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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 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 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 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 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 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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