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Vidaza (Azacitidine Subcutaneous) - Acute Myeloid Leukaemia - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Acute Myeloid Leukaemia (135)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Vidaza (Azacitidine Subcutaneous) where reactions include acute myeloid leukaemia. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 135   Next >>

Possible Vidaza side effects in 72 year old male

Reported by a physician from Japan on 2012-08-27

Patient: 72 year old male, weighing 61.0 kg (134.2 pounds)

Reactions: Acute Myeloid Leukaemia

Adverse event resulted in: death

Drug(s) suspected as cause:
Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-07-11
    End date: 2011-07-17

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-08-08
    End date: 2011-08-14

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-09-20
    End date: 2011-09-26

Other drugs received by patient: Almarl; Kytril; Alinamin-F; Fluconazole; Armodafinil; Norvasc; Ciprofloxacin HCL; Dexamethasone Sodium Phosphate; Neophagen; Mohrus Tape L; Dexamethasone Sodium Phosphate; Cifroquinon; Amlodipine; Heparin NA Lock; Neophagen; Norvasc; Kytril; Neophagen



Possible Vidaza side effects in 36 year old male

Reported by a physician from United States on 2012-08-24

Patient: 36 year old male

Reactions: Pneumonia, Acute Myeloid Leukaemia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Midostaurin
    Dosage: 50 milligram
    Administration route: Oral
    Start date: 2012-02-21
    End date: 2012-02-22

Vidaza
    Dosage: 142 milligram
    Start date: 2012-02-14
    End date: 2012-02-20

Other drugs received by patient: Valtrex; Tessalon; Entocort EC; Voriconazole; Hydrea; Ativan; Phenergan HCL; Hydrocodone Bitartrate; Prograf; Claritin; Nexium; Metroprolot Tartrate; Ambien; Magnesium Oxide; Lisinopril; Dilaudid; Zofran; Magnesium Sulfate



Possible Vidaza side effects in

Reported by a physician from Switzerland on 2012-08-23

Patient:

Reactions: Death, Acute Myeloid Leukaemia

Adverse event resulted in: death

Drug(s) suspected as cause:
Vidaza



Possible Vidaza side effects in female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-22

Patient: female, weighing 66.3 kg (145.9 pounds)

Reactions: Weight Decreased, Vomiting, Gout, Nausea, Acute Myeloid Leukaemia, NO Therapeutic Response, Cerebral Haemorrhage

Adverse event resulted in: death, hospitalization, disablity

Drug(s) suspected as cause:
Vidaza
    Dosage: 130 milligram
    Start date: 2012-02-13
    End date: 2012-02-17

Vidaza
    Dosage: 130 milligram
    Indication: Myelodysplastic Syndrome
    Start date: 2012-01-16
    End date: 2012-01-24

Other drugs received by patient: Allopurinol; Tranexamic Acid; Domperidone; Granisetron



Possible Vidaza side effects in male

Reported by a physician from Switzerland on 2012-08-20

Patient: male

Reactions: Acute Myeloid Leukaemia

Adverse event resulted in: death

Drug(s) suspected as cause:
Vidaza



Possible Vidaza side effects in male

Reported by a physician from France on 2012-08-17

Patient: male, weighing 80.0 kg (176.0 pounds)

Reactions: Rash Generalised, Acute Myeloid Leukaemia, Febrile Bone Marrow Aplasia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ccnu
    Administration route: Oral
    Start date: 2012-04-18
    End date: 2012-04-18

Cytarabine
    Start date: 2012-04-18
    End date: 2012-04-24

Idarubicin HCL
    Start date: 2012-04-18
    End date: 2012-04-22

Revlimid
    Dosage: 10 milligram
    Administration route: Oral
    Start date: 2012-04-18
    End date: 2012-06-28

Vidaza
    Dosage: 1330 milligram
    Start date: 2012-04-18
    End date: 2012-04-24

