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Warfarin (Warfarin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Warfarin and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (29)
Death (5)
Life Threatening Events (4)

Reports by Reaction Type

International Normalised Ratio Increased (9)Drug Interaction (6)Drug Ineffective (2)Skin Exfoliation (2)Pyrexia (2)Completed Suicide (2)Hallucination (2)Toxicity To Various Agents (2)Renal Impairment (2)Diarrhoea (2)Rhabdomyolysis (1)Infection (1)

Possible Warfarin side effects in 51 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23

Patient: 51 year old female

Reactions: International Normalised Ratio Abnormal, Lower Gastrointestinal Haemorrhage, Gastritis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Ibuprofen
    Dosage: unk
    Indication: Back Pain

Warfarin
    Indication: Product Used FOR Unknown Indication



Possible Warfarin side effects in 62 year old male

Reported by a physician from Portugal on 2012-08-15

Patient: 62 year old male, weighing 70.0 kg (154.0 pounds)

Reactions: Product Quality Issue, Product Substitution Issue, Ischaemic Stroke, Drug Interaction, Hemiparesis, Hemianopia, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Simvastatin
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Carvedilol
    Dosage: 25 mg/day
    Administration route: Oral
    Indication: Hypertension

Captopril
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Potassium Chloride
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Spironolactone
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Acetylsalicylic Acid SRT
    Dosage: 300 mg, unk
    Administration route: Oral
    Indication: Transient Ischaemic Attack

Diazepam
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Warfarin
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Nifedipine
    Dosage: 30 mg, 2x/day
    Indication: Product Used FOR Unknown Indication

Enalapril
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Amlodipine
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Enoxaparin
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Lisinopril Dihydrate; Irbesartan and Hydrochlorothiazide; Rilmenidine



Possible Warfarin side effects in 75 year old male

Reported by a pharmacist from United Kingdom on 2012-08-01

Patient: 75 year old male

Reactions: Haemorrhage, International Normalised Ratio Increased, Drug Interaction

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Benylin Chesty Cough
    Administration route: Oral
    Indication: Cough

Warfarin
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Bisoprolol Fumarate; Spironolactone; Atorvastatin; Folic Acid; Colchicine



Possible Warfarin side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-01

Patient:

Reactions: Haemoglobin Decreased, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, International Normalised Ratio Increased, Drug Interaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cymbalta
    Dosage: 50 mg, qd

Acetaminophen
    Dosage: 650 mg, qid
    Administration route: Oral

Warfarin
    Dosage: 1-6 mg, qd
    Administration route: Oral

Zocor
    Dosage: 20 mg, qd
    Administration route: Oral



Possible Warfarin side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-31

Patient: female

Reactions: Thrombosis, Diarrhoea, Dehydration, International Normalised Ratio Increased, Muscular Weakness

Drug(s) suspected as cause:
Xalkori
    Dosage: unk

Warfarin
    Dosage: unk

Xalkori
    Dosage: 250 mg, 2x/day
    Administration route: Oral
    Indication: Lung Neoplasm Malignant
    Start date: 2012-04-03



Possible Warfarin side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-12

Patient: female

Reactions: Drug Ineffective, Drug Interaction, Pulmonary Oedema, Shock

Drug(s) suspected as cause:
Warfarin

Cephalexin
    Indication: Pulmonary Oedema

Other drugs received by patient possibly interacting with the suspect drug:
Dofetilide

Azithromycin
    Indication: Pulmonary Oedema



Possible Warfarin side effects in 79 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-06-11

Patient: 79 year old female

Reactions: Skin Exfoliation

Drug(s) suspected as cause:
Amiodarone Hydrochloride
    Dosage: unk

Nicorandil
    Dosage: unk
    Administration route: Oral

Warfarin
    Dosage: unk
    Administration route: Oral

Diltiazem HCL
    Dosage: 100 mg, unk
    Administration route: Oral
    Start date: 2012-04-01
    End date: 2012-05-01



Possible Warfarin side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-08

Patient: female, weighing 113.0 kg (248.6 pounds)

Reactions: Gingival Recession, Stomatitis, Tongue Disorder

Drug(s) suspected as cause:
Nicotrol
    Dosage: 4 cartridges of 4 mg
    Start date: 2012-05-06
    End date: 2012-05-07

Nicotrol
    Dosage: 3 cartridges of 4 mg
    Indication: Smoking Cessation Therapy
    Start date: 2012-05-05
    End date: 2012-05-05

