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Index of reports
> Serious Reactions (34)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Mylotarg (Gemtuzumab Ozogamicin) serious reactions. The selected reports were submitted to the FDA during the sample period of about a year. Reports 1 - 30 of 34 Next >>
Possible Mylotarg side effects in 44 year old female
Reported by a physician from France on 2012-08-17
Patient: 44 year old female
Reactions: Lung Disorder, Gastrointestinal Haemorrhage, Mesenteric Panniculitis, Sepsis, Febrile Bone Marrow Aplasia
Drug(s) suspected as cause:
Cytarabine
Dosage: 348 mg, 1x/day
Indication: Acute Leukaemia
Start date: 2008-07-22
End date: 2008-07-28
Mylotarg
Dosage: 10.4 mg, 1x/day
Indication: Acute Leukaemia
Start date: 2008-07-25
End date: 2008-07-25
Daunorubicin HCL
Dosage: 104.4 mg, 1x/day
Indication: Acute Leukaemia
Start date: 2008-07-22
End date: 2008-07-24
Possible Mylotarg side effects in 44 year old female
Reported by a physician from France on 2012-07-27
Patient: 44 year old female
Reactions: Lung Disorder, Gastrointestinal Haemorrhage, Mesenteric Panniculitis, Sepsis, Febrile Bone Marrow Aplasia
Drug(s) suspected as cause:
Mylotarg
Dosage: 10.4 mg, 1x/day
Indication: Acute Leukaemia
Start date: 2008-07-25
End date: 2008-07-25
Cytarabine
Dosage: 348 mg, 1x/day
Indication: Acute Leukaemia
Start date: 2008-07-22
End date: 2008-07-28
Cerubidine
Dosage: 104.4 mg, 1x/day
Indication: Acute Leukaemia
Start date: 2008-07-22
End date: 2008-07-24
Possible Mylotarg side effects in 60 year old female
Reported by a physician from France on 2012-07-13
Patient: 60 year old female
Reactions: Cytolytic Hepatitis
Drug(s) suspected as cause:
Mylotarg
Dosage: 10.98 mg, 1x/day
Indication: Acute Leukaemia
Start date: 2010-04-29
End date: 2010-04-29
Cytarabine
Dosage: 1830 mg, 2x/day
Indication: Acute Leukaemia
Start date: 2010-04-26
End date: 2010-05-01
Mitoxantrone
Dosage: 21.96 mg, 1x/day
Indication: Acute Leukaemia
Start date: 2010-04-26
End date: 2010-04-27
Possible Mylotarg side effects in 44 year old female
Reported by a physician from France on 2012-07-13
Patient: 44 year old female
Reactions: Gastrointestinal Haemorrhage, Lung Disorder, Mesenteric Panniculitis, Sepsis, Febrile Bone Marrow Aplasia
Drug(s) suspected as cause:
Cerubidine
Dosage: 104.4 mg, 1x/day
Indication: Acute Leukaemia
Start date: 2008-07-22
End date: 2008-07-24
Mylotarg
Dosage: 10.4 mg, 1x/day
Indication: Acute Leukaemia
Start date: 2008-07-25
End date: 2008-07-25
Cytarabine
Dosage: 348 mg, 1x/day
Indication: Acute Leukaemia
Start date: 2008-07-22
End date: 2008-07-28
Possible Mylotarg side effects in 61 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-04-25
Patient: 61 year old female
Reactions: Pancytopenia, Neutropenia
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Daunorubicin HCL
Indication: Acute Myeloid Leukaemia
Start date: 2007-03-14
End date: 2007-03-18
Evoltra (Clofarabine) Solution FOR Infusion
Indication: Acute Myeloid Leukaemia
Start date: 2007-03-14
End date: 2007-03-18
Mylotarg
Indication: Acute Myeloid Leukaemia
Start date: 2007-03-14
End date: 2007-03-18
Other drugs received by patient: Lorazepam; Loperamide; Oral Balance (Xylitol, Potassium Thiocyanate, Glucose Oxidase, Lysozym; Combivent Nebulizer; Itraconazole; Phosphate Sandoz; Chlorhexidine Gluconate; Vancomycin; Amphotericin B; Cotrim; Combivent Nebuliser; Omeprazole; Potassium Chloride; Phosphate Sandoz; Alimemazine Tartrate; Meropenem; Caspofungin Acetate; Teicoplanin; Calcium Gluconate; Acyclovir; Chlorpheniramine Maleate; Clobestasol Propionate; G-CSF (Granulocyte Colony Stimulating Factor); Calcium Carbonate