Other drugs received by patient: Rocephin; Amikacin; Bisoprolol Fumarate



Possible Vidaza side effects in

Reported by a physician from Italy on 2012-08-17

Patient:

Reactions: Pneumonia, Acute Myeloid Leukaemia, Anaemia, Recurrent Cancer, Constipation, Injection Site Erythema, Sepsis, Neutropenia, Thrombocytopenia, Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Vidaza
    Dosage: 100 milligram
    Start date: 2005-10-01
    End date: 2011-08-01

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2005-10-01
    End date: 2011-08-01



Possible Vidaza side effects in 82 year old male

Reported by a physician from Germany on 2012-08-14

Patient: 82 year old male, weighing 70.0 kg (154.0 pounds)

Reactions: Acute Myeloid Leukaemia

Adverse event resulted in: death

Drug(s) suspected as cause:
Vidaza

Other drugs received by patient: Platelets



Possible Vidaza side effects in

Reported by a individual with unspecified qualification from Austria on 2012-08-13

Patient:

Reactions: Lung Infection, Myocardial Ischaemia, Pyrexia, Device Related Infection, Neoplasm, Cardiac Disorder, Upper Respiratory Tract Infection, Fracture, Herpes Simplex, Metabolic Disorder, Blood Pressure Abnormal, Anaemia, Gastrointestinal Disorder, NO Therapeutic Response, Nervous System Disorder, Neutropenia, Abscess, Haemorrhage, Pain, Left Ventricular Failure, Constipation, Liver Disorder, Disease Progression, Death, Fatigue, Injection Site Reaction, Thrombocytopenia, Renal Disorder, Vomiting, Nausea, Urinary Tract Infection, Acute Myeloid Leukaemia, Febrile Neutropenia, Arrhythmia, Gastrointestinal Infection, Embolism, Diarrhoea, Sepsis, Cytomegalovirus Infection, Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Vidaza
    Start date: 2007-02-01
    End date: 2012-02-01

Vidaza
    Start date: 2007-02-01
    End date: 2011-07-01

Other drugs received by patient: Erythropoiesis Stimulating Agents; Integrative Cancer Treatment; Neupogen



Possible Vidaza side effects in female

Reported by a physician from France on 2012-08-10

Patient: female, weighing 87.0 kg (191.4 pounds)

Reactions: Acute Myeloid Leukaemia, Pyrexia, Treatment Failure, Thrombocytopenia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Vidaza

Vidaza
    Dosage: 100 milligram
    Start date: 2012-01-10
    End date: 2012-01-18

Vidaza
    Dosage: 140 milligram
    Indication: Acute Myeloid Leukaemia
    Start date: 2011-10-10
    End date: 2011-10-20

Other drugs received by patient: Rocephin; Rocephin; Theophylline



Possible Vidaza side effects in male

Reported by a physician from Poland on 2012-08-09

Patient: male

Reactions: Acute Myeloid Leukaemia, Malignant Melanoma, Infection

Drug(s) suspected as cause:
Vidaza



Possible Vidaza side effects in female

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

Patient: female, weighing 66.3 kg (145.9 pounds)

Reactions: Weight Decreased, Vomiting, Gout, Nausea, Acute Myeloid Leukaemia, NO Therapeutic Response, Subdural Haemorrhage

Adverse event resulted in: death, hospitalization, disablity

Drug(s) suspected as cause:
Vidaza
    Dosage: 130 milligram
    Indication: Myelodysplastic Syndrome
    Start date: 2012-01-16
    End date: 2012-01-24

Vidaza
    Dosage: 130 milligram
    Start date: 2012-02-13
    End date: 2012-02-17

Other drugs received by patient: Tranexamic Acid; Domperidone; Granisetron; Allopurinol



Possible Vidaza side effects in 71 year old male

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-07

Patient: 71 year old male, weighing 71.9 kg (158.2 pounds)