Nicotrol
    Dosage: 3 cartridges of 4 mg
    Start date: 2012-05-08
    End date: 2012-05-08

Warfarin
    Dosage: unk
    Indication: Anticoagulant Therapy



Possible Warfarin side effects in 79 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-06-04

Patient: 79 year old female

Reactions: Skin Exfoliation

Drug(s) suspected as cause:
Diltiazem HCL
    Dosage: 100 mg, unk
    Administration route: Oral
    Start date: 2012-04-01
    End date: 2012-05-01

Nicorandil
    Dosage: unk
    Administration route: Oral

Warfarin
    Dosage: unk
    Administration route: Oral

Amiodarone Hydrochloride
    Dosage: unk



Possible Warfarin side effects in 40 year old male

Reported by a physician from Japan on 2012-05-31

Patient: 40 year old male, weighing 69.0 kg (151.8 pounds)

Reactions: International Normalised Ratio Increased

Drug(s) suspected as cause:
Zyvox
    Dosage: 600 mg, 2x/day
    Indication: Graft Infection
    Start date: 2011-09-16
    End date: 2011-10-04

Warfarin
    Dosage: 4 mg/day
    Administration route: Oral
    Start date: 2011-09-13
    End date: 2011-09-15

Warfarin
    Dosage: unk
    Start date: 2011-09-08

Warfarin
    Dosage: 4.5 mg/day
    Administration route: Oral
    Start date: 2011-09-16
    End date: 2011-09-17

Warfarin
    Dosage: 5 mg/day
    Administration route: Oral
    Start date: 2011-09-18
    End date: 2011-09-20

Other drugs received by patient: Verapamil HCL; Lansoprazole; Lopressor; Heparin



Possible Warfarin side effects in 65 year old male

Reported by a physician from United States on 2012-05-30

Patient: 65 year old male

Reactions: Cardio-Respiratory Arrest, Completed Suicide, Toxicity To Various Agents

Adverse event resulted in: death

Drug(s) suspected as cause:
Venlafaxine
    Dosage: unk
    Administration route: Oral

Lamotrigine
    Dosage: unk
    Administration route: Oral

Acetaminophen
    Dosage: unk
    Administration route: Oral

Alprazolam
    Dosage: unk
    Administration route: Oral

Propranolol HCL
    Dosage: unk
    Administration route: Oral

Modafinil
    Dosage: unk
    Administration route: Oral

Doxepin
    Dosage: unk
    Administration route: Oral

Warfarin
    Dosage: unk
    Administration route: Oral



Possible Warfarin side effects in 64 year old female

Reported by a physician from Japan on 2012-05-29

Patient: 64 year old female, weighing 59.0 kg (129.8 pounds)

Reactions: International Normalised Ratio Increased, Pancytopenia

Drug(s) suspected as cause:
Warfarin
    Dosage: 3.5 mg, daily
    Start date: 2011-11-04
    End date: 2011-11-17

Zyvox
    Dosage: 600 mg, 2x/day
    Indication: Endocarditis
    Start date: 2011-09-23
    End date: 2011-10-20

Warfarin
    Dosage: 2.5 mg, daily
    Start date: 2011-09-28
    End date: 2011-10-24

Warfarin
    Dosage: 3 mg, daily
    Start date: 2011-10-25
    End date: 2011-11-03

Other drugs received by patient: Meropenem; Lasix; Lasix; DAI-Kenchu-TO; Enalapril Maleate; Aldactone; Bisoprolol Fumarate; Magnesium Sulfate; Lansoprazole; Adona; Seroquel; Aspirin; Phenytoin Sodium CAP; Slow-K; Aldactone; Lanirapid; Lasix; Gasmotin; Carvedilol; Miya BM; Aldactone



Possible Warfarin side effects in 63 year old male

Reported by a physician from Japan on 2012-05-29

Patient: 63 year old male, weighing 68.8 kg (151.4 pounds)

Reactions: Renal Impairment, International Normalised Ratio Increased

Drug(s) suspected as cause:
Zyvox
    Dosage: 600 mg, 2x/day
    Indication: Endocarditis
    Start date: 2011-10-11
    End date: 2011-11-29

Rifadin
    Dosage: 600 mg, 1x/day
    Administration route: Oral
    Indication: Endocarditis
    Start date: 2011-10-14
    End date: 2011-12-10

Warfarin
    Dosage: unk
    Administration route: Oral
    Indication: Endocarditis
    Start date: 2011-09-29
    End date: 2011-12-10

