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Mylotarg (Gemtuzumab Ozogamicin) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Mylotarg (Gemtuzumab Ozogamicin) 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 (76)
Death (24)
Life Threatening Events (13)
Disability (1)

Reports by Reaction Type

Sepsis (17)Pyrexia (15)Febrile Neutropenia (15)Multi-Organ Failure (12)Pneumonitis (9)Atrial Fibrillation (7)Pancytopenia (7)Bacteraemia (7)Pleural Effusion (6)White Blood Cell Count Decreased (6)Neutropenic Sepsis (6)Cardiac Failure (6)

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

Possible Mylotarg side effects in 66 year old male

Reported by a physician from United Kingdom on 2012-08-17

Patient: 66 year old male, weighing 60.0 kg (132.0 pounds)

Reactions: Multi-Organ Failure, Neutropenic Sepsis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Cytarabine
    Dosage: unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2007-09-20
    End date: 2007-09-22

Daunorubicin HCL
    Dosage: unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2007-09-20
    End date: 2007-09-22

Mylotarg
    Dosage: 5.3 mg (total dose)
    Indication: Acute Myeloid Leukaemia
    Start date: 2007-09-20
    End date: 2007-09-22



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 66 year old male

Reported by a physician from United Kingdom on 2012-06-29

Patient: 66 year old male, weighing 60.0 kg (132.0 pounds)

Reactions: Multi-Organ Failure, Neutropenic Sepsis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Cytarabine
    Dosage: unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2007-09-20
    End date: 2007-09-22

Mylotarg
    Dosage: unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2007-09-20
    End date: 2007-09-22

Daunorubicin HCL
    Dosage: unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2007-09-20
    End date: 2007-09-22



Possible Mylotarg side effects in 66 year old male

Reported by a physician from United Kingdom on 2012-06-18

Patient: 66 year old male

Reactions: Multi-Organ Failure, Neutropenic Sepsis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Mylotarg
    Dosage: unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2007-09-20
    End date: 2007-09-22

Cytarabine
    Dosage: unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2007-09-20
    End date: 2007-09-22

Daunorubicin HCL
    Dosage: unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2007-09-20
    End date: 2007-09-22



Possible Mylotarg side effects in 56 year old female

Reported by a physician from United States on 2012-06-11

Patient: 56 year old female, weighing 60.9 kg (133.9 pounds)

Reactions: Acute Myeloid Leukaemia, Supraventricular Tachycardia, Pneumothorax, Pyrexia, Pneumonitis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Zolinza
    Dosage: 400 milligram
    Administration route: Oral
    Start date: 2011-11-07
    End date: 2011-11-13

Mylotarg
    Dosage: 3 milligram/sq. meter
    Start date: 2011-11-10
    End date: 2011-11-10

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-11-07
    End date: 2011-11-13

Other drugs received by patient: Metoprolol Tartrate; Oxycodone HCL; Docusate; Ipratropium Bromide; Metoclopramide; Vitamin D; Lanolin; Benadryl; Benadryl; Senna-Mint WAF; Fluconazole; Levofloxacin; Omeprazole; Aluminum-Magnesium-Simethicone; Prochlorperazine; Zofran; Acyclovir; Ascorbic Acid; Hypromellose; Loperamide; Lorazepam; Magnesium Hydroxide TAB; Dalteparin Sodium; Acetaminophen; Lorazepam; Magnesium Citrate; Multi-Vitamins; Miralax; Albuterol; Chlorhexidine Gluconate; Prednisone TAB; Morphine; Eucerin



Possible Mylotarg side effects in 74 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-05

Patient: 74 year old male

Reactions: Diarrhoea, Dehydration, Pancytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
CAP Vorinostat UNK
    Dosage: 400 mg/daily/po
    Administration route: Oral
    Indication: Acute Myeloid Leukaemia
    Start date: 2011-08-19
    End date: 2011-10-24

Mylotarg
    Dosage: 3 mg/m[2]//sc, 3 mg/m[2]/iv
    Indication: Acute Myeloid Leukaemia
    Start date: 2011-08-19

