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Tasigna (Nilotinib) - Electrocardiogram QT Prolonged - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Electrocardiogram QT Prolonged (126)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Tasigna (Nilotinib) where reactions include electrocardiogram qt prolonged. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 126   Next >>

Possible Tasigna side effects in female

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

Patient: female, weighing 59.0 kg (129.8 pounds)

Reactions: Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Tasigna
    Dosage: 600 mg, unk
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia
    Start date: 2012-05-14
    End date: 2012-07-04

Tasigna
    Dosage: 450 mg, unk
    Administration route: Oral
    Start date: 2012-07-05
    End date: 2012-08-06



Possible Tasigna side effects in male

Reported by a physician from Barbados on 2012-08-14

Patient: male

Reactions: Death, Electrocardiogram QT Prolonged, Blood Calcium Decreased

Adverse event resulted in: death

Drug(s) suspected as cause:
Tasigna



Possible Tasigna side effects in male

Reported by a physician from Japan on 2012-08-14

Patient: male

Reactions: Weight Decreased, Electrocardiogram QT Prolonged, Rash Generalised, Rash Papular, Hypoglycaemia, Muscular Weakness, Abdominal Pain Upper, Abdominal Discomfort, Blood Phosphorus Decreased, Platelet Count Decreased, Lacunar Infarction, Bacterial Infection, Abdominal Distension, Altered State of Consciousness, Blood Glucose Increased, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amaryl
    Dosage: 2 mg,daily
    Administration route: Oral
    Start date: 2009-08-07
    End date: 2009-08-20

Amaryl
    Dosage: 1 mg,daily
    Administration route: Oral
    Start date: 2010-03-12
    End date: 2010-04-22

Amaryl
    Dosage: 3 mg, daily
    Administration route: Oral
    Start date: 2009-08-21
    End date: 2010-03-10

Amaryl
    Dosage: 2 mg, daily
    Administration route: Oral
    Start date: 2010-04-23
    End date: 2011-05-09

Amaryl
    Dosage: 1 mg,daily
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2008-12-17
    End date: 2009-08-06

Januvia
    Dosage: 50 mg, daily
    Administration route: Oral
    Start date: 2010-09-27
    End date: 2012-08-29

Januvia
    Dosage: 50 mg, daily
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2010-01-23
    End date: 2010-03-10

Januvia
    Dosage: 50 mg, daily
    Administration route: Oral
    Start date: 2010-03-12
    End date: 2010-07-24

Tasigna
    Dosage: 400 mg, daily
    Administration route: Oral
    Start date: 2010-03-26
    End date: 2010-07-24

Tasigna
    Dosage: 400 mg, daily
    Administration route: Oral
    Start date: 2010-08-09
    End date: 2010-12-06

Tasigna
    Dosage: 800 mg, daily
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia
    Start date: 2009-05-08
    End date: 2009-05-12

Tasigna
    Dosage: 800 mg daily
    Administration route: Oral
    Start date: 2009-05-22
    End date: 2009-06-02

Tasigna
    Dosage: 400 mg, daily
    Administration route: Oral
    Start date: 2010-12-13
    End date: 2011-06-27

Tasigna
    Dosage: 400 mg, daily
    Administration route: Oral
    Start date: 2009-12-18
    End date: 2010-03-08

Tasigna
    Dosage: 400 mg daily
    Administration route: Oral
    Start date: 2009-08-07
    End date: 2009-12-11

Tasigna
    Dosage: 400 mg daily
    Administration route: Oral
    Start date: 2009-06-12
    End date: 2009-07-24

Other drugs received by patient: Glucobay; Sennoside; Kamag G; Stogar; Glimepiride; Glimicron; Plavix; Sennoside; Ticlopidine Hydrochloride; Hydrea; Kamag G; Alosenn



Possible Tasigna side effects in

Reported by a physician from United States on 2012-08-09

Patient:

Reactions: Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Tasigna

Other drugs received by patient: Verapamil; Atenolol



Possible Tasigna side effects in male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-07

Patient: male

Reactions: Electrocardiogram QT Prolonged, Interstitial Lung Disease, Lipase Increased, Blood Creatinine Increased

Drug(s) suspected as cause:
Tasigna
    Dosage: 200 mg, daily
    Administration route: Oral
    Start date: 2010-01-07

Tasigna
    Dosage: 400 mg, daily
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia
    Start date: 2009-12-08
    End date: 2010-01-04



Possible Tasigna side effects in 75 year old female

Reported by a physician from United States on 2012-07-31

Patient: 75 year old female

Reactions: Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Tasigna
    Dosage: 300 mg, bid
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia
    Start date: 2012-06-19

Tasigna



Possible Tasigna side effects in male

Reported by a physician from United States on 2012-07-31

Patient: male, weighing 74.8 kg (164.6 pounds)

