isosorbide dinitrate or any of its ingredients. Do not use Isosorbide Dinitrate in patients who are taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors), such as sildenafil, tadalafil, or vardenafil. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia. Do not use Isosorbide Dinitrate in patients who are taking the soluble guanylate cyclase stimulator riociguat. Concomitant use can cause hypotension.
Source: US FDA prescribing information
Amplification of the vasodilatory effects of Isosorbide Dinitrate by sildenafil can result in severe hypotension. The time course and dose dependence of this interaction have not been studied. Appropriate supportive care has not been studied, but it seems reasonable to treat this as a nitrate overdose, with elevation of the extremities and with central volume expansion. The benefits of immediate-release oral isosorbide dinitrate in patients with acute myocardial infarction or congestive heart failure have not been established. If one elects to use isosorbide dinitrate in these conditions, careful clinical or hemodynamic monitoring must be used to avoid the hazards of hypotension and tachycardia. Because the effects of oral isosorbide dinitrate are so difficult to terminate rapidly, this formulation is not recommended in these settings.
Source: US FDA prescribing information
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.
Source: US FDA prescribing information
The vasodilating effects of isosorbide dinitrate may be additive with those of other vasodilators. Alcohol, in particular, has been found to exhibit additive effects of this variety. Concomitant use of Isosorbide Dinitrate with phosphodiesterase inhibitors in any form is contraindicated. Concomitant use of Isosorbide Dinitrate with riociguat, a soluble guanylate cyclase stimulator, is contraindicated.
Source: US FDA prescribing information
Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). Protect from light.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
5 presentations of Isosorbide dinitrate, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Isosorbide dinitrate 10 mg tabletOralGeneric name | — | US FDA | Available on request |
| Isosorbide dinitrate 20 mg tabletOralGeneric name | — | US FDA | Available on request |
| Isosorbide dinitrate 5 mg tabletOralGeneric name | — | US FDA | Available on request |
| Isosorbide dinitrate 30 mg tabletOralGeneric name | — | US FDA | Available on request |
| Isosorbide dinitrate 40 mg tabletOralGeneric name | — | US FDA | Available on request |
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 9 November 1959 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Isosorbide dinitrate in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 5 presentations of Isosorbide dinitrate and sources them for licensed hospitals, importers and physicians against valid import documents.
Yes. The US FDA first approved Isosorbide dinitrate on 9 November 1959, according to Drugs@FDA.
No listed presentation of Isosorbide dinitrate is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Isosorbide dinitrate is classified under ATC code C01DA08 (Isosorbide dinitrate).
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