Index of reports
> Life Threatening Events (45)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Multaq (Dronedarone) life threatening events. The selected reports were submitted to the FDA during the sample period of about a year.
Reports 1 - 30 of 45 Next >>
Possible Multaq side effects in 82 year old male
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-21
Patient: 82 year old male, weighing 98.0 kg (215.6 pounds)
Reactions: Muscle Atrophy, Gout, Decreased Immune Responsiveness, Bacterial Infection, Axonal Neuropathy, Polyneuropathy
Adverse event resulted in: life threatening event, disablity
Drug(s) suspected as cause:
Multaq
Other drugs received by patient: Marcumar; Perindopril Erbumine; Lasix
Possible Multaq side effects in 53 year old male
Reported by a physician from United States on 2012-08-13
Patient: 53 year old male, weighing 98.1 kg (215.8 pounds)
Reactions: Abdominal Pain, Diarrhoea, Oedema Peripheral, Prothrombin Time Prolonged, Cerebrovascular Accident
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Multaq
Start date: 2012-05-15
End date: 2012-05-15
Xarelto
Indication: Anticoagulant Therapy
Start date: 2012-05-03
Xarelto
Indication: Cerebrovascular Accident Prophylaxis
Start date: 2012-05-03
Xarelto
Indication: Atrial Fibrillation
Start date: 2012-05-03
Other drugs received by patient: Flecainide Acetate; Furosemide; Nebivolol
Possible Multaq side effects in male
Reported by a physician from Germany on 2012-08-02
Patient: male
Reactions: Alanine Aminotransferase Increased, Hepatic Failure
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Multaq
Possible Multaq side effects in male
Reported by a physician from United States on 2012-07-31
Patient: male, weighing 98.0 kg (215.6 pounds)
Reactions: Abdominal Pain, Diarrhoea, Oedema Peripheral, Prothrombin Time Prolonged, Cerebrovascular Accident
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Multaq
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-05-15
End date: 2012-05-16
Xarelto
Administration route: Oral
Indication: Anticoagulant Therapy
Start date: 2012-05-03
Xarelto
Administration route: Oral
Indication: Cerebrovascular Accident Prophylaxis
Start date: 2012-05-03
Xarelto
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2012-05-03
Other drugs received by patient: Furosemide; Flecainide Acetate; Bystolic
Possible Multaq side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-27
Patient: male, weighing 89.8 kg (197.6 pounds)
Reactions: Palpitations, Arrhythmia
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Multaq
Possible Multaq side effects in 74 year old female
Reported by a physician from France on 2012-06-18
Patient: 74 year old female
Reactions: Cardiac Failure, Atrial Fibrillation, Hyperthyroidism
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Cordarone
Administration route: Oral
Start date: 2006-04-27
End date: 2010-10-28
Multaq
Administration route: Oral
Start date: 2010-10-29
End date: 2011-10-14
Other drugs received by patient: Previscan; Lansoprazole; Valsartan; Atorvastatin
Possible Multaq side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-31
Patient: male, weighing 77.1 kg (169.6 pounds)
Reactions: Haemoptysis, Drug Intolerance, Atrial Fibrillation
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Multaq
Dosage: 2 per day multaq
Start date: 2012-03-01
Pradaxa
Ventolin
Dosage: 4 per day pradaxa
Indication: Atrial Fibrillation
Start date: 2011-10-01
Possible Multaq side effects in female
Reported by a consumer/non-health professional from United States on 2012-04-16
Patient: female
Reactions: Heart Rate Decreased, Atrial Fibrillation, Blood Potassium Increased
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Lasix
Lopressor
Multaq
Administration route: Oral
Other drugs received by patient: Vitamin D; Aspirin; Colace; Vitamin B Complex CAP; Coumadin
Possible Multaq side effects in 57 year old male
Reported by a individual with unspecified qualification from United States on 2012-04-06