Possible Mylotarg side effects in male
Reported by a physician from United Kingdom on 2012-04-20
Patient: male
Reactions: Neutropenia, Drug Prescribing Error
Drug(s) suspected as cause:
Evoltra
Dosage: 40 mg, unk
Start date: 2009-03-26
End date: 2009-03-30
Mylotarg
Dosage: unk
Indication: Acute Myeloid Leukaemia
Start date: 2009-03-26
End date: 2009-03-30
Evoltra
Dosage: 40 mg, unk
Indication: Acute Myeloid Leukaemia
Start date: 2009-01-08
End date: 2009-01-12
Daunorubicin HCL
Dosage: unk
Indication: Acute Myeloid Leukaemia
Daunorubicin HCL
Dosage: unk
Evoltra
Dosage: 40 mg, unk
Start date: 2009-02-23
End date: 2009-02-27
Other drugs received by patient: Ramipril; Propranolol; Simvastatin; Zopiclone; Itraconazole; Corsodyl
Possible Mylotarg side effects in 51 year old male
Reported by a physician from United Kingdom on 2012-03-30
Patient: 51 year old male
Reactions: Venoocclusive Disease, Aspartate Aminotransferase Increased
Adverse event resulted in: death
Drug(s) suspected as cause:
Daunorubicin Citrate Liposome
Dosage: unk
Indication: Acute Myeloid Leukaemia
Start date: 2011-09-23
End date: 2011-10-03
Mylotarg
Daunorubicin Citrate Liposome
Indication: Myelodysplastic Syndrome
Cytarabine
Other drugs received by patient: Gentamycin Sulfate; Meropenem; Piperacillin and Tazobactam; Linezolid; Vancomycin; Caspofungin Acetate
Possible Mylotarg side effects in 51 year old male
Reported by a physician from United Kingdom on 2012-02-20
Patient: 51 year old male
Reactions: Venoocclusive Disease, Aspartate Aminotransferase Increased
Adverse event resulted in: death
Drug(s) suspected as cause:
Daunorubicin Citrate Liposome
Dosage: unk
Indication: Acute Myeloid Leukaemia
Start date: 2011-09-23
End date: 2011-10-03
Daunorubicin Citrate Liposome
Indication: Myelodysplastic Syndrome
Cytarabine
Mylotarg
Other drugs received by patient: Piperacillin and Tazobactam; Meropenem; Vancomycin; Gentamycin Sulfate; Caspofungin; Linezolid
Possible Mylotarg side effects in 60 year old female
Reported by a physician from United States on 2012-02-07
Patient: 60 year old female, weighing 75.0 kg (165.0 pounds)
Reactions: Acute Myeloid Leukaemia, Sepsis, Febrile Neutropenia, Pyrexia, Disease Progression
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Vidaza
Dosage: 75 mg/m2, sc or iv on days 1-7
Indication: Acute Myeloid Leukaemia
Start date: 2011-09-03
Mylotarg
Dosage: 3 mg/m2, on days 4 and 8
Indication: Acute Myeloid Leukaemia
Start date: 2011-09-07
End date: 2011-09-07
Zolinza
Dosage: 400 mg, on days 1-9
Administration route: Oral
Indication: Acute Myeloid Leukaemia
Start date: 2011-09-03
Other drugs received by patient: Acyclovir; Insulin; Oxycodone; Omeprazole; Meperidine HCL; Allopurinol; Aluminium Hydroxide / Diphenhydramine / Magnesium Hydroxide / Lidocaine; Acetaminophen; Chlorhexidine Gluconate; Albuterol; Loratadine; Ondansetron; Diphenhydramine; Lorazepam; Metoclopramide; Prochlorperazine
Possible Mylotarg side effects in male
Reported by a consumer/non-health professional from United Kingdom on 2012-01-25
Patient: male, weighing 105.0 kg (231.0 pounds)
Reactions: Rash Generalised, Pyrexia
Drug(s) suspected as cause:
Daunorubicin HCL
Dosage: 110 mg, od
Start date: 2007-07-16
End date: 2007-07-20
Daunorubicin HCL
Dosage: 110 mg, od
Start date: 2007-08-29
End date: 2007-08-31
Mylotarg
Dosage: 6.6 mg, once
Indication: Acute Myeloid Leukaemia
Start date: 2007-06-06
End date: 2007-06-06
Evoltra
Dosage: 44 mg, od
Start date: 2007-07-16
End date: 2007-07-20
Daunorubicin HCL
Dosage: 110 mg, od
