This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Arranon (Nelarabine) 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 (16)
Death (6)
Life Threatening Events (2)
Reports by Reaction Type
Nervous System Disorder (5),
Blood Creatine Phosphokinase Increased (4),
Muscle Atrophy (3),
Decreased Vibratory Sense (3),
Fall (3),
Nerve Conduction Studies Abnormal (3),
Neuropathy Peripheral (3),
Monoplegia (3),
Dyspnoea (3),
Muscular Weakness (3),
Hypoaesthesia (3),
Nuclear Magnetic Resonance Imaging Abnormal (3)
Possible Arranon side effects in female
Reported by a physician from Japan on 2012-08-20
Patient: female
Reactions: Blood Creatine Phosphokinase Increased
Drug(s) suspected as cause:
Arranon
Start date: 2012-04-08
End date: 2012-04-08
Arranon
Start date: 2012-05-24
End date: 2012-05-24
Arranon
Start date: 2012-04-06
End date: 2012-04-06
Arranon
Start date: 2012-05-26
End date: 2012-05-26
Arranon
Start date: 2012-05-22
End date: 2012-05-22
Arranon
Dosage: 1800mg per day
Indication: T-Cell Chronic Lymphocytic Leukaemia
Start date: 2012-04-04
End date: 2012-04-04
Other drugs received by patient: Fentanyl Citrate; Neophagen C
Possible Arranon side effects in female
Reported by a physician from Japan on 2012-07-25
Patient: female, weighing 39.6 kg (87.1 pounds)
Reactions: Hepatic Function Abnormal, Hyperphosphataemia, Hyperkalaemia, Hypotension, Ventricular Arrhythmia, Acidosis, Coagulation Time Abnormal
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Arranon
Dosage: 650mgm2 per day
Indication: T-Cell Type Acute Leukaemia
Start date: 2011-04-23
End date: 2011-04-27
Dexamethasone
Dosage: 6.6mg per day
Start date: 2011-04-28
End date: 2011-04-29
Dexamethasone
Dosage: 6.6mg per day
Indication: Neoplasm Malignant
Start date: 2011-04-20
End date: 2011-04-20
Dexamethasone
Dosage: 6.6mg per day
Start date: 2011-05-06
End date: 2011-05-06
Dexamethasone
Dosage: 13.2mg per day
Start date: 2011-04-21
End date: 2011-04-27
Other drugs received by patient: Decadron; Hydrocortisone Sodium Succinate; Sodium Bicarbonate; Pentazocine Lactate; Granisetron; Ifosfamide; Allopurinol; Fentanyl; Bosmin; Mucosta; Solita-T NO 3; Furosemide; Atarax; Potassium Chloride; Ketoprofen; Daunorubicin HCL; Fildesin; Methotrexate; Decadron; Polaramine; Diamox; Loxoprofen; Leunase; Furosemide; Seishoku; Lorcam; Platelets; Ketalar
Possible Arranon side effects in female
Reported by a physician from Japan on 2012-07-10
Patient: female, weighing 39.6 kg (87.1 pounds)
Reactions: Hepatic Function Abnormal, Hyperkalaemia, Hyperphosphataemia, Hypotension, Ventricular Arrhythmia, Acidosis, Coagulation Time Abnormal
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Arranon
Dosage: 650mgm2 per day
Indication: T-Cell Type Acute Leukaemia
Start date: 2011-04-23
End date: 2011-04-27
Dexamethasone
Dosage: 13.2mg per day
Start date: 2011-04-21
End date: 2011-04-27
Dexamethasone
Dosage: 6.6mg per day
Start date: 2011-04-28
End date: 2011-04-29
Dexamethasone
Dosage: 6.6mg per day
Start date: 2011-05-06
End date: 2011-05-06
Dexamethasone
Dosage: 6.6mg per day
Indication: Neoplasm Malignant
