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Multaq (Dronedarone) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Multaq (Dronedarone) 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 (659)
Death (43)
Life Threatening Events (45)
Disability (22)

Reports by Reaction Type

Atrial Fibrillation (159)Dyspnoea (74)Blood Creatinine Increased (66)Fatigue (43)Dizziness (37)Diarrhoea (37)Nausea (27)Asthenia (27)Hyperthyroidism (25)Interstitial Lung Disease (23)Renal Failure Acute (22)Malaise (20)

Below are a few examples of reports where side effects / adverse reactions may be related to Multaq (Dronedarone). For a complete list or a specific selection of reports, please use the links above.

Possible Multaq side effects in 71 year old male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 71 year old male

Reactions: Prostate Cancer

Drug(s) suspected as cause:
Multaq



Possible Multaq side effects in 84 year old female

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

Patient: 84 year old female

Reactions: Atrial Fibrillation

Drug(s) suspected as cause:
Multaq



Possible Multaq side effects in female

Reported by a physician from United States on 2012-08-24

Patient: female, weighing 106.6 kg (234.5 pounds)

Reactions: Pulmonary Fibrosis

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Multaq



Possible Multaq side effects in 80 year old female

Reported by a physician from United States on 2012-08-23

Patient: 80 year old female

Reactions: Dyspnoea, Anaemia, Pleural Effusion

Drug(s) suspected as cause:
Multaq

Other drugs received by patient: Xarelto



Possible Multaq side effects in male

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

Patient: male, weighing 104.0 kg (228.8 pounds)

Reactions: Paralysis, Muscular Weakness, Gait Disturbance, Hypoaesthesia, Coordination Abnormal, Polyneuropathy

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Multaq
    Administration route: Oral
    Start date: 2010-01-24

Multaq
    Administration route: Oral
    Start date: 2010-01-24

Other drugs received by patient: Hydrochlorothiazide; Pantoprazole; Ramipril; Torsemide; Simvastatin; Plavix; Metoprolol Tartrate; Marcumar; Ramipril; Ezetimibe; Clopidogrel Bisulfate; Fluvastatin Sodium; Metoprolol Tartrate; Embolex; Isosorbide Dinitrate



Possible Multaq side effects in 40 year old male

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

Patient: 40 year old male

Reactions: Atrial Fibrillation, Hyperthyroidism

Drug(s) suspected as cause:
Multaq
    Administration route: Oral
    Indication: Atrial Fibrillation

Proscar



Possible Multaq side effects in 49 year old female

Reported by a physician from United States on 2012-08-21

Patient: 49 year old female

Reactions: Weight Increased, Pericarditis, Wheezing, Chest Pain, Cough

Drug(s) suspected as cause:
Multaq

Other drugs received by patient: Toprol-XL; Multi-Vitamins; Aspirin



Possible Multaq side effects in 79 year old male

Reported by a pharmacist from United States on 2012-08-21

Patient: 79 year old male, weighing 61.2 kg (134.7 pounds)

Reactions: Product Label Issue, Anaphylactic Reaction, Urticaria

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Multaq



Possible Multaq side effects in 85 year old male

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: 85 year old male

Reactions: Anxiety, Atrial Fibrillation, Sleep Apnoea Syndrome

Drug(s) suspected as cause:
Multaq

Other drugs received by patient: Coumadin; Simvastatin; Ambien; Atenolol



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 65 year old female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: 65 year old female

Reactions: Lung Infection

Drug(s) suspected as cause:
Multaq



Possible Multaq side effects in 74 year old male

Reported by a physician from United States on 2012-08-21

Patient: 74 year old male, weighing 81.0 kg (178.2 pounds)

Reactions: Pupillary Reflex Impaired, Colour Vision Tests Abnormal, Visual Acuity Reduced, Headache, Scotoma, Photopsia, Papilloedema, Eye Pain, Optic Neuropathy, Vitreous Floaters, Visual Impairment, Blindness Unilateral

Drug(s) suspected as cause:
Multaq



Possible Multaq side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Multaq



Possible Multaq side effects in 73 year old female

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

Patient: 73 year old female

Reactions: Metabolic Acidosis, Pneumonia, Coagulopathy, Urinary Tract Infection, Atrial Fibrillation, Antinuclear Antibody Positive, Hepatic Encephalopathy, Diarrhoea, Acute Hepatic Failure, Acute Respiratory Failure, Renal Failure Acute

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Multaq
    Start date: 2011-07-01

Tylenol
    Dosage: 2 tabs 500mg or 650mg (1000mg) (1300mg) prn
    Administration route: Oral

Vicodin
    Dosage: 500/5mg 1-2 tabs prn
    Administration route: Oral

Other drugs received by patient: Alendronate Sodium; Potassium Chloride; Metoprolol Tartrate; Coumadin; Lasix; Iron; Aspirin; Diltiazem; Diltiazem; Vitamin D; Vitamin TAB; Calcium



Possible Multaq side effects in 65 year old female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: 65 year old female, weighing 63.2 kg (139.0 pounds)

Reactions: Generalised Anxiety Disorder, Skin Exfoliation, Wheezing, Tooth Infection, Tension Headache, Depression, Heart Rate Irregular, Blood Glucose Increased, Nervousness, Product Quality Issue, Nightmare, Blepharospasm, Atrial Fibrillation, Pulmonary Function Test Abnormal, Angle Closure Glaucoma, Eye Pain, Circadian Rhythm Sleep Disorder, Heart Rate Decreased, Heart Rate Increased, Visual Impairment, Rash Erythematous