Habekacin
    Dosage: 200 mg, 1x/day
    Indication: Endocarditis
    Start date: 2011-10-14
    End date: 2011-11-11

Other drugs received by patient: Gentamicin Sulfate; Celoop; Aspirin; Lasix; Cefazolin Sodium; Vancomycin; Magnesium Oxide Heavy; Aldactone; Miya BM; Rabeprazole Sodium; Gaslon; Avapro; Sigmart; Miya BM; Isosorbide Dinitrate; Lendormin



Possible Warfarin side effects in 75 year old male

Reported by a consumer/non-health professional from United Kingdom on 2012-04-18

Patient: 75 year old male

Reactions: Hallucination

Drug(s) suspected as cause:
Prednisolone
    Indication: Chronic Obstructive Pulmonary Disease

Albuterol

Ramipril

Warfarin
    Indication: Atrial Fibrillation

Formoterol Fumarate

Cysteine

Formoterol Fumarate

Metformin HCL

Verapamil
    Indication: Atrial Fibrillation

Furosemide

Atorvastatin

Other drugs received by patient: Spiriva; Symbicort



Possible Warfarin side effects in 95 year old male

Reported by a physician from Japan on 2012-04-16

Patient: 95 year old male

Reactions: Jaundice

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Warfarin
    Dosage: unk

Lipitor
    Dosage: unk
    Administration route: Oral

Lansoprazole
    Dosage: unk

Plavix
    Dosage: unk



Possible Warfarin side effects in male

Reported by a physician from United Kingdom on 2012-03-26

Patient: male

Reactions: Renal Impairment, Diarrhoea, Flatulence, Abdominal Distension

Drug(s) suspected as cause:
Warfarin
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2011-12-13
    End date: 2012-01-01

Warfarin
    Administration route: Oral

Other drugs received by patient: Lansoprazole; Lansoprazole; Warfarin



Possible Warfarin side effects in 75 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-03-22

Patient: 75 year old male

Reactions: Hallucination

Drug(s) suspected as cause:
Formoterol Fumarate
    Dosage: unk

Metformin HCL
    Dosage: unk

Atorvastatin
    Dosage: unk

Verapamil
    Dosage: unk

Cysteine
    Dosage: unk

Warfarin
    Dosage: unk

Albuterol
    Dosage: unk

Furosemide
    Dosage: unk

Prednisolone
    Dosage: unk

Ramipril
    Dosage: unk



Possible Warfarin side effects in 73 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-02-28

Patient: 73 year old female, weighing 98.0 kg (215.6 pounds)

Reactions: International Normalised Ratio Increased

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Warfarin
    Dosage: 10 mg, unk
    Administration route: Oral
    Indication: Pulmonary Embolism
    Start date: 2012-02-03
    End date: 2012-02-05

Piperacillin and Tazobactam
    Dosage: 4.5 g, unk
    Indication: Pneumonia
    Start date: 2012-02-02
    End date: 2012-02-06

Other drugs received by patient: Isosorbide Mononitrate; Rosuvastatin; Acetylsalicylic Acid; Enoxaparin; Furosemide; Novorapid; Fluticasone Propionate / Salmeterol; Insulin Detemir; Ramipril; Salbutamol; Tramadol; Alendronate Sodium; Levothyroxine; Diltiazem; Paracetamol



Possible Warfarin side effects in 51 year old male

Reported by a physician from Japan on 2012-02-21

Patient: 51 year old male

Reactions: Hepatic Function Abnormal, Pyrexia, Eosinophil Count Increased

Drug(s) suspected as cause:
Argatroban
    Dosage: unk
    Start date: 2011-07-24
    End date: 2011-07-25

Argatroban
    Dosage: unk
    Indication: Heparin-Induced Thrombocytopenia
    Start date: 2011-07-23
    End date: 2011-07-24

Vancomycin
    Indication: Endocarditis

Warfarin
    Indication: Anticoagulant Therapy

Argatroban
    Dosage: unk
    Start date: 2011-07-26
    End date: 2011-07-27

Argatroban
    Dosage: unk
    Start date: 2011-07-28
    End date: 2011-07-29

Zyvox

Rifampicin
    Indication: Endocarditis

Argatroban
    Dosage: unk
    Start date: 2011-07-29
    End date: 2011-07-30

Argatroban
    Dosage: unk
    Start date: 2011-07-25
    End date: 2011-07-26

Heparin
    Dosage: unk
    Indication: Anticoagulant Therapy
    Start date: 2011-07-16

