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Vidaza (Azacitidine Subcutaneous) - Pancytopenia - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Pancytopenia (58)

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

 Reports 1 - 30 of 58   Next >>

Possible Vidaza side effects in 80 year old male

Reported by a physician from Germany on 2012-08-24

Patient: 80 year old male, weighing 75.0 kg (165.0 pounds)

Reactions: Pneumonia, Cardiac Failure, Sepsis, Pulmonary Oedema, Pancytopenia, Abscess Sweat Gland

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Vidaza
    Dosage: 145 milligram
    Start date: 2012-02-20
    End date: 2012-02-24

Vidaza
    Dosage: 145 milligram
    Start date: 2012-03-26
    End date: 2012-03-27

Vidaza
    Dosage: 145 milligram
    Start date: 2012-02-27
    End date: 2012-02-28

Vidaza
    Dosage: 145 milligram
    Start date: 2012-03-19
    End date: 2012-03-23

Other drugs received by patient: Esidrix; Flutrimazole; Ramipril; Lorazepam; Xylocaine; Prednisolone; Pantoprazole; Polyethylene Glycol; Sodium Chloride; Ondansetron; Carvedilol; Ondansetron; Torsemide



Possible Vidaza side effects in 63 year old male

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

Patient: 63 year old male

Reactions: Aortitis, Blast Crisis in Myelogenous Leukaemia, Coronary Artery Stenosis, Pancytopenia, Febrile Neutropenia, Rash, Constipation, Cardiac Failure, Joint Swelling, Disease Recurrence, Pseudomonal Sepsis, Neutropenia, Arteritis Coronary

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Vidaza
    Dosage: 50% dose reduction

Vidaza
    Dosage: 75 milligram/sq. meter

Thalidomide
    Dosage: 100 milligram
    Administration route: Oral

Other drugs received by patient: Cytarabine; Fludarabine Phosphate



Possible Vidaza side effects in 80 year old male

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

Patient: 80 year old male, weighing 75.0 kg (165.0 pounds)

Reactions: Pneumonia, Cardiac Failure, Sepsis, Pulmonary Oedema, Pancytopenia, Abscess Sweat Gland

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Vidaza
    Dosage: 145 milligram
    Start date: 2012-02-20
    End date: 2012-02-28

Vidaza
    Dosage: 145 milligram
    Start date: 2012-03-19
    End date: 2012-03-27

Other drugs received by patient: Vancomycin; Meropenem; Armodafinil; Diuretics; Nitrate; Morphine



Possible Vidaza side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-15

Patient: male, weighing 91.7 kg (201.7 pounds)

Reactions: Pneumonia, Anaemia, Pancytopenia, Febrile Neutropenia, Respiratory Failure, Muscle Abscess, Thrombocytopenia, Cardiac Arrest

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Rituxan
    Dosage: 150 milligram
    Start date: 2012-05-14

Vidaza
    Dosage: 150 milligram
    Start date: 2012-05-14

Rituxan
    Start date: 2012-06-22

Vidaza
    Dosage: 150 milligram
    Start date: 2012-07-19
    End date: 2012-07-20

Rituxan
    Start date: 2012-07-19
    End date: 2012-07-20

Rituxan
    Dosage: 17.8571 milligram
    Start date: 2012-08-04

Other drugs received by patient: Procrit; Fluticasone Propionate; Folic Acid; Hydrocortisone-Pramoxine; Metoprolol Tartrate; Rosuvastatin; Meropenem; Vancomycin; Dextrose; Acetaminophen; Calcium + Vitamin D; Ciprofloxacin-Dexamethasone Otic; Diphenhydramine Hydrochloride; Filgrastim; Multi-Vitamins; Phenylephrine Hydrochloride; Acetaminophen; Naproxen; Whole Blood; Prednisone TAB; Vitamin B-12; Acetaminophen; Benazepril Hydrochloride; Augmentin '500'; Amlodipine; Omeprazole; Sodium Chloride



