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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.

PHENPROCOUMON: 1,387 Adverse Event Reports & Safety Profile

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1,387
Total FAERS Reports
140 (10.1%)
Deaths Reported
1,068
Hospitalizations
1,387
As Primary/Secondary Suspect
214
Life-Threatening
22
Disabilities
Approved Prior to Jan 1, 1982
FDA Approved
Discontinued
Status

FDA Application: 011228 ·

First Report: 19990501 · Latest Report: 20250105

What Are the Most Common PHENPROCOUMON Side Effects?

#1 Most Reported
Anaemia
242 reports (17.4%)
#2 Most Reported
General physical health deterioration
172 reports (12.4%)
#3 Most Reported
Haematochezia
162 reports (11.7%)

All PHENPROCOUMON Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Anaemia 242 17.5% 1 230
General physical health deterioration 172 12.4% 4 171
Haematochezia 162 11.7% 5 162
Dyspnoea 140 10.1% 6 130
Gastrointestinal haemorrhage 122 8.8% 29 68
Overdose 109 7.9% 13 96
Dizziness 108 7.8% 11 87
Haematoma 108 7.8% 24 76
Product prescribing error 104 7.5% 4 101
Fall 92 6.6% 5 87
International normalised ratio increased 81 5.8% 4 57
Product monitoring error 76 5.5% 0 76
Haemorrhage 67 4.8% 5 47
Atrial fibrillation 66 4.8% 2 63
Nausea 63 4.5% 2 61
Oedema peripheral 63 4.5% 2 60
Haemoglobin decreased 61 4.4% 2 57
Drug interaction 59 4.3% 15 29
Renal failure 58 4.2% 35 24
Acute kidney injury 56 4.0% 6 40

Who Reports PHENPROCOUMON Side Effects? Age & Gender Data

Gender: 45.8% female, 54.2% male. Average age: 71.3 years. Most reports from: DE. View detailed demographics →

Is PHENPROCOUMON Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 1 0 1
2003 15 7 8
2005 10 1 10
2007 5 1 4
2008 1 0 1
2009 8 0 7
2010 8 0 6
2011 9 1 8
2012 6 1 4
2013 40 3 31
2014 49 3 43
2015 104 16 77
2016 53 7 45
2017 137 24 106
2018 61 2 41
2019 42 9 29
2020 69 1 58
2021 65 11 43
2022 15 1 12
2023 5 0 3
2024 7 2 2
2025 1 0 0

View full timeline →

What Is PHENPROCOUMON Used For?

IndicationReports
Product used for unknown indication 707
Atrial fibrillation 182
Anticoagulant therapy 90
Thrombosis prophylaxis 28
Cardiac disorder 24
Pulmonary embolism 16
Deep vein thrombosis 11
Heart valve replacement 11
Mitral valve replacement 11
Factor v deficiency 10

PHENPROCOUMON vs Alternatives: Which Is Safer?

PHENPROCOUMON vs PHENTERMINE PHENPROCOUMON vs PHENTERMINE\TOPIRAMATE PHENPROCOUMON vs PHENTOLAMINE PHENPROCOUMON vs PHENYLEPHRINE PHENPROCOUMON vs PHENYLEPHRINE\PHENYLEPHRINE PHENPROCOUMON vs PHENYLPROPANOLAMINE PHENPROCOUMON vs PHENYTOIN PHENPROCOUMON vs PHLEUM PRATENSE POLLEN PHENPROCOUMON vs PHLOROGLUCINOL PHENPROCOUMON vs PHLOROGLUCINOL\1,3,5-TRIMETHOXYBENZENE

Official FDA Label for PHENPROCOUMON

Official prescribing information from the FDA-approved drug label.