Start date: 2011-04-20
End date: 2011-04-20
Other drugs received by patient: Leunase; Decadron; Solita-T; Daunorubicin HCL; Methotrexate; Mucosta; Decadron; Hydrocortisone Sodium Succinate; Furosemide; Fentanyl; Ketoprofen; Fildesin; Sodium Bicarbonate; Potassium Chloride; Pentazocine Lactate; Furosemide; Polaramine; Atarax; Bosmin; Lorcam; Ifosfamide; Allopurinol; Granisetron; Diamox; Seishoku; Platelets; Ketalar; Loxoprofen
Possible Arranon side effects in 69 year old male
Reported by a physician from United States on 2012-07-03
Patient: 69 year old male, weighing 80.0 kg (176.0 pounds)
Reactions: Neuropathy Peripheral, Disease Progression
Drug(s) suspected as cause:
Arranon
Other drugs received by patient: Hydrodiuril; Finasteride; Zyloprim; Xanax; Altace
Possible Arranon side effects in
Reported by a pharmacist from Japan on 2012-06-07
Patient:
Reactions: Myalgia, Blood Creatine Phosphokinase Increased
Drug(s) suspected as cause:
Arranon
Possible Arranon side effects in
Reported by a physician from United States on 2012-05-23
Patient:
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Arranon
Possible Arranon side effects in male
Reported by a physician from Japan on 2012-03-15
Patient: male, weighing 43.0 kg (94.6 pounds)
Reactions: Nervous System Disorder
Adverse event resulted in: death
Drug(s) suspected as cause:
Arranon
Dosage: 650mgm2 per day
Indication: Precursor T-Lymphoblastic Lymphoma / Leukaemia
Start date: 2011-02-28
End date: 2011-03-04
Arranon
Dosage: 650mgm2 per day
Start date: 2011-03-22
End date: 2011-03-26
Cytarabine
Indication: Cord Blood Transplant Therapy
Start date: 2011-02-05
End date: 2011-02-05
Cytarabine
Indication: Neoplasm Malignant
Start date: 2011-02-01
End date: 2011-02-01
Methotrexate
Start date: 2011-02-01
End date: 2011-02-02
Methotrexate
Indication: Neoplasm Malignant
Start date: 2011-02-01
End date: 2011-02-01
Vincristine Sulfate
Dosage: 2mg per day
Indication: Neoplasm Malignant
Start date: 2011-02-01
End date: 2011-02-07
Vincristine Sulfate
Dosage: 2mg per day
Start date: 2011-04-14
End date: 2011-04-21
Other drugs received by patient: Elspar; Bortezomib; Dexamethasone; Mercaptopurine; Cytarabine; Melphalan Hydrochloride; Funguard; Vfend; Etoposide; Zovirax; Cotrim; Azactam; Vicclox; Fludarabine Phosphate; Fludarabine Phosphate; Elspar; Fludarabine Phosphate; Ambisome; Zosyn; Carbenin; Fragmin; Etoposide; Doxorubicin HCL; Prednisolone; Maxipime; Tacrolimus; Targocid
Possible Arranon side effects in male
Reported by a physician from Japan on 2012-02-17
Patient: male, weighing 43.0 kg (94.6 pounds)
Reactions: Nervous System Disorder
Adverse event resulted in: death
Drug(s) suspected as cause:
Arranon
Dosage: 650mgm2 per day
Indication: Precursor T-Lymphoblastic Lymphoma / Leukaemia
Start date: 2011-02-28
End date: 2011-03-04
Arranon
Dosage: 650mgm2 per day
Start date: 2011-03-22
End date: 2011-03-26
Bortezomib
Dosage: 1.9mg per day
Indication: Neoplasm Malignant
Start date: 2011-04-14
End date: 2011-04-24