Indication: Acute Myeloid Leukaemia
Start date: 2007-06-06
End date: 2007-06-10
Evoltra
Dosage: 44 mg, od
Indication: Acute Myeloid Leukaemia
Start date: 2007-06-06
End date: 2007-06-10
Possible Mylotarg side effects in 55 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-01-17
Patient: 55 year old female
Reactions: Bacteraemia
Drug(s) suspected as cause:
Mylotarg
Dosage: 3 mg/m2, on days 1, 4 and 7
Indication: Acute Myeloid Leukaemia
Daunorubicin HCL
Dosage: 60 mg/m2, for 3 days
Indication: Acute Myeloid Leukaemia
Cytarabine
Dosage: 200 mg/m2, for 7 days
Indication: Acute Myeloid Leukaemia
Possible Mylotarg side effects in 49 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-01-13
Patient: 49 year old female
Reactions: Pyrexia
Drug(s) suspected as cause:
Mylotarg
Dosage: 3 mg/m2, on days 1, 4 and 7
Indication: Acute Myeloid Leukaemia
Cytarabine
Dosage: 200 mg/m2, for 7 days
Indication: Acute Myeloid Leukaemia
Daunorubicin HCL
Dosage: 60 mg/m2, for 3 days
Indication: Acute Myeloid Leukaemia
Possible Mylotarg side effects in 59 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-01-13
Patient: 59 year old female
Reactions: Pyrexia
Drug(s) suspected as cause:
Daunorubicin HCL
Dosage: 60 mg/m2, for 3 days
Indication: Acute Myeloid Leukaemia
Mylotarg
Dosage: 3 mg/m2, on days 1, 4 and 7
Indication: Acute Myeloid Leukaemia
Cytarabine
Dosage: 100 mg/m2, for 7 days
Indication: Acute Myeloid Leukaemia
Possible Mylotarg side effects in 60 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-01-13
Patient: 60 year old male
Reactions: Hepatotoxicity, Bacteraemia
Drug(s) suspected as cause:
Mylotarg
Dosage: 3mg/m2 on day 1, 4, and 7
Indication: Acute Myeloid Leukaemia
Daunorubicin HCL
Dosage: 60 mg/m2 for 3 days
Indication: Acute Myeloid Leukaemia
Cytarabine
Dosage: 200 mg/m2 for 7 days
Indication: Acute Myeloid Leukaemia
Possible Mylotarg side effects in 55 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-01-13
Patient: 55 year old male
Reactions: Bacteraemia
Drug(s) suspected as cause:
Daunorubicin HCL
Dosage: 60 mg/m2 for 3 days
Indication: Acute Myeloid Leukaemia
Mylotarg
Dosage: 3 mg/m2 on days 1, 4, and 7
Indication: Acute Myeloid Leukaemia
Cytarabine
Dosage: 100 mg/m2 for 7 days
Indication: Acute Myeloid Leukaemia
Possible Mylotarg side effects in 61 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-01-13
Patient: 61 year old female
Reactions: Bacteraemia
Drug(s) suspected as cause:
Cytarabine
Dosage: 200 mg/m2 for 7 days
Daunorubicin HCL
Dosage: 60 mg/m2 for 3 days
Indication: Acute Myeloid Leukaemia
Mylotarg
Dosage: 3mg/m2 on day 1, 4, and 7
Indication: Acute Myeloid Leukaemia
Possible Mylotarg side effects in 64 year old
Reported by a health professional (non-physician/pharmacist) from France on 2012-01-13
Patient: 64 year old
Reactions: Bacteraemia
Drug(s) suspected as cause:
Daunorubicin HCL
Dosage: 60 mg/m2 for 3 days
Indication: Acute Myeloid Leukaemia
Cytarabine
Dosage: 200 mg/m2 for 7 days
Indication: Acute Myeloid Leukaemia
Mylotarg
Dosage: 3 mg/m2 on days 1, 4, and 7
Indication: Acute Myeloid Leukaemia
Possible Mylotarg side effects in 58 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-01-13
Patient: 58 year old female
Reactions: Bacteraemia
Drug(s) suspected as cause:
Mylotarg
Dosage: 3 mg/m2, on days 1, 4 and 7
Indication: Acute Myeloid Leukaemia
Daunorubicin HCL
Dosage: 60 mg/m2, for 3 days
Indication: Acute Myeloid Leukaemia
Cytarabine
Dosage: 200 mg/m2, for 7 days
Indication: Acute Myeloid Leukaemia
Possible Mylotarg side effects in 70 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-01-13
