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Arranon (Nelarabine) - Side Effect Reports to FDA

 
 



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)Dyspnoea (3)Monoplegia (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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