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Tasigna (Nilotinib) - Hepatic Function Abnormal - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Hepatic Function Abnormal ()

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

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



Possible Tasigna side effects in female

Reported by a physician from Japan on 2012-08-10

Patient: female

Reactions: Hepatic Function Abnormal, Diabetes Mellitus, Alanine Aminotransferase Increased, Eosinophil Count Increased

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Tasigna

Other drugs received by patient: Amlodipine; Theo-DUR; Fluticasone Propionate; Plavix; Candesartan Cilexetil; Prednisolone; Pletal; Allopurinol; Zonisamide; Lipitor



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 Japan on 2012-06-13

Patient: male

Reactions: Dyspnoea, Renal Disorder, Hepatic Function Abnormal, Anaemia, Hyperglycaemia, Atrial Fibrillation, Cardiac Disorder, Tumour Lysis Syndrome, Blood Uric Acid Abnormal, Cardiac Failure, Platelet Count Decreased, Pleural Effusion

Drug(s) suspected as cause:
Tasigna

Other drugs received by patient: Amaryl; Lasix; Amaryl; Nipolazin; Basen; Carvedilol; Amaryl; Actos; Diovan; Urso 250; Gastrom



Possible Tasigna side effects in female

Reported by a physician from Japan on 2012-06-11

Patient: female

Reactions: Hyperbilirubinaemia, Hepatic Function Abnormal, Hyperphosphataemia, Hyperkalaemia, Anaemia, Monocyte Count Increased, Eosinophil Count Increased, Chronic Myeloid Leukaemia, Tremor, Renal Impairment, Mental Disorder, Platelet Count Decreased, Neutropenia, Blood Glucose Increased

Adverse event resulted in: death, life threatening event, disablity

Drug(s) suspected as cause:
Tasigna
    Dosage: 800 mg, daily
    Administration route: Oral
    Start date: 2011-03-17
    End date: 2011-04-11

Tasigna
    Dosage: 800 mg, bid
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia
    Start date: 2009-05-01

Other drugs received by patient: Pravastatin Sodium; Aldactone; Diovan; Lasix; Aspara K; Methylprednisolone Sodium Succinate; Sumiferon; Omeprazole; Cefoperazone Sodium / Sulbactam Sodium; Famotidine; Amlodipine; Allopurinol; Mannitol; Omegacin



Possible Tasigna side effects in male

Reported by a physician from Japan on 2012-05-22

Patient: male, weighing 46.0 kg (101.2 pounds)

Reactions: Electrocardiogram QT Prolonged, Jaundice, Hyperbilirubinaemia, Hepatic Function Abnormal, DRY Skin

Drug(s) suspected as cause:
Tasigna
    Dosage: 400 mg/day
    Administration route: Oral
    Start date: 2009-11-13
    End date: 2010-03-29

Tasigna
    Dosage: 600 mg/day
    Administration route: Oral
    Start date: 2010-03-30
    End date: 2010-08-11

Tasigna
    Dosage: 200 mg, daily
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia
    Start date: 2009-08-11
    End date: 2009-11-12

Tasigna
    Dosage: 800 mg/day
    Administration route: Oral
    Start date: 2010-08-12
    End date: 2010-08-19

Tasigna
    Dosage: 600 mg, daily
    Administration route: Oral
    Start date: 2010-08-20
    End date: 2010-09-14

Tasigna
    Dosage: 400 mg/day
    Administration route: Oral
    Start date: 2010-10-01
    End date: 2011-01-13

Tasigna
    Dosage: 200 mg/day
    Administration route: Oral
    Start date: 2011-01-14

Other drugs received by patient: Allegra; Ebastine; Lidomex; Olopatadine HCL



Possible Tasigna side effects in male

Reported by a physician from Japan on 2012-05-14

Patient: male, weighing 46.0 kg (101.2 pounds)

Reactions: Jaundice, Electrocardiogram QT Prolonged, Hepatic Function Abnormal, DRY Skin

Drug(s) suspected as cause:
Tasigna
    Dosage: 200 mg, daily
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia
    Start date: 2009-08-11
    End date: 2009-11-12

Tasigna
    Dosage: 400 mg/day
    Administration route: Oral
    Start date: 2010-10-01
    End date: 2011-01-13

Tasigna
    Dosage: 200 mg/day
    Administration route: Oral
    Start date: 2011-01-14