Patient: 70 year old female
Reactions: Device Related Infection
Drug(s) suspected as cause:
Cytarabine
Dosage: 100 mg/m2, for 7 days
Indication: Acute Myeloid Leukaemia
Daunorubicin HCL
Dosage: 45 mg/m2, for 3 days
Indication: Acute Myeloid Leukaemia
Mylotarg
Dosage: 3 mg/m2, on days 1, 4 and 7
Indication: Acute Myeloid Leukaemia
Possible Mylotarg side effects in 60 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-01-13
Patient: 60 year old male
Reactions: Hepatotoxicity, Bacteraemia
Drug(s) suspected as cause:
Cytarabine
Dosage: 100 mg/m2 for 7 days
Indication: Acute Myeloid Leukaemia
Mylotarg
Dosage: 3 mg/m2 days 1, 4, and 7
Indication: Acute Myeloid Leukaemia
Daunorubicin HCL
Dosage: 60 mg/m2 for 3 days
Indication: Acute Myeloid Leukaemia
Possible Mylotarg side effects in 69 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-01-13
Patient: 69 year old female
Reactions: Pyrexia
Drug(s) suspected as cause:
Daunorubicin HCL
Dosage: 45 mg/m2, for 3 days
Indication: Acute Myeloid Leukaemia
Cytarabine
Dosage: 100 mg/m2, for 7 days
Indication: Acute Myeloid Leukaemia
Mylotarg
Dosage: 3 mg/m2, on days 1, 4 and 7
Indication: Acute Myeloid Leukaemia
Possible Mylotarg side effects in 64 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-01-12
Patient: 64 year old female
Reactions: Pyrexia
Drug(s) suspected as cause:
Daunorubicin HCL
Dosage: 45 mg/m2, for 3 days
Indication: Acute Myeloid Leukaemia
Cytarabine
Dosage: 100 mg/m2, for 7 days
Indication: Acute Myeloid Leukaemia
Mylotarg
Dosage: 3 mg/m2, on days 1, 4, and 7
Indication: Acute Myeloid Leukaemia
Possible Mylotarg side effects in 51 year old male
Reported by a physician from United Kingdom on 2011-12-15
Patient: 51 year old male
Reactions: Urine Output Decreased, General Physical Health Deterioration, Purpura, Ascites, Multi-Organ Failure, Weight Increased, Venoocclusive Disease, Dialysis, Sepsis, Aspartate Aminotransferase Increased, Pleural Effusion, Blood Creatinine Increased
Adverse event resulted in: death
Drug(s) suspected as cause:
Daunorubicin Citrate Liposome
Dosage: unk
Indication: Acute Myeloid Leukaemia
Start date: 2011-09-23
End date: 2011-10-03
Daunorubicin Citrate Liposome
Indication: Myelodysplastic Syndrome
Mylotarg
Cytarabine
Other drugs received by patient: Piperacillin and Tazobactam; Vancomycin; Linezolid; Gentamycin Sulfate; Meropenem; Caspofungin Acetate
Possible Mylotarg side effects in 56 year old male
Reported by a physician from Japan on 2011-11-30
Patient: 56 year old male
Reactions: Haemoglobin Decreased, Brain Abscess, Sepsis, Neutropenia, Thrombocytopenia, Leukopenia
Drug(s) suspected as cause:
Cytarabine
Dosage: 100 mg/m2, unk
Indication: Acute Myeloid Leukaemia
Cytarabine
Dosage: 100 mg/m2, unk
Mylotarg
Dosage: 3 mg/m2, unk
Indication: Acute Myeloid Leukaemia
Mylotarg
Dosage: 3 mg/m2, unk
Mylotarg
Dosage: 5 mg/m2, unk
Cytarabine
Dosage: 100 mg/m2, unk
Idamycin
Dosage: 12 mg/m2, 1x/day
Idamycin
Dosage: 12 mg/m2, 1x/day
Idamycin
Dosage: 10 mg/m2, 1x/day
Indication: Acute Myeloid Leukaemia
Possible Mylotarg side effects in 46 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-11-14
Patient: 46 year old female
Reactions: Alanine Aminotransferase Increased, Platelet Count Increased
Drug(s) suspected as cause:
Ambisome
Dosage: 1000 mg, total dose
Indication: Product Used FOR Unknown Indication
Start date: 2011-08-31
End date: 2011-08-31
Daunorubicin HCL
Dosage: unk
Indication: Acute Myeloid Leukaemia
Start date: 2011-08-19
End date: 2011-08-28
Mylotarg
Dosage: 3 mg, uid/qd
Indication: Acute Myeloid Leukaemia
Start date: 2011-08-19
End date: 2011-08-28