Reactions: Electrocardiogram QT Prolonged, Electrocardiogram Abnormal

Drug(s) suspected as cause:
Tasigna



Possible Tasigna side effects in 64 year old female

Reported by a physician from Spain on 2012-07-30

Patient: 64 year old female

Reactions: Electrocardiogram QT Prolonged, Vomiting, Nausea, Palpitations, Chest Pain, Lipase Increased

Drug(s) suspected as cause:
Tasigna
    Dosage: 200 mg, q12h

Tasigna
    Dosage: 400 mg, q12h
    Start date: 2012-01-10



Possible Tasigna side effects in 72 year old male

Reported by a physician from Germany on 2012-07-24

Patient: 72 year old male, weighing 65.0 kg (143.0 pounds)

Reactions: Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Tasigna

Other drugs received by patient: Pentaerythritol Tetranitrate; Nitroglycerin



Possible Tasigna side effects in 43 year old female

Reported by a physician from Greece on 2012-07-24

Patient: 43 year old female

Reactions: Electrocardiogram QT Prolonged, Extrasystoles, Hepatic Enzyme Increased

Drug(s) suspected as cause:
Tasigna
    Dosage: 600 mg, daily
    Administration route: Oral

Tasigna
    Dosage: 300 mg, daily
    Administration route: Oral

Tasigna
    Dosage: 800 mg, daily
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia



Possible Tasigna side effects in

Reported by a physician from United States on 2012-07-23

Patient:

Reactions: Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Tasigna



Possible Tasigna side effects in male

Reported by a physician from Italy on 2012-07-19

Patient: male, weighing 73.0 kg (160.6 pounds)

Reactions: Electrocardiogram QT Prolonged, Syncope, Acute Myocardial Infarction, Arrhythmia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tasigna
    Dosage: 800 mg, unk
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2010-05-13
    End date: 2010-05-16

Tasigna
    Dosage: 800 mg, unk
    Administration route: Oral

Other drugs received by patient: Moxifloxacin; Aspirin; Bisoprolol Fumarate; Norvasc; Ramipril



Possible Tasigna side effects in male

Reported by a physician from Germany on 2012-07-19

Patient: male

Reactions: Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Tasigna

Other drugs received by patient: Pentaerythritol Tetranitrate; Nitroglycerin



Possible Tasigna side effects in male

Reported by a physician from France on 2012-07-16

Patient: male, weighing 91.0 kg (200.2 pounds)

Reactions: Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Tasigna



Possible Tasigna side effects in 63 year old

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-07-09

Patient: 63 year old

Reactions: Electrocardiogram QT Prolonged, Angina Pectoris, Acute Coronary Syndrome

Drug(s) suspected as cause:
Tasigna

Other drugs received by patient: Ponatinib; Dasatinib



Possible Tasigna side effects in female

Reported by a physician from United States on 2012-07-09

Patient: female

Reactions: Electrocardiogram QT Prolonged, Heart Rate Decreased, Blood Potassium Decreased, Peripheral Vascular Disorder, Bone Marrow Failure, Pleural Effusion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tasigna
    Dosage: 300 mg, bid
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia
    Start date: 2010-01-23

Tasigna
    Dosage: 200 mg, qd
    Administration route: Oral
    Start date: 2010-07-01

Tasigna
    Dosage: 200 mg, bid
    Administration route: Oral

Other drugs received by patient: Levothyroxine Sodium; Vitamin A; Vitamin B NOS; Calcium; Triamterene; Vitamin E; Niacin; Verapamil



Possible Tasigna side effects in female

Reported by a physician from Tunisia on 2012-07-05

Patient: female

Reactions: Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Tasigna



Possible Tasigna side effects in 77 year old male

Reported by a physician from Japan on 2012-07-03

Patient: 77 year old male

Reactions: Electrocardiogram QT Prolonged, Blood Urea Increased, Hepatic Function Abnormal, Nausea, Renal Failure Chronic, Hyperuricaemia, Oedema, Blood Creatinine Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tasigna
    Dosage: 800 mg, daily
    Administration route: Oral
    Start date: 2009-08-14
    End date: 2009-09-10

Tasigna
    Dosage: 800 mg, qd
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia
    Start date: 2009-04-30
    End date: 2009-05-21

Tasigna
    Dosage: 400 mg, qd
    Administration route: Oral
    Start date: 2009-05-22
    End date: 2009-08-13

Other drugs received by patient: Urso 250; Lansoprazole; Menest; Lasix; Alosenn; Motilium; Juso



Possible Tasigna side effects in male

Reported by a physician from France on 2012-07-03

Patient: male

Reactions: Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Tasigna

Other drugs received by patient: Levothyroxine Sodium; Irbesartan



Possible Tasigna side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-03

Patient: female

Reactions: Electrocardiogram QT Prolonged, Heart Rate Decreased, Blood Potassium Decreased, Peripheral Vascular Disorder, Bone Marrow Failure

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tasigna
    Dosage: 200 mg, qd
    Administration route: Oral
    Start date: 2010-07-01

