This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Tasigna (Nilotinib) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (2325)
Death (374)
Life Threatening Events (108)
Disability (108)
Reports by Reaction Type
Fatigue (185),
Nausea (175),
Death (167),
Dyspnoea (166),
Rash (153),
Pruritus (134),
Electrocardiogram QT Prolonged (126),
Pyrexia (120),
Headache (110),
Neoplasm Malignant (110),
Vomiting (96),
Anaemia (93)
Below are a few examples of reports where side effects / adverse reactions may be related to Tasigna (Nilotinib). For a complete list or a specific selection of reports, please use the links above.
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 female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female, weighing 159.0 kg (349.8 pounds)
Reactions: Vomiting, Diarrhoea, Dyspepsia, Blood Glucose Increased
Drug(s) suspected as cause:
Tasigna
Other drugs received by patient: Glipizide; Fish OIL; Nabumetone; Imodium A-D; Diltiazem; Pepcid AC; Fosinopril Sodium; Fenofibrate; Arimidex; Multi-Vitamins; Methotrexate; Aspirin
Possible Tasigna side effects in male
Reported by a physician from United States on 2012-08-27
Patient: male
Reactions: Confusional State, Chills
Drug(s) suspected as cause:
Tasigna
Other drugs received by patient: Levetiracetam; Carvedilol; Isosorbide; Restoril; Simvastatin
Possible Tasigna side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female
Reactions: Myalgia, Headache
Drug(s) suspected as cause:
Tasigna
Other drugs received by patient: Foltx; Nexium; Diovan; Hydralazine HCL; Lipitor; Levoxyl; Amlodipine; Nadolol; Zetia; Estrace
Possible Tasigna side effects in 60 year old male
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 60 year old male
Reactions: Fatigue, Oedema Peripheral
Drug(s) suspected as cause:
Tasigna
Other drugs received by patient: Fenofibrate; Klor-CON; Crestor; Glipizide; Furosemide; Androgel; Potassium
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 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 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 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 Spain on 2012-08-24
Patient: male
Reactions: Acute Myocardial Infarction
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 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 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 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 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 health professional (non-physician/pharmacist) from United States on 2012-08-24
Patient: male
Reactions: Photosensitivity Reaction, Rash, Constipation, Eye Pain, Abnormal Sensation in Eye, Memory Impairment, DRY Eye, Blood Glucose Increased
Drug(s) suspected as cause:
Tasigna
Dosage: unk
Start date: 2011-01-06
Tasigna
Dosage: 300 mg, bid
Administration route: Oral
Indication: Chronic Myeloid Leukaemia
Start date: 2010-12-30
Other drugs received by patient: Multiple Vitamins; Cinnamon; Alpha Lipoic Acid; Chlorella Vulgaris; Zinc Sulfate; Ferrous Sulfate TAB; Lovaza; Selenium; Restasis; Spirulina; Allopurinol; Metformin HCL; Chromium Chloride; Metformin HCL
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 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 male
Reported by a physician from United States on 2012-08-23
Patient: male
Reactions: Malaise
Drug(s) suspected as cause:
Tasigna
Dosage: 200 mg, bid
Start date: 2012-03-22
Tasigna
Dosage: 200 mg, bid
Start date: 2012-04-19
Tasigna
Dosage: 200 mg, bid
Start date: 2012-05-08
Tasigna
Dosage: 200 mg, bid
Start date: 2012-07-01
Tasigna
Dosage: 400 mg, unk
Indication: Chronic Myeloid Leukaemia
Start date: 2012-03-03
Other drugs received by patient: Topiramate; Topiramate; Losartan Potassium; Losartan Potassium; Atorvastatin; Zolpidem; Primidone; Topiramate; Gabapentin; Metformin; Levothyroxine Sodium; Primidone; Trazodone Hydrochloride; Bupropion HCL; Aspirin; Metformin; Atorvastatin; Lamotrigine; Zolpidem; Trazodone Hydrochloride; Topiramate; Hydrocodone; Ultram; Gabapentin; Cymbalta; Metformin; Lamotrigine; Levothyroxine Sodium; Zolpidem; Primidone; Trazodone Hydrochloride; Bupropion HCL; Bupropion HCL; Iron; Gabapentin; Losartan Potassium; Lamotrigine; Lamotrigine; Levothyroxine Sodium; Cymbalta; Cymbalta; Metformin; Losartan Potassium; Atorvastatin; Levothyroxine Sodium; Trazodone Hydrochloride; Bupropion HCL; Gabapentin; Cymbalta; Atorvastatin; Zolpidem; Primidone
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 United States on 2012-08-23
Patient: female
Reactions: LIP Swelling, Weight Decreased, Fatigue, Hypoaesthesia, Asthenia, Somnolence, Paraesthesia
Drug(s) suspected as cause:
Tasigna
Other drugs received by patient: Plavix; Lasix; Levothyroxine Sodium; Simvastatin; Tramadol HCL; Pravastatin; Digoxin; Acidophilus ^zyma^; Aspirin
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 female
Reported by a consumer/non-health professional from United States on 2012-08-22
Patient: female, weighing 75.0 kg (165.0 pounds)
Reactions: Fatigue, Rash Generalised, Dehydration
Drug(s) suspected as cause:
Tasigna
Dosage: 300 mg, bid
Administration route: Oral
Tasigna
Dosage: 150 mg, bid
Administration route: Oral
Other drugs received by patient: Synthroid; Monopril; Vitamin B-12; Wellbutrin; Enpresse; Neurontin; Multivitamin; Xanax; Crestor; Valtrex; Lunesta; Glumetza
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 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 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 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 United States on 2012-08-22
Patient: female, weighing 72.1 kg (158.6 pounds)
Reactions: Fatigue, Pruritus, Exfoliative Rash, Abnormal Behaviour, DRY Skin, Rash, Memory Impairment
Drug(s) suspected as cause:
Tasigna
Dosage: 300 mg, bid
Administration route: Oral
Tasigna
Dosage: 300 mg, bid
Administration route: Oral
Indication: Chronic Myeloid Leukaemia
Start date: 2011-09-07
Other drugs received by patient: Hydroxyzine; Aspirin; Tasmar; Colace
Possible Tasigna side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-22
Patient: female
Reactions: Pruritus, Erythema
Drug(s) suspected as cause:
Tasigna
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