Generic name
Isosorbide mononitrate: adverse event reports filed with FDA
3,171 reports list it as a suspect or interacting product, 2004–2026. Class: Nitrate vasodilator. Also reported as Isosorbide Mononitrate Extended Release, Isosorbide Mononitrate Er, Isosorbide Mononitrate Er Tablets 60mg.
- 3,171
- reports as suspect product
- 0% of all reports · about 141 a year
- 174
- reports, 12 months to June 2026
- 144 in the 12 months before
- 91.6%
- marked serious by the reporter
- 85.3% across the class
- 13.7%
- record death among outcomes, as reported
- 435 reports · not verified by FDA
Between January 2004 and June 2026, 3,171 adverse event reports received by FDA list isosorbide mononitrate, a generic name as a suspect or interacting product. Reports that mention it only as a concomitant medication (17,935) are left out of every figure here.
In the 12 months to June 2026, 174 reports listed it, up 21% from 144 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 141 reports a year and 0% of the 20,646,523 reports in the database, and 26.5% of the reports for the nitrate vasodilator class. How many people take it is not in the data, so a count is not a rate of occurrence.
The MedDRA terms listed most often are dizziness (22.1%), headache (17.7%) and chest pain (16.8%). A report can list several reactions, so shares add to more than 100%; 701 different terms appear across these reports. Dizziness is recorded in 22.1% of these reports, a larger share than in the median nitrate vasodilator drug (10.2%).
91.6% of the reports are marked serious by the reporter (85.3% across the class); 13.7% record death among the outcomes and 51.1% record hospitalisation, as reported. 29% of the reports came from consumers, and the largest patient age group is 75 and over (31.3%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Isosorbide mononitrate reports recording the termmedian drug in nitrate vasodilator
- Dizzinesslight-headedness or unsteadiness22.1%702
- Headachehead pain17.7%562
- Chest painchest pain16.8%533
- Nauseafeeling sick16.4%520
- Dyspnoeashortness of breath16.1%509
- Hypotensionlow blood pressure15.4%488
- Diarrhoealoose or frequent stools15.3%485
- Fatiguetiredness14.6%463
- Myocardial infarctionheart attack14.5%460
- Pruritusitching13.9%442
- Dehydrationdehydration13.7%435
- Arthralgiajoint pain13.6%431
- Insomniadifficulty sleeping13.5%428
- Vomitingbeing sick13.3%423
- Malaisegeneral feeling of being unwell13.3%421
- Cognitive disorderproblems with thinking or memory13%412
- Subarachnoid haemorrhage12.8%407
- Painpain, site not specified12.7%404
- Palpitationsawareness of the heartbeat12.7%403
- Visual impairmentreduced vision12.6%400
- Abdominal pain upperupper stomach pain12.5%397
- Off label useused for a purpose or in a way not on the label12.5%397
- Heart rate increaseda fast heart rate reading12.4%393
- Abdominal discomfortstomach discomfort12.4%392
- Feeling abnormalfeeling odd or not right12.3%391
- Hyperhidrosisexcessive sweating12.3%391
- Amnesiamemory loss12.3%390
- Angioedemadeep swelling of skin or mucous membranes12.3%390
- Ventricular tachycardiaa fast rhythm from the lower heart chambers12.3%389
- Muscular weaknessmuscle weakness12.2%386
Top 30 of 701 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 5 drugs in the nitrate vasodilator class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 11,960 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 39.3% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Angina pectoris | 310 | 9.8% |
| Cardiac disorder | 120 | 3.8% |
| Coronary artery disease | 119 | 3.8% |
| Hypertension | 113 | 3.6% |
| Chest pain | 40 | 1.3% |
| Prinzmetal angina | 39 | 1.2% |
The indication field is filled in by the reporter and is often blank; shares are of all 3,171 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Isosorbide mononitrate reports |
|---|---|---|
| Aspirin | 770 | 24.3% |
| Omeprazole | 646 | 20.4% |
| Bisoprolol | 581 | 18.3% |
| Simvastatin | 571 | 18% |
| Furosemide | 557 | 17.6% |
| Lansoprazole | 544 | 17.2% |
| Atorvastatin | 533 | 16.8% |
| Digoxin | 512 | 16.1% |
| Hydrochlorothiazide | 496 | 15.6% |
| Levothyroxine sodium | 446 | 14.1% |
Other products listed in reports where Isosorbide mononitrate is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Isosorbide mononitrate | Nitrate vasodilator | All reports |
|---|---|---|---|
| Reports as suspect product | 3,171 | 11,960 | 20,646,523 |
| Share of that pool | — | 26.5% | 0% |
| Reports, latest 12 months | 174 | — | 1,332,454 |
| Marked serious | 91.6% | 85.3% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 137 | 149 | 91 |
| Hospitalisation recorded, per 1,000 reports | 511 | 457 | 213 |
| Consumer-filed share | 29% | 25% | 45.8% |
| Top term, share of reports | Dizziness 22.1% | median 10.2% | 2.4% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the nitrate vasodilator class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Nitroglycerin | generic | 6,041 | 356 | 85.5% |
| Isosorbide dinitrate | generic | 1,322 | 59 | 93.9% |
| Nitrostat | brand | 823 | 1 | 49.3% |
| Isosorbide | brand | 603 | 37 | 80.4% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Isosorbide mononitrate reports
How many adverse event reports has FDA received for Isosorbide mononitrate?
3,171 reports list Isosorbide mononitrate as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 174 of them arrived in the latest 12 months. Another 17,935 list it only as a concomitant medication.
What reactions are recorded in Isosorbide mononitrate reports?
dizziness (22.1%), headache (17.7%), chest pain (16.8%), nausea (16.4%) and dyspnoea (16.1%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Isosorbide mononitrate was responsible.
How serious are the reports?
91.6% are marked serious by the reporter. Among the outcomes recorded, 13.7% of reports include death and 51.1% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (29%), other health professional (28.9%) and physician (26.2%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Isosorbide mononitrate rising?
174 reports in the 12 months to June 2026, up 21% from 144 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Isosorbide mononitrate was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Isosorbide mononitrate?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Isosorbide mononitrate as a suspect or interacting product; reports listing it only as a concomitant medication (17,935) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.