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Tasigna (Nilotinib) - Serious Reactions - Suspected Cause - Side Effect Reports

 
 



Index of reports > Serious Reactions (1113)

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

 Reports 1 - 30 of 1113   Next >>

Possible Tasigna side effects in female

Reported by a physician from Taiwan, Province of China on 2012-08-27

Patient: female

Reactions: Deafness Bilateral, Headache, Death, Subdural Haematoma, Brain Oedema, Hydrocephalus, Intracranial Pressure Increased, Thrombocytopenia, Stomatitis, Vomiting, Pneumonia, Pain in Extremity, Nausea, Haemorrhage Intracranial, Febrile Neutropenia, Haemoglobin Decreased, Subarachnoid Haemorrhage, Sepsis, Depressed Level of Consciousness, Neutropenia, Herpes Virus Infection

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Tasigna

Other drugs received by patient: Dasatinib



Possible Tasigna side effects in female

Reported by a physician from Japan on 2012-08-27

Patient: female

Reactions: Anaemia, Concomitant Disease Aggravated, Hypokalaemia

Drug(s) suspected as cause:
Lasix
    Dosage: 20 mg, daily
    Administration route: Oral
    Start date: 2011-05-26

Lasix
    Dosage: 40 mg, daily
    Administration route: Oral
    Start date: 2010-07-09
    End date: 2011-05-25

Tasigna
    Dosage: 800 mg, daily
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia
    Start date: 2010-07-09

Other drugs received by patient: Aspara K; Aspara K; Lansoprazole; Mucosta



Possible Tasigna side effects in 55 year old female

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

Patient: 55 year old female

Reactions: Renal Tubular Disorder, Renal Injury, Renal Failure, Blood Creatinine Increased

Drug(s) suspected as cause:
Tasigna

Other drugs received by patient: Diuretics; Metformin HCL; ACE Inhibitor NOS



Possible Tasigna side effects in female

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

Patient: female

Reactions: Emphysema, Dyspnoea

Drug(s) suspected as cause:
Tasigna



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 Spain on 2012-08-24

Patient: male

Reactions: Acute Myocardial Infarction

Drug(s) suspected as cause:
Tasigna



Possible Tasigna side effects in female

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

Patient: female, weighing 82.0 kg (180.4 pounds)

Reactions: Back Pain, Dyspnoea, Skin Burning Sensation, Rash, Joint Stiffness, Abdominal Pain Upper, Arthralgia, Dyspepsia, Kidney Infection

Drug(s) suspected as cause:
Tasigna



Possible Tasigna side effects in 30 year old male

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

Patient: 30 year old male

Reactions: Death, Drug Ineffective, Platelet Count Decreased, Nervous System Disorder, Pyrexia

Adverse event resulted in: death

Drug(s) suspected as cause:
Sprycel

Tasigna
    Dosage: 400 mg, bid
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia
    Start date: 2012-03-15
    End date: 2012-04-26



Possible Tasigna side effects in male

Reported by a physician from Germany on 2012-08-23

Patient: male

Reactions: Hyperglycaemia, Thyroxine Decreased, Condition Aggravated, Blood Thyroid Stimulating Hormone Increased, Blood Thyroid Stimulating Hormone Decreased, Autoimmune Thyroiditis, Anti-Thyroid Antibody Positive, TRI-Iodothyronine Decreased, Hypothyroidism, Thyroid Disorder, Thyroid Neoplasm

Drug(s) suspected as cause:
Tasigna

Other drugs received by patient: Acetylsalicylic Acid SRT; Procoralan; Januvia; Hydroxyurea; Allopurinol; Metformin; Diovan; Hydroxyurea; Valsartan / Hydrochlorothiazide



Possible Tasigna side effects in female

Reported by a physician from Taiwan, Province of China on 2012-08-23

Patient: female

Reactions: Pneumonia, Vomiting, Stomatitis, Nausea, Febrile Neutropenia, Headache, Haemoglobin Decreased, Subarachnoid Haemorrhage, Sepsis, Brain Oedema, Depressed Level of Consciousness, Hydrocephalus, Neutropenia, Thrombocytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tasigna

