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Cordarone (Amiodarone) - Side Effect Reports to FDA

 
 



Index of reports > All Cases (468)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Cordarone (Amiodarone) all cases. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 468   Next >>

Possible Cordarone side effects in 57 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-24

Patient: 57 year old male

Reactions: Hepatic Function Abnormal, Hyperkalaemia, Hyponatraemia, Atrial Fibrillation, Drug Interaction, Torsade DE Pointes, Cardio-Respiratory Arrest, Decubitus Ulcer, Sepsis, Cardiac Failure Congestive

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Cordarone

Other drugs received by patient possibly interacting with the suspect drug:
Bisoprolol Fumarate
    Dosage: 10 mg, daily
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Solian
    Dosage: 100 mg, 1 tablet daily
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2007-01-01
    End date: 2012-07-01

Other drugs received by patient: Paroxetine HCL; Simvastatin; Inspra; Furosemide; Plavix; Xanax



Possible Cordarone side effects in 91 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-24

Patient: 91 year old female

Reactions: Blood Potassium Increased, Atrioventricular Block, Drug Interaction, Bradycardia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cordarone

Other drugs received by patient possibly interacting with the suspect drug:
Exelon
    Dosage: 4.5 mg, 2x/day
    Administration route: Oral
    Indication: Cognitive Disorder
    End date: 2012-06-02

Other drugs received by patient: Zoloft; Previscan; Nitroglycerin; Atacand



Possible Cordarone side effects in 70 year old female

Reported by a physician from China on 2012-08-24

Patient: 70 year old female

Reactions: Arrhythmia Supraventricular, Vomiting, Nausea, Atrial Fibrillation, Atrioventricular Block

Drug(s) suspected as cause:
Cordarone



Possible Cordarone side effects in 65 year old male

Reported by a consumer/non-health professional from France on 2012-08-24

Patient: 65 year old male

Reactions: Thyroid Disorder, Hyperthyroidism

Drug(s) suspected as cause:
Cordarone

Other drugs received by patient: Crestor; Plavix; Aspirin; Perindopril Erbumine; Praxilene



Possible Cordarone side effects in 60 year old male

Reported by a physician from Belgium on 2012-08-24

Patient: 60 year old male

Reactions: Cerebellar Ataxia, Hyperthyroidism

Drug(s) suspected as cause:
Cordarone
    Dosage: 4 df, weekly
    Start date: 2012-01-01

Cordarone
    Dosage: 3 df, weekly
    Start date: 2012-02-01

Cordarone
    Dosage: 1 df, weekly
    Start date: 2012-04-01
    End date: 2012-04-30

Cordarone
    Dosage: 5 df, weekly
    Indication: Atrial Fibrillation
    Start date: 2010-01-01

Cordarone
    Dosage: 2 df, weekly
    Start date: 2012-03-01

Other drugs received by patient: Cortisone; Strumazole



Possible Cordarone side effects in 77 year old male

Reported by a physician from China on 2012-08-23

Patient: 77 year old male

Reactions: Electrocardiogram Abnormal

Drug(s) suspected as cause:
Cordarone
    Dosage: 0.2 g, 2x/day
    Administration route: Oral
    Indication: Arrhythmia
    Start date: 2009-01-14
    End date: 2009-01-25

Digoxin
    Dosage: 0.125 mg, 1x/day
    Administration route: Oral
    Start date: 2009-01-15
    End date: 2009-01-24



Possible Cordarone side effects in 87 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-22

Patient: 87 year old male

Reactions: Peritoneal Haemorrhage, Anaemia, Aortic Intramural Haematoma, Pericardial Effusion, Muscle Haemorrhage, Renal Failure, Cardio-Respiratory Arrest, Pericarditis, Pleural Effusion, Pulmonary Oedema

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Aspegic 1000
    Dosage: 1 g, 3x/day
    Administration route: Oral
    Start date: 2012-07-02
    End date: 2012-07-02