Possible Vidaza side effects in 74 year old female

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

Patient: 74 year old female, weighing 68.0 kg (149.6 pounds)

Reactions: White Blood Cell Count Decreased, Death, Haemoglobin Decreased, Myelodysplastic Syndrome, Pancytopenia, General Physical Health Deterioration, Platelet Count Decreased, Asthenia, Granulocytes Abnormal

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-06-14
    End date: 2011-06-16

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-05-20

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-05-16
    End date: 2011-05-18

Other drugs received by patient: Platelets; Ciprofloxacin; Platelets; RED Blood Cells; RED Blood Cells



Possible Vidaza side effects in 59 year old female

Reported by a physician from Germany on 2012-08-07

Patient: 59 year old female, weighing 67.0 kg (147.4 pounds)

Reactions: Haemoglobin Abnormal, Myelodysplastic Syndrome, Pancytopenia, Platelet Disorder, White Blood Cell Disorder, Fatigue, Sepsis, Granulocytes Abnormal, Infection

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Vidaza

Other drugs received by patient: Neupogen; Ciprofloxacin



Possible Vidaza side effects in male

Reported by a pharmacist from Spain on 2012-07-24

Patient: male

Reactions: Haemorrhage, Pancytopenia

Drug(s) suspected as cause:
Revlimid
    Dosage: 10 milligram
    Administration route: Oral

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2012-03-27
    End date: 2012-05-30



Possible Vidaza side effects in

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-23

Patient:

Reactions: Death, Haemorrhage, Sepsis, Pancytopenia, Hepatic Failure, Treatment Failure, Polychondritis, Cerebrovascular Accident, Disease Progression

Adverse event resulted in: death

Drug(s) suspected as cause:
Vidaza



Possible Vidaza side effects in 68 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-13

Patient: 68 year old male, weighing 93.4 kg (205.6 pounds)

Reactions: Dyspnoea, Musculoskeletal Pain, Pancytopenia, Febrile Neutropenia, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vidaza

Vidaza
    Dosage: 150 milligram
    Start date: 2012-05-14

Rituxan
    Dosage: 750 milligram
    Start date: 2012-06-22

Rituxan



Possible Vidaza side effects in

Reported by a consumer/non-health professional from France on 2012-06-21

Patient:

Reactions: Death, Bone Marrow Failure, General Physical Health Deterioration, Pancytopenia

Adverse event resulted in: death

Drug(s) suspected as cause:
Vidaza



Possible Vidaza side effects in

Reported by a physician from United States on 2012-06-21

Patient:

Reactions: Respiratory Failure, Sepsis, Pancytopenia, Hypoalbuminaemia, Febrile Neutropenia, Renal Failure Acute, Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Vidaza
    Indication: Acute Myeloid Leukaemia

CAP Vorinostat UNK
    Dosage: po
    Administration route: Oral
    Indication: Acute Myeloid Leukaemia

Gemtuzumab Oxogemicin UNK
    Indication: Leukaemia



Possible Vidaza side effects in 38 year old female

Reported by a physician from Canada on 2012-06-18

Patient: 38 year old female

Reactions: Incorrect Route of Drug Administration, Mucosal Haemorrhage, Compartment Syndrome, Febrile Neutropenia, Petechiae, Pancytopenia, Purpura, Injection Site Movement Impairment, Injection Site Nodule, Epistaxis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vidaza
    Start date: 2011-12-05

Vidaza
    Start date: 2012-02-27

Vidaza
    Start date: 2011-10-10

Vidaza
    Start date: 2011-09-12

Vidaza
    Start date: 2012-01-02

Vidaza
    Start date: 2012-01-30

Vidaza
    Start date: 2012-03-26

Vidaza
    Start date: 2011-11-07

Vidaza
    Start date: 2012-04-23

Vidaza
    Start date: 2012-05-21

Other drugs received by patient: RED Blood Cells; Vorinostat



Possible Vidaza side effects in male

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-06-12

Patient: male

Reactions: Anaemia, Chronic Myelomonocytic Leukaemia, Pancytopenia, Thrombocytopenia, Neutrophil Count Decreased, Oesophageal Varices Haemorrhage, Leukopenia