Patient: 57 year old male, weighing 87.1 kg (191.6 pounds)
Reactions: Pulmonary Hypertension, Dyspnoea, Insomnia, Cerebrovascular Accident, Cardiac Failure Congestive
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Multaq
Possible Multaq side effects in 80 year old female
Reported by a individual with unspecified qualification from France on 2012-03-14
Patient: 80 year old female
Reactions: Renal Tubular Disorder, Overdose, Dyspnoea, Dialysis, International Normalised Ratio Increased, Bronchitis, Renal Failure Acute
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Augmentin
Dosage: (3 gm (1 gm, 3 in 1 d) unknown), (3 gm, (1 gm 3 in 1 d) unknown)
Indication: Product Used FOR Unknown Indication
Start date: 2011-04-14
End date: 2011-04-21
Augmentin
Dosage: (3 gm (1 gm, 3 in 1 d) unknown), (3 gm, (1 gm 3 in 1 d) unknown)
Indication: Product Used FOR Unknown Indication
Start date: 2011-03-28
End date: 2011-04-08
Erythromycin
Dosage: (3 gm (3 gm, 1 in 1 d) unknown)
Indication: Product Used FOR Unknown Indication
Start date: 2011-04-20
End date: 2011-04-26
Levofloxacin
Dosage: (1 gm (1 gm in 1 d), (500 mg (500 mg in 1d) unknown
Indication: Product Used FOR Unknown Indication
Start date: 2011-04-15
End date: 2011-04-15
Levofloxacin
Dosage: (1 gm (1 gm in 1 d), (500 mg (500 mg in 1d) unknown
Indication: Product Used FOR Unknown Indication
Start date: 2011-04-16
End date: 2011-04-26
Multaq
Dosage: (800 mg (400 mg, 2 in 1 d) unknown)
Indication: Product Used FOR Unknown Indication
Start date: 2011-03-17
End date: 2011-04-26
Neomercazole (Neomercazole) (Not Specified)
Dosage: (40 mg (20 mg, 2 in 1 d) unknown), (60 mg (20 mg, 3 in 1 d) unknown)
Indication: Hyperthyroidism
Start date: 2011-03-16
End date: 2011-03-28
Neomercazole (Neomercazole) (Not Specified)
Dosage: (40 mg (20 mg, 2 in 1 d) unknown), (60 mg (20 mg, 3 in 1 d) unknown)
Indication: Hyperthyroidism
Start date: 2011-03-29
End date: 2011-04-26
Other drugs received by patient: Previscan / 00789001 /; Lasix; Fluticasone Propionate / Salmeterol; Amlodipine Besylate; Pulmicort
Possible Multaq side effects in 80 year old female
Reported by a consumer/non-health professional from France on 2012-03-08
Patient: 80 year old female
Reactions: Renal Failure Acute
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Augmentin '125'
Indication: Product Used FOR Unknown Indication
Start date: 2011-03-28
End date: 2011-04-08
Augmentin '125'
Start date: 2011-04-14
End date: 2011-04-21
Erythromycin
Indication: Product Used FOR Unknown Indication
Start date: 2011-04-20
End date: 2011-04-26
Levofloxacin
Indication: Product Used FOR Unknown Indication
Start date: 2011-04-15
End date: 2011-04-15
Levofloxacin
Start date: 2011-04-16
End date: 2011-04-26
Multaq
Indication: Product Used FOR Unknown Indication
Start date: 2011-03-17
End date: 2011-04-26
NEO-Mercazole TAB
Indication: Hyperthyroidism
Start date: 2011-03-16
End date: 2011-03-28
NEO-Mercazole TAB
Start date: 2011-03-29
End date: 2011-04-26
Other drugs received by patient: Lasix; Amlodipine Besylate; Previscan; Atorvastatin; Fluticasone Propionate / Salmeterol; Pulmicort
Possible Multaq side effects in 52 year old female
Reported by a physician from United States on 2012-03-08
Patient: 52 year old female
Reactions: Pneumonia Primary Atypical, Dyspnoea, Interstitial Lung Disease, Respiratory Failure, Acute Respiratory Distress Syndrome, Bronchiolitis, Cardiac Arrest
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Multaq
Other drugs received by patient: Coumadin; Aspirin; Metoprolol Succinate
Possible Multaq side effects in 78 year old male
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-03-05
Patient: 78 year old male, weighing 69.0 kg (151.8 pounds)
Reactions: Ventricular Fibrillation
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Multaq
Other drugs received by patient: Digitoxin TAB
Possible Multaq side effects in female
Reported by a consumer/non-health professional from United States on 2012-02-29