Aspegic 1000
    Dosage: 1 g, daily
    Indication: Pain
    Start date: 2012-06-27

Aspirin
    Dosage: 75 mg, single
    Administration route: Oral
    Start date: 2012-06-29
    End date: 2012-06-29

Clopidogrel Bisulfate and Aspirin
    Dosage: 75 mg, unk
    Administration route: Oral
    Indication: Acute Coronary Syndrome
    Start date: 2012-01-01
    End date: 2012-06-26

Cordarone
    Dosage: 6 df, daily
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2012-06-29
    End date: 2012-06-29

Cordarone
    Dosage: 4 df, daily
    Administration route: Oral
    Start date: 2012-06-30
    End date: 2012-07-01

Cordarone
    Dosage: 1 df, daily
    Administration route: Oral
    Start date: 2012-07-02
    End date: 2012-07-02

Lovenox
    Dosage: 0.6 ml, 2x/day
    Indication: Atrial Fibrillation
    Start date: 2012-06-29
    End date: 2012-07-02

Plavix
    Dosage: 75 mg, single
    Administration route: Oral
    Start date: 2012-06-29
    End date: 2012-06-29

Previscan
    Dosage: unk
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2012-01-01
    End date: 2012-06-26

Other drugs received by patient: Ramipril; Atorvastatin; Aldactone; Permixon; Bisoprolol Fumarate; Alfuzosin Hydrochloride; Lasix



Possible Cordarone side effects in 60 year old male

Reported by a physician from Belgium on 2012-08-22

Patient: 60 year old male

Reactions: Cerebellar Ataxia, Hyperthyroidism

Drug(s) suspected as cause:
Cordarone
    Dosage: 1 df, weekly
    Start date: 2012-04-01
    End date: 2012-04-01

Cordarone
    Dosage: 2 df, weekly
    Start date: 2012-03-01

Cordarone
    Dosage: 5 df, weekly
    Indication: Atrial Fibrillation
    Start date: 2010-01-01

Cordarone
    Dosage: 4 df, weekly
    Start date: 2012-01-01

Cordarone
    Dosage: 3 df, weekly
    Start date: 2012-02-01

Other drugs received by patient: Strumazole; Cortisone



Possible Cordarone side effects in

Reported by a pharmacist from Canada on 2012-08-21

Patient:

Reactions: NO Adverse Event

Drug(s) suspected as cause:
Cordarone



Possible Cordarone side effects in 89 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-20

Patient: 89 year old female

Reactions: Anaemia, International Normalised Ratio Increased, Hypothyroidism, Thrombocytopenia, Leukopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cordarone

Other drugs received by patient: Coumadin; Pantoprazole; Pravastatin; Aspirin; Lasix; Plavix



Possible Cordarone side effects in 81 year old male

Reported by a physician from Australia on 2012-08-17

Patient: 81 year old male

Reactions: Neuropathy Peripheral, Abscess Limb

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cordarone
    Dosage: 100 mg, 2x/day
    Administration route: Oral
    Start date: 2011-11-01
    End date: 2012-01-01

Cordarone
    Dosage: 200 mg, 2x/day
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2011-11-03

Cordarone
    Dosage: 100 mg, daily
    Administration route: Oral
    Start date: 2012-01-01
    End date: 2012-06-20

Other drugs received by patient: Warfarin; Lipitor; Ramipril



Possible Cordarone side effects in 67 year old female

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-08-16

Patient: 67 year old female

Reactions: Retinopathy, Pigmentation Disorder

Drug(s) suspected as cause:
Cordarone
    Indication: Chest Pain

Cordarone
    Dosage: 400mg, daily
    Indication: Tachycardia Paroxysmal
    Start date: 1976-01-01
    End date: 1983-05-01



