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side effects patient, weighting 93.48 lb, took L-asparaginase 21200 Unit . View more Serious Adverse Events reported to FDA.

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List of L-asparaginase Adverse Effects reported to US Food and Drug Administration (FDA)

Showing 1-25 of 32 

Muscular Weakness, Depression (8490894-5)
on Jun 28, 2012 Male patient from UNITED STATES , weighting 93.48 lb, was treated with L-asparaginase. Patient experienced the following unwanted or unexpected effects: muscular weakness, depression. L-asparaginase dosage: 21200 Unit.
Patient also using the following medications:
  • Methotrexate (140 Mg)


Dizziness (7366279-1)
Patient was taking L-asparaginase. Patient had the following side effects: dizziness on Mar 17, 2011 from UNITED STATES Additional patient health information: Male patient , weighting 231.5 lb, . L-asparaginase dosage: 52850 Mg.
Patient also using the following medications:
  • Vincristine Sulfate (2 Mg)
  • Methotrexate (190 Mg)
  • Dexamethasone (84 Mg)
Patient was hospitalized.

Acidosis, Ammonia Increased, Azotaemia, Back Pain, Blood Creatinine Increased, Blood Culture Positive, Blood Pressure Abnormal, Candidiasis, Cardiac Disorder (6700030-0)
Adverse event was reported on Apr 27, 2010 by a Female patient taking L-asparaginase (Dosage: 45600 Mg) . Location: UNITED STATES , weighting 184.7 lb, After L-asparaginase was administered, patient had the following side effects: acidosis, ammonia increased, azotaemia, back pain, blood creatinine increased, blood culture positive, blood pressure abnormal, candidiasis, cardiac disorder.
Patient also using the following medications:
  • Cytarabine (45600 Mg)
Patient was hospitalized.

Acute Lymphocytic Leukaemia, Apraxia, Epistaxis, Fatigue, Fungal Infection, Haemoglobin Decreased, Interleukin Level Increased, Malignant Neoplasm Progression, Mental Status Changes (6600250-X)
on Feb 19, 2010 Female patient from INDIA , child 10 years of age, was diagnosed with
  • t-cell type acute leukaemia
and was treated with L-asparaginase (asparaginase). Patient experienced the following unwanted or unexpected effects: acute lymphocytic leukaemia, apraxia, epistaxis, fatigue, fungal infection, haemoglobin decreased, interleukin level increased, malignant neoplasm progression, mental status changes. L-asparaginase (asparaginase) dosage: N/A.
Patient also using the following medications:
  • Dexamethasone Tab
  • Methotrexate



Acidosis, Back Pain, Bacterial Test Positive, Blood Creatinine Increased, Cardiac Disorder, Dyspnoea, Hepatic Function Abnormal, Hypoglycaemia, Hypotension (6538179-8)
on Jan 12, 2010 Female patient from UNITED STATES , weighting 184.7 lb, was treated with L-asparaginase. Patient had the following side effects: acidosis, back pain, bacterial test positive, blood creatinine increased, cardiac disorder, dyspnoea, hepatic function abnormal, hypoglycaemia, hypotension. L-asparaginase dosage: 22800 Iu.
Patient also using the following medications:
  • Cytarabine (456000 Mg)
Patient was hospitalized.

Hyperglycaemia, Pancreatitis Acute, Pseudocyst (6537249-8)
Patient was taking L-asparaginase (asparaginase). After L-asparaginase was administered, patient had the following side effects: hyperglycaemia, pancreatitis acute, pseudocyst on Dec 23, 2009 from MEXICO Additional patient health information: Female patient , child 4 years of age, was diagnosed with
  • acute lymphocytic leukaemia
and. L-asparaginase (asparaginase) dosage: N/A.
Patient also using the following medications:
  • Methotrexate (; 1x;)
  • Daunorubicin Hcl (50 Mg/m**2; 1x;)
  • Vincristine (1.5 Mg/m**2; Qw; Iv)
  • Prednisone (60 Mg/m**2; Qd; Po)


Hyperglycaemia, Pancreatic Necrosis, Pancreatitis Acute, Pseudocyst (6537248-6)
Adverse event was reported on Dec 23, 2009 by a Male patient taking L-asparaginase (asparaginase) (Dosage: N/A) was diagnosed with
  • acute lymphocytic leukaemia
and. Location: MEXICO , child 12 years of age, Patient experienced the following unwanted or unexpected effects: hyperglycaemia, pancreatic necrosis, pancreatitis acute, pseudocyst.
Patient also using the following medications:
  • Methotrexate (; 1x;)
  • Daunocuribicin (daunorubicin) (50 Mg/m**2; 1x;)
  • Vincristine (1.5 Mg/m**2; Qw; Iv)
  • Prednisone (60 Mg/m**2; Qd; Po)


