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Oncaspar (Pegaspargase) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Oncaspar (Pegaspargase) 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 (66)
Death (8)
Life Threatening Events (17)
Disability (5)

Reports by Reaction Type

Hypersensitivity (12)Hypertriglyceridaemia (10)Dyspnoea (8)Pruritus (7)Hypotension (7)Pancreatitis (7)Urticaria (6)Pyrexia (6)Infusion Related Reaction (6)Death (5)Blood Cholesterol Increased (5)Cough (5)

Below are a few examples of reports where side effects / adverse reactions may be related to Oncaspar (Pegaspargase). For a complete list or a specific selection of reports, please use the links above.

Possible Oncaspar side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: male, weighing 121.9 kg (268.2 pounds)

Reactions: Pruritus, Unresponsive To Stimuli, Device Related Infection, Pyrexia, Candidiasis, Abscess Limb, Ventricular Extrasystoles, Metabolic Acidosis, Dyspnoea, Hypotension, Pancytopenia, Tremor, Convulsion, Respiratory Failure, Fungal Infection, Ventricular Tachycardia, Sepsis, Respiratory Arrest, Pulse Absent, Sinus Tachycardia, Hypertension, Feeling Abnormal, Cardiac Arrest, Escherichia Infection, Infusion Related Reaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Epinephrine
    Dosage: 4 df, unk
    Indication: Cardiac Arrest
    Start date: 2012-07-14
    End date: 2012-07-14

Cyclophosphamide
    Dosage: daily for 5 days
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-06-19
    End date: 2012-06-23

Oncaspar
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-07-02
    End date: 2012-07-02

Epinephrine
    Dosage: unk
    Start date: 2012-07-14
    End date: 2012-07-14

Clolar
    Dosage: 74.4 mg, qd
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-06-19
    End date: 2012-06-23

Etoposide
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-06-19
    End date: 2012-06-23

Vincristine Sulfate
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-07-02
    End date: 2012-07-02

Other drugs received by patient: Colace; Bactrim; Stomatitis Mouthwash; Prilosec; Lortab; Cymbalta; Ondansetron; Ambien



Possible Oncaspar side effects in

Reported by a physician from United States on 2012-08-15

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Methotrexate
    Dosage: unk, cyclic
    Indication: Acute Lymphocytic Leukaemia

Velcade
    Dosage: 1.3 mg/m2, cyclic
    Indication: Acute Lymphocytic Leukaemia

Hydrocortisone
    Indication: Acute Lymphocytic Leukaemia

Cytarabine
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia

Decadron
    Dosage: 10 mg/m2, cyclic
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia

Doxorubicin Hydrochloride
    Dosage: 60 mg/m2, cyclic
    Indication: Acute Lymphocytic Leukaemia

Oncaspar
    Dosage: unk, cyclic
    Indication: Acute Lymphocytic Leukaemia

Vincristine
    Dosage: 1.5 mg/m2, cyclic
    Indication: Acute Lymphocytic Leukaemia



Possible Oncaspar side effects in

Reported by a physician from United States on 2012-08-15

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Vincristine
    Dosage: 1.5 mg/m2, cyclic
    Indication: Acute Lymphocytic Leukaemia

Doxorubicin Hydrochloride
    Dosage: 60 mg/m2, cyclic
    Indication: Acute Lymphocytic Leukaemia

Hydrocortisone
    Indication: Acute Lymphocytic Leukaemia

Velcade
    Dosage: 1.3 mg/m2, cyclic
    Indication: Acute Lymphocytic Leukaemia

Cytarabine
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia

Methotrexate
    Dosage: unk, cyclic
    Indication: Acute Lymphocytic Leukaemia

Decadron
    Dosage: 10 mg/m2, cyclic
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia

Oncaspar
    Dosage: unk, cyclic
    Indication: Acute Lymphocytic Leukaemia



Possible Oncaspar side effects in

Reported by a physician from United States on 2012-08-15

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Hydrocortisone
    Indication: Acute Lymphocytic Leukaemia

Oncaspar
    Dosage: unk, cyclic
    Indication: Acute Lymphocytic Leukaemia

Velcade
    Dosage: 1.3 mg/m2, cyclic
    Indication: Acute Lymphocytic Leukaemia

Cytarabine
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia

Methotrexate
    Dosage: unk, cyclic
    Indication: Acute Lymphocytic Leukaemia

Decadron
    Dosage: 10 mg/m2, cyclic
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia

Vincristine
    Dosage: 1.5 mg/m2, cyclic
    Indication: Acute Lymphocytic Leukaemia

Doxorubicin Hydrochloride
    Dosage: 60 mg/m2, cyclic
    Indication: Acute Lymphocytic Leukaemia



Possible Oncaspar side effects in

Reported by a physician from United States on 2012-08-15

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Decadron
    Dosage: 10 mg/m2, cyclic
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia

Oncaspar
    Dosage: unk, cyclic
    Indication: Acute Lymphocytic Leukaemia

Doxorubicin Hydrochloride
    Dosage: 60 mg/m2, cyclic
    Indication: Acute Lymphocytic Leukaemia

Hydrocortisone
    Indication: Acute Lymphocytic Leukaemia

Vincristine
    Dosage: 1.5 mg/m2, cyclic
    Indication: Acute Lymphocytic Leukaemia

Cytarabine
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia

Methotrexate
    Dosage: unk, cyclic
    Indication: Acute Lymphocytic Leukaemia

Velcade
    Dosage: 1.3 mg/m2, cyclic
    Indication: Acute Lymphocytic Leukaemia



Possible Oncaspar side effects in female

Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-07-30

Patient: female, weighing 49.0 kg (107.8 pounds)

Reactions: Death, Febrile Neutropenia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Clofarabine
    Dosage: 71 mg, qdx5
    Start date: 2010-11-25
    End date: 2010-11-29

Oncaspar
    Dosage: 3206.3 iu, unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2010-11-01
    End date: 2010-11-01

Oncaspar
    Dosage: 3375 iu, unk
    Start date: 2010-11-25
    End date: 2010-11-25

Vincristine
    Dosage: 2 mg, unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2010-11-25
    End date: 2010-11-25

Clofarabine
    Dosage: 71 mg, qdx5
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2010-11-01
    End date: 2010-11-05

Other drugs received by patient: Itraconazole; Valaciclovir



Possible Oncaspar side effects in male

Reported by a individual with unspecified qualification from United States on 2012-07-26

Patient: male, weighing 27.7 kg (60.9 pounds)

Reactions: Acute Pulmonary Oedema, Hypotension, Tachycardia, General Physical Health Deterioration, Respiratory Distress, Ascites, Heart Rate Decreased, Pleural Effusion, Septic Shock, Oxygen Saturation Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Oncaspar
    Dosage: 2500 iu

Vincristine Sulfate
    Dosage: 3 mg

Methotrexate Sodium
    Dosage: 15 mg

Cytarabine
    Dosage: 70 mg

Dexamethasone
    Dosage: 78 mg



Possible Oncaspar side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-12

Patient:

Reactions: Blood Triglycerides Increased

Drug(s) suspected as cause:
Dexamethasone
    Dosage: 6 mg/m*2;qd;po
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia

Oncaspar
    Dosage: 2500 iu/m*2;x1;iv
    Indication: Acute Lymphocytic Leukaemia



Possible Oncaspar side effects in 17 year old female

Reported by a physician from United States on 2012-06-08

Patient: 17 year old female, weighing 47.6 kg (104.7 pounds)

Reactions: Blood Bilirubin Increased, Pyrexia, Caecitis, Loss of Consciousness, Oedema Peripheral, Pulmonary Oedema, Hypocalcaemia, Acute Respiratory Distress Syndrome, Melaena, Hypertriglyceridaemia, Epistaxis, Dysphagia, Anaemia, Hyperglycaemia, General Physical Health Deterioration, Eating Disorder, Tremor, Cerebral Infarction, Depressed Level of Consciousness, Neutropenia, Confusional State, Dyskinesia, Somnolence, Splenic Infarction, Hypokalaemia, Pleural Effusion, White Blood Cell Count Decreased, Cerebrovascular Accident, Ascites, Diarrhoea, Hypophagia, Hypoalbuminaemia, Sinus Tachycardia, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mercaptopurine
    Dosage: 60mgm2 cyclic
    Administration route: Oral
    Indication: T-Cell Type Acute Leukaemia

Vincristine
    Dosage: 1.5mgm2 cyclic
    Indication: T-Cell Type Acute Leukaemia

Cyclophosphamide
    Dosage: 1000mgm2 cyclic
    Indication: T-Cell Type Acute Leukaemia

Methotrexate
    Indication: T-Cell Type Acute Leukaemia

Oncaspar
    Indication: T-Cell Type Acute Leukaemia

Nelarabine
    Dosage: 650mgm2 cyclic
    Indication: T-Cell Type Acute Leukaemia
    Start date: 2012-04-13

Cytarabine
    Dosage: 75mgm2 cyclic
    Indication: T-Cell Type Acute Leukaemia

Dalteparin Sodium
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Nystatin; Lansoprazole; Insulin Aspart; Piperacillin and Tazobactam; Vancomycin; Voriconazole



Possible Oncaspar side effects in 21 year old female

Reported by a physician from United States on 2012-06-07

Patient: 21 year old female

Reactions: Abdominal Pain, Hyperbilirubinaemia, Nausea, Hyperglycaemia, Malnutrition, Hepatic Steatosis, Cholelithiasis, Fatigue, Activities of Daily Living Impaired, Hepatotoxicity, Cholangitis, Pancreatitis, Asthenia, Mobility Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vincristine Sulfate
    Indication: Acute Lymphocytic Leukaemia

Oncaspar
    Indication: Acute Lymphocytic Leukaemia

Daunorubicin HCL
    Indication: Acute Lymphocytic Leukaemia

Prednisone TAB
    Indication: Acute Lymphocytic Leukaemia



Possible Oncaspar side effects in female

Reported by a physician from United States on 2012-05-25

Patient: female

Reactions: Lung Consolidation, Osteonecrosis, Joint Range of Motion Decreased, Arthralgia, Limb Asymmetry, Gait Disturbance

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Cytarabine
    Dosage: intrathecal
    Indication: Acute Lymphocytic Leukaemia

Daunorubicin HCL
    Indication: Acute Lymphocytic Leukaemia

Doxorubicin HCL
    Indication: Acute Lymphocytic Leukaemia

Cyclophosphamide
    Indication: Acute Lymphocytic Leukaemia

Mercaptopurine
    Indication: Acute Lymphocytic Leukaemia

Vincristine Sulfate
    Indication: Acute Lymphocytic Leukaemia

Dexamethasone
    Dosage: intrathecal
    Indication: Acute Lymphocytic Leukaemia

Methotrexate
    Dosage: intrathecal
    Indication: Acute Lymphocytic Leukaemia

Oncaspar
    Indication: Acute Lymphocytic Leukaemia

Thioguanine
    Indication: Acute Lymphocytic Leukaemia



Possible Oncaspar side effects in 10 year old male

Reported by a physician from United States on 2012-05-24

Patient: 10 year old male, weighing 22.3 kg (49.1 pounds)

Reactions: Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Doxorubicin HCL
    Dosage: 27 mg, qd on day 1 and 5
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-03-31
    End date: 2012-05-01

Methylprednisolone Acetate
    Dosage: 9.7 mg, q8h on day 4 to day 32
    Indication: Acute Lymphocytic Leukaemia

Methotrexate
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-05-03

Etoposide
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-05-10

Afinitor
    Dosage: 2 mg, qd on day 1 to day 32
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-03-31
    End date: 2012-05-01

Oncaspar
    Dosage: 2275 iu, qd on days 4 to 32
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-03-31
    End date: 2012-05-01

Vincristine
    Dosage: 1.4 mg, qd on day 4, 11, 18 and 25
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-03-31
    End date: 2012-05-01

Cytoxan
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-05-10

Other drugs received by patient: Leucovorin Calcium; Ondansetron; Senna-Mint WAF; Colace; Sulfamethoxypyrazine / Trimethoprim; Ondansetron; Concerta; Calcium Carbonate; Clonidine



Possible Oncaspar side effects in 7 year old female

Reported by a individual with unspecified qualification from United States on 2012-05-17

Patient: 7 year old female, weighing 39.0 kg (85.8 pounds)

Reactions: Retching, Nausea, Hypophagia, Hypertriglyceridaemia, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Velcade
    Dosage: 1.3 mg/m**2; iv
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-02-28
    End date: 2012-04-17

Doxorubicin HCL
    Dosage: 60 mg/m**2;qd;iv
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-02-28
    End date: 2012-03-01

Oncaspar
    Dosage: 2500 iu/m**2; iv
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-02-28
    End date: 2012-03-22

Cytarabine
    Dosage: 70 mg;x1;inth
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-02-28
    End date: 2012-02-28

Vincristine
    Dosage: 1.5 mg/m**2; iv
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-02-28
    End date: 2012-03-22

Prednisone TAB
    Dosage: 20 mg/m**2;qd;po
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-02-28
    End date: 2012-03-01

Methotrexate
    Dosage: 500 mg/m**2; inth; 4500 mg/m**2; iv
    Indication: Acute Lymphocytic Leukaemia
    End date: 2012-04-10

Methotrexate
    Dosage: 500 mg/m**2; inth; 4500 mg/m**2; iv
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-02-28

Methotrexate
    Dosage: 500 mg/m**2; inth; 4500 mg/m**2; iv
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-04-10
    End date: 2012-04-14



Possible Oncaspar side effects in 13 year old female

Reported by a physician from United States on 2012-04-25

Patient: 13 year old female, weighing 64.8 kg (142.6 pounds)

Reactions: Alanine Aminotransferase Increased, Acute Lymphocytic Leukaemia Recurrent, Mental Status Changes, Cerebral Artery Occlusion, Hypokalaemia, Gamma-Glutamyltransferase Increased, Aspartate Aminotransferase Increased, Pancreatitis, Depressed Level of Consciousness, Neurological Symptom, Hypertriglyceridaemia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Prednisone
    Dosage: 20 mg/m2, bid, po
    Administration route: Oral
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2012-02-11
    End date: 2012-02-18

Velcade
    Dosage: 1.3 mg/m2, x1, iv
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2012-02-11
    End date: 2012-02-18

Oncaspar
    Dosage: 2500 iu/m2,x1
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2012-02-11
    End date: 2012-03-02

Cytarabine

Other drugs received by patient: Doxorubicin HCL; Dalteparin Sodium; Vincristine; Methotrexate



Possible Oncaspar side effects in 17 year old male

Reported by a physician from United States on 2012-04-25

Patient: 17 year old male, weighing 45.0 kg (99.0 pounds)

Reactions: Back Pain, Gastrointestinal Haemorrhage, Hypotension, Malnutrition, Neoplasm Progression, Haemorrhoidal Haemorrhage, Convulsion, Leukaemia, Cachexia, Diarrhoea, NO Therapeutic Response, Sepsis, Nervous System Disorder, Altered State of Consciousness

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Methotrexate
    Dosage: ;x1;inth
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2012-03-05
    End date: 2012-03-05

Methotrexate
    Dosage: ;x1;inth
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2012-02-20
    End date: 2012-02-20

Cytarabine
    Dosage: ;x1;inth
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2012-02-20
    End date: 2012-02-20

Prednisone
    Dosage: 20 mg/m**2; po
    Administration route: Oral
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2012-02-20
    End date: 2012-03-14

Vincristine
    Dosage: 1.5 mg/m**2;x1;iv
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2012-02-20
    End date: 2012-02-20

Vincristine
    Dosage: 1.5 mg/m**2;x1;iv
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2012-03-12
    End date: 2012-03-12

Oncaspar
    Dosage: 2500 iu/m**2;qw;im
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2012-02-20
    End date: 2012-03-12

Doxorubicin HCL
    Dosage: 60 ug/m**2;x1;iv
    Indication: B Precursor Type Acute Leukaemia

Velcade
    Dosage: 1.3 mg/m**2;x1;iv
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2012-02-20
    End date: 2012-02-20

Other drugs received by patient: Keppra



Possible Oncaspar side effects in 19 year old female

Reported by a physician from United States on 2012-04-24

Patient: 19 year old female, weighing 160.0 kg (352.0 pounds)

Reactions: Axillary Vein Thrombosis, Pyrexia, High Density Lipoprotein Decreased, Very LOW Density Lipoprotein Increased, Vena Cava Thrombosis, Thrombophlebitis, Blood Cholesterol Increased, Hypertriglyceridaemia

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Oncaspar
    Dosage: 4500 iu;x1; 2125 iu;x1;
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2011-12-01
    End date: 2011-12-01

Oncaspar
    Dosage: 4500 iu;x1; 2125 iu;x1;
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-01-17
    End date: 2012-01-17

Oncaspar
    Dosage: 4500 iu;x1; 2125 iu;x1;
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-02-14
    End date: 2012-02-14

Oncaspar



Possible Oncaspar side effects in 13 year old female

Reported by a physician from United States on 2012-04-06

Patient: 13 year old female, weighing 83.0 kg (182.6 pounds)

Reactions: Pancreatitis Acute, Diabetes Mellitus, Disseminated Intravascular Coagulation, Hepatic Failure, Renal Failure, Pancreatitis Necrotising, Respiratory Failure, Pancreatic Pseudocyst, Pleural Effusion, Pancreatic Insufficiency

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Oncaspar

Oncaspar
    Dosage: 4925 iu; x1; sc
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2011-11-07
    End date: 2011-11-07

Oncaspar
    Dosage: 4925 iu; x1; sc
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2011-12-20
    End date: 2011-12-20

Oncaspar
    Dosage: 4925 iu; x1; sc
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-01-17
    End date: 2012-01-17

Other drugs received by patient: Mercaptopurine; Zofran; Methotrexate; Cyclophosphamide; Cytarabine



Possible Oncaspar side effects in 18 year old male

Reported by a physician from United States on 2012-04-03

Patient: 18 year old male, weighing 126.4 kg (278.1 pounds)

Reactions: White Blood Cell Count Decreased, Abdominal Pain, Metabolic Acidosis, Clostridium Test Positive, Urine Output Decreased, Hypotension, Hyponatraemia, Capillary Leak Syndrome, Platelet Count Decreased, Septic Shock

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Oncaspar
    Dosage: 2500 iu;x1;iv
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-02-24
    End date: 2012-03-02

Doxorubicin HCL
    Dosage: 60 mg/m**2;x1;iv
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-02-24
    End date: 2012-02-24

Velcade
    Dosage: 1.3 mg/m**2; qd; iv
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-02-24
    End date: 2012-03-02

Vincristine
    Dosage: 1.5 mg/m**2;qd;iv
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-02-24
    End date: 2012-03-02

Prednisone TAB
    Dosage: 20 mg/m**2;qd;po
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-02-24
    End date: 2012-03-04

Cytarabine
    Dosage: 70 mg;x1;inth
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-02-24

Hydrocortisone
    Indication: Acute Lymphocytic Leukaemia

Methotrexate
    Dosage: inth
    Indication: Acute Lymphocytic Leukaemia



Possible Oncaspar side effects in 15 year old male

Reported by a consumer/non-health professional from United States on 2012-04-03

Patient: 15 year old male, weighing 110.0 kg (242.0 pounds)

Reactions: Hypersensitivity, Hypokalaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cytarabine
    Dosage: last dose on 24nov09; 60 mg it:15oct09
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2009-04-08

Oncaspar
    Dosage: lats dose:05oct2009
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2009-04-08

Cyclophosphamide
    Dosage: last dose on 27nov09. 2352mg:05oct2009
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2009-04-08

Methotrexate
    Dosage: last dose on 09nov2009: 24000 mg iv mtx
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2009-04-08

Daunorubicin HCL
    Dosage: last dose:02oct2009
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2009-04-08

Vincristine Sulfate
    Dosage: last dose:15oct2009
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2009-04-08

Etoposide
    Dosage: last dose on 27nov09.
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2009-04-08

Asparaginase
    Dosage: last dose on 06jan10.
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2009-04-08

Dexamethasone
    Dosage: last dose:21oct2009
    Start date: 2009-04-08

Sprycel
    Dosage: last dose on 27dec09. 1820mg:14oct2009
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2009-04-08

Hydrocortisone
    Dosage: last dose on 24nov2009, 15oct2009
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2009-04-08



Possible Oncaspar side effects in 8 year old female

Reported by a pharmacist from United States on 2012-04-02

Patient: 8 year old female, weighing 26.0 kg (57.2 pounds)