Other drugs received by patient: Dasatinib



Possible Tasigna side effects in male

Reported by a physician from Germany on 2012-08-22

Patient: male

Reactions: Thyroxine Decreased, Hyperglycaemia, Condition Aggravated, Blood Thyroid Stimulating Hormone Increased, Blood Thyroid Stimulating Hormone Decreased, Autoimmune Thyroiditis, Anti-Thyroid Antibody Positive, TRI-Iodothyronine Decreased, Thyroid Disorder, Hypothyroidism, Thyroid Neoplasm

Drug(s) suspected as cause:
Tasigna
    Dosage: 600 mg, daily
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia
    Start date: 2011-10-12

Tasigna
    Dosage: unk

Other drugs received by patient: Hydroxyurea; Metformin; Acetylsalicylic Acid SRT; Allopurinol; Januvia; Valsartan / Hydrochlorothiazide; Diovan; Hydroxyurea



Possible Tasigna side effects in 30 year old male

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

Patient: 30 year old male

Reactions: Death, Drug Ineffective, Platelet Count Decreased, Nervous System Disorder, Pyrexia

Adverse event resulted in: death

Drug(s) suspected as cause:
Sprycel
    Dosage: unk

Tasigna
    Dosage: 400 mg, bid
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia
    Start date: 2012-03-15
    End date: 2012-04-26



Possible Tasigna side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-21

Patient: male, weighing 91.0 kg (200.2 pounds)

Reactions: Atrial Tachycardia, Abdominal Pain, Musculoskeletal Stiffness, Atrial Fibrillation, Pyrexia, Asthenia

Drug(s) suspected as cause:
Tasigna

Other drugs received by patient: Xatral Extended Release



Possible Tasigna side effects in female

Reported by a physician from United Kingdom on 2012-08-21

Patient: female

Reactions: Renal Tubular Disorder, Renal Impairment

Drug(s) suspected as cause:
Tasigna
    Dosage: 400 mg/day
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia
    Start date: 2011-04-01
    End date: 2011-11-01

Tasigna
    Dosage: unk

Other drugs received by patient: ACE Inhibitors; Diuretics; Metformin HCL



Possible Tasigna side effects in

Reported by a physician from Australia on 2012-08-20

Patient:

Reactions: Psoriasis

Drug(s) suspected as cause:
Tasigna



Possible Tasigna side effects in female

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

Patient: female

Reactions: Arthralgia, Autonomic Nervous System Imbalance, Full Blood Count Increased, Joint Dislocation, Vision Blurred, Muscle Spasms

Drug(s) suspected as cause:
Tasigna

Other drugs received by patient: Synthroid; Magnesium; Iron W / Vitamins NOS; Octreotide Acetate; Calcium; Midodrine Hydrochloride; Ascorbic Acid; Crestor; Topamax; Symbicort; Potassium



Possible Tasigna side effects in male

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

Patient: male

Reactions: Ventricular Extrasystoles, Supraventricular Extrasystoles, Oedema Peripheral, Injury

Drug(s) suspected as cause:
Tasigna
    Dosage: unk
    Start date: 2011-08-02
    End date: 2011-09-01

Tasigna
    Dosage: 400 mg, bid
    Indication: Chronic Myeloid Leukaemia
    Start date: 2011-06-17
    End date: 2011-07-14

Other drugs received by patient: Flecainide Acetate; Beta Blockers; Acetaminophen and Tramadol HCL



Possible Tasigna side effects in male

Reported by a physician from Germany on 2012-08-17

Patient: male

Reactions: Blood Creatine Phosphokinase Increased

Drug(s) suspected as cause:
Tasigna



Possible Tasigna side effects in male

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

Patient: male, weighing 96.1 kg (211.5 pounds)

Reactions: Rash, Blister

Drug(s) suspected as cause:
Gleevec
    Dosage: 600 mg, daily
    Administration route: Oral
    Start date: 2011-08-21

Gleevec
    Dosage: 400 mg, qd
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia

Tasigna
    Dosage: 150 mg, bid
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia
    Start date: 2010-12-27
    End date: 2011-02-23

Tasigna
    Dosage: 300 mg, bid
    Administration route: Oral
    Start date: 2011-02-23
    End date: 2011-06-29

