Drug Safety Information for IMDUR (Isosorbide mononitrate)

Adverse Drug Reactions for IMDUR* (Isosorbide mononitrate)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with IMDUR
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Myocardial infarction1197
2Dyspnoea1039
3Chest pain922
4Cardiac failure congestive921
5Dizziness*799
6Nausea777
7Asthenia630
8Hypotension*600
9Fatigue*591
10Pain585
11Diarrhoea558
12Coronary artery disease558
13Fall544
14Renal failure acute508
15Renal failure505
16Vomiting*499
17Pneumonia476
18Product quality issue470
19Anaemia451
20Headache*439

* This side effect also appears in "Top 10 Side Effects of IMDUR " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking IMDUR
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication6775
2Angina pectoris*2589
3Cardiac disorder1782
4Hypertension1075
5Chest pain756
6Coronary artery disease660
7Myocardial ischaemia461
8Ill-defined disorder315
9Prophylaxis264
10Blood pressure173

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for IMDUR

Total Reports Filed with FDA: 73143


Number of FDA Adverse Event Reports by Patient Age for IMDUR

Total Reports Filed with FDA: 73143*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Isosorbide mononitrate (Imdur, Mononit, Elantan, Ismo, Monoket)

Charts are based on 73143 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and IMDUR Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.