Isosorbide Mononitrate

Common brands: Aspirin 325, Aspirin 81, Ecotrin, Bayer Low Dose, Aspirin Enteric Coated

Top reporter: Ani Pharmaceuticals, Inc.

Nitrate Vasodilator [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]Platelet Aggregation Inhibitor [EPC]Loop Diuretic [EPC]Proton Pump Inhibitor [EPC]
20,264
Total Reports
7,762
Serious Reports
2,572
Death Reports
30
Reported Reactions
Death Report Ratio: High (12.69%)

Patient Demographics

Male
10,097
Female
8,628

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Isosorbide Mononitrate.

# Reaction Reports % of Total
1 DYSPNOEA 1,523
5.8%
2 DIZZINESS 1,420
5.4%
3 DIARRHOEA 1,273
4.9%
4 FATIGUE 1,271
4.9%
5 NAUSEA 1,246
4.8%
6 CHEST PAIN 1,193
4.6%
7 MYOCARDIAL INFARCTION 1,035
4.0%
8 HEADACHE 1,029
3.9%
9 VOMITING 954
3.7%
10 HYPOTENSION 914
3.5%
11 MALAISE 907
3.5%
12 ACUTE KIDNEY INJURY 899
3.4%
13 OFF LABEL USE 874
3.4%
14 PAIN 859
3.3%
15 FALL 835
3.2%
16 ARTHRALGIA 765
2.9%
17 PRURITUS 735
2.8%
18 DRUG INTERACTION 714
2.7%
19 DEHYDRATION 684
2.6%
20 DEATH 683
2.6%
21 ASTHENIA 665
2.5%
22 BACK PAIN 655
2.5%
23 RENAL FAILURE 655
2.5%
24 PYREXIA 639
2.4%
25 DRUG INEFFECTIVE 628
2.4%
26 INSOMNIA 625
2.4%
27 CHRONIC KIDNEY DISEASE 608
2.3%
28 PERIPHERAL SWELLING 605
2.3%
29 ANXIETY 602
2.3%
30 ABDOMINAL PAIN UPPER 591
2.3%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.