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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

NICORANDIL: 646 Adverse Event Reports & Safety Profile

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646
Total FAERS Reports
71 (11.0%)
Deaths Reported
402
Hospitalizations
646
As Primary/Secondary Suspect
87
Life-Threatening
8
Disabilities

First Report: 19980321 · Latest Report: 20250717

What Are the Most Common NICORANDIL Side Effects?

#1 Most Reported
Hypotension
90 reports (13.9%)
#2 Most Reported
Acute kidney injury
63 reports (9.8%)
#3 Most Reported
Fall
47 reports (7.3%)

All NICORANDIL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Hypotension 90 13.9% 13 64
Acute kidney injury 63 9.8% 1 44
Fall 47 7.3% 0 39
Dizziness 37 5.7% 0 35
Intentional overdose 34 5.3% 7 23
Diarrhoea 30 4.6% 4 20
Malaise 27 4.2% 10 16
Toxicity to various agents 27 4.2% 7 11
Cardiac arrest 26 4.0% 3 20
Lactic acidosis 24 3.7% 6 3
Drug ineffective 23 3.6% 5 15
Rectal haemorrhage 23 3.6% 0 17
Orthostatic hypotension 22 3.4% 4 17
Bradycardia 21 3.3% 0 17
Dyspnoea 21 3.3% 2 17
Eosinophilia 21 3.3% 0 6
Head injury 21 3.3% 14 7
Off label use 21 3.3% 6 9
Hypoglycaemia 20 3.1% 0 11
Upper gastrointestinal haemorrhage 20 3.1% 0 20

Who Reports NICORANDIL Side Effects? Age & Gender Data

Gender: 46.0% female, 54.0% male. Average age: 75.4 years. Most reports from: FR. View detailed demographics →

Is NICORANDIL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2002 1 0 1
2007 6 1 4
2008 7 0 6
2009 7 0 7
2010 3 0 3
2011 13 0 13
2012 8 2 3
2013 40 7 21
2014 18 9 10
2015 32 4 25
2016 52 5 41
2017 61 6 51
2018 51 1 37
2019 78 25 30
2020 7 0 3
2021 29 1 13
2022 29 0 15
2023 23 3 8
2024 13 0 3
2025 4 0 3

View full timeline →

What Is NICORANDIL Used For?

IndicationReports
Product used for unknown indication 266
Angina pectoris 128
Myocardial ischaemia 27
Prinzmetal angina 13
Hypertension 11
Angina unstable 10
Coronary artery disease 10
Coronary artery insufficiency 8
Cardiac disorder 7
Atrial fibrillation 5

NICORANDIL vs Alternatives: Which Is Safer?

NICORANDIL vs NICORETTE OTC NICORANDIL vs NICORETTE OTC, UNSPECIFIED NICORANDIL vs NICOTINE NICORANDIL vs NIFEDIPINE NICORANDIL vs NILOTINIB NICORANDIL vs NIMESULIDE NICORANDIL vs NIMODIPINE NICORANDIL vs NINTEDANIB NICORANDIL vs NINTEDANIB ESYLATE NICORANDIL vs NIRAPARIB

Official FDA Label for NICORANDIL

Official prescribing information from the FDA-approved drug label.