Mylotarg
    Dosage: 3 mg/m[2]//sc, 3 mg/m[2]/iv
    Indication: Acute Myeloid Leukaemia
    Start date: 2011-10-25

Vidaza
    Dosage: 75 mg/m[2]/daily/sc, 75 mg/m[2]/daily/sc
    Indication: Acute Myeloid Leukaemia
    Start date: 2011-10-25

Vidaza
    Dosage: 75 mg/m[2]/daily/sc, 75 mg/m[2]/daily/sc
    Indication: Acute Myeloid Leukaemia
    Start date: 2011-08-19



Possible Mylotarg side effects in female

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

Patient: female, weighing 64.9 kg (142.8 pounds)

Reactions: White Blood Cell Count Decreased, Pneumonia, Febrile Neutropenia, Disease Progression, Cardiac Failure, Injection Site Reaction, Sepsis, Pleural Effusion, Neutrophil Count Decreased

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Zolinza
    Dosage: 400 milligram
    Administration route: Oral
    Start date: 2011-11-04
    End date: 2011-11-12

Vidaza
    Dosage: 125 milligram/sq. meter
    Start date: 2011-11-04
    End date: 2011-11-10

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-10-04
    End date: 2011-10-10

Zolinza
    Dosage: 400 milligram
    Administration route: Oral
    Start date: 2011-10-04
    End date: 2011-10-12

Mylotarg
    Dosage: 3 milligram/sq. meter
    Start date: 2011-10-04
    End date: 2011-10-11

Mylotarg
    Dosage: 5.1 milligram
    Start date: 2011-11-07
    End date: 2011-11-11

Other drugs received by patient: Levothyroxine Sodium; Diphenhydramine HCL; Lipitor; Hydrocodone



Possible Mylotarg side effects in 66 year old male

Reported by a physician from United Kingdom on 2012-06-01

Patient: 66 year old male

Reactions: Multi-Organ Failure, Neutropenic Sepsis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Cytarabine
    Dosage: unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2007-09-20
    End date: 2007-09-22

Mylotarg
    Dosage: unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2007-09-20
    End date: 2007-09-22

Daunorubicin HCL
    Dosage: unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2007-09-20
    End date: 2007-09-22



Possible Mylotarg side effects in 66 year old male

Reported by a physician from United Kingdom on 2012-05-29

Patient: 66 year old male

Reactions: Multi-Organ Failure, Neutropenic Sepsis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Mylotarg
    Dosage: unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2007-09-20
    End date: 2007-09-22

Cytarabine
    Dosage: unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2007-09-20
    End date: 2007-09-22

Daunorubicin HCL
    Dosage: unk
    Indication: Acute Myeloid Leukaemia
    Start date: 2007-09-20
    End date: 2007-09-22



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 66 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-16

Patient: 66 year old female, weighing 64.9 kg (142.8 pounds)

Reactions: White Blood Cell Count Decreased, Pneumonia, Cardiac Failure, Injection Site Reaction, Pleural Effusion, Febrile Neutropenia, Neutrophil Count Decreased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mylotarg
    Dosage: 3 milligram/sq. meter
    Start date: 2011-10-04
    End date: 2011-10-11

Zolinza
    Dosage: 400 milligram
    Administration route: Oral
    Start date: 2011-11-04
    End date: 2011-11-12

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-10-04
    End date: 2011-10-10

Mylotarg
    End date: 2011-11-11

Zolinza
    Dosage: 400 milligram
    Administration route: Oral
    Start date: 2011-10-04
    End date: 2011-10-12

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-11-04

Other drugs received by patient: Hydrocodone; Lipitor; Diphenhydramine HCL; Levothyroxine Sodium



Possible Mylotarg side effects in male

Reported by a physician from United States on 2012-04-13

Patient: male, weighing 104.6 kg (230.1 pounds)

Reactions: White Blood Cell Count Decreased, Adverse Drug Reaction, Pyrexia, Perirectal Abscess, Device Related Infection, Faeces Hard, Soft Tissue Infection, Anorectal Infection Bacterial