Patient: female, weighing 59.9 kg (131.7 pounds)
Reactions: Heart Valve Operation, Brain Natriuretic Peptide Increased, Cardiac Failure Congestive
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Multaq
Possible Multaq side effects in 67 year old male
Reported by a physician from Germany on 2012-02-27
Patient: 67 year old male
Reactions: Blood Pressure Decreased, Cardiac Arrest, Haemodynamic Instability
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Multaq
Other drugs received by patient: Propofol; Ultiva; Phenprocoumon
Possible Multaq side effects in 67 year old male
Reported by a physician from Germany on 2012-02-27
Patient: 67 year old male, weighing 110.0 kg (242.0 pounds)
Reactions: Blood Pressure Decreased, Cardiac Arrest, Haemodynamic Instability
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Multaq
Other drugs received by patient: Ultiva; Marcumar; Propofol
Possible Multaq side effects in 52 year old female
Reported by a physician from United States on 2012-02-16
Patient: 52 year old female
Reactions: Pneumonia Primary Atypical, Dyspnoea, Respiratory Failure, Interstitial Lung Disease, Acute Respiratory Distress Syndrome, Bronchiolitis, Cardiac Arrest
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Multaq
Other drugs received by patient: Coumadin; Metoprolol Tartrate; Aspirin
Possible Multaq side effects in 76 year old male
Reported by a physician from United States on 2012-01-30
Patient: 76 year old male
Reactions: Multi-Organ Failure, Pancreatitis Necrotising, Septic Shock, Duodenal Perforation
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Multaq
Other drugs received by patient: Lopressor; Monopril; Ativan; Pravachol; Prilosec; Coumadin; Lisinopril and Hydrochlorothiazide; Glucovance
Possible Multaq side effects in 53 year old male
Reported by a physician from Germany on 2012-01-24
Patient: 53 year old male, weighing 130.0 kg (286.0 pounds)
Reactions: Torsade DE Pointes, Underdose
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Multaq
Other drugs received by patient: Digitoxin TAB; Metoprolol Succinate; Kalinor; Prednisolone; Torsemide; Simvastatin; Colecalciferol; Calcium; Magnesium Aspartate Hydrochloride; Ramipril; Hydromorphone HCL; Omeprazole; Promethazine; Spironolactone
Possible Multaq side effects in 78 year old male
Reported by a health professional (non-physician/pharmacist) from Germany on 2012-01-12
Patient: 78 year old male, weighing 69.0 kg (151.8 pounds)
Reactions: Ventricular Fibrillation
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Multaq
Other drugs received by patient: Digitoxin TAB
Possible Multaq side effects in 79 year old male
Reported by a physician from United States on 2011-12-29
Patient: 79 year old male, weighing 98.0 kg (215.5 pounds)
Reactions: Dyspnoea Exertional, Gastrointestinal Haemorrhage, Dizziness
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Multaq
Indication: Atrial Flutter
Pradaxa
Other drugs received by patient: Toprol-XL; Lovaza; Furosemide; Crestor; Eplerenone; Colchicine; Aspirin
Possible Multaq side effects in 74 year old male
Reported by a pharmacist from Germany on 2011-12-28
Patient: 74 year old male, weighing 79.0 kg (173.8 pounds)
Reactions: Blood Bilirubin Increased, Hyperkalaemia, Hyperhidrosis, Sinus Bradycardia, Malaise, Gamma-Glutamyltransferase Increased, Liver Function Test Abnormal, Dizziness, Blood Creatinine Increased, Renal Failure Acute, Glomerular Filtration Rate Decreased, Alanine Aminotransferase Increased, Blood Cholinesterase Decreased, Dyspnoea AT Rest, Anxiety, Aspartate Aminotransferase Increased, Cardiovascular Disorder
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Multaq
Other drugs received by patient: Vitamine B12; Ramipril; Tolterodine Tartrate; Janumet; ST Mary's Thistle; Bisoprolol; Allobeta; Pravastatin Sodium; Verapamil
Possible Multaq side effects in 74 year old male
Reported by a physician from Germany on 2011-12-28
Patient: 74 year old male, weighing 69.0 kg (151.8 pounds)