Drug(s) suspected as cause:
Multaq
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2010-11-25

Multaq
    Administration route: Oral
    Start date: 2010-11-25

Multaq
    Administration route: Oral
    Start date: 2010-11-25

Multaq
    Administration route: Oral
    Start date: 2010-11-25

Multaq
    Administration route: Oral
    Start date: 2010-11-25

Multaq
    Administration route: Oral
    Start date: 2010-11-25

Multaq
    Administration route: Oral
    Start date: 2010-11-25

Multaq
    Administration route: Oral
    Start date: 2010-11-25

Multaq
    Administration route: Oral
    Start date: 2010-11-25

Multaq
    Administration route: Oral
    Start date: 2010-11-25

Multaq
    Administration route: Oral
    Start date: 2010-11-25

Multaq
    Administration route: Oral
    Start date: 2010-11-25

Multaq
    Administration route: Oral
    Indication: Atrial Flutter
    Start date: 2010-11-25

Multaq
    Administration route: Oral
    Start date: 2010-11-25

Multaq
    Administration route: Oral
    Start date: 2010-11-25

Multaq
    Administration route: Oral
    Start date: 2010-11-25

Other drugs received by patient: Xanax; Aspirin; Rosuvastatin; Alprazolam; Alprazolam; Alprazolam; Fish OIL; Aspirin; Atorvastatin; Actonel; Caltrate +D; Centrum



Possible Multaq side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: male

Reactions: Product Counterfeit, Angina Pectoris, Gait Disturbance

Drug(s) suspected as cause:
Multaq
    Administration route: Oral
    Start date: 2012-04-25

Multaq
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2010-01-01



Possible Multaq side effects in male

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

Patient: male

Reactions: Anxiety, Atrial Fibrillation, Sleep Apnoea Syndrome

Drug(s) suspected as cause:
Multaq

Other drugs received by patient: Ambien; Coumadin; Simvastatin; Atenolol



Possible Multaq side effects in female

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

Patient: female

Reactions: Vomiting, Dyspnoea, Extrasystoles, Hyperhidrosis, Tremor, Suicidal Ideation, Dysgeusia, Fatigue, Palpitations, Feeling Hot, Heart Rate Increased, Asthenia

Drug(s) suspected as cause:
Multaq
    Dosage: 10am and 10pm.
    Administration route: Oral
    Indication: Atrial Fibrillation

Sotalol HCL
    Dosage: sotalol 80 mg in the morning as well as 40 mg of sotalol in the evening
    Administration route: Oral

Spironolactone
    Administration route: Oral

Other drugs received by patient: Actonel; Aspirin



Possible Multaq side effects in female

Reported by a physician from United States on 2012-08-15

Patient: female

Reactions: Respiratory Disorder

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 2012-08-14

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 2012-08-13

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 74 year old female

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

Patient: 74 year old female

Reactions: Alanine Aminotransferase Increased, Renal Failure Acute, Liver Disorder

Drug(s) suspected as cause:
Multaq



Possible Multaq side effects in 84 year old male

Reported by a physician from United States on 2012-08-10

Patient: 84 year old male, weighing 66.0 kg (145.2 pounds)

Reactions: Glaucoma, Ocular Hyperaemia, Condition Aggravated, Heart Rate Irregular, Hypertension

Drug(s) suspected as cause:
Multaq

Other drugs received by patient: Warfarin Sodium; Lumigan; Ascorbic Acid; Aspirin; Metoprolol Tartrate; Isosorbide; Rosuvastatin; Multivitamin; Alphagan; Vitamin D; Lotemax



Possible Multaq side effects in 82 year old male

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: 82 year old male

Reactions: AGE-Related Macular Degeneration

Drug(s) suspected as cause:
Multaq



Possible Multaq side effects in 71 year old female

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

Patient: 71 year old female, weighing 102.0 kg (224.4 pounds)

Reactions: Myalgia, Diarrhoea, Transaminases Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Multaq

Other drugs received by patient: Nebivolol; Nebivolol; Aliskiren; Valsartan; Amlodipine; Marcumar; Torsemide



Possible Multaq side effects in 69 year old male

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

Patient: 69 year old male, weighing 75.0 kg (165.0 pounds)

Reactions: Renal Failure, Blood Creatinine Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Multaq



Possible Multaq side effects in 85 year old female

Reported by a consumer/non-health professional from United States on 2012-08-09

Patient: 85 year old female

Reactions: Hypotension, Dizziness, Atrial Fibrillation

Drug(s) suspected as cause:
Metoprolol Tartrate
    Administration route: Oral
    Indication: Blood Pressure
    Start date: 2008-01-01

Multaq
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2010-12-01

Other drugs received by patient: Other Respiratory System Products; Prednisone TAB



Possible Multaq side effects in 40 year old male

Reported by a physician from Israel on 2012-08-08

Patient: 40 year old male

Reactions: Atrial Fibrillation, Hyperthyroidism

Drug(s) suspected as cause:
Multaq
    Administration route: Oral
    Indication: Atrial Fibrillation

Proscar



Possible Multaq side effects in 63 year old female

Reported by a pharmacist from India on 2012-08-08

Patient: 63 year old female, weighing 70.0 kg (154.0 pounds)

Reactions: Nasopharyngitis, Vomiting, Nausea, Heart Rate Increased, Blood Creatine Increased, Blood Sodium Decreased, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ambroxol

Multaq



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

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