ISOSORBIDE: 526 Adverse Event Reports & Safety Profile
Lower Your Cholesterol — The Natural Way
The Oxidized Cholesterol Strategy: a science-backed plan for heart health.
526
Total FAERS Reports
78 (14.8%)
Deaths Reported
255
Hospitalizations
526
As Primary/Secondary Suspect
44
Life-Threatening
19
Disabilities
Approved Prior to Jan 1, 1982
FDA Approved
Discontinued
Status
FDA Application: 017063 ·
First Report: 20001231 · Latest Report: 20250601
What Are the Most Common ISOSORBIDE Side Effects?
#1 Most Reported
Headache
47 reports (8.9%)
#2 Most Reported
Hypotension
41 reports (7.8%)
#3 Most Reported
Dyspnoea
40 reports (7.6%)
All ISOSORBIDE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Headache | 47 | 8.9% | 0 | 18 |
| Hypotension | 41 | 7.8% | 5 | 24 |
| Dyspnoea | 40 | 7.6% | 0 | 17 |
| Dizziness | 39 | 7.4% | 0 | 16 |
| Drug hypersensitivity | 39 | 7.4% | 0 | 2 |
| Off label use | 39 | 7.4% | 1 | 35 |
| Chest pain | 37 | 7.0% | 0 | 23 |
| Subarachnoid haemorrhage | 35 | 6.7% | 0 | 35 |
| Completed suicide | 31 | 5.9% | 31 | 16 |
| Fatigue | 30 | 5.7% | 0 | 14 |
| Pain | 30 | 5.7% | 0 | 12 |
| Intentional product misuse | 29 | 5.5% | 0 | 27 |
| Malaise | 25 | 4.8% | 0 | 12 |
| Drug ineffective | 23 | 4.4% | 1 | 7 |
| Toxicity to various agents | 23 | 4.4% | 18 | 18 |
| Medication error | 22 | 4.2% | 16 | 11 |
| Myocardial infarction | 21 | 4.0% | 0 | 15 |
| Nausea | 21 | 4.0% | 0 | 12 |
| Asthenia | 20 | 3.8% | 0 | 6 |
| Intentional product use issue | 20 | 3.8% | 0 | 20 |
Who Reports ISOSORBIDE Side Effects? Age & Gender Data
Gender: 62.5% female, 37.5% male. Average age: 70.2 years. Most reports from: US. View detailed demographics →
Is ISOSORBIDE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2000 | 1 | 0 | 1 |
| 2001 | 3 | 0 | 0 |
| 2004 | 1 | 0 | 1 |
| 2008 | 1 | 0 | 1 |
| 2010 | 5 | 0 | 1 |
| 2012 | 2 | 0 | 0 |
| 2013 | 3 | 0 | 1 |
| 2014 | 7 | 0 | 2 |
| 2015 | 24 | 0 | 19 |
| 2016 | 22 | 2 | 17 |
| 2017 | 16 | 1 | 4 |
| 2018 | 42 | 0 | 28 |
| 2019 | 25 | 0 | 17 |
| 2020 | 28 | 14 | 12 |
| 2021 | 14 | 7 | 5 |
| 2022 | 14 | 0 | 5 |
| 2023 | 32 | 4 | 21 |
| 2024 | 7 | 0 | 3 |
| 2025 | 3 | 0 | 2 |
What Is ISOSORBIDE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 257 |
| Angina pectoris | 19 |
| Hypertension | 19 |
| Prophylaxis | 17 |
| Cardiac disorder | 11 |
| Myocardial ischaemia | 10 |
| Angiocardiogram | 9 |
| Chest pain | 9 |
| Acute myocardial infarction | 6 |
| Cardiac failure | 6 |
ISOSORBIDE vs Alternatives: Which Is Safer?
ISOSORBIDE vs ISOSORBIDE DINITRATE
ISOSORBIDE vs ISOSORBIDE MONONITRATE
ISOSORBIDE vs ISOTRETINOIN
ISOSORBIDE vs ISRADIPINE
ISOSORBIDE vs ISTRADEFYLLINE
ISOSORBIDE vs ITACITINIB
ISOSORBIDE vs ITRACONAZOLE
ISOSORBIDE vs ITRACONAZOLE\SODIUM
ISOSORBIDE vs IVABRADINE
ISOSORBIDE vs IVACAFTOR
Official FDA Label for ISOSORBIDE
Official prescribing information from the FDA-approved drug label.