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Tikosyn (Dofetilide) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Tikosyn (Dofetilide) 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 (478)
Death (36)
Life Threatening Events (7)
Disability (5)

Reports by Reaction Type

Electrocardiogram QT Prolonged (33)Dizziness (33)Drug Ineffective (32)Atrial Fibrillation (32)Headache (30)Fatigue (28)Death (27)Malaise (23)Drug Interaction (21)Dyspnoea (20)Arrhythmia (19)Heart Rate Increased (16)

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

Possible Tikosyn side effects in 70 year old female

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

Patient: 70 year old female, weighing 90.7 kg (199.5 pounds)

Reactions: Abnormal Behaviour, Headache, Rash Pruritic, Fatigue, Diarrhoea, Palpitations, Heart Rate Irregular, Hypertension, LIP Discolouration, Decreased Appetite

Drug(s) suspected as cause:
Tikosyn

Other drugs received by patient: Diltiazem; Coumadin



Possible Tikosyn side effects in 15 year old female

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

Patient: 15 year old female, weighing 67.1 kg (147.7 pounds)

Reactions: Cardiac Failure, Feeling Hot, Hyperhidrosis, Abdominal Pain Upper

Adverse event resulted in: death

Drug(s) suspected as cause:
Tikosyn

Other drugs received by patient: Aspirin



Possible Tikosyn side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: male

Reactions: Renal Disorder, Convulsion

Drug(s) suspected as cause:
Tikosyn



Possible Tikosyn side effects in 69 year old female

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

Patient: 69 year old female, weighing 100.0 kg (220.0 pounds)

Reactions: Torsade DE Pointes, Heart Rate Increased, Loss of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tikosyn

Other drugs received by patient: Diltiazem; Diltiazem; Synthroid; Lipitor; Pradaxa; Lasix; Multi-Vitamins



Possible Tikosyn side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: male

Reactions: Small Intestinal Obstruction

Drug(s) suspected as cause:
Tikosyn



Possible Tikosyn side effects in 78 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 78 year old female, weighing 49.4 kg (108.8 pounds)

Reactions: Cardiac Disorder

Drug(s) suspected as cause:
Tikosyn
    Dosage: 125 ug, 2x/day
    Administration route: Oral
    Indication: Heart Rate Increased
    Start date: 2010-01-01
    End date: 2012-07-02

Tikosyn
    Dosage: unk

Tikosyn
    Dosage: unk

Other drugs received by patient: Lisinopril



Possible Tikosyn side effects in 69 year old female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 69 year old female, weighing 95.2 kg (209.5 pounds)

Reactions: Dysgeusia, Pollakiuria

Drug(s) suspected as cause:
Tikosyn

Other drugs received by patient: Bisoprolol



Possible Tikosyn side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: female

Reactions: Pain in Extremity, Dizziness

Drug(s) suspected as cause:
Metformin HCL
    Dosage: unk

Tikosyn
    Dosage: unk



Possible Tikosyn side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: female

Reactions: Anxiety, Drug Interaction, Tremor

Drug(s) suspected as cause:
Tikosyn

Other drugs received by patient possibly interacting with the suspect drug:
Ativan

Lasix

Tikosyn
    Dosage: 125 ug, unk



Possible Tikosyn side effects in 70 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23

Patient: 70 year old female, weighing 64.4 kg (141.7 pounds)

Reactions: Arrhythmia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tikosyn

Other drugs received by patient: Ascorbic Acid; Estrace; Zolpidem Tartrate; Citracal Plus; Estradiol; Extra Strength Tylenol; Amiodarone; Alprazolam; Aspirin; Zolpidem Tartrate; Multi-Vitamins



Possible Tikosyn side effects in 81 year old female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 81 year old female, weighing 85.3 kg (187.7 pounds)

Reactions: Heart Rate Increased, DRY Mouth, Dizziness, DRY Eye

Drug(s) suspected as cause:
Tikosyn

Other drugs received by patient: Aspirin; Cozaar



Possible Tikosyn side effects in 70 year old female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 70 year old female, weighing 77.1 kg (169.6 pounds)

