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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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
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
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