Adverse event resulted in: death

Drug(s) suspected as cause:
Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2010-07-05

Vidaza
    Dosage: thrid of initial dose
    End date: 2010-11-02

Other drugs received by patient: Idroxyurea; Mercaptopurine; Mercaptopurine; Idroxyurea; RH-EPO



Possible Vidaza side effects in 65 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-11

Patient: 65 year old male

Reactions: Pancytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vidaza

Plerixafor / G-CSF
    Indication: Myelodysplastic Syndrome
    Start date: 2012-05-05



Possible Vidaza side effects in

Reported by a individual with unspecified qualification from United States on 2012-06-11

Patient:

Reactions: Respiratory Failure, Sepsis, Febrile Neutropenia, Pancytopenia, Hypoalbuminaemia, Toxicity To Various Agents, Renal Failure Acute, Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
CAP Vorinostat
    Dosage: //po
    Administration route: Oral
    Indication: Acute Myeloid Leukaemia

Gemtuzumab Ozogamicin
    Indication: Acute Myeloid Leukaemia

Vidaza
    Indication: Acute Myeloid Leukaemia



Possible Vidaza side effects in male

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

Patient: male

Reactions: Pancytopenia

Adverse event resulted in: death

Drug(s) suspected as cause:
Vidaza



Possible Vidaza 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 Vidaza side effects in male

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

Patient: male

Reactions: Pancytopenia

Adverse event resulted in: death

Drug(s) suspected as cause:
Vidaza



Possible Vidaza side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-01

Patient:

Reactions: Respiratory Failure, Sepsis, Pancytopenia, Febrile Neutropenia, Hypoalbuminaemia, Renal Failure Acute, Infection

Adverse event resulted in: death

Drug(s) suspected as cause:
Gemtuzumab Ozogamicin UNK
    Indication: Acute Myeloid Leukaemia

Vidaza
    Indication: Acute Myeloid Leukaemia

CAP Vorinostat UNK
    Dosage: po
    Administration route: Oral
    Indication: Acute Myeloid Leukaemia



Possible Vidaza side effects in 38 year old female

Reported by a physician from Canada on 2012-06-01

Patient: 38 year old female

Reactions: Incorrect Route of Drug Administration, Injection Site Movement Impairment, Haemorrhage, Compartment Syndrome, Pancytopenia, Pyrexia, Injection Site Nodule

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vidaza

Vidaza
    Start date: 2011-09-12

Other drugs received by patient: Vorinostat; Platelets; RED Blood Cells



Possible Vidaza side effects in 38 year old female

Reported by a physician from Canada on 2012-05-29

Patient: 38 year old female

Reactions: Incorrect Route of Drug Administration, Injection Site Movement Impairment, Haemorrhage, Compartment Syndrome, Pancytopenia, Pyrexia, Injection Site Nodule

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vidaza

Vidaza
    Start date: 2011-09-12

Other drugs received by patient: Platelets; Vorinostat; RED Blood Cells



Possible Vidaza side effects in

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-05-29

Patient:

Reactions: Confusional State, Device Related Infection, Pyrexia, Somnolence, Skin Reaction, Constipation, Hypokalaemia, Fatigue, Bone Marrow Failure, Dyspnoea, Pneumonia, Nausea, Febrile Neutropenia, Pancytopenia, Rash, Diarrhoea, Sepsis, Nervous System Disorder, Neutropenia, Leukocytosis, Influenza

Adverse event resulted in: death

Drug(s) suspected as cause:
Vidaza
    Dosage: 100 milligram/sq. meter

Valproic Acid
    Dosage: acheive and maintain serum level 80-110ug/ml
    Administration route: Oral



Possible Vidaza side effects in 65 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-25

Patient: 65 year old male

Reactions: Pancytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Granulocyte Colony Stimulating Factor
    Dosage: 10 mcg/kg, qd; days 1-5
    Indication: Myelodysplastic Syndrome
    Start date: 2012-05-05