Reactions: Hypersensitivity, Vomiting, Nausea, Chills, Pyrexia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Oncaspar



Possible Oncaspar side effects in 10 year old male

Reported by a pharmacist from United States on 2012-04-02

Patient: 10 year old male, weighing 44.0 kg (96.8 pounds)

Reactions: Face Oedema, Vomiting, Anaphylactic Reaction, Urticaria, Wheezing, Blood Pressure Decreased

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Oncaspar
    Dosage: ;x1; iv, 3300 iu;x1; iv
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2011-07-07
    End date: 2011-07-07

Oncaspar
    Dosage: ;x1; iv, 3300 iu;x1; iv
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2011-05-15
    End date: 2011-05-15

Other drugs received by patient: Cotrim



Possible Oncaspar side effects in 12 year old male

Reported by a pharmacist from United States on 2012-04-02

Patient: 12 year old male, weighing 38.0 kg (83.6 pounds)

Reactions: Hypersensitivity, Pruritus, Dyspnoea, Laryngeal Oedema, Cough

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Oncaspar
    Dosage: 3150 iu;x1;iv
    Indication: Acute Lymphocytic Leukaemia Recurrent
    Start date: 2011-10-23
    End date: 2011-10-23

Oncaspar

Other drugs received by patient: Cytarabine; Pentamidine Isethionate; Cetirizine Scopolamine / 00008701 /



Possible Oncaspar side effects in 9 year old female

Reported by a pharmacist from United States on 2012-04-02

Patient: 9 year old female, weighing 25.0 kg (55.0 pounds)

Reactions: LIP Swelling, Hypersensitivity, Urticaria, Rash

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Oncaspar



Possible Oncaspar side effects in 22 month old male

Reported by a pharmacist from United States on 2012-04-02

Patient: 22 month old male, weighing 13.0 kg (28.6 pounds)

Reactions: Agitation, Dyspnoea, Anaphylactic Reaction, Erythema, Cough

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Oncaspar



Possible Oncaspar side effects in 4 year old male

Reported by a pharmacist from United States on 2012-04-02

Patient: 4 year old male, weighing 17.0 kg (37.4 pounds)

Reactions: Hypersensitivity, Dyspnoea, Urticaria, Respiratory Distress, Cough

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Oncaspar

Other drugs received by patient: Ranitidine; CO-Trimazole; Dexamethasone



Possible Oncaspar side effects in 18 year old female

Reported by a pharmacist from United States on 2012-04-02

Patient: 18 year old female, weighing 66.7 kg (146.7 pounds)

Reactions: Hypersensitivity, Chest Discomfort, Wheezing, Cough

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Oncaspar
    Dosage: 4650 iu;x1;iv
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2011-10-17
    End date: 2011-10-17

Oncaspar

Other drugs received by patient: Cotrimaxazole; Vincristine; Daunorubicin HCL; Acyclovir; Prednisone; Ondansetron; Cefepime; Ranitidine



Possible Oncaspar side effects in 7 year old female

Reported by a pharmacist from United States on 2012-04-02

Patient: 7 year old female, weighing 22.0 kg (48.4 pounds)

Reactions: Hypersensitivity, Swelling Face, Eye Swelling

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Oncaspar



Possible Oncaspar side effects in 15 year old female

Reported by a pharmacist from United States on 2012-04-02

Patient: 15 year old female, weighing 62.0 kg (136.4 pounds)

Reactions: Hypersensitivity, Chest Discomfort, Throat Tightness, Cough

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Oncaspar

Other drugs received by patient: Methotrexate; Vincristine



Possible Oncaspar side effects in 15 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-02

Patient: 15 year old male, weighing 70.5 kg (155.0 pounds)

Reactions: Periorbital Oedema, Hypersensitivity, Swelling Face, Urticaria, Oedema, Throat Tightness

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Oncaspar



Possible Oncaspar side effects in 4 year old female

Reported by a pharmacist from United States on 2012-04-02

Patient: 4 year old female, weighing 17.0 kg (37.4 pounds)

Reactions: Dyspnoea, Cyanosis, Anaphylactic Shock, Erythema

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Oncaspar
    Dosage: 1725 iu;x1;iv
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-01-06
    End date: 2012-01-06

Oncaspar

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