Reactions: Hot Flush, Dizziness, Atrial Fibrillation, Feeling Abnormal

Drug(s) suspected as cause:
Amlodipine Besylate
    Dosage: 5 mg, unk

Tikosyn
    Dosage: 250 ug, 2x/day
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2012-08-02

Other drugs received by patient: Loperamide; Citalopram; Losartan; Lovaza; Ascorbic Acid; Folic Acid; Metoprolol; Azelastine; Coumadin; Vitamin D; CO-Q-10; Maxzide; Fexofenadine; Hydrochlorothiazide; Synthroid; Crestor; Potassium; Nasonex



Possible Tikosyn side effects in male

Reported by a pharmacist from United States on 2012-08-22

Patient: male

Reactions: Prostate Cancer, Heart Valve Stenosis, Atrial Fibrillation, Coronary Artery Disease, Gastric Disorder, Chronic Obstructive Pulmonary Disease, Hypercholesterolaemia, Small Intestinal Obstruction, Musculoskeletal Disorder, Pneumonia Staphylococcal, Myocardial Infarction, Hyperthyroidism, Arterial Stenosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tikosyn



Possible Tikosyn side effects in male

Reported by a physician from United States on 2012-08-20

Patient: male

Reactions: Electrocardiogram QT Prolonged, Drug Interaction

Drug(s) suspected as cause:
Tikosyn

Other drugs received by patient possibly interacting with the suspect drug:
Hydrochlorothiazide
    Dosage: unk



Possible Tikosyn side effects in 48 year old female

Reported by a lawyer from United States on 2012-08-20

Patient: 48 year old female, weighing 147.0 kg (323.4 pounds)

Reactions: Glomerular Filtration Rate Decreased, Blood Potassium Increased, Blood Creatinine Increased, Vitamin B1 Increased

Drug(s) suspected as cause:
Lasix
    Dosage: unk
    End date: 2012-08-01

Lisinopril
    Dosage: unk
    End date: 2012-08-01

Potassium Chloride
    Dosage: unk
    End date: 2012-08-01

Tikosyn
    Dosage: 0.5 mg, 2x/day
    Indication: Atrial Fibrillation
    Start date: 2009-09-01

Other drugs received by patient: Melatonin; Amlodipine; Gabapentin; Vitamin D; Humulin R; Edarbi; Spiriva; Humulin N; Formoterol Fumarate; Warfarin Sodium; Lipitor; Magnesium Oxide; Acetylsalicylic Acid



Possible Tikosyn side effects in 83 year old female

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

Patient: 83 year old female, weighing 73.0 kg (160.6 pounds)

Reactions: Muscle Twitching, Tremor, Discomfort

Drug(s) suspected as cause:
Tikosyn

Other drugs received by patient: Aspirin; Zocor



Possible Tikosyn side effects in male

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

Patient: male

Reactions: Back Pain, Cyanosis, Poor Peripheral Circulation, Oedema Peripheral

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tikosyn



Possible Tikosyn side effects in 75 year old male

Reported by a pharmacist from United States on 2012-08-17

Patient: 75 year old male, weighing 97.5 kg (214.5 pounds)

Reactions: Aphthous Stomatitis, Drug Ineffective, Nasal Congestion, Blood Test Abnormal

Drug(s) suspected as cause:
Celecoxib
    Dosage: 200 mg, 1x/day
    Administration route: Oral
    Indication: Arthritis
    Start date: 2012-05-01
    End date: 2012-06-19

Tikosyn
    Dosage: 250 ug, 2x/day
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2012-05-16



Possible Tikosyn side effects in female

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

Patient: female

Reactions: LIP Blister

Drug(s) suspected as cause:
Tikosyn



Possible Tikosyn side effects in 79 year old male

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

Patient: 79 year old male, weighing 84.4 kg (185.6 pounds)