Reactions: Gingival Bleeding, Nausea, Mouth Haemorrhage, Acute Myeloid Leukaemia, General Physical Health Deterioration, Haemoglobin Decreased, Fatigue, Sepsis, Platelet Count Decreased, Blood Creatinine Increased, Renal Failure Acute

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Vidaza

Other drugs received by patient: RED Blood Cells



Possible Vidaza side effects in 78 year old female

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-07

Patient: 78 year old female, weighing 60.6 kg (133.3 pounds)

Reactions: Hepatic Enzyme Abnormal, Vomiting, Nausea, Acute Myeloid Leukaemia, Anaemia, Skin Disorder, Pyrexia, Constipation, Fatigue, White Blood Cell Disorder, Thrombocytopenia, Granulocytes Abnormal

Adverse event resulted in: death

Drug(s) suspected as cause:
Vidaza
    Start date: 2011-04-09
    End date: 2011-04-15

Vidaza
    Start date: 2011-05-09
    End date: 2011-11-20



Possible Vidaza side effects in 72 year old male

Reported by a physician from Japan on 2012-08-06

Patient: 72 year old male

Reactions: Acute Myeloid Leukaemia

Adverse event resulted in: death

Drug(s) suspected as cause:
Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-09-20
    End date: 2011-09-26

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-07-11
    End date: 2011-07-17

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-08-08
    End date: 2011-08-14

Other drugs received by patient: Ciprofloxacin HCL; Dexamethasone Sodium Phosphate; Alinamin-F; Cifroquinon; Dexamethasone Sodium Phosphate; Neophagen; Neophagen; Norvasc; Norvasc; Fluconazole; Amlodipine; Kytril; Armodafinil; Heparin NA Lock; Almarl; Neophagen; Kytril; Mohrus Tape L



Possible Vidaza side effects in 81 year old female

Reported by a physician from United States on 2012-07-30

Patient: 81 year old female, weighing 95.7 kg (210.5 pounds)

Reactions: Bacteraemia, Lung Infection, Acute Myeloid Leukaemia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Gemtuzumab
    Dosage: 3 milligram/sq. meter
    Start date: 2012-01-18
    End date: 2012-01-25

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2012-01-18
    End date: 2012-01-24

Other drugs received by patient: Hydroxyurea; Lorazepam; Losartan Potassium; Ondansetron Hydrochloride; Hydromorphone Hydrochloride; Lorazepam; Coreg; Albuterol Sulfate Autohaler



Possible Vidaza side effects in male

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

Patient: male, weighing 97.5 kg (214.5 pounds)

Reactions: Acute Myeloid Leukaemia, Neutropenic Sepsis

Adverse event resulted in: death

Drug(s) suspected as cause:
Vidaza

Other drugs received by patient: Simvastatin; Acyclovir; Diazepam



Possible Vidaza side effects in 45 year old male

Reported by a physician from Japan on 2012-07-23

Patient: 45 year old male, weighing 52.0 kg (114.4 pounds)

Reactions: Subarachnoid Haemorrhage, Acute Myeloid Leukaemia, Febrile Neutropenia

Adverse event resulted in: death

Drug(s) suspected as cause:
Vidaza
    Dosage: 100 milligram
    Start date: 2011-06-21
    End date: 2011-06-27

Vidaza
    Dosage: 100 milligram
    Start date: 2011-07-25
    End date: 2011-07-31

Vidaza
    Dosage: 100 milligram
    Indication: Acute Myeloid Leukaemia
    Start date: 2011-04-25
    End date: 2011-05-01

Vidaza
    Dosage: 100 milligram
    Start date: 2011-08-22
    End date: 2011-08-25

Vidaza
    Dosage: 100 milligram
    Start date: 2011-05-23
    End date: 2011-05-29

Other drugs received by patient: Maxipime; Maxipime; Mercaptopurine; Levofloxacin; Maxipime; Antibiotics; Sulfamethoxazole and Trimethoprim; Fluconazole; Novantrone; Meropenem; Hydrea; Valtrex; Mercaptopurine; Antibiotics