Possible Cordarone side effects in female

Reported by a physician from France on 2012-08-16

Patient: female

Reactions: Hepatic Function Abnormal, Cardiac Tamponade, Somnolence, Haemodynamic Instability, Death, Meningococcal Infection, Enterococcal Sepsis, Sedation, Acute Respiratory Distress Syndrome, Acute Coronary Syndrome, Renal Failure Acute, Medical Device Complication, Neurological Decompensation, Atrial Fibrillation, General Physical Health Deterioration, Staphylococcal Sepsis, Pulmonary Function Test Abnormal, Arrhythmia, Renal Impairment, Lung Disorder, Bradycardia, Electrocardiogram ST Segment Elevation, Septic Shock, Cardiac Arrest, Shock

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Cordarone
    Dosage: 600mg per day
    Indication: Arrhythmia
    Start date: 2012-07-07
    End date: 2012-07-12

Digoxin
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-08
    End date: 2012-07-08

Isoptin
    Dosage: 120mg per day
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-07-12
    End date: 2012-07-12

Rythmol
    Dosage: 150mg per day
    Administration route: Oral
    Indication: Hypertension
    Start date: 2012-07-12
    End date: 2012-07-12

Other drugs received by patient: Mianserine; Plavix; Lorazepam; Zocor; Aldactazine



Possible Cordarone side effects in male

Reported by a consumer/non-health professional from Denmark on 2012-08-16

Patient: male

Reactions: Peripheral Coldness, Restless Legs Syndrome

Drug(s) suspected as cause:
Amlodipine
    Indication: Product Used FOR Unknown Indication

Cordarone
    Indication: Product Used FOR Unknown Indication

Digoxin
    Indication: Product Used FOR Unknown Indication

Metformin HCL
    Indication: Product Used FOR Unknown Indication

Metoprolol Succinate
    Indication: Product Used FOR Unknown Indication

Ramipril
    Indication: Product Used FOR Unknown Indication

Warfarin Sodium
    Indication: Product Used FOR Unknown Indication



Possible Cordarone side effects in

Reported by a pharmacist from Canada on 2012-08-16

Patient:

Reactions: NO Adverse Event

Drug(s) suspected as cause:
Cordarone



Possible Cordarone side effects in female

Reported by a consumer/non-health professional from Poland on 2012-08-15

Patient: female

Reactions: Threatened Labour, Amniocentesis Abnormal, Placental Insufficiency

Drug(s) suspected as cause:
Cordarone



Possible Cordarone side effects in 75 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-15

Patient: 75 year old male

Reactions: Pupillary Reflex Impaired, Orthostatic Hypotension, Hyponatraemia, Muscular Weakness, Fall, Malaise, Oedema Peripheral, Hyperthyroidism

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cordarone
    Dosage: 200 mg, daily
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2008-01-01
    End date: 2012-05-01

Furosemide
    Dosage: 1 df, daily
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-05-01

Levothyroxine Sodium
    Dosage: 25 ug, daily
    Administration route: Oral
    Indication: Thyroid Disorder
    Start date: 2008-05-30
    End date: 2012-05-01

Losartan Potassium
    Dosage: 1 df, daily
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-05-01

Other drugs received by patient: Potassium Chloride; Aspirin



Possible Cordarone side effects in male

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

Patient: male

Reactions: Skin Discolouration, Hypothyroidism, Hypoaesthesia, Tremor, Walking Disability

Drug(s) suspected as cause:
Cordarone

Other drugs received by patient: Perindopril; Flecainide Acetate



Possible Cordarone side effects in

Reported by a consumer/non-health professional from Poland on 2012-08-15

Patient:

Reactions: Congenital Infection, Foetal Growth Restriction, Temperature Regulation Disorder, Hypomagnesaemia, Maternal Exposure Timing Unspecified