Other drugs received by patient: Fludarabine Phosphate; Prednisolone; Funguard; Vincristine Sulfate; Melphalan Hydrochloride; Ambisome; Vfend; Carbenin; Fludarabine Phosphate; Dexamethasone; Zosyn; Azactam; Doxorubicin HCL; Elspar; Maxipime; Cytarabine; Mercaptopurine; Methotrexate; Zovirax; Vincristine Sulfate; Cytarabine; Cytarabine; Methotrexate; Fragmin; Elspar; Fludarabine Phosphate; Etoposide; Etoposide; Sulfamethoxazole; Tacrolimus; Targocid; Vicclox
Possible Arranon side effects in male
Reported by a physician from Japan on 2012-01-04
Patient: male
Reactions: Movement Disorder, Monoplegia, Muscle Atrophy, Dyspnoea, Muscular Weakness, Decreased Vibratory Sense, Hypoaesthesia, Fall, Nerve Conduction Studies Abnormal, Sensory Disturbance, Nuclear Magnetic Resonance Imaging Abnormal, Areflexia, Nervous System Disorder, Respiratory Arrest, Gait Disturbance
Adverse event resulted in: death
Drug(s) suspected as cause:
Arranon
Dosage: 650mgm2 per day
Start date: 2011-03-22
End date: 2011-03-22
Arranon
Dosage: 650mgm2 per day
Indication: T-Cell Type Acute Leukaemia
Start date: 2011-02-28
End date: 2011-02-28
Bortezomib
Indication: T-Cell Type Acute Leukaemia
Start date: 2011-01-01
End date: 2011-01-01
Cyclophosphamide
Indication: T-Cell Type Acute Leukaemia
Start date: 2011-01-01
End date: 2011-01-01
Other drugs received by patient: Etoposide; Fludarabine Phosphate; Etoposide; Fludarabine Phosphate; Cytarabine; Melphalan Hydrochloride
Possible Arranon side effects in 16 year old male
Reported by a physician from Japan on 2011-12-28
Patient: 16 year old male
Reactions: Dyspnoea, Monoplegia, Muscle Atrophy, Muscular Weakness, Decreased Vibratory Sense, Hypoaesthesia, Fall, Nerve Conduction Studies Abnormal, Areflexia, Respiratory Arrest, Nuclear Magnetic Resonance Imaging Abnormal, Nervous System Disorder
Drug(s) suspected as cause:
Arranon
Indication: T-Cell Type Acute Leukaemia
Bortezomib
Indication: T-Cell Type Acute Leukaemia
Cyclophosphamide
Indication: T-Cell Type Acute Leukaemia
Other drugs received by patient: Cytarabine; Fentanyl; Fludarabine Phosphate; Melphalan Hydrochloride
Possible Arranon side effects in 16 year old male
Reported by a physician from Japan on 2011-12-14
Patient: 16 year old male
Reactions: Muscle Atrophy, Dyspnoea, Monoplegia, Muscular Weakness, Decreased Vibratory Sense, Hypoaesthesia, Fall, Nerve Conduction Studies Abnormal, Respiratory Arrest, Areflexia, Nervous System Disorder, Nuclear Magnetic Resonance Imaging Abnormal
Drug(s) suspected as cause:
Arranon
Indication: T-Cell Type Acute Leukaemia
Bortezomib
Indication: T-Cell Type Acute Leukaemia
Cyclophosphamide
Indication: T-Cell Type Acute Leukaemia
Other drugs received by patient: Fentanyl; Fludarabine Phosphate; Cytarabine; Melphalan Hydrochloride
Possible Arranon side effects in female
Reported by a physician from Japan on 2011-12-05
Patient: female, weighing 48.0 kg (105.6 pounds)
Reactions: Herpes Zoster
Drug(s) suspected as cause:
Arranon
Dosage: 1500mgm2 per day
Start date: 2011-10-03
End date: 2011-10-03
Arranon
Dosage: 1500mgm2 per day
Indication: T-Cell Type Acute Leukaemia
Start date: 2011-09-09
End date: 2011-09-09
