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

 
 



Index of reports > Serious Events (1880)

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

 Reports 1 - 30 of 1880   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 male

Reported by a consumer/non-health professional from India on 2012-08-26

Patient: male

Reactions: Death, Dyspnoea, Vomiting, Infection

Adverse event resulted in: death

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 male

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

Patient: male, weighing 80.0 kg (176.0 pounds)

Reactions: Acute Myocardial Infarction

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tasigna



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 male

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

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Tasigna
    Start date: 2012-03-08

Tasigna
    Dosage: 300 mg, bid
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia
    Start date: 2012-03-08

Other drugs received by patient: Allopurinol; Lasix; Multi-Vitamin; Ditropan; Ruxolitinib; Flomax; Colace; Gleevec



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 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 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 male

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

Patient: male, weighing 75.0 kg (165.0 pounds)

Reactions: Cerebellar Infarction, Brain Herniation, Dizziness, Brain Oedema, Vertigo

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Tasigna

Other drugs received by patient: Prednisone; Hydrochlorothiazide; Magnesium; Enalapril Maleate; Betahistine; Omeprazole; Amlodipine



Possible Tasigna side effects in 51 year old female

Reported by a physician from United States on 2012-08-23

Patient: 51 year old female

Reactions: Dyspnoea

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tasigna

Other drugs received by patient: Niaspan; Zocor; Coumadin; Coreg; Aspirin; Metformin; Allopurinol



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 2012-08-23

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 consumer/non-health professional from Philippines on 2012-08-23

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Tasigna



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 female

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

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Tasigna



Possible Tasigna side effects in male

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

Patient: male

Reactions: Stress, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tasigna



Possible Tasigna side effects in female

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

Patient: female, weighing 49.0 kg (107.8 pounds)

Reactions: Malaise, Ecchymosis, Pain, Drug Intolerance, Pancytopenia

Adverse event resulted in: hospitalization

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

Tasigna
    Dosage: 200 mg per day
    Administration route: Oral
    End date: 2012-06-26

Tasigna
    Dosage: 200 mg, per day
    Administration route: Oral
    Start date: 2012-01-26
    End date: 2012-05-15

Tasigna
    Dosage: 200 mg, bid
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia
    Start date: 2011-06-15

Tasigna
    Dosage: 800 mg, daily
    Administration route: Oral

Tasigna
    Dosage: 800 mg, daily
    Administration route: Oral

Tasigna
    Dosage: 400 mg, daily
    Administration route: Oral

Tasigna
    Dosage: 800 mg, daily
    Administration route: Oral
    Start date: 2011-11-15
    End date: 2011-12-30



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 male

Reported by a physician from France on 2012-08-21

Patient: male, weighing 85.0 kg (187.0 pounds)

Reactions: Urinary Retention

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tasigna

Other drugs received by patient: Atorvastatin; Permixon; Meteospasmyl; Etioven; Lansoprazole



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 consumer/non-health professional from United States on 2012-08-21

Patient: female

Reactions: Renal Failure, Hypotension, Dysuria, Swelling, Constipation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tasigna

Other drugs received by patient: Coreg; Omeprazole; PMS-Lactulose; Amlodipine; Levothyroxine Sodium



Possible Tasigna side effects in male

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

Patient: male

Reactions: Acute Coronary Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nicotine

Tasigna
    Dosage: 600 mg, bid
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia
    Start date: 2011-06-02

Other drugs received by patient: Trileptal; Hydrochlorothiazide; Ramipril



Possible Tasigna side effects in male

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

Patient: male, weighing 165.0 kg (363.0 pounds)

Reactions: Chronic Myeloid Leukaemia Transformation

Adverse event resulted in: death

Drug(s) suspected as cause:
Tasigna
    Dosage: 800 mg, daily
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia
    Start date: 2009-05-18
    End date: 2009-08-05

Tasigna
    Dosage: 200 mg, daily
    Administration route: Oral
    Start date: 2009-08-06
    End date: 2011-12-08

Other drugs received by patient: Garenoxacin Mesylate; Itraconazole



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

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

Patient:

Reactions: Pancreatic Carcinoma

Adverse event resulted in: death

Drug(s) suspected as cause:
Tasigna



Possible Tasigna side effects in male

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

Patient: male, weighing 132.1 kg (290.6 pounds)

Reactions: Dyspnoea, Nausea, Renal Failure, Malaise, Fatigue, Acute Respiratory Failure, Pneumonitis, Cough

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Tasigna



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