Tasigna
    Dosage: 800 mg/day
    Administration route: Oral
    Start date: 2010-08-12
    End date: 2010-08-19

Tasigna
    Dosage: 600 mg, daily
    Administration route: Oral
    Start date: 2010-08-20
    End date: 2010-09-14

Tasigna
    Dosage: 400 mg/day
    Administration route: Oral
    Start date: 2009-11-13
    End date: 2010-03-29

Tasigna
    Dosage: 600 mg/day
    Administration route: Oral
    Start date: 2010-03-30
    End date: 2010-08-11

Other drugs received by patient: Ebastine; Olopatadine HCL; Allegra; Lidomex



Possible Tasigna side effects in female

Reported by a physician from Japan on 2012-04-10

Patient: female

Reactions: Hepatic Function Abnormal, Gamma-Glutamyltransferase Increased, Alanine Aminotransferase Increased

Drug(s) suspected as cause:
Tasigna
    Dosage: 400 mg, daily
    Administration route: Oral
    Start date: 2010-01-09

Tasigna
    Dosage: 800 mg, daily
    Administration route: Oral
    Start date: 2009-12-05
    End date: 2009-12-11

Tasigna
    Dosage: 800 mg, daily
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia
    Start date: 2009-11-07
    End date: 2009-11-16

Other drugs received by patient: Lansoprazole; Silece; Zolpidem; Sucralfate; Lansoprazole; Mucosta; Loxonin; Magnesium Sulfate; Neurotropin; Famotidine



Possible Tasigna side effects in 81 year old female

Reported by a consumer/non-health professional from Germany on 2012-04-10

Patient: 81 year old female

Reactions: Pneumonia, Hepatic Function Abnormal, Pruritus, Renal Function Test Abnormal, Dyspnoea, Pleural Effusion, Cardiac Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tasigna

Other drugs received by patient: Marcumar; Metoprolol Tartrate and Hydrochlorothiazide



Possible Tasigna side effects in male

Reported by a physician from Japan on 2012-04-10

Patient: male

Reactions: Hepatic Function Abnormal, Renal Disorder, Dyspnoea, Hyperglycaemia, Anaemia, Atrial Fibrillation, Cardiac Disorder, Blood Uric Acid Abnormal, Tumour Lysis Syndrome, Cardiac Failure, Pleural Effusion

Drug(s) suspected as cause:
Tasigna

Other drugs received by patient: Nipolazin; Diovan; Carvedilol; Urso 250; Amaryl; Lasix; Basen; Amaryl; Gastrom; Actos



Possible Tasigna side effects in 64 year old male

Reported by a physician from Japan on 2012-04-09

Patient: 64 year old male

Reactions: Hepatic Function Abnormal, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased, Pyrexia, Headache, Rash, Erythema

Drug(s) suspected as cause:
Tasigna

Other drugs received by patient: Prednisolone; Prednisolone



Possible Tasigna side effects in male

Reported by a physician from Italy on 2012-02-03

Patient: male, weighing 57.0 kg (125.4 pounds)

Reactions: Abdominal Pain, Hepatic Function Abnormal, Metastases To Liver, Coma, Neoplasm, Gastric Cancer, Hepatomegaly, Renal Impairment, Fatigue, Induration, Decreased Appetite

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Tasigna

Other drugs received by patient: Eurax; Hirudoid; Zyrtec



Possible Tasigna side effects in male

Reported by a physician from Italy on 2012-01-23

Patient: male, weighing 57.0 kg (125.4 pounds)

Reactions: Abdominal Pain, Hepatic Function Abnormal, Metastases To Liver, Coma, Neoplasm, Gastric Cancer, Hepatomegaly, Fatigue, Renal Impairment, Induration, Decreased Appetite

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Tasigna

Other drugs received by patient: Eurax; Hirudoid; Zyrtec



Possible Tasigna side effects in female

Reported by a physician from Japan on 2012-01-12

Patient: female

Reactions: White Blood Cell Count Decreased, Hepatic Function Abnormal, Anaemia, Platelet Count Decreased, Lipase Increased

Drug(s) suspected as cause:
Tasigna
    Dosage: 400 mg, daily
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia
    Start date: 2009-07-08
    End date: 2009-07-14

Tasigna
    Dosage: 400 mg, daily
    Administration route: Oral
    Start date: 2009-10-23
    End date: 2010-05-14