Reactions: Hyperkalaemia, Alanine Aminotransferase Increased, Dyspnoea AT Rest, Transaminases Increased, Sinus Bradycardia, Aspartate Aminotransferase Increased, Dizziness, Blood Creatinine Increased, Cardiovascular Disorder, Renal Failure Acute
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Multaq
Other drugs received by patient: Bisoprolol; Janumet; Ramipril
Possible Multaq side effects in 64 year old female
Reported by a physician from Slovenia on 2011-12-20
Patient: 64 year old female
Reactions: Off Label Use, Tachycardia, Underdose
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Multaq
Other drugs received by patient: Simvastatin; Lekoptin; Andol; Losartan Potassium
Possible Multaq side effects in 52 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-20
Patient: 52 year old female
Reactions: Dyspnoea, Interstitial Lung Disease, Respiratory Failure, Acute Respiratory Distress Syndrome, Cardiac Arrest
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Multaq
Other drugs received by patient: Beta Blocking Agents; Coumadin
Possible Multaq side effects in 46 year old male
Reported by a physician from France on 2011-12-19
Patient: 46 year old male
Reactions: Arrhythmia Supraventricular, Circulatory Collapse, Multiple Drug Overdose Intentional, Bradycardia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Acetaminophen
Administration route: Oral
Indication: Intentional Overdose
Start date: 2011-10-17
End date: 2011-10-17
Multaq
Administration route: Oral
Start date: 2011-10-17
End date: 2011-10-17
Multaq
Administration route: Oral
Start date: 2011-03-30
End date: 2011-10-16
Multaq
Administration route: Oral
Indication: Intentional Overdose
Start date: 2011-03-30
End date: 2011-10-16
Multaq
Administration route: Oral
Start date: 2011-10-17
End date: 2011-10-17
Perindopril Erbumine
Administration route: Oral
End date: 2011-10-16
Perindopril Erbumine
Administration route: Oral
Start date: 2011-10-17
End date: 2011-10-17
Perindopril Erbumine
Administration route: Oral
Indication: Intentional Overdose
End date: 2011-10-16
Perindopril Erbumine
Administration route: Oral
Start date: 2011-10-17
End date: 2011-10-17
Trimeprazine Tartrate
Administration route: Oral
Start date: 2011-10-17
End date: 2011-10-17
Trimeprazine Tartrate
Administration route: Oral
Indication: Intentional Overdose
End date: 2011-10-16
Trimeprazine Tartrate
Administration route: Oral
Indication: Insomnia
End date: 2011-10-16
Trimeprazine Tartrate
Administration route: Oral
Start date: 2011-10-17
End date: 2011-10-17
Other drugs received by patient: Carbosymag / FRA /; Nexium; Tramadol HCL; Myolastan; Remicade; Aspirin
Possible Multaq side effects in 79 year old male
Reported by a physician from Slovenia on 2011-12-16
Patient: 79 year old male
Reactions: Respiratory Rate Decreased, Hyperkalaemia, Atrioventricular Block Complete, Bradycardia, Blood Creatinine Increased
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Multaq
Other drugs received by patient: Sintrom; Coryol; Aldactone; Perindopril; Crestor; Lasix
Possible Multaq side effects in 52 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-14
Patient: 52 year old female
Reactions: Dyspnoea, Interstitial Lung Disease, Respiratory Failure, Acute Respiratory Distress Syndrome, Cardiac Arrest
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Multaq
Other drugs received by patient: Coumadin; Beta Blocking Agents
Possible Multaq side effects in 52 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-12
Patient: 52 year old female
Reactions: Dyspnoea, Interstitial Lung Disease, Respiratory Failure, Acute Respiratory Distress Syndrome, Cardiac Arrest
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Multaq
Other drugs received by patient: Beta Blocking Agents; Coumadin
Possible Multaq side effects in female
Reported by a physician from Slovenia on 2011-12-12
Patient: female
Reactions: Tachycardia
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Multaq
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