Other drugs received by patient: Omeprazole; Oncovin; Magmitt; Cytarabine; Methotrexate; Cyclophosphamide; Prednisolone; Sucralfate; Doxorubicin Hydrochloride; Methotrexate; Cytarabine; Methycobal
Possible Arranon side effects in male
Reported by a physician from Japan on 2011-11-18
Patient: male, weighing 56.0 kg (123.2 pounds)
Reactions: White Blood Cell Count Decreased, Blood Creatine Phosphokinase Increased, Neuropathy Peripheral, Somnolence
Drug(s) suspected as cause:
Arranon
Dosage: 1500mgm2 twice per day
Indication: T-Cell Type Acute Leukaemia
Start date: 2010-09-06
End date: 2010-09-10
Arranon
Dosage: 1500mgm2 twice per day
Start date: 2010-10-08
End date: 2010-10-12
Firstcin
Indication: Pyrexia
Start date: 2010-09-24
End date: 2010-09-29
Other drugs received by patient: Sulfamethoxazole and Trimethoprim; Oxycontin; Calcium Carbonate; Novorapid; Ramelteon; Amlodipine; Alfarol; Zovirax; Prednisolone; Unspecified Medication; Lansoprazole; Acetaminophen
Possible Arranon side effects in male
Reported by a physician from Japan on 2011-11-03
Patient: male, weighing 58.0 kg (127.6 pounds)
Reactions: Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Liver Disorder
Drug(s) suspected as cause:
Arranon
Dosage: 1500mgm2 per day
Start date: 2008-09-22
End date: 2008-09-22
Arranon
Dosage: 1500mgm2 per day
Start date: 2008-10-14
End date: 2008-10-14
Arranon
Dosage: 1500mgm2 per day
Start date: 2008-09-17
End date: 2008-09-17
Arranon
Dosage: 1500mgm2 per day
Start date: 2008-08-06
End date: 2008-08-06
Arranon
Dosage: 1500mgm2 per day
Start date: 2008-08-11
End date: 2008-08-11
Arranon
Dosage: 1500mgm2 per day
Start date: 2008-09-19
End date: 2008-09-19
Arranon
Dosage: 1500mgm2 per day
Start date: 2008-10-08
End date: 2008-10-08
Arranon
Dosage: 1500mgm2 twice per day
Indication: T-Cell Type Acute Leukaemia
Start date: 2008-07-14
End date: 2008-07-18
Arranon
Dosage: 1500mgm2 per day
Start date: 2008-08-08
End date: 2008-08-08
Arranon
Dosage: 1500mg twice per day
Start date: 2008-08-25
End date: 2008-08-29
Arranon
Dosage: 1500mgm2 per day
Start date: 2008-10-10
End date: 2008-10-10
Other drugs received by patient: Urso 250; Prograf; Famotidine; Mucosta; Itraconazole; Levofloxacin; Entomol
Possible Arranon side effects in male
Reported by a physician from Japan on 2011-10-17
Patient: male, weighing 56.0 kg (123.2 pounds)
Reactions: White Blood Cell Count Decreased, Neuropathy Peripheral, Blood Creatine Phosphokinase Increased
Drug(s) suspected as cause:
Arranon
Dosage: 1500mgm2 twice per day
Start date: 2010-10-08
End date: 2010-10-12
Arranon
Dosage: 1500mgm2 twice per day
Indication: T-Cell Type Acute Leukaemia
Start date: 2010-09-06
End date: 2010-09-10
Firstcin
Indication: Pyrexia
Start date: 2010-09-24
End date: 2010-09-29
Other drugs received by patient: Calcium Carbonate; Zovirax; Lansoprazole; Amlodipine; Sulfamethoxazole; Ramelteon; Prednisolone; Unspecified Medication; Acetaminophen; Alfarol; Oxycontin; Novorapid
Possible Arranon side effects in female
Reported by a physician from Japan on 2011-10-04
Patient: female
Reactions: Herpes Zoster
Drug(s) suspected as cause:
Arranon
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