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vorinostat
    Dosage: 400 milligram
    Administration route: Oral
    Start date: 2012-03-02
    End date: 2012-03-10

Mylotarg
    Dosage: 3 milligram/sq. meter
    Start date: 2011-12-05
    End date: 2011-12-05

Mylotarg
    Dosage: 6.69 milligram
    Start date: 2012-03-09
    End date: 2012-03-09

Vorinostat
    Dosage: 400 milligram
    Administration route: Oral
    Start date: 2011-12-02
    End date: 2011-12-10

Vidaza
    Dosage: 167 milligram
    Start date: 2012-03-02
    End date: 2012-03-08

Mylotarg
    Dosage: 6.69 milligram
    Start date: 2012-02-10
    End date: 2012-02-10

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-12-02
    End date: 2011-12-08

Mylotarg
    Dosage: 6.75 milligram
    Start date: 2012-02-06
    End date: 2012-02-06

Mylotarg
    Dosage: 6.69 milligram
    Start date: 2012-03-05
    End date: 2012-03-05

Mylotarg
    Dosage: 3 milligram/sq. meter
    Start date: 2011-12-30
    End date: 2011-12-30

Vorinostat
    Dosage: 400 milligram
    Administration route: Oral
    Start date: 2011-12-23
    End date: 2011-12-31

Vorinostat
    Dosage: 400 milligram
    Administration route: Oral
    Start date: 2012-02-03
    End date: 2012-02-11

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-12-23
    End date: 2011-12-29

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2012-02-03
    End date: 2012-02-09

Mylotarg
    Dosage: 3 milligram/sq. meter
    Start date: 2011-12-09
    End date: 2011-12-09

Mylotarg
    Dosage: 3 milligram/sq. meter
    Start date: 2011-12-26
    End date: 2011-12-26

Other drugs received by patient: Hydrocortisone; Diphenhydramine HCL; Diphenhydramine HCL; Acetaminophen; RED Cell; Hydrocortisone; Claritin; Platelets; Ativan; Metformin HCL; Hydrocortisone; Protonix; Compazine; Hydrocortisone; Cozaar; Hydrocortisone; Diphenhydramine HCL; Diphenhydramine HCL; Acetaminophen; Acetaminophen; Prochlorperazine; Actos; Acetaminophen



Possible Mylotarg side effects in male

Reported by a consumer/non-health professional from United Kingdom on 2012-04-02

Patient: male

Reactions: Renal Impairment, Intravascular Haemolysis, Clostridium Difficile Sepsis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Evoltra
    Dosage: unk
    Indication: Acute Leukaemia
    Start date: 2009-04-25

Daunorubicin HCL
    Dosage: unk
    Indication: Acute Leukaemia
    Start date: 2009-04-25

Mylotarg
    Dosage: unk
    Indication: Acute Leukaemia
    Start date: 2009-04-25



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 male

Reported by a physician from United States on 2012-03-29

Patient: male

Reactions: Adverse Drug Reaction, Perirectal Abscess

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mylotarg
    Dosage: 6.75 milligram
    Start date: 2012-02-06
    End date: 2012-02-06

Vidaza
    Dosage: 167 milligram
    Start date: 2012-03-02
    End date: 2012-03-08

Mylotarg
    Dosage: 6.69 milligram
    Start date: 2012-03-09
    End date: 2012-03-09

Vidaza
    Dosage: 169 milligram
    Start date: 2012-02-03
    End date: 2012-02-09

Mylotarg
    Dosage: 6.75 milligram
    Start date: 2012-02-10
    End date: 2012-02-10

Vorinostat
    Dosage: 400
    Administration route: Oral
    Start date: 2012-02-03
    End date: 2012-02-11

Vorinostat
    Dosage: 400
    Administration route: Oral
    Start date: 2012-03-02
    End date: 2012-03-10

Mylotarg
    Dosage: 6.69 milligram
    Start date: 2012-03-05
    End date: 2012-03-05

Other drugs received by patient: Actos; Ativan; RED Cell; Platelets; Compazine; Claritin; Metformin HCL; Cozaar; Protonix



