What the label lists and what reports show
Isosorbide dinitrate side effects
Isosorbide dinitrate's FDA label: “Headache, which may be severe, is the most commonly reported side effect.” FAERS holds 19,415 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dyspnoea (1,664 reports).
- Generic listed
Check it at the source: the isosorbide dinitrate FDA label on DailyMed (effective March 2, 2020, Oceanside Pharmaceuticals); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsHeadache, which may be severe, is the most commonly reported side effect.
From the label: adverse reactions, continuedAdverse 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 (see OVERDOSAGE ). Data are not available to allow estimation of the frequency of adverse reactions during treatment with Isosorbide Dinitrate tablets. To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Source: FDA drug label, NDA012093 (Bausch), as published by Oceanside Pharmaceuticals, effective March 2, 2020 (SPL set 723d9f78-9d77-4575-af27-1aa117e6b8d7), via openFDA; the full label on DailyMed
What do FAERS reports show?
19,415 reports list isosorbide dinitrate among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,553 are coded as a death and 8,318 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 1 is named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Isosorbide dinitrate: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions