This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Cordarone (Amiodarone) 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 (468)
Death (62)
Life Threatening Events (38)
Disability (13)
Reports by Reaction Type
Interstitial Lung Disease (37),
Drug Interaction (36),
Bradycardia (34),
Renal Failure (29),
Atrial Fibrillation (26),
Hypothyroidism (26),
Cardiac Arrest (26),
Fall (25),
Dyspnoea (23),
Torsade DE Pointes (22),
Lung Disorder (22),
Hyperthyroidism (22)
Below are a few examples of reports where side effects / adverse reactions may be related to Cordarone (Amiodarone). For a complete list or a specific selection of reports, please use the links above.
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 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 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 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 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 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 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 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
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 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 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 64 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-08-09
Patient: 64 year old male, weighing 71.0 kg (156.2 pounds)
Reactions: Gamma-Glutamyltransferase Increased, Transaminases Increased, Bilirubin Conjugated Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cordarone
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2012-06-12
End date: 2012-06-15
Pradaxa
Dosage: 300 mg
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2012-06-12
End date: 2012-06-15
Other drugs received by patient: Ramipril
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