Possible Mylotarg side effects in male

Reported by a individual with unspecified qualification from United States on 2012-03-13

Patient: male, weighing 15.7 kg (34.5 pounds)

Reactions: Cardiac Failure

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cytarabine
    Dosage: 15510 mg

Etoposide
    Dosage: 585 mg

Mitoxantrone Hydrochloride
    Dosage: 16.4 mg

Mylotarg
    Dosage: 2 mg

Elspar
    Dosage: 4120 iu

Daunorubicin HCL
    Dosage: 100.5 mg

Other drugs received by patient: Mitoxantrone; Doxorubicin HCL; Fludarabine Phosphate; Busulfan



Possible Mylotarg side effects in 60 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-12

Patient: 60 year old female, weighing 75.1 kg (165.2 pounds)

Reactions: Sepsis, Acute Myeloid Leukaemia, Pyrexia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Zolinza
    Dosage: 400 milligram
    Administration route: Oral
    Start date: 2011-09-03

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-09-03

Mylotarg
    Dosage: 3 milligram/sq. meter
    Start date: 2011-09-07
    End date: 2011-09-07

Other drugs received by patient: Oxycodone HCL; Ondansetron; Loratadine; Allopurinol; Diphenhydramine HCL; Lorazepam; Insulin; Albuterol; Metoclopramide; Metronidazole; Vancomycin; Meropenem; Chlorhexidine Gluconate; Omeprazole; Acyclovir; Acetaminophen; Meperidine HCL; Lidocaine / Diphenhydra / AL-MG Hydrox; Prochlorperazine; Voriconazole



Possible Mylotarg side effects in 74 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-07

Patient: 74 year old male, weighing 92.0 kg (202.4 pounds)

Reactions: Multi-Organ Failure, Sepsis, Febrile Neutropenia, Atrial Fibrillation

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Mylotarg
    Dosage: 3 milligram/sq. meter
    Start date: 2011-11-22
    End date: 2011-11-22

Azacitidine
    Dosage: 160 milligram
    Start date: 2011-11-15
    End date: 2011-11-21



Possible Mylotarg side effects in 66 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-28

Patient: 66 year old female, weighing 64.9 kg (142.8 pounds)

Reactions: White Blood Cell Count Decreased, Cardiac Failure, Injection Site Reaction, Febrile Neutropenia, Pleural Effusion, Pneumonitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mylotarg
    Dosage: 3 milligram/sq. meter
    Start date: 2011-10-04
    End date: 2011-10-11

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-10-04
    End date: 2011-10-10

Zolinza
    Dosage: 400 milligram
    Administration route: Oral
    Start date: 2011-10-04
    End date: 2011-10-12

Other drugs received by patient: Levothyroxine Sodium; Lipitor; Diphenhydramine HCL; Hydrocodone



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 56 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-14

Patient: 56 year old female, weighing 60.9 kg (133.9 pounds)

Reactions: Supraventricular Tachycardia, Pneumothorax, Pyrexia, Pneumonitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zolinza
    Dosage: 400 milligram
    Administration route: Oral
    Start date: 2011-11-07
    End date: 2011-11-13

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-11-07
    End date: 2011-11-13

Mylotarg
    Dosage: 3 milligram/sq. meter
    Start date: 2011-11-10
    End date: 2011-11-10

Other drugs received by patient: Levofloxacin; Acetaminophen; Aluminum-Magnesium-Simethicone; Magnesium Hydroxide TAB; Docusate; Vitamin D; Riboflavin; Chlorhexidine Gluconate; Hypromellose; Lorazepam; Oxycodone HCL; Magnesium Citrate; Eucerin; Miralax; Morphine; Acyclovir; Albuterol; Senna; Omeprazole; Benadryl; Dalteparin Sodium; Loperamide HCL; Multi-Vitamins; Ascorbic Acid; Fluconazole; Ipratropium Bromide; Lanolin; Metoclopramide; Zofran; Benadryl; Prednisone TAB; Lorazepam; Metoclopramide; Prochlorperazine



