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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.

FLUINDIONE: 2,174 Adverse Event Reports & Safety Profile

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2,174
Total FAERS Reports
459 (21.1%)
Deaths Reported
1,440
Hospitalizations
2,174
As Primary/Secondary Suspect
305
Life-Threatening
19
Disabilities

First Report: 19790101 · Latest Report: 20250125

What Are the Most Common FLUINDIONE Side Effects?

#1 Most Reported
International normalised ratio increased
286 reports (13.2%)
#2 Most Reported
Acute kidney injury
269 reports (12.4%)
#3 Most Reported
Anaemia
222 reports (10.2%)

All FLUINDIONE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
International normalised ratio increased 286 13.2% 45 220
Acute kidney injury 269 12.4% 61 165
Anaemia 222 10.2% 40 160
Shock haemorrhagic 133 6.1% 88 43
Haematoma 126 5.8% 12 96
Hyperkalaemia 106 4.9% 23 46
Melaena 97 4.5% 23 79
Interstitial lung disease 86 4.0% 12 55
Drug interaction 84 3.9% 13 67
Lactic acidosis 81 3.7% 38 19
Rectal haemorrhage 78 3.6% 19 71
Cerebral haematoma 66 3.0% 25 29
Overdose 62 2.9% 16 37
Subdural haematoma 61 2.8% 29 27
Cerebral haemorrhage 60 2.8% 42 21
Bradycardia 56 2.6% 12 29
Renal failure 56 2.6% 31 30
Cholestasis 52 2.4% 5 39
Hypotension 52 2.4% 31 20
Diarrhoea 48 2.2% 11 12

Who Reports FLUINDIONE Side Effects? Age & Gender Data

Gender: 40.8% female, 59.2% male. Average age: 75.4 years. Most reports from: FR. View detailed demographics →

Is FLUINDIONE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2004 5 0 5
2005 2 0 2
2006 9 1 6
2007 6 1 6
2008 12 0 10
2009 9 1 9
2010 15 6 14
2011 12 4 12
2012 56 13 39
2013 46 5 30
2014 190 25 157
2015 215 51 169
2016 141 26 114
2017 270 64 159
2018 385 66 252
2019 217 68 136
2020 144 18 65
2021 92 32 49
2022 86 34 40
2023 64 1 59
2024 37 5 23
2025 1 0 0

View full timeline →

What Is FLUINDIONE Used For?

IndicationReports
Atrial fibrillation 874
Product used for unknown indication 346
Thrombosis prophylaxis 130
Pulmonary embolism 92
Anticoagulant therapy 44
Deep vein thrombosis 40
Arrhythmia 36
Prophylaxis 34
Myocardial ischaemia 30
Thrombosis 24

FLUINDIONE vs Alternatives: Which Is Safer?

FLUINDIONE vs FLUMAZENIL FLUINDIONE vs FLUMETHASONE FLUINDIONE vs FLUMETHASONE PIVALATE FLUINDIONE vs FLUMETHASONE\SALICYLIC ACID FLUINDIONE vs FLUNARIZINE FLUINDIONE vs FLUNISOLIDE FLUINDIONE vs FLUNITRAZEPAM FLUINDIONE vs FLUOCINOLONE FLUINDIONE vs FLUOCINOLONE ACETONIDE FLUINDIONE vs FLUOCINOLONE ACETONIDE\HYDROQUINONE\TRETINOIN

Official FDA Label for FLUINDIONE

Official prescribing information from the FDA-approved drug label.