Pancreatitis Acute, Pseudocyst (6537247-4)
on Dec 23, 2009 Female patient from MEXICO , 14 years of age, was diagnosed with
  • acute lymphocytic leukaemia
and was treated with L-asparaginase (asparaginase). Patient had the following side effects: pancreatitis acute, pseudocyst. L-asparaginase (asparaginase) dosage: N/A.
Patient also using the following medications:
  • Methotrexate (; 1x;)
  • Daunorubicin Hcl (50 Mg/m**2; 1x;)
  • Vincristine (1.5 Mg/m**2; Qw; Iv)
  • Prednisone (60 Mg/m**2; Qd; Po)


Hyperglycaemia, Pancreatic Necrosis, Pancreatitis Acute (6537231-0)
on Dec 23, 2009 Female patient from MEXICO , 14 years of age, was diagnosed with
  • acute lymphocytic leukaemia
and was treated with L-asparaginase (asparaginase). After L-asparaginase was administered, patient had the following side effects: hyperglycaemia, pancreatic necrosis, pancreatitis acute. L-asparaginase (asparaginase) dosage: N/A.
Patient also using the following medications:
  • Methotrexate (1x)
  • Daunorubicin Hcl (50 Mg/m**2;1x)
  • Vincristine (1.5 Mg/m**2;qw;iv)
  • Prednisone (60 Mg/m**2;qd;po)


Blood Glucose Increased, Pancreatic Necrosis, Pancreatic Pseudocyst, Pancreatitis Acute (6537222-X)
Patient was taking L-asparaginase (asparaginase). Patient experienced the following unwanted or unexpected effects: blood glucose increased, pancreatic necrosis, pancreatic pseudocyst, pancreatitis acute on Dec 23, 2009 from MEXICO Additional patient health information: Female patient , child 12 years of age, was diagnosed with
  • acute lymphocytic leukaemia
and. L-asparaginase (asparaginase) dosage: N/A.
Patient also using the following medications:
  • Methotrexate (1x)
  • Daunorubicin Hcl (50 Mg/m**2;1x)
  • Vincristine (1.5 Mg/m**2;qw;iv)
  • Prednisone (60 Mg/m**2;qd;po)


Hyperglycaemia, Pancreatic Necrosis, Pancreatitis Acute (6537221-8)
Adverse event was reported on Dec 23, 2009 by a Female patient taking L-asparaginase (asparaginase) (Dosage: N/A) was diagnosed with
  • acute lymphocytic leukaemia
and. Location: MEXICO , child 10 years of age, Patient had the following side effects: hyperglycaemia, pancreatic necrosis, pancreatitis acute.
Patient also using the following medications:
  • Methotrexate (1x)
  • Daunorubicin Hcl (50 Mg/m**2;1x)
  • Vincristine (1.5 Mg/m**2;qw;iv)
  • Prednisone (60 Mg/m**2;qd;po)


Blood Glucose Increased, Pancreatic Necrosis, Pancreatic Pseudocyst, Pancreatitis Acute (6537215-2)
on Dec 23, 2009 Male patient from MEXICO , child 5 years of age, was diagnosed with
  • acute lymphocytic leukaemia
and was treated with L-asparaginase (asparaginase). After L-asparaginase was administered, patient had the following side effects: blood glucose increased, pancreatic necrosis, pancreatic pseudocyst, pancreatitis acute. L-asparaginase (asparaginase) dosage: N/A.
Patient also using the following medications:
  • Methotrexate (; 1x;)
  • Daunorubicin Hcl (50 Mg/m**2; 1x;)
  • Vincristine (1.5 Mg/m**2; Qw; Iv)
  • Prednisone (60 Mg/m**2; Qd; Po)


Pancreatic Necrosis, Pancreatitis Acute (6537206-1)
on Dec 23, 2009 Female patient from MEXICO , child 6 years of age, was diagnosed with
  • acute lymphocytic leukaemia
and was treated with L-asparaginase (asparaginase). Patient experienced the following unwanted or unexpected effects: pancreatic necrosis, pancreatitis acute. L-asparaginase (asparaginase) dosage: N/A.
Patient also using the following medications:
  • Methotrexate (; 1x;)
  • Daunorubicin Hcl (50 Mg/m**2; 1x;)
  • Vincristine (1.5 Mg/m**2; Qw; Iv)
  • Prednisone (60 Mg/m**2; Qd; Po)