Norethidrone
Dosage: 5 g, unknown/d
Indication: Product Used FOR Unknown Indication
Start date: 2011-08-18
Meropenem
Dosage: 1 g, unknown/d
Indication: Product Used FOR Unknown Indication
Start date: 2011-09-05
End date: 2011-09-10
Cytarabine
Dosage: unk
Indication: Acute Myeloid Leukaemia
Start date: 2011-08-19
End date: 2011-08-28
Etoposide
Dosage: unk
Indication: Acute Myeloid Leukaemia
Start date: 2011-08-19
End date: 2011-08-28
Piperacillin and Tazobactam
Dosage: 4.5 g, unknown/d
Indication: Product Used FOR Unknown Indication
Start date: 2011-08-22
End date: 2011-08-25
Vancomycin
Dosage: 1 g, unknown/d
Indication: Product Used FOR Unknown Indication
Start date: 2011-09-04
End date: 2011-09-09
Other drugs received by patient: Docusate Sodium; Ondansetron; Codeine SUL TAB; Cyclizine; Acyclovir; Tranexamic Acid; Allopurinol; Anti-D Immunoglobulin; Oramorph SR; Ranitidine; Omeprazole; Acetaminophen
Possible Mylotarg side effects in 67 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-11-14
Patient: 67 year old male
Reactions: Renal Tubular Disorder, Renal Impairment, Hypomagnesaemia, Hypotension, Pulmonary Embolism, Febrile Neutropenia, Hypokalaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Evoltra (Clofarabine) Solution FOR Infusion, UNK
Dosage: 45 mg, qdx5, intravenous ; 45 mg, qdx5, intravenous
Indication: Acute Myeloid Leukaemia
Start date: 2009-10-08
End date: 2009-10-12
Evoltra (Clofarabine) Solution FOR Infusion, UNK
Dosage: 45 mg, qdx5, intravenous ; 45 mg, qdx5, intravenous
Indication: Acute Myeloid Leukaemia
Start date: 2009-11-17
End date: 2009-11-21
Daunorubicin HCL
Dosage: 1 df, qod, intravenous ; 1 df, qod, intravenous
Indication: Acute Myeloid Leukaemia
Start date: 2009-11-17
End date: 2009-11-21
Daunorubicin HCL
Dosage: 1 df, qod, intravenous ; 1 df, qod, intravenous
Indication: Acute Myeloid Leukaemia
Start date: 2009-10-08
End date: 2009-10-12
Mylotarg
Dosage: 1 df, once, intravenous
Indication: Acute Myeloid Leukaemia
Start date: 2009-10-08
End date: 2009-10-08
Possible Mylotarg side effects in male
Reported by a consumer/non-health professional from United Kingdom on 2011-11-14
Patient: male
Reactions: Gamma-Glutamyltransferase Increased
Drug(s) suspected as cause:
Mylotarg
Dosage: unk
Indication: Acute Leukaemia
Start date: 2007-03-07
Evoltra
Dosage: unk
Indication: Acute Leukaemia
Start date: 2007-03-07
Daunorubicin HCL
Dosage: unk
Indication: Acute Leukaemia
Start date: 2007-03-07
Possible Mylotarg side effects in female
Reported by a physician from Japan on 2011-11-03
Patient: female
Reactions: Multi-Organ Failure, Sepsis, Venoocclusive Liver Disease, General Physical Health Deterioration
Drug(s) suspected as cause:
Mylotarg
Possible Mylotarg side effects in male
Reported by a consumer/non-health professional from United Kingdom on 2011-10-14
Patient: male
Reactions: Rash Generalised, Pyrexia
Drug(s) suspected as cause:
Mylotarg
Dosage: unk
Indication: Acute Leukaemia
Start date: 2007-06-06
Evoltra
Dosage: unk
Indication: Acute Leukaemia
Start date: 2007-06-06
Daunorubicin HCL
Dosage: unk
Indication: Acute Leukaemia
Possible Mylotarg side effects in male
Reported by a consumer/non-health professional from United Kingdom on 2011-10-14
Patient: male
Reactions: Gamma-Glutamyltransferase Increased
Drug(s) suspected as cause:
Evoltra
Dosage: unk
Indication: Acute Leukaemia
Start date: 2007-03-07
Daunorubicin HCL
Dosage: unk
Indication: Acute Leukaemia
Start date: 2007-03-07
Mylotarg
Dosage: unk
Indication: Acute Leukaemia
Start date: 2007-03-07
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