Possible Mylotarg side effects in 74 year old male

Reported by a physician from United States on 2012-02-10

Patient: 74 year old male, weighing 92.0 kg (202.4 pounds)

Reactions: Multi-Organ Failure, Sepsis, Febrile Neutropenia, Atrial Fibrillation

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Mylotarg
    Dosage: 3 mg/m2 over 2 hours on day 8
    Indication: Acute Myeloid Leukaemia
    Start date: 2011-11-22
    End date: 2011-11-22

Azacitidine
    Dosage: 75 mg/m2 on days 1-7, 160 mg per day
    Indication: Acute Myeloid Leukaemia
    Start date: 2011-11-15
    End date: 2011-11-21



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 65 year old male

Reported by a physician from United States on 2012-01-26

Patient: 65 year old male, weighing 70.0 kg (153.9 pounds)

Reactions: Respiratory Failure, Sepsis, Febrile Neutropenia, Pneumonitis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Zolinza
    Dosage: 400 milligram
    Administration route: Oral
    Start date: 2011-08-23

Mylotarg
    Dosage: 3 milligram/sq. meter
    Start date: 2011-10-25
    End date: 2011-10-31

Zolinza
    Dosage: 400 milligram
    Administration route: Oral
    Start date: 2011-10-25
    End date: 2011-11-02

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-08-23

Mylotarg
    Dosage: 3 milligram/sq. meter
    Start date: 2011-08-23

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-10-25
    End date: 2011-10-30



Possible Mylotarg side effects in 56 year old female

Reported by a physician from United States on 2012-01-26

Patient: 56 year old female, weighing 60.8 kg (133.8 pounds)

Reactions: Supraventricular Tachycardia, Pneumothorax, Pyrexia, Pneumonitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zolinza
    Dosage: 400 mg, on days 1-9
    Administration route: Oral
    Indication: Acute Myeloid Leukaemia
    Start date: 2011-11-07
    End date: 2011-11-13

Mylotarg
    Dosage: 3 mg/m2, on days 4 and 8
    Indication: Acute Myeloid Leukaemia
    Start date: 2011-11-10
    End date: 2011-11-10

Vidaza
    Dosage: 75 mg/m2/day on days 1-7
    Indication: Acute Myeloid Leukaemia
    Start date: 2011-11-07
    End date: 2011-11-13

Other drugs received by patient: Ascorbic Acid; Lanolin; Prednisone; Morphine; Multi-Vitamins; Miralax; Ipratropium; Magnesium Hydroxide; Prochlorperazine; Eucerin; Ondansetron HCL; Loperamide; Chlorhexidine Gluconate; Dalteparin Sodium; Docusate; Metoprolol; Levofloxacin; Omeprazole; Lorazepam; Oxycodone; Senna; Benadryl; Albuterol; Acetaminophen; Vitamin D; Acyclovir; Benadryl; Fluconazole; Aluminum Phosphate Gel / Magnesium Hydroxide / Simethicone; Hypromellose; Lorazepam; Metoclopramide; Magnesium Citrate



Possible Mylotarg side effects in 66 year old female

Reported by a physician from United States on 2012-01-26

Patient: 66 year old female, weighing 64.9 kg (142.8 pounds)

Reactions: White Blood Cell Count Decreased, Cardiac Failure, Injection Site Reaction, Febrile Neutropenia, Pleural Effusion, Pneumonitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Zolinza
    Dosage: 400 mg, on days 1-9
    Administration route: Oral
    Indication: Acute Myeloid Leukaemia
    Start date: 2011-10-04
    End date: 2011-10-12

Mylotarg
    Dosage: 3 mg/m2, on days 4 and 8
    Indication: Acute Myeloid Leukaemia
    Start date: 2011-10-04
    End date: 2011-10-11

Vidaza
    Dosage: 75 mg/m2, on days 1-7
    Indication: Acute Myeloid Leukaemia
    Start date: 2011-10-04
    End date: 2011-10-10

Other drugs received by patient: Hydrocodone; Lipitor; Benadryl; Levothyroxine Sodium

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