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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 56 year old male
Reported by a physician from Ireland on 2012-08-06
Patient: 56 year old male
Reactions: Weight Decreased, Hyperthyroidism
Drug(s) suspected as cause:
Multaq
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