Hyperglycaemia, Pancreatic Necrosis, Pancreatitis Acute, Pseudocyst (6537205-X)
Patient was taking L-asparaginase (asparaginase). Patient had the following side effects: hyperglycaemia, pancreatic necrosis, pancreatitis acute, pseudocyst on Dec 23, 2009 from MEXICO Additional patient health information: Female patient , child 11 years of age, was diagnosed with
  • acute lymphocytic leukaemia
and. L-asparaginase (asparaginase) dosage: N/A.
Patient also using the following medications:
  • Methotrexate (; 1x;)
  • Daunorubicin Hcl (50 Mg/m**2; 1x;)
  • Vincristine (1.5 Mg/m**2; Qw; Iv)
  • Prednisone (60 Mg/m**2; Qd; Po)


Hyperglycaemia, Pancreatic Necrosis, Pancreatitis Acute (6537200-0)
Adverse event was reported on Dec 23, 2009 by a Male patient taking L-asparaginase (asparaginase) (Dosage: N/A) was diagnosed with
  • acute lymphocytic leukaemia
and. Location: MEXICO , 15 years of age, After L-asparaginase was administered, patient had the following side effects: hyperglycaemia, pancreatic necrosis, pancreatitis acute.
Patient also using the following medications:
  • Methotrexate (; 1x;)
  • Daunorubicin Hcl (50 Mg/m**2; 1x;)
  • Vincristine (1.5 Mg/m**2; Qw; Iv)
  • Prednisone (60 Mg/m**2; Qd; Po)


Hyperglycaemia, Pancreatic Necrosis, Pancreatitis Acute, Pseudocyst (6537193-6)
on Dec 23, 2009 Male patient from MEXICO , child 11 years of age, was diagnosed with
  • acute lymphocytic leukaemia
and was treated with L-asparaginase (asparaginase). Patient experienced the following unwanted or unexpected effects: hyperglycaemia, pancreatic necrosis, pancreatitis acute, pseudocyst. L-asparaginase (asparaginase) dosage: N/A.
Patient also using the following medications:
  • Methotrexate (; 1x;)
  • Daunorubicin Hcl (50 Mg/m**2; 1x;)
  • Vincristine (1.5 Mg/m**2; Qw; Iv)
  • Prednisone (60 Mg/m**2; Qd; Po)


Pancreatic Necrosis, Pancreatitis Acute (6537180-8)
on Dec 23, 2009 Female patient from MEXICO , child 12 years of age, was diagnosed with
  • acute lymphocytic leukaemia
and was treated with L-asparaginase (asparaginase). Patient had the following side effects: pancreatic necrosis, pancreatitis acute. L-asparaginase (asparaginase) dosage: N/A.
Patient also using the following medications:
  • Methotrexate (; 1x;)
  • Daunorubicin Hcl (50 Mg/m**2; 1x;)
  • Vincristine (1.5 Mg/m**2; Qw; Iv)
  • Prednisone (60 Mg/m**2; Qd; Po)


Deep Vein Thrombosis, Erythema, Liver Function Test Abnormal, Pancreatic Enzymes Increased, Pyrexia, Rash, Retroperitoneal Haematoma, Syncope (6168855-0)
Patient was taking L-asparaginase. After L-asparaginase was administered, patient had the following side effects: deep vein thrombosis, erythema, liver function test abnormal, pancreatic enzymes increased, pyrexia, rash, retroperitoneal haematoma, syncope on Apr 24, 2009 from UNITED STATES Additional patient health information: Male patient , weighting 194.4 lb, . L-asparaginase dosage: 66000 Iu.
Patient also using the following medications:
  • Vincristine Sulfate (8 Mg)
  • Daunorubicin Hcl (396 Mg)
  • Dexamethasone (77 Mg)
Patient was hospitalized.

Laryngeal Ulceration, Mouth Ulceration, Mucosal Inflammation, Neutrophil Count Abnormal, Neutrophil Count Decreased, Pharyngolaryngeal Pain, Staphylococcal Infection (5595529-7)
Adverse event was reported on Jan 16, 2008 by a Female patient taking L-asparaginase (Dosage: 36000 Million Iu) . Location: UNITED STATES , weighting 160.9 lb, Patient experienced the following unwanted or unexpected effects: laryngeal ulceration, mouth ulceration, mucosal inflammation, neutrophil count abnormal, neutrophil count decreased, pharyngolaryngeal pain, staphylococcal infection.
Patient also using the following medications:
  • Methotrexate (400 Mg)
Patient was hospitalized.