Reactions: Drug Ineffective

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

Tikosyn
    Dosage: 250 ug, unk
    Administration route: Oral
    Indication: Arrhythmia

Other drugs received by patient: Vitamin B-12; Lasix; Omeprazole; Carvedilol; Vitamin D; Iron; Chondroitin / Glucosamine; Acetylsalicylic Acid; Doxazosin; Warfarin; Enalapril; Pravastatin; Potassium



Possible Tikosyn side effects in female

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

Patient: female

Reactions: Pruritus, Insomnia

Drug(s) suspected as cause:
Tikosyn



Possible Tikosyn side effects in 61 year old female

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

Patient: 61 year old female, weighing 49.9 kg (109.8 pounds)

Reactions: Blood Pressure Increased, Anaemia, Heart Rate Increased, Dehydration, Dizziness, Atrial Fibrillation, Nervousness

Drug(s) suspected as cause:
Tikosyn

Other drugs received by patient: Digoxin; Metoprolol; Pradaxa



Possible Tikosyn side effects in 78 year old male

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

Patient: 78 year old male, weighing 87.5 kg (192.6 pounds)

Reactions: HIP Arthroplasty, Accident AT Home

Drug(s) suspected as cause:
Tikosyn

Other drugs received by patient: Multi-Vitamins



Possible Tikosyn side effects in 82 year old female

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

Patient: 82 year old female

Reactions: Cataract, Drug Hypersensitivity, Stress, Fall, Cerebral Haemorrhage, Malaise, Fatigue, Heart Rate Increased, Facial Bones Fracture, Dizziness, Blindness Unilateral, Gait Disturbance

Drug(s) suspected as cause:
Aspirin
    Administration route: Oral

Digoxin

Losartan Potassium

Metoprolol Tartrate
    Administration route: Oral

Spironolactone

Tikosyn
    Administration route: Oral

Tylenol

Zestril
    Administration route: Oral



Possible Tikosyn side effects in female

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

Patient: female

Reactions: Lung Infection, Arrhythmia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tikosyn



Possible Tikosyn side effects in female

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

Patient: female

Reactions: Urinary Tract Infection

Drug(s) suspected as cause:
Tikosyn

Other drugs received by patient: Coumadin



Possible Tikosyn side effects in male

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

Patient: male

Reactions: Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Tikosyn



Possible Tikosyn side effects in 68 year old male

Reported by a physician from United States on 2012-08-07

Patient: 68 year old male, weighing 81.6 kg (179.6 pounds)

Reactions: Blood Immunoglobulin M Increased

Drug(s) suspected as cause:
Tikosyn

Other drugs received by patient: Carvedilol; Warfarin; Pravastatin



Possible Tikosyn side effects in 51 year old female

Reported by a consumer/non-health professional from United States on 2012-08-07

Patient: 51 year old female, weighing 114.7 kg (252.4 pounds)

Reactions: Pruritus, Blood Potassium Decreased, Urinary Tract Infection, Rash, Blood Magnesium Decreased

Drug(s) suspected as cause:
Magnesium
    Dosage: unk
    End date: 2012-07-01

Magnesium
    Dosage: unk
    Start date: 2012-07-01

Potassium
    Dosage: unk
    End date: 2012-07-01

Potassium
    Dosage: unk
    Start date: 2012-07-01

Tikosyn
    Dosage: 0.25 mg, 2x/day
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2012-07-23

Other drugs received by patient: Metformin; Spironolactone; Levothyroxine; Metoprolol; Norvasc; Glipizide; Losartan; Clonidine



Possible Tikosyn side effects in 60 year old female

Reported by a consumer/non-health professional from United States on 2012-08-07

Patient: 60 year old female, weighing 50.0 kg (110.0 pounds)

Reactions: Blood Pressure Increased, Heart Rate Increased, Anaemia, Dehydration, Atrial Fibrillation, Dizziness, Nervousness

Drug(s) suspected as cause:
Tikosyn

Other drugs received by patient: Metoprolol; Digoxin; Pradaxa

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