isosorbide dinitrate Side Effects
Also known as: Isordil
Analysis of 19,058 adverse event reports submitted to the FDA from 1996 to 2025.
Total Reports
19,058
Death-Related
2,531
13.3% of reports
Hospitalizations
8,172
42.9% 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 2,531 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 784 |
| RENAL FAILURE | 224 |
| CARDIAC FAILURE CONGESTIVE | 205 |
| PNEUMONIA | 198 |
| MYOCARDIAL INFARCTION | 173 |
| DYSPNOEA | 167 |
| CARDIAC ARREST | 138 |
| ACUTE KIDNEY INJURY | 129 |
| CARDIAC FAILURE | 127 |
| CHRONIC KIDNEY DISEASE | 120 |
| ASTHENIA | 116 |
| NAUSEA | 112 |
| RESPIRATORY FAILURE | 109 |
| HYPOTENSION | 104 |
| PAIN | 101 |
| DIARRHOEA | 99 |
| CARDIO-RESPIRATORY ARREST | 97 |
| ANAEMIA | 96 |
| ATRIAL FIBRILLATION | 95 |
| COMPLETED SUICIDE | 95 |
Reactions in Hospitalization Reports
Top reactions in 8,172 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| DYSPNOEA | 804 |
| MYOCARDIAL INFARCTION | 713 |
| CHEST PAIN | 619 |
| CARDIAC FAILURE CONGESTIVE | 563 |
| NAUSEA | 557 |
| DIZZINESS | 553 |
| PNEUMONIA | 553 |
| DIARRHOEA | 486 |
| FATIGUE | 481 |
| VOMITING | 470 |
| ASTHENIA | 449 |
| FALL | 446 |
| RENAL FAILURE | 414 |
| HYPOTENSION | 412 |
| PAIN | 394 |
| PYREXIA | 364 |
| ACUTE KIDNEY INJURY | 363 |
| MALAISE | 363 |
| DEHYDRATION | 347 |
| ANAEMIA | 346 |
Nearby — Related Medications
What the FAERS Data Reveals About isosorbide dinitrate Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 19,058 voluntary reports linked to isosorbide dinitrate and its brand equivalents (Isordil), spanning 1996 through 2025. Of those, 2,531 (13.3%) listed death as an outcome and 8,172 (42.9%) 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, 47% were female and 53% male; age distribution skews toward 75+, with 5,434 reports in that bracket. The single most reported reaction is dyspnoea with 1,608 submissions, followed by nausea and fatigue.
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.
Read our methodology — how this data is sourced, computed, and verified.