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Multaq (Dronedarone) - Life Threatening Events - Suspected Cause - Side Effect Reports

 
 



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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