Arbekacin Sulfate
    Indication: Endocarditis

Argatroban
    Dosage: unk
    Start date: 2011-07-27
    End date: 2011-07-28



Possible Warfarin side effects in male

Reported by a physician from Italy on 2012-02-17

Patient: male, weighing 77.7 kg (170.9 pounds)

Reactions: Pneumonia, Anaemia, Condition Aggravated, Concomitant Disease Progression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ilaris
    Dosage: double blinded
    Indication: Cardiovascular Event Prophylaxis
    Start date: 2012-01-17

Blinded NO Treatment Received
    Dosage: double blinded
    Indication: Cardiovascular Event Prophylaxis
    Start date: 2012-01-17

Placebo
    Dosage: double blinded
    Indication: Cardiovascular Event Prophylaxis
    Start date: 2012-01-17

Warfarin
    Dosage: unk
    Start date: 2011-04-29

Other drugs received by patient: Aspirin; Furosemide; Nitroglycerin; Ramipril



Possible Warfarin side effects in 52 year old female

Reported by a physician from United Kingdom on 2012-02-15

Patient: 52 year old female, weighing 68.5 kg (150.7 pounds)

Reactions: Sinus Headache, Nasal Congestion, Erythema, Sinusitis, Eye Pain, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Warfarin
    Indication: Pulmonary Hypertension

Warfarin
    Indication: Atrial Septal Defect

Sildenafil Citrate
    Dosage: 20 mg, 3x/day
    Administration route: Oral
    Indication: Pulmonary Hypertension
    Start date: 2009-07-01

Bosentan
    Dosage: 125 mg, 2x/day
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2009-07-01

Warfarin
    Dosage: unk
    Indication: Coagulopathy
    Start date: 2004-01-01

Other drugs received by patient: Digoxin; Ferrous Sulfate TAB; Omeprazole



Possible Warfarin side effects in 71 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-08

Patient: 71 year old female

Reactions: Activated Partial Thromboplastin Time Prolonged, Drug Ineffective, International Normalised Ratio Increased, Drug Interaction

Drug(s) suspected as cause:
Levetiracetam
    Dosage: 2.5 g, bid, iv
    Indication: Complex Partial Seizures

Warfarin
    Dosage: 0.75 mg, ngt
    Indication: Deep Vein Thrombosis

Valproic Acid
    Dosage: 250 mg, q6h, hgt

Midazolam
    Dosage: 3 mg, x1; iv
    Indication: Complex Partial Seizures

Other drugs received by patient: Dexamethasone; Temozolomide; Pravastatin; Fish OIL



Possible Warfarin side effects in 91 year old female

Reported by a physician from Japan on 2012-01-06

Patient: 91 year old female

Reactions: Gastrointestinal Haemorrhage, Shock Haemorrhagic

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Celecoxib
    Dosage: unk
    Administration route: Oral

Warfarin
    Dosage: unk

Other drugs received by patient: Aspirin



Possible Warfarin side effects in 52 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-04

Patient: 52 year old male

Reactions: Intentional Overdose

Adverse event resulted in: death

Drug(s) suspected as cause:
Warfarin
    Dosage: unk
    Administration route: Oral
    Start date: 2006-01-01
    End date: 2006-01-01

Acetaminophen
    Dosage: unk
    Administration route: Oral
    Start date: 2006-01-01
    End date: 2006-01-01

Propafenone
    Dosage: unk
    Administration route: Oral
    Start date: 2006-01-01
    End date: 2006-01-01

Carvedilol
    Dosage: unk
    Administration route: Oral
    Start date: 2006-01-01
    End date: 2006-01-01

Oxazepam
    Dosage: unk
    Administration route: Oral
    Start date: 2006-01-01
    End date: 2006-01-01

Ibuprofen
    Dosage: unk
    Administration route: Oral
    Start date: 2006-01-01
    End date: 2006-01-01

Temazepam
    Dosage: unk
    Administration route: Oral
    Start date: 2006-01-01
    End date: 2006-01-01



Possible Warfarin side effects in 36 year old male

Reported by a physician from Japan on 2011-12-23

Patient: 36 year old male, weighing 96.0 kg (211.2 pounds)

Reactions: Colorectal Cancer, Cerebral Haemorrhage

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Panitumumab
    Dosage: 6 mg/kg, q2wk
    Indication: Colorectal Cancer
    Start date: 2010-10-26
    End date: 2010-10-26