Drug(s) suspected as cause:
Cordarone



Possible Cordarone side effects in 79 year old female

Reported by a pharmacist from China on 2012-08-15

Patient: 79 year old female

Reactions: Blood Pressure Increased, Vomiting, Dyspnoea, Chest Discomfort, Nausea, Urinary Incontinence, Convulsion, Asphyxia, Respiratory Rate Decreased, Heart Rate Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cordarone
    Dosage: 200 mg (1 tablet), 3x/day
    Administration route: Oral
    Indication: Arrhythmia
    Start date: 2008-12-05
    End date: 2009-04-01

Metoprolol Tartrate
    Dosage: unk



Possible Cordarone side effects in 87 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-14

Patient: 87 year old male

Reactions: Peritoneal Haemorrhage, Anaemia, Aortic Intramural Haematoma, Pericardial Effusion, Muscle Haemorrhage, Renal Failure, Cardio-Respiratory Arrest, Pericarditis, Pulmonary Oedema, Pleural Effusion

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Aspegic 1000
    Dosage: 1 g, daily
    Indication: Pain
    Start date: 2012-06-27

Aspegic 1000
    Dosage: 1 g, 3x/day
    Administration route: Oral
    Start date: 2012-07-02
    End date: 2012-07-02

Aspirin
    Dosage: 75 mg, single
    Administration route: Oral
    Start date: 2012-06-29
    End date: 2012-06-29

Clopidogrel Bisulfate and Aspirin
    Dosage: 75 mg, unk
    Administration route: Oral
    Indication: Acute Coronary Syndrome
    Start date: 2012-01-01
    End date: 2012-06-26

Cordarone
    Dosage: 4 df, daily
    Administration route: Oral
    Start date: 2012-06-30
    End date: 2012-07-01

Cordarone
    Dosage: 6 df, daily
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2012-06-29
    End date: 2012-06-29

Cordarone
    Dosage: 1 df, daily
    Administration route: Oral
    Start date: 2012-07-02
    End date: 2012-07-02

Lovenox
    Dosage: 0.6 ml, 2x/day
    Indication: Atrial Fibrillation
    Start date: 2012-06-29
    End date: 2012-07-02

Plavix
    Dosage: 75 mg, single
    Administration route: Oral
    Start date: 2012-06-29
    End date: 2012-06-29

Previscan
    Dosage: unk
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2012-01-01
    End date: 2012-06-26

Other drugs received by patient: Aldactone; Bisoprolol Fumarate; Alfuzosin Hydrochloride; Ramipril; Atorvastatin; Lasix; Permixon



Possible Cordarone side effects in 82 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-14

Patient: 82 year old female

Reactions: Cardiac Failure, Interstitial Lung Disease, Atrial Thrombosis, Pulmonary Embolism

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cordarone

Other drugs received by patient: Vitamin K TAB; Levofloxacin; Rocephin; Heparin



Possible Cordarone side effects in 74 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-14

Patient: 74 year old male

Reactions: Renal Failure, Overdose, Rales, Bradycardia, Cardioactive Drug Level Increased, Blood Pressure Decreased

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Cordarone
    Dosage: unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-03-01

Digoxin
    Dosage: unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-03-01
    End date: 2012-03-01

Other drugs received by patient: Omeprazole; Hydrocortisone; Valacyclovir Hydrochloride



Possible Cordarone side effects in 69 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-14

Patient: 69 year old male, weighing 74.0 kg (162.8 pounds)

Reactions: Off Label Use, Dyspnoea, Interstitial Lung Disease, Eosinophilia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cordarone
    Administration route: Oral
    Start date: 2009-10-05
    End date: 2011-01-02

Multaq
    Start date: 2011-06-30
    End date: 2011-08-12

Multaq
    Administration route: Oral
    Start date: 2011-01-11
    End date: 2011-01-31

Other drugs received by patient: Corgard; Bisoprolol Fumarate; Bisoprolol Fumarate; Imovane; Previscan



Possible Cordarone side effects in 71 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-13

Patient: 71 year old male

Reactions: Optic Neuropathy, Visual Acuity Reduced, Septic Shock, Papilloedema

Adverse event resulted in: death, hospitalization, disablity

Drug(s) suspected as cause:
Cordarone

Other drugs received by patient: Aspirin



Possible Cordarone side effects in

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-08-13

Patient:

