What the label lists and what reports show
Isosorbide mononitrate side effects
Isosorbide mononitrate's FDA label lists its adverse reactions in its own words. FAERS holds 20,616 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 (1,567 reports).
- Generic listed
Check it at the source: the isosorbide mononitrate FDA label on DailyMed (effective May 11, 2026, Torrent Pharmaceuticals Limited); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe 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 extended-release 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. …
Frequency of Adverse Reactions (Discontinuations)*
This table is printed in the isosorbide mononitrate label published by OMNIVIUM PHARMACEUTICALS LLC. of August 6, 2025; the label quoted above does not print one.
| Dose | Placebo | 5 mg | 10 mg | 20 mg |
|---|---|---|---|---|
| Patients | 160 | 54 | 52 | 159 |
| Headache | 6% (0%) | 17% (0%) | 13% (0%) | 35% (5%) |
| Fatigue | 2% (0%) | 0% (0%) | 4% (0%) | 1% (0%) |
| Upper Respiratory Infection | <1% (0%) | 0% (0%) | 4% (0%) | 1% (0%) |
| Pain | <1% (0%) | 4% (0%) | 0% (0%) | <1% (0%) |
| Dizziness | 1% (0%) | 0% (0%) | 0% (0%) | 4% (0%) |
| Nausea | <1% (0%) | 0% (0%) | 0% (0%) | 3% (2%) |
| Increased Cough | <1% (0%) | 0% (0%) | 2% (0%) | <1% (0%) |
| Rash | 0% (0%) | 2% (2%) | 0% (0%) | <1% (0%) |
| Abdominal Pain | <1% (0%) | 0% (0%) | 2% (0%) | 0% (0%) |
| Allergic Reaction | 0% (0%) | 0% (0%) | 2% (0%) | 0% (0%) |
| Cardiovascular Disorder | 0% (0%) | 2% (0%) | 0% (0%) | 0% (0%) |
| Chest Pain | <1% (0%) | 0% (0%) | 2% (0%) | <1% (0%) |
| Diarrhea | 0% (0%) | 0% (0%) | 2% (0%) | 0% (0%) |
| Flushing | 0% (0%) | 0% (0%) | 2% (0%) | 0% (0%) |
| Emotional Lability | 0% (0%) | 2% (0%) | 0% (0%) | 0% (0%) |
| Pruritus | 1% (0%) | 2% (2%) | 0% (0%) | 0% (0%) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, Torrent Pharmaceuticals Limited, effective May 11, 2026 (SPL set 0a1e317a-7b05-4d30-9bbc-1d4ccd56ba3c), via openFDA; the full label on DailyMed
What do FAERS reports show?
20,616 reports list isosorbide mononitrate among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,596 are coded as a death and 9,840 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, 16 are 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 mononitrate: 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