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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 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 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 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 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 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 2011-11-17
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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