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Tambocor (Flecainide) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Tambocor (Flecainide) 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 (8)
Death (4)
Life Threatening Events (1)

Reports by Reaction Type

Product Substitution Issue (2)Sudden Death (2)Death (2)Nausea (2)Weight Decreased (1)Hepatic Function Abnormal (1)Hallucination, Auditory (1)Visual Acuity Reduced (1)Fall (1)Abdominal Pain Upper (1)Face Oedema (1)Oedema Peripheral (1)

Possible Tambocor side effects in 64 year old male

Reported by a consumer/non-health professional from United States on 2012-06-25

Patient: 64 year old male, weighing 190.0 kg (418.0 pounds)

Reactions: Product Quality Issue, Product Substitution Issue, Chest Discomfort, Blood Pressure Systolic Increased

Drug(s) suspected as cause:
Tambocor
    Dosage: 100 mg;tid;
    Indication: Atrial Fibrillation
    Start date: 2012-05-30

Tambocor
    Dosage: 100 mg;tid;
    Indication: Atrial Fibrillation
    Start date: 2000-01-01
    End date: 2010-03-01

Flecainide Acetate
    Dosage: 100 mg;tid;
    Indication: Atrial Fibrillation
    Start date: 2010-03-01

Other drugs received by patient: Veiva-Prostate Supplement; Whey Protein



Possible Tambocor side effects in female

Reported by a consumer/non-health professional from United States on 2012-02-22

Patient: female, weighing 90.7 kg (199.6 pounds)

Reactions: Product Substitution Issue, Nausea, Abdominal Pain Upper

Drug(s) suspected as cause:
Tambocor



Possible Tambocor side effects in 81 year old female

Reported by a pharmacist from Japan on 2012-02-10

Patient: 81 year old female, weighing 40.0 kg (88.0 pounds)

Reactions: Weight Decreased, Hallucination, Auditory, Visual Acuity Reduced, Fall, Face Oedema, Oedema Peripheral, Dizziness, Neuroleptic Malignant Syndrome, Hallucination, Persecutory Delusion, Vomiting, Nausea, Hypochloraemia, Hyponatraemia, Head Banging, Pancreatitis, Pollakiuria, Corneal Oedema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Galantamine Hydrobromide
    Administration route: Oral
    Start date: 2011-05-13
    End date: 2011-05-22

Rabeprazole Sodium
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2011-09-08

Tambocor
    Indication: Product Used FOR Unknown Indication
    End date: 2011-09-08

Symmetrel
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2011-09-08

Galantamine Hydrobromide
    Administration route: Oral
    Indication: Dementia Alzheimer's Type
    Start date: 2011-05-23
    End date: 2011-09-08

Lorazepam
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Ketas
    Indication: Product Used FOR Unknown Indication
    End date: 2011-09-08

Norvasc
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2011-09-08

Diart
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-05-31
    End date: 2011-09-06

Diart
    Administration route: Oral
    Start date: 2011-05-23
    End date: 2011-05-30

Tolterodine Tartrate
    Administration route: Oral
    Indication: Pollakiuria
    Start date: 2011-08-09
    End date: 2011-09-08

Shimbu-TO (Chinese Herbal Medicine)
    Indication: Pollakiuria
    Start date: 2011-08-09
    End date: 2011-09-08



Possible Tambocor side effects in 45 year old male

Reported by a physician from Netherlands on 2012-01-30

Patient: 45 year old male, weighing 88.0 kg (193.6 pounds)

Reactions: Hepatic Function Abnormal, Cardiac Arrest

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Metoprolol Succinate
    Administration route: Oral
    Indication: Arrhythmia
    Start date: 2005-06-15
    End date: 2005-06-15

Tambocor
    Indication: Arrhythmia
    Start date: 2005-06-15
    End date: 2005-06-15



Possible Tambocor side effects in female

Reported by a physician from Japan on 2011-12-20

Patient: female, weighing 47.3 kg (104.1 pounds)

Reactions: Sudden Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Tambocor
    Dosage: 100 mg
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2011-08-10

Tambocor
    Indication: Hypertrophic Cardiomyopathy

Pradaxa
    Dosage: 300 mg
    Administration route: Oral
    Indication: Cerebrovascular Accident Prophylaxis
    Start date: 2011-08-10

Pradaxa
    Dosage: 220 mg
    Administration route: Oral
    Start date: 2011-09-07
    End date: 2011-11-27

Tambocor
    Indication: non-Obstructive Cardiomyopathy

Other drugs received by patient: Digoxin; Digoxin; Digoxin; Verapamil HCL



Possible Tambocor side effects in female

Reported by a physician from Japan on 2011-12-13

Patient: female, weighing 47.3 kg (104.1 pounds)

Reactions: Sudden Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Pradaxa
    Dosage: 220 mg
    Administration route: Oral
    Start date: 2011-09-07

Pradaxa
    Dosage: 300 mg
    Administration route: Oral
    Indication: Cerebrovascular Accident Prophylaxis
    Start date: 2011-08-10

Tambocor
    Dosage: 100 mg
    Administration route: Oral
    Indication: Hypertrophic Cardiomyopathy
    Start date: 2011-08-10

Tambocor
    Indication: Atrial Fibrillation

Other drugs received by patient: Digoxin; Verapamil HCL; Digoxin



Possible Tambocor side effects in female

Reported by a physician from Japan on 2011-12-08

Patient: female, weighing 47.3 kg (104.1 pounds)

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Tambocor
    Indication: Atrial Fibrillation

Pradaxa
    Dosage: 220 mg
    Administration route: Oral
    Start date: 2011-10-17

Pradaxa
    Dosage: 300 mg
    Administration route: Oral
    Indication: Cerebrovascular Accident Prophylaxis
    Start date: 2011-08-10
    End date: 2011-11-27

Tambocor
    Dosage: 100 mg
    Administration route: Oral
    Indication: Hypertrophic Cardiomyopathy
    Start date: 2011-08-10

Other drugs received by patient: Verapamil HCL; Digoxin; Digoxin



Possible Tambocor side effects in 60 year old female

Reported by a physician from Japan on 2011-11-30

Patient: 60 year old female, weighing 47.9 kg (105.4 pounds)

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Pradaxa
    Dosage: 300 mg
    Administration route: Oral
    Indication: Cerebrovascular Accident Prophylaxis
    Start date: 2011-08-10
    End date: 2011-10-16

Pradaxa
    Dosage: 220 mg
    Administration route: Oral
    Start date: 2011-10-17

Tambocor
    Dosage: 100 mg
    Administration route: Oral
    Indication: Hypertrophic Cardiomyopathy

Other drugs received by patient: Digoxin; Verapamil HCL

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