Warfarin
    Dosage: unk
    Administration route: Oral

Other drugs received by patient: Lobu; Ketoprofen; Lansoprazole; Depas



Possible Warfarin side effects in 59 year old male

Reported by a physician from Japan on 2011-12-23

Patient: 59 year old male, weighing 46.0 kg (101.2 pounds)

Reactions: Arthropod Sting, Anaphylactic Shock, Tonsillitis, Pyrexia, Oral Candidiasis, Granulocytopenia, Pharyngeal Ulceration, Infection

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Enalapril Maleate
    Administration route: Oral
    Start date: 2011-11-17
    End date: 2011-11-24

Lasix
    Dosage: (75); therapy start date: 4 oct (year not specified)
    Administration route: Oral
    Start date: 2011-10-17
    End date: 2011-11-10

Magnesium Oxide
    Dosage: dose: 0.67
    Administration route: Oral
    Indication: Constipation
    Start date: 2011-10-14
    End date: 2011-11-10

Plavix
    Dosage: therapy started: 8 oct (year not specified), therapy end date: 10 nov (year not specified)
    Administration route: Oral
    Start date: 2011-10-03
    End date: 2011-11-10

Enalapril Maleate
    Administration route: Oral
    Start date: 2011-10-11
    End date: 2011-11-10

Sennoside A+B
    Dosage: dose: 2
    Administration route: Oral
    Indication: Constipation
    Start date: 2011-10-14
    End date: 2011-11-10

Aspirin
    Administration route: Oral
    Start date: 2011-11-17
    End date: 2011-11-24

Teprenone
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2011-10-13
    End date: 2011-11-10

Warfarin
    Administration route: Oral
    Indication: Cardiac Disorder
    Start date: 2011-10-15
    End date: 2011-11-10

Lasix
    Dosage: (75); therapy start date: 4 oct (year not specified)
    Administration route: Oral
    Start date: 2011-11-17
    End date: 2011-11-24

Carvedilol
    Dosage: (2.5); therapy start date: 06 oct (year not specified)
    Administration route: Oral
    Start date: 2011-10-09
    End date: 2011-11-10

Lansoprazole
    Dosage: (15); therapy start date: 5 oct (year not specified)
    Administration route: Oral
    Start date: 2011-10-05
    End date: 2011-11-10

Livalo
    Administration route: Oral
    Indication: Dyslipidaemia
    Start date: 2011-10-26
    End date: 2011-11-10

Aspirin
    Administration route: Oral
    Indication: Myocardial Infarction
    Start date: 2011-10-03
    End date: 2011-11-10

Other drugs received by patient: Aldactone



Possible Warfarin side effects in 82 year old male

Reported by a physician from United States on 2011-12-22

Patient: 82 year old male

Reactions: Completed Suicide, Toxicity To Various Agents

Adverse event resulted in: death

Drug(s) suspected as cause:
Pregabalin
    Dosage: unk
    Administration route: Oral

Cyclobenzaprine
    Dosage: unk
    Administration route: Oral

Acetaminophen and Hydrocodone Bitartrate
    Dosage: unk
    Administration route: Oral

Warfarin
    Dosage: unk
    Administration route: Oral

Amlodipine Besylate
    Dosage: unk
    Administration route: Oral

Methadone
    Dosage: unk
    Administration route: Oral

Hydroxychloroquine
    Dosage: unk
    Administration route: Oral



Possible Warfarin side effects in 81 year old male

Reported by a pharmacist from United States on 2011-12-21

Patient: 81 year old male, weighing 58.0 kg (127.6 pounds)

Reactions: Rhabdomyolysis, International Normalised Ratio Increased, Drug Interaction, Blue TOE Syndrome, Transaminases Increased, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Warfarin
    Administration route: Oral

Zocor
    Administration route: Oral
    Start date: 2007-01-01

Gemfibrozil
    Administration route: Oral
    Start date: 2005-01-01

Other drugs received by patient: Acetaminophen and Codeine; Lisinopril; Nortriptyline; Aspirin



Possible Warfarin side effects in male

Reported by a consumer/non-health professional from United States on 2011-10-31

Patient: male, weighing 104.3 kg (229.5 pounds)

Reactions: Fatigue, Balance Disorder, Head Injury, Total Lung Capacity Decreased, Fall

Drug(s) suspected as cause:
Warfarin
    Dosage: unk

Cordarone
    Dosage: 200 mg, 2x/day
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2010-10-01
    End date: 2011-04-01

Cordarone
    Indication: Heart Rate Irregular

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