ACENOCOUMAROL: 1,240 Adverse Event Reports & Safety Profile
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1,240
Total FAERS Reports
182 (14.7%)
Deaths Reported
852
Hospitalizations
1,240
As Primary/Secondary Suspect
111
Life-Threatening
20
Disabilities
First Report: 19920228 · Latest Report: 20250514
What Are the Most Common ACENOCOUMAROL Side Effects?
#1 Most Reported
International normalised ratio increased
143 reports (11.5%)
#2 Most Reported
Drug interaction
129 reports (10.4%)
#3 Most Reported
Anaemia
109 reports (8.8%)
All ACENOCOUMAROL Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| International normalised ratio increased | 143 | 11.5% | 9 | 105 |
| Drug interaction | 129 | 10.4% | 19 | 91 |
| Anaemia | 109 | 8.8% | 7 | 99 |
| Drug ineffective | 95 | 7.7% | 32 | 60 |
| Off label use | 65 | 5.2% | 4 | 55 |
| Cardiac failure | 63 | 5.1% | 20 | 52 |
| Haematoma | 61 | 4.9% | 3 | 57 |
| Hypotension | 59 | 4.8% | 3 | 44 |
| Condition aggravated | 56 | 4.5% | 20 | 27 |
| Dyspnoea | 54 | 4.4% | 16 | 42 |
| Fatigue | 51 | 4.1% | 8 | 16 |
| Epistaxis | 50 | 4.0% | 5 | 20 |
| Diarrhoea | 47 | 3.8% | 14 | 34 |
| Acute kidney injury | 45 | 3.6% | 2 | 40 |
| Gastrointestinal haemorrhage | 38 | 3.1% | 7 | 32 |
| Respiratory tract infection | 38 | 3.1% | 18 | 38 |
| Vomiting | 38 | 3.1% | 4 | 18 |
| Atrial fibrillation | 37 | 3.0% | 8 | 21 |
| Confusional state | 36 | 2.9% | 17 | 29 |
| Upper gastrointestinal haemorrhage | 36 | 2.9% | 3 | 36 |
Who Reports ACENOCOUMAROL Side Effects? Age & Gender Data
Gender: 44.6% female, 55.4% male. Average age: 72.6 years. Most reports from: ES. View detailed demographics →
Is ACENOCOUMAROL Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2001 | 10 | 7 | 0 |
| 2006 | 2 | 0 | 2 |
| 2007 | 21 | 15 | 5 |
| 2009 | 2 | 0 | 2 |
| 2010 | 1 | 0 | 1 |
| 2011 | 6 | 1 | 2 |
| 2012 | 13 | 2 | 12 |
| 2013 | 24 | 5 | 20 |
| 2014 | 100 | 16 | 74 |
| 2015 | 90 | 24 | 78 |
| 2016 | 110 | 9 | 82 |
| 2017 | 109 | 9 | 71 |
| 2018 | 74 | 12 | 58 |
| 2019 | 62 | 5 | 45 |
| 2020 | 50 | 3 | 42 |
| 2021 | 44 | 12 | 23 |
| 2022 | 24 | 1 | 20 |
| 2023 | 16 | 3 | 12 |
| 2024 | 12 | 2 | 8 |
| 2025 | 6 | 0 | 2 |
What Is ACENOCOUMAROL Used For?
| Indication | Reports |
|---|---|
| Atrial fibrillation | 320 |
| Product used for unknown indication | 315 |
| Anticoagulant therapy | 120 |
| Thrombosis prophylaxis | 43 |
| Arrhythmia | 42 |
| Pulmonary embolism | 31 |
| Deep vein thrombosis | 24 |
| Antiplatelet therapy | 21 |
| Pulmonary arterial hypertension | 18 |
| Cardiac disorder | 15 |
ACENOCOUMAROL vs Alternatives: Which Is Safer?
ACENOCOUMAROL vs ACEON
ACENOCOUMAROL vs ACETAMINOPHEN
ACENOCOUMAROL vs ACETAMINOPHEN AND OR DEXTROMETHORPHAN AND OR DIPHENHYDRAMINE AND OR GUAIFENESIN AND OR PHENYLEPHRINE AND OR PSEUDOEPHEDRINE
ACENOCOUMAROL vs ACETAMINOPHEN W/HYDROCODONE
ACENOCOUMAROL vs ACETAMINOPHEN\ASPIRIN\CAFFEINE
ACENOCOUMAROL vs ACETAMINOPHEN\ASPIRIN\CAFFEINE\SALICYLAMIDE
ACENOCOUMAROL vs ACETAMINOPHEN\BELLADONNA LEAF\CAFFEINE\OPIUM
ACENOCOUMAROL vs ACETAMINOPHEN\BUTALBITAL
ACENOCOUMAROL vs ACETAMINOPHEN\BUTALBITAL\CAFFEINE
ACENOCOUMAROL vs ACETAMINOPHEN\BUTALBITAL\CAFFEINE\CODEINE
Official FDA Label for ACENOCOUMAROL
Official prescribing information from the FDA-approved drug label.