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Index of reports
> Cases with Off Label Use ()
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Multaq (Dronedarone) where reactions include off label use. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Multaq 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 Multaq side effects in 53 year old male
Reported by a physician from United States on 2012-08-06
Patient: 53 year old male
Reactions: Off Label Use, Torsade DE Pointes, Electrocardiogram QT Prolonged
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Multaq
Possible Multaq side effects in 69 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-06-15
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: 2009-10-01
End date: 2011-01-01
Multaq
Administration route: Oral
Start date: 2011-01-11
End date: 2011-01-31
Multaq
Administration route: Oral
Start date: 2011-07-01
End date: 2011-08-08
Other drugs received by patient: Imovane; Bisoprolol Fumarate; Bisoprolol Fumarate; Corgard; Previscan
Possible Multaq side effects in 66 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-01-04
Patient: 66 year old male
Reactions: Off Label Use, Cardio-Respiratory Arrest
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Multaq
Other drugs received by patient: Atacand; Plavix; Lercanidipine
Possible Multaq side effects in 84 year old male
Reported by a health professional (non-physician/pharmacist) from Switzerland on 2011-12-23
Patient: 84 year old male
Reactions: Off Label Use, Cardiac Failure, Diarrhoea, Dehydration, Hepatocellular Injury, Atrial Fibrillation, Renal Failure Chronic
Adverse event resulted in: death
Drug(s) suspected as cause:
Fluoxetine
Administration route: Oral
End date: 2011-11-28
Multaq
Administration route: Oral
Start date: 2001-06-01
End date: 2011-11-28
Multaq
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2001-06-01
End date: 2011-11-28
Multaq
Administration route: Oral
Indication: Atrial Flutter
Start date: 2001-06-01
End date: 2011-11-28
Other drugs received by patient: Aspirin; Fluticasone Propionate / Salmeterol; Aspirin
Possible Multaq side effects in 73 year old female
Reported by a physician from Spain on 2011-12-21
Patient: 73 year old female
Reactions: Off Label Use, Hepatic Failure, Oedema DUE To Hepatic Disease, Ascites, Cardiac Failure Congestive
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Multaq
Other drugs received by patient: Sintrom; Irbesartan and Hydrochlorothiazide; Levothyroxine Sodium; Lexatin
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 female
Reported by a physician from Czech Republic on 2011-12-16
Patient: female
Reactions: Off Label Use
Drug(s) suspected as cause:
Multaq
Possible Multaq side effects in 69 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2011-11-14
Patient: 69 year old male
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: 2009-10-01
End date: 2011-01-01
Multaq
Administration route: Oral
Start date: 2011-01-11
End date: 2011-01-31
Multaq
Administration route: Oral
Start date: 2011-07-01
End date: 2011-08-08
Other drugs received by patient: Previscan; Bisoprolol Fumarate; Bisoprolol Fumarate; Corgard; Imovane
Possible Multaq side effects in 75 year old male
Reported by a health professional (non-physician/pharmacist) from Spain on 2011-10-24
Patient: 75 year old male, weighing 80.0 kg (176.0 pounds)
Reactions: Off Label Use, Vomiting, Cardiac Failure, Coagulopathy, Acute Hepatic Failure, Drug Interaction, Asthenia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
ALL Other Therapeutic Products
Multaq
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2011-06-03
End date: 2011-06-05
Other drugs received by patient: Amiodarone HCL; Allopurinol; Sintrom; Atenolol; Furosemide; Tirodril; Atenolol; Radioactive Iodine Solution; Furosemide; Atenolol
Possible Multaq side effects in 75 year old male
Reported by a health professional (non-physician/pharmacist) from Spain on 2011-10-10
Patient: 75 year old male, weighing 80.0 kg (176.0 pounds)
Reactions: Off Label Use, Vomiting, Cardiac Failure, Coagulopathy, Drug Interaction, Acute Hepatic Failure, Asthenia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
ALL Other Therapeutic Products
Multaq
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2011-06-03
End date: 2011-06-05
Other drugs received by patient: Atenolol; Furosemide; Atenolol; Tirodril; Furosemide; Atenolol; Radioactive Iodine Solution; Sintrom; Amiodarone HCL; Allopurinol
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