Possible Vidaza side effects in female

Reported by a physician from United States on 2012-07-16

Patient: female

Reactions: Sepsis, Acute Myeloid Leukaemia

Adverse event resulted in: death

Drug(s) suspected as cause:
Revlimid
    Dosage: 50 milligram
    Administration route: Oral
    Start date: 2012-06-01
    End date: 2012-06-21

Vidaza
    Dosage: 154 milligram
    Start date: 2012-05-25
    End date: 2012-05-31

Other drugs received by patient: Platelets; Ducosate; Miralax; Lasix; Allopurinol; Potassium Chloride; Vitamin B-12; Vitamin D; Insulin; NS Bolus; Vancomycin; Bisacodyl; Dexamethasone; Filgrastim; Glutose; Senna-Mint WAF; Insulin; Insulin; Magnesium Hydroxide TAB; Zosyn; Activase; Metoclopramide; Acetaminophen; Compazine; Insulin Lispro; Triple MIX; Anusol; Cefepime; RED Blood Cells; Reglan; Magnesium Citrate; Insulin Lispro; Dextrose; Pantoprazole; Calcium; Ondansetron HCL; Morphine



Possible Vidaza side effects in female

Reported by a health professional (non-physician/pharmacist) from Netherlands on 2012-07-16

Patient: female

Reactions: Pulmonary Sepsis, Acute Myeloid Leukaemia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Revlimid
    Administration route: Oral
    Indication: Acute Myeloid Leukaemia

Vidaza

Other drugs received by patient: Hydrea



Possible Vidaza side effects in

Reported by a individual with unspecified qualification from Austria on 2012-07-06

Patient:

Reactions: Myocardial Ischaemia, Lung Infection, Pyrexia, Device Related Infection, Neoplasm, Cardiac Disorder, Herpes Simplex, Fracture, Upper Respiratory Tract Infection, Metabolic Disorder, Blood Pressure Abnormal, Anaemia, Gastrointestinal Disorder, NO Therapeutic Response, Nervous System Disorder, Abscess, Neutropenia, Haemorrhage, Pain, Constipation, Left Ventricular Failure, Disease Progression, Liver Disorder, Death, Fatigue, Injection Site Reaction, Thrombocytopenia, Renal Disorder, Vomiting, Nausea, Acute Myeloid Leukaemia, Urinary Tract Infection, Febrile Neutropenia, Arrhythmia, Gastrointestinal Infection, Embolism, Diarrhoea, Sepsis, Cytomegalovirus Infection, Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Vidaza
    Start date: 2007-02-01
    End date: 2012-02-01

Vidaza
    Start date: 2007-02-01
    End date: 2011-07-01

Other drugs received by patient: Neupogen; Erythropoiesis Stimulating Agents; Integrative Cancer Treatment



Possible Vidaza side effects in 70 year old male

Reported by a physician from Israel on 2012-07-05

Patient: 70 year old male

Reactions: Acute Myeloid Leukaemia, General Physical Health Deterioration, Myelodysplastic Syndrome Transformation

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Vidaza



Possible Vidaza side effects in female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-05

Patient: female, weighing 66.3 kg (145.9 pounds)

Reactions: Weight Decreased, Vomiting, Gout, Nausea, Acute Myeloid Leukaemia, Myelodysplastic Syndrome Transformation, Subdural Haemorrhage, NO Therapeutic Response

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Vidaza
    Dosage: 130 milligram
    Indication: Myelodysplastic Syndrome
    Start date: 2012-01-16
    End date: 2012-01-24

Vidaza
    Dosage: 130 milligram
    Start date: 2012-02-13
    End date: 2012-02-17

Other drugs received by patient: Domperidone; Allopurinol; Granisetron; Tranexamic Acid



Possible Vidaza side effects in

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

Patient:

Reactions: Death, Acute Graft Versus Host Disease, Graft Versus Host Disease, Acute Myeloid Leukaemia, NO Therapeutic Response, Myelodysplastic Syndrome

Adverse event resulted in: death

Drug(s) suspected as cause:
Vidaza

Vidaza



Possible Vidaza side effects in female

Reported by a physician from Philippines on 2012-07-02

Patient: female, weighing 56.0 kg (123.2 pounds)

Reactions: Acute Myeloid Leukaemia, Leukaemia Plasmacytic

Adverse event resulted in: death

Drug(s) suspected as cause:
Revlimid
    Dosage: 15 milligram
    Administration route: Oral
    End date: 2012-03-01

Vidaza
    Dosage: 100 milligram
    Start date: 2012-01-01
    End date: 2012-01-01



Possible Vidaza side effects in 75 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-06-27

Patient: 75 year old female, weighing 38.0 kg (83.6 pounds)

Reactions: Pruritus, C-Reactive Protein Increased, Haemorrhoids, Acute Myeloid Leukaemia, Blood Lactate Dehydrogenase Increased, Hypokalaemia, Haemorrhage Subcutaneous

Adverse event resulted in: death, life threatening event

Drug(s) suspected as cause:
Vidaza
    Dosage: 25 milligram/sq. meter
    Start date: 2011-06-15
    End date: 2011-06-22

Vidaza
    Dosage: 25 milligram/sq. meter
    Start date: 2011-05-16
    End date: 2011-05-24

Vidaza
    Dosage: 25 milligram/sq. meter
    Start date: 2011-07-27
    End date: 2011-08-03

Vidaza
    Dosage: 25 milligram/sq. meter
    Start date: 2011-08-25
    End date: 2011-09-02

Vidaza
    Dosage: 75 milligram/sq. meter
    Indication: Myelodysplastic Syndrome
    Start date: 2011-03-23
    End date: 2011-03-31

Other drugs received by patient: Gasmotin; TPN Electrolytes IN Plastic Container; Morphine Hydrochloride Hydrate; Bactrim; Serotone; Oxycodone Hydrochloride; Acetaminophen; Prednisolone; Imipenem and Cilastatin Sodium; Methylprednisolone Sodium Succinate; Famotidine; Hochuekkito (Chinese Herbal Extract); Itraconazole; Gastrom; Magmitt; Exjade; Neriproct; Meropenem; Lendormin; Kytril; Funguard



Possible Vidaza side effects in female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-06-25

Patient: female

Reactions: Death, Neuropathy Peripheral, Acute Myeloid Leukaemia, Myelodysplastic Syndrome Transformation

Adverse event resulted in: death, disablity

Drug(s) suspected as cause:
Vidaza



Possible Vidaza side effects in 81 year old female

Reported by a physician from United States on 2012-06-12

Patient: 81 year old female, weighing 95.7 kg (210.5 pounds)

Reactions: Bacteraemia, Lung Infection, Acute Myeloid Leukaemia

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Gemtuzumab
    Dosage: 3 milligram/sq. meter
    Start date: 2012-01-18
    End date: 2012-01-25

Hydroxyurea
    Administration route: Oral
    End date: 2012-01-18

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2012-01-18
    End date: 2012-01-24

Other drugs received by patient: Losartan; Coreg



Possible Vidaza side effects in male

Reported by a physician from Taiwan, Province of China on 2012-06-12

Patient: male, weighing 69.8 kg (153.6 pounds)

Reactions: Multi-Organ Failure, Acute Myeloid Leukaemia, Myelodysplastic Syndrome Transformation, Septic Shock, Leukocytosis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Vidaza
    Start date: 2011-05-25
    End date: 2011-08-30

Vidaza
    Start date: 2011-09-27
    End date: 2012-02-07



Possible Vidaza 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:
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

Zolinza
    Dosage: 400 milligram
    Administration route: Oral
    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



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