Tasigna
    Dosage: 300 mg, bid
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia
    Start date: 2010-01-23

Tasigna
    Dosage: 200 mg, bid
    Administration route: Oral

Other drugs received by patient: Vitamin E; Niacin; Levothyroxine Sodium; Vitamin B NOS; Calcium; Triamterene; Vitamin A; Verapamil



Possible Tasigna side effects in male

Reported by a physician from France on 2012-06-28

Patient: male

Reactions: Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Tasigna



Possible Tasigna side effects in 34 year old female

Reported by a physician from Palestinian Territory, Occupied on 2012-06-28

Patient: 34 year old female

Reactions: Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Tasigna
    Dosage: 400 mg, bid
    Administration route: Oral

Tasigna
    Dosage: 200 mg, bid
    Administration route: Oral

Tasigna
    Dosage: 200 mg, bid
    Administration route: Oral
    Start date: 2012-01-24



Possible Tasigna side effects in 75 year old male

Reported by a physician from Japan on 2012-06-26

Patient: 75 year old male

Reactions: Electrocardiogram QT Prolonged, Pneumonia, Pyrexia, Hypokalaemia, Renal Impairment, Malaise, Pleural Effusion, Acute Respiratory Failure, Cough

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Tasigna
    Dosage: 200 mg daily
    Administration route: Oral
    Start date: 2010-02-19
    End date: 2010-04-08

Tasigna
    Dosage: 400 mg, daily
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia
    Start date: 2010-02-05
    End date: 2010-02-18

Tasigna
    Dosage: 400 mg, daily
    Administration route: Oral
    Start date: 2010-11-19
    End date: 2011-08-26

Tasigna
    Dosage: 400 mg and 600 mg alternately
    Start date: 2010-09-24
    End date: 2010-11-18

Tasigna
    Dosage: 400 mg daily
    Administration route: Oral
    Start date: 2010-04-09
    End date: 2010-09-23

Other drugs received by patient: Zopiclone; Flivastatin Sodium; Mucosolvan; BUP-4; Mucosolvan; Ambroxol Hydrochloride; Livact; Astomin; Rohypnol; Norvasc; Depas; Magmitt; Sawatene; Urso 250



Possible Tasigna side effects in 64 year old female

Reported by a physician from Spain on 2012-06-26

Patient: 64 year old female

Reactions: Electrocardiogram QT Prolonged, Vomiting, Nausea, Palpitations, Chest Pain, Lipase Increased

Drug(s) suspected as cause:
Tasigna
    Dosage: 400 mg, q12h
    Start date: 2012-01-10

Tasigna
    Dosage: 200 mg, q12h



Possible Tasigna side effects in

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

Patient:

Reactions: Electrocardiogram QT Prolonged, Rash Generalised

Drug(s) suspected as cause:
Tasigna
    Dosage: 600 mg per day (3 capsules) on odd days and 800 mg per day (4 capsules) on even days
    Administration route: Oral

Tasigna
    Dosage: 400 mg, bid
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia

Tasigna
    Dosage: 200 mg, daily
    Administration route: Oral

Tasigna
    Dosage: 400 mg, daily
    Administration route: Oral



Possible Tasigna side effects in 64 year old female

Reported by a physician from Spain on 2012-06-22

Patient: 64 year old female

Reactions: Electrocardiogram QT Prolonged, Vomiting, Lipase Increased

Drug(s) suspected as cause:
Tasigna



Possible Tasigna side effects in 59 year old male

Reported by a physician from Japan on 2012-06-21

Patient: 59 year old male

Reactions: Blood Bilirubin Increased, Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Tasigna



Possible Tasigna side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-20

Patient: female

Reactions: Abdominal Pain, Electrocardiogram QT Prolonged, Anaemia, Hypocalcaemia, Thrombocytopenia

Drug(s) suspected as cause:
Tasigna



Possible Tasigna side effects in female

Reported by a physician from United States on 2012-06-20

Patient: female

Reactions: Electrocardiogram QT Prolonged

Drug(s) suspected as cause:
Tasigna
    Dosage: 400 mg, bid
    Administration route: Oral
    Indication: Chromosome Analysis Abnormal
    Start date: 2010-01-01
    End date: 2010-06-01

Tasigna
    Indication: Chronic Myeloid Leukaemia



Possible Tasigna side effects in male

Reported by a physician from Japan on 2012-06-18

Patient: male

Reactions: Electrocardiogram QT Prolonged, Lipase Increased, Pyrexia

Drug(s) suspected as cause:
Tasigna
    Dosage: 800 mg, unk
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia
    Start date: 2009-03-28
    End date: 2010-07-29

Tasigna
    Dosage: 600 mg, daily
    Start date: 2010-07-30

Other drugs received by patient: Pravastatin; Tamsulosin HCL; Verapamil HCL; Ferrum; Spiriva; Theo-DUR; Vitamin B12; Alvesco



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