Vidaza
    Dosage: 75 mg/m2, qd; days 1-5
    Indication: Myelodysplastic Syndrome
    Start date: 2012-04-30

Mozobil
    Dosage: unk; days 1-5
    Indication: Myelodysplastic Syndrome
    Start date: 2012-05-05



Possible Vidaza side effects in 72 year old female

Reported by a physician from Germany on 2012-05-23

Patient: 72 year old female, weighing 55.0 kg (121.0 pounds)

Reactions: Dysphagia, Pancytopenia, Renal Failure Chronic, Cachexia, Mucosal Inflammation, Oesophageal Candidiasis, Agranulocytosis, Oral Candidiasis, Sepsis, Dehydration, Decreased Appetite

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Vidaza
    Dosage: 130 milligram
    Start date: 2011-10-17
    End date: 2011-11-28

Vidaza

Other drugs received by patient: Dipyrone TAB; Fentanyl-100; Pantoprazole; Diflucan; Mouth Rinse; Granisetron; Levothyroxine Sodium; Exjade; Levofloxacin; Diflucan



Possible Vidaza side effects in 80 year old male

Reported by a physician from Germany on 2012-05-23

Patient: 80 year old male, weighing 75.0 kg (165.0 pounds)

Reactions: Pneumonia, Cardiac Failure, Sepsis, Pulmonary Oedema, Pancytopenia, Abscess Sweat Gland

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Vidaza
    Dosage: 145 milligram
    Start date: 2012-03-19
    End date: 2012-03-27

Vidaza
    Dosage: 145 milligram
    Start date: 2012-02-20
    End date: 2012-02-28

Other drugs received by patient: Morphine; Diuretics; Meropenem; Vancomycin; Nitrate; Diflucan



Possible Vidaza side effects in

Reported by a individual with unspecified qualification from France on 2012-05-15

Patient:

Reactions: Haemorrhage, Pancytopenia, Hepatic Failure, Cerebrovascular Accident, Disease Progression, Death, Sepsis, Polychondritis, Treatment Failure

Adverse event resulted in: death

Drug(s) suspected as cause:
Vidaza



Possible Vidaza side effects in 82 year old female

Reported by a physician from Germany on 2012-05-03

Patient: 82 year old female, weighing 45.0 kg (99.0 pounds)

Reactions: Pancytopenia, Cerebral Haemorrhage

Adverse event resulted in: death

Drug(s) suspected as cause:
Vidaza

Other drugs received by patient: Bisoprolol Fumarate



Possible Vidaza side effects in

Reported by a health professional (non-physician/pharmacist) from France on 2012-04-27

Patient:

Reactions: Fatigue, Dyspepsia, NO Therapeutic Response, Pancytopenia, Transfusion, Skin Sensitisation, Disease Progression

Drug(s) suspected as cause:
Vidaza



Possible Vidaza side effects in 38 year old female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-04-27

Patient: 38 year old female

Reactions: Incorrect Route of Drug Administration, Injection Site Movement Impairment, Compartment Syndrome, Pancytopenia, Injection Site Nodule

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vidaza

Other drugs received by patient: Vorinostat



Possible Vidaza side effects in 72 year old female

Reported by a physician from Germany on 2012-04-13

Patient: 72 year old female, weighing 55.0 kg (121.0 pounds)

Reactions: Dysphagia, Lung Infection, Pancytopenia, Renal Failure Chronic, Oesophageal Candidiasis, Cachexia, Mucosal Inflammation, Agranulocytosis, Oral Candidiasis, Dehydration, Sepsis, Decreased Appetite

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Vidaza

Vidaza
    Dosage: 130 milligram
    Start date: 2011-10-17
    End date: 2011-11-28

Other drugs received by patient: Dipyrone TAB; Diflucan; Fentanyl; Levothyroxine Sodium; Levofloxacin; Diflucan; Mouth Rinse; Exjade; Granisetron; Pantoprazole



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