Reactions: Retinopathy, Pigmentation Disorder

Drug(s) suspected as cause:
Cordarone



Possible Cordarone side effects in 43 year old female

Reported by a consumer/non-health professional from Germany on 2012-08-13

Patient: 43 year old female, weighing 83.0 kg (182.6 pounds)

Reactions: Cytolytic Hepatitis, Cholestasis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Alfuzosin Hydrochloride
    Dosage: strngth:10mg prolonged release tabs
    Administration route: Oral
    Start date: 2012-01-21

Atorvastatin
    Administration route: Oral
    Start date: 2012-01-15
    End date: 2012-01-18

Cordarone
    Dosage: strength:200mg
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2011-12-01
    End date: 2012-01-25

Depamide
    Dosage: strength:300mg,tabs
    Administration route: Oral
    End date: 2011-11-18

Eupressyl
    Dosage: 60 mg caps
    Administration route: Oral
    Start date: 2012-01-14

Glucophage
    Dosage: strength 850 mg
    Administration route: Oral

Paroxetine
    End date: 2011-11-18

Rabeprazole Sodium
    Dosage: strength: 20mg tabs
    Administration route: Oral

Seroquel
    Dosage: strength 300mg,prolonged release tab
    Administration route: Oral
    Start date: 2012-01-04
    End date: 2012-01-29

Tercian
    Dosage: strength:100mg
    Administration route: Oral
    End date: 2011-11-18

Zolpidem Tartrate
    Dosage: 10 mg tabs
    Administration route: Oral
    End date: 2011-11-18

Other drugs received by patient: Valium; Sulfarlem; Lyrica; Lepticur; Lithium Carbonate; Fluticasone Propionate / Salmeterol; Ventolin; Acamprosate Calcium; Theralene



Possible Cordarone side effects in 43 year old female

Reported by a pharmacist from China on 2012-08-10

Patient: 43 year old female, weighing 48.0 kg (105.6 pounds)

Reactions: Torsade DE Pointes, Electrocardiogram QT Prolonged, Dyspnoea, Atrial Fibrillation, Respiratory Arrest, Ventricular Fibrillation, Cardiac Arrest, Loss of Consciousness

Drug(s) suspected as cause:
Avelox
    Dosage: unk
    End date: 2010-10-11

Cedilanid

Cordarone
    Dosage: unk
    End date: 2010-10-11

Other drugs received by patient: Spirolone; Perindopril Erbumine; Warfarin Sodium; Cefoperazone W / Sulbactam



Possible Cordarone side effects in male

Reported by a physician from France on 2012-08-10

Patient: male

Reactions: Hypothyroidism, Tremor, Walking Disability

Drug(s) suspected as cause:
Cordarone

Other drugs received by patient: Perindopril; Flecainide Acetate



Possible Cordarone side effects in 51 year old male

Reported by a health professional (non-physician/pharmacist) from Tunisia on 2012-08-09

Patient: 51 year old male

Reactions: Oestradiol Increased, Blood Follicle Stimulating Hormone Increased, Hypothyroidism, Blood Luteinising Hormone Increased, Gynaecomastia

Drug(s) suspected as cause:
Cordarone
    Dosage: unk
    Start date: 2008-09-01
    End date: 2009-01-01

Cordarone
    Dosage: 200 mg, daily
    Indication: Atrial Fibrillation
    Start date: 1982-01-01
    End date: 2007-01-01

Digoxin
    Dosage: 0.25 mg, daily
    Indication: Hypothyroidism
    Start date: 2007-01-01
    End date: 2008-09-01

Digoxin
    Dosage: unk
    Start date: 2009-01-01
    End date: 2009-11-12

Other drugs received by patient: Sintrom; Levothyroxine Sodium; Lasix



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