Tasigna
    Dosage: 600 mg, daily
    Administration route: Oral
    Start date: 2009-07-15
    End date: 2009-07-22

Tasigna
    Dosage: 200 mg, daily
    Administration route: Oral
    Start date: 2011-03-17

Tasigna
    Dosage: 400 mg, daily
    Administration route: Oral
    Start date: 2010-06-07

Tasigna
    Dosage: 400 mg, qw4
    Administration route: Oral
    Start date: 2011-04-14

Tasigna
    Dosage: 800 mg, daily
    Administration route: Oral
    Start date: 2009-07-23
    End date: 2009-10-12

Tasigna
    Dosage: 400 mg, qw5
    Administration route: Oral
    Start date: 2010-08-27
    End date: 2011-02-16

Tasigna
    Dosage: 400 mg, qw5
    Administration route: Oral
    Start date: 2011-03-24

Other drugs received by patient: Diltiazem HCL



Possible Tasigna side effects in 70 year old male

Reported by a physician from Japan on 2011-12-28

Patient: 70 year old male

Reactions: Blood Alkaline Phosphatase Increased, Blood Bilirubin Increased, Hepatic Function Abnormal, Chills, Sepsis, Pyrexia

Drug(s) suspected as cause:
Tasigna

Other drugs received by patient: Levothyroxine Sodium; Berizym; Exjade; Levothyroxine Sodium; Furosemide; Allopurinol; Slow-K; Cymerin; Cortril; Furosemide; Slow-K; Selbex; Hicort; Furosemide; LAC B; Desferal; Omeprazole; Berizym; Albumin (Human); Exjade; Cortril; Allopurinol; RED Blood Cells, Concentrated; Cymerin



Possible Tasigna side effects in female

Reported by a physician from Japan on 2011-12-26

Patient: female

Reactions: Blood Bilirubin Increased, White Blood Cell Count Decreased, Hepatic Function Abnormal, Palpitations, Platelet Count Decreased, Blood Magnesium Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tasigna
    Dosage: 800 mg per day
    Indication: Chronic Myeloid Leukaemia
    Start date: 2009-04-17
    End date: 2009-05-29

Tasigna
    Dosage: 400 mg per day
    Administration route: Oral
    Start date: 2009-07-10

Magmitt
    Dosage: 990 mg, unk
    Administration route: Oral
    Start date: 2009-04-23

Other drugs received by patient: Lendormin; Claritin; Meilax; Isodine; Anplag; Pursennid



Possible Tasigna side effects in male

Reported by a physician from Japan on 2011-12-26

Patient: male, weighing 56.0 kg (123.2 pounds)

Reactions: Jaundice, Hepatic Function Abnormal, Cholecystitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tasigna

Other drugs received by patient: BIO Three; Anplag



Possible Tasigna side effects in male

Reported by a physician from Japan on 2011-11-17

Patient: male

Reactions: Weight Decreased, Blood Alkaline Phosphatase Increased, Blood Urea Increased, Hepatic Function Abnormal, Blood Lactate Dehydrogenase Increased, Hyperglycaemia, Neoplasm Progression, Constipation, Basophil Count Increased, Malaise, Gamma-Glutamyltransferase Increased, Neoplasm Malignant, Palpitations, Dysphonia, Photophobia, Blood Creatinine Increased, White Blood Cell Count Increased

Drug(s) suspected as cause:
Tasigna
    Dosage: 400 mg per day
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia
    Start date: 2009-03-23
    End date: 2009-08-24

Tasigna
    Dosage: 800 mg per day
    Administration route: Oral
    Start date: 2009-08-24
    End date: 2009-12-27

Other drugs received by patient: Wytens; Shakuyakukanzoutou; Alosenn; Allopurinol; Shakuyakukanzoutou; Ketoprofen; Sprycel; Adalat; Penfill N; Penfill N; Adalat; Ketoprofen; Wytens; Allopurinol; Trichlormethiazide; Diovan; Diovan; Rinderon-VG; Diovan; Gleevec; Trichlormethiazide; Rinderon-VG; Cefaclor



Possible Tasigna side effects in female

Reported by a consumer/non-health professional from Germany on 2011-11-03

Patient: female

Reactions: Hepatic Function Abnormal, Renal Function Test Abnormal, Dyspnoea, Pneumonia, Pleural Effusion, Cardiac Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Tasigna



