Drug side effects
isosorbide mononitrate Side Effects
The reactions most often reported to the FDA for isosorbide mononitrate (also sold as Imdur), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 19,947
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 2002 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.
The most commonly reported side effects of isosorbide mononitrate come from 19,947 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 19,947 reports to the FDA Adverse Event Reporting System (FAERS) for isosorbide mononitrate (Imdur): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.
Total Reports
19,947
Reports Mentioning Death
2,526
12.7% of reports — not proof the medicine caused the death
Hospitalizations
9,610
48.2% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 2,526 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 671 |
| ACUTE KIDNEY INJURY | 192 |
| RENAL FAILURE | 168 |
| PNEUMONIA | 164 |
| MYOCARDIAL INFARCTION | 162 |
| CARDIAC ARREST | 158 |
| CARDIAC FAILURE CONGESTIVE | 142 |
| CARDIAC FAILURE | 135 |
| DYSPNOEA | 126 |
| CHRONIC KIDNEY DISEASE | 125 |
| DIARRHOEA | 118 |
| NAUSEA | 113 |
| HYPOTENSION | 105 |
| SEPSIS | 104 |
| FALL | 102 |
| MULTIPLE ORGAN DYSFUNCTION SYNDROME | 92 |
| ASTHENIA | 90 |
| END STAGE RENAL DISEASE | 88 |
| GASTROINTESTINAL HAEMORRHAGE | 83 |
| PRODUCT QUALITY ISSUE | 79 |
Reactions in Hospitalization Reports
Top reactions in 9,610 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| DYSPNOEA | 786 |
| CHEST PAIN | 660 |
| DIZZINESS | 656 |
| HYPOTENSION | 641 |
| FALL | 615 |
| ACUTE KIDNEY INJURY | 582 |
| MYOCARDIAL INFARCTION | 575 |
| NAUSEA | 550 |
| DIARRHOEA | 539 |
| DRUG INTERACTION | 477 |
| VOMITING | 474 |
| PNEUMONIA | 465 |
| FATIGUE | 448 |
| CARDIAC FAILURE CONGESTIVE | 393 |
| MALAISE | 392 |
| DEHYDRATION | 384 |
| ATRIAL FIBRILLATION | 359 |
| ANAEMIA | 347 |
| ASTHENIA | 347 |
| HEADACHE | 338 |
Nearby, Related Medications
What the FAERS Data Reveals About isosorbide mononitrate Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 19,947 voluntary reports linked to isosorbide mononitrate and its brand equivalents (Imdur), spanning 2002 through 2025. Of those, 2,526 (12.7%) listed death as an outcome and 9,610 (48.2%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 46% were female and 54% male; age distribution skews toward 75+, with 6,516 reports in that bracket. The single most reported reaction is dyspnoea with 1,503 submissions, followed by dizziness and diarrhoea.
How to read these numbers
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice, speak with a licensed clinician about any side-effect concerns.
Drugs With a Similar FAERS Report Volume
Other medications with a total FDA adverse-event report count closest to isosorbide mononitrate's 19,947.
Read our methodology - how this data is sourced, computed, and verified.