Erythema, Paraesthesia Oral, Pruritus, Swollen Tongue, Urticaria (5316643-7)
on Apr 30, 2007 Female patient from UNITED STATES , weighting 230.8 lb, was treated with L-asparaginase. Patient had the following side effects: erythema, paraesthesia oral, pruritus, swollen tongue, urticaria. L-asparaginase dosage: 1340 Unit.
Patient also using the following medications:
  • Cotrimoxazole Ds
Patient was hospitalized.

Hypotension, Loss Of Consciousness (5301796-7)
on Apr 16, 2007 Female patient from UNITED STATES , weighting 173.9 lb, was treated with L-asparaginase. After L-asparaginase was administered, patient had the following side effects: hypotension, loss of consciousness. L-asparaginase dosage: 10000 Iu.
Patient also using the following medications:
  • Methotrexate (5000 Mg)
Patient was hospitalized.

Intussusception (5272923-5)
Patient was taking L-asparaginase. Patient experienced the following unwanted or unexpected effects: intussusception on Oct 18, 2006 from Additional patient health information: Female patient , child 7 years of age, . L-asparaginase dosage: Dose: Unk.
Patient also using the following medications:
  • Daunorubicin Hydrochloride (Dose: Unk)
  • Vincristine (Dose: Unk)


Vena Cava Thrombosis (5247663-9)
Adverse event was reported on Feb 06, 2007 by a Female patient taking L-asparaginase (asparaginase) (Dosage: N/A) was diagnosed with
  • acute lymphocytic leukaemia
  • contraception
and. Location: UNITED STATES , 18 years of age, Patient had the following side effects: vena cava thrombosis.
Patient also using the following medications:
  • Oral Contraceptive Nos (oral Contraceptive Nos)


Bone Marrow Failure, Deep Vein Thrombosis, Iliac Vein Occlusion, Leukaemia Recurrent, Septic Shock (5158696-5)
on Nov 01, 2006 Male patient from POLAND , 17 years of age, was diagnosed with
  • acute lymphocytic leukaemia
and was treated with L-asparaginase (asparaginase). After L-asparaginase was administered, patient had the following side effects: bone marrow failure, deep vein thrombosis, iliac vein occlusion, leukaemia recurrent, septic shock. L-asparaginase (asparaginase) dosage: See Image.
Patient also using the following medications:
  • Prednisone Tab (See Image)
  • Vincristine
  • Daunorubicin Hcl
  • Doxorubicin Hcl


Intussusception (5140263-0)
on Oct 18, 2006 Female patient from , child 7 years of age, was diagnosed with
  • acute lymphocytic leukaemia
and was treated with L-asparaginase. Patient experienced the following unwanted or unexpected effects: intussusception. L-asparaginase dosage: Dose: Unk.
Patient also using the following medications:
  • Daunorubicin Hydrochloride (Dose: Unk)
  • Vincristine (Dose: Unk)


Showing 1-25 of 32 

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L-asparaginase Information

More About L-asparaginase

Side Effects reported to FDA: 32. View FDA Adverse Reports

L-asparaginase safety alerts: No

Reported deaths: 1

Reported hospitalizations: 11

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L-asparaginase Adverse Reactions

Pancreatitis Acute ( 12 Reports)

Pancreatic Necrosis ( 10 Reports)

Hyperglycaemia ( 7 Reports)

Pseudocyst ( 5 Reports)

Back Pain ( 3 Reports)

Deep Vein Thrombosis ( 3 Reports)

Hypotension ( 3 Reports)

Acidosis ( 2 Reports)

Blood Creatinine Increased ( 2 Reports)

Blood Glucose Increased ( 2 Reports)

Cardiac Disorder ( 2 Reports)

Erythema ( 2 Reports)

Haemoglobin Decreased ( 2 Reports)

Hemiparesis ( 2 Reports)

Intussusception ( 2 Reports)

Leukaemia Recurrent ( 2 Reports)

Pancreatic Pseudocyst ( 2 Reports)

Pharyngolaryngeal Pain ( 2 Reports)

Pyrexia ( 2 Reports)

Abdominal Pain Upper ( 1 Reports)

Acute Lymphocytic Leukaemia ( 1 Reports)

Ammonia Increased ( 1 Reports)

Antithrombin Iii Decreased ( 1 Reports)

Apraxia ( 1 Reports)

Azotaemia ( 1 Reports)

Bacteraemia ( 1 Reports)

Bacterial Test Positive ( 1 Reports)

Blood Culture Positive ( 1 Reports)

Blood Electrolytes Abnormal ( 1 Reports)

Blood Fibrinogen Decreased ( 1 Reports)

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