Possible Tasigna side effects in male

Reported by a physician from Japan on 2011-10-21

Patient: male

Reactions: Hepatic Function Abnormal, Hyperkalaemia, Flatulence, Orthostatic Hypotension, Hypokalaemia, Chest Pain, Abdominal Distension, Blood Creatinine Increased, Decreased Appetite, Vomiting, Blood Urea Increased, Chronic Myeloid Leukaemia Transformation, Hypoaesthesia, Ileus Paralytic, Renal Failure, Renal Impairment, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Diflucan
    Dosage: 200 mg, daily
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2010-04-24
    End date: 2010-05-06

Tasigna
    Dosage: 800 mg, daily
    Administration route: Oral
    Start date: 2010-04-02
    End date: 2011-04-12

Oncovin
    Start date: 2010-04-02
    End date: 2010-04-15

Sulfamethoxazole
    Dosage: 1 df, unk
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2009-08-07
    End date: 2009-10-13

Tasigna
    Dosage: 600 mg, daily
    Administration route: Oral
    Start date: 2010-02-17
    End date: 2011-04-01

Oxycontin
    Dosage: 15 mg, unk
    Administration route: Oral
    Start date: 2009-08-07
    End date: 2011-04-11

Acetaminophen
    Dosage: 4 df, unk
    Start date: 2009-08-19
    End date: 2010-04-09

Prednisolone
    Dosage: 60 mg, unk
    Start date: 2009-08-07
    End date: 2009-08-12

Tasigna
    Dosage: 800 mg daily
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia
    Start date: 2009-08-07
    End date: 2009-08-19

Mexitil
    Dosage: 300 mg, daily
    Administration route: Oral
    Start date: 2010-04-09
    End date: 2010-05-06

Anafranil
    Dosage: 35 mg daily
    Administration route: Oral
    Start date: 2009-08-26
    End date: 2009-08-30

Acetaminophen
    Dosage: 6 df, unk
    Administration route: Oral
    Start date: 2010-04-15
    End date: 2010-05-06

Tasigna
    Dosage: 400 mg daily
    Administration route: Oral
    Start date: 2009-08-24
    End date: 2010-02-16

Sulfamethoxazole
    Dosage: 1 df, unk
    Administration route: Oral
    Start date: 2010-04-17
    End date: 2010-05-06

Prednisolone
    Dosage: 50 mg, unk
    Start date: 2009-08-13
    End date: 2009-08-13

Other drugs received by patient: Lasix; Carbocain; Allopurinol; Lulicon; Laxoberon; Meropenem; Mentax; Candesartan Cilexetil; Magnesium Sulfate; Ropivacaine Hydrochloride; Decadron; Aldomet; Kytril; Prochlorperazine; Oxinorm; Atarax; Famotidine; Magnesium Sulfate; Pydoxal; Pursennid; Magnesium Sulfate; Isoniazid; Leunase; Decadron; Norvasc; Doxorubicin Hydrochloride



Possible Tasigna side effects in female

Reported by a physician from Japan on 2011-10-19

Patient: female

Reactions: White Blood Cell Count Decreased, Hepatic Function Abnormal, Anaemia, Platelet Count Decreased, Lipase Increased

Drug(s) suspected as cause:
Tasigna
    Dosage: 800 mg, daily
    Administration route: Oral
    Start date: 2009-07-23
    End date: 2009-10-12

Tasigna
    Dosage: 600 mg, daily
    Administration route: Oral
    Start date: 2009-07-15
    End date: 2009-07-22

Tasigna
    Dosage: 400 mg, daily
    Administration route: Oral
    Indication: Chronic Myeloid Leukaemia
    Start date: 2009-07-08
    End date: 2009-07-14

Tasigna
    Dosage: 400 mg, daily
    Administration route: Oral
    Start date: 2010-06-07

Tasigna
    Dosage: 400 mg, daily
    Administration route: Oral
    Start date: 2009-10-23
    End date: 2010-05-14

Other drugs received by patient: Diltiazem HCL



Possible Tasigna side effects in female

Reported by a physician from Japan on 2011-10-14

Patient: female

Reactions: Hepatic Function Abnormal, Diabetes Mellitus, Alanine Aminotransferase Increased, Eosinophil Count Increased

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Tasigna

Other drugs received by patient: Prednisolone; Candesartan Cilexetil; Amlodipine; Theo-DUR; Advair Diskus 100 / 50; Allopurinol

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