Other drugs received by patient: Claritin; Lisinopril; Augmentin '500'



Possible Tasigna side effects in female

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

Patient: female, weighing 55.3 kg (121.7 pounds)

Reactions: Weight Decreased, Abdominal Pain, Nasopharyngitis, Flatulence, Eye Infection, Abdominal Pain Upper, Fatigue, Food Allergy, Tooth Discolouration, Chest Pain, Liver Function Test Abnormal, Toothache, Epistaxis, White Blood Cell Count Decreased, Pneumonia, Nausea, Dental Caries, Acute Abdomen, Uveitis, Cholelithiasis, Platelet Count Decreased

Drug(s) suspected as cause:
Tasigna
    Dosage: 150 mg, bid
    Start date: 2012-04-17

Tasigna
    Dosage: 300 mg, bid
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia
    Start date: 2012-02-15
    End date: 2012-02-01



Possible Tasigna side effects in male

Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-08-16

Patient: male, weighing 93.3 kg (205.3 pounds)

Reactions: Epididymitis, Restlessness, Visual Impairment, Insomnia, Drug Interaction, Hyperhidrosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tasigna

Other drugs received by patient possibly interacting with the suspect drug:
Ciprofloxacin
    Dosage: 500 mg, bid
    Indication: Epididymitis
    Start date: 2012-07-10

Tasigna
    Administration route: Oral
    Start date: 2012-07-28

Tasigna
    Dosage: no treatment received
    Start date: 2012-07-21
    End date: 2012-07-27

Other drugs received by patient: Pantoprazole Sodium; Metformin Hydrochloride



Possible Tasigna side effects in

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: , weighing 2.8 kg (6.1 pounds)

Reactions: Premature Baby, Foetal Exposure During Pregnancy, Drug Withdrawal Syndrome

Drug(s) suspected as cause:
Tasigna



Possible Tasigna side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-16

Patient: female

Reactions: Anaemia, Pain, Maternal Exposure During Pregnancy, Premature Labour, PRE-Eclampsia

Drug(s) suspected as cause:
Tasigna



Possible Tasigna side effects in female

Reported by a physician from Australia on 2012-08-15

Patient: female

Reactions: Vomiting, Suicidal Behaviour, Nausea, Hypotension, Anaemia, Liver Disorder, Weight Increased, Fatigue, Diarrhoea, Depression, Fluid Retention

Drug(s) suspected as cause:
Imatinib Mesylate
    Dosage: 400 mg, unk
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia
    Start date: 2010-08-02
    End date: 2011-01-01

Tasigna
    Dosage: 400 mg, bid
    Administration route: Oral
    Start date: 2011-08-11

Tasigna
    Dosage: unk
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia
    Start date: 2011-01-01



Possible Tasigna side effects in female

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

Patient: female, weighing 59.0 kg (129.8 pounds)

Reactions: Alopecia, DRY Skin, Rash, Keratosis Pilaris

Drug(s) suspected as cause:
Tasigna

Other drugs received by patient: Xyzal



Possible Tasigna side effects in male

Reported by a physician from United States on 2012-08-14

Patient: male

Reactions: Blood Alkaline Phosphatase Increased, White Blood Cell Count Decreased, Blood Bilirubin Increased, Alanine Aminotransferase Increased, Chills, Headache, Hepatitis Cholestatic, Aspartate Aminotransferase Increased, Liver Function Test Abnormal

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 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: Pneumonia, Blood Urea Increased, C-Reactive Protein Increased, Blood Uric Acid Increased, Lipase Increased

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Tasigna
    Dosage: 400 mg, per day
    Administration route: Oral
    Start date: 2009-04-25
    End date: 2011-08-24

Tasigna
    Dosage: 800 mg, daily
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia
    Start date: 2009-04-15
    End date: 2009-04-19

Other drugs received by patient: Loxonin; Allegra; Prednisolone



Possible Tasigna side effects in 64 year old male

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

Patient: 64 year old male

Reactions: Hepatic Function Abnormal, Rash Generalised, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Headache, Pyrexia, Eosinophil Count Increased, Liver Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tasigna



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