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Vidaza (Azacitidine Subcutaneous) - Side Effect Reports to FDA

 
 



Index of reports > All Cases (1313)

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

 Reports 1 - 30 of 1313   Next >>

Possible Vidaza side effects in 74 year old female

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

Patient: 74 year old female, weighing 50.0 kg (110.0 pounds)

Reactions: White Blood Cell Count Decreased, Blast Cell Count Increased, Febrile Neutropenia

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Vidaza
    Dosage: 75 milligram/sq. meter
    Indication: Myelodysplastic Syndrome
    Start date: 2011-09-07
    End date: 2011-09-12

Vidaza
    Dosage: 37.5 milligram/sq. meter
    Start date: 2011-10-21
    End date: 2011-10-25

Vidaza
    Start date: 2011-11-30
    End date: 2011-12-04

Vidaza
    Dosage: 25 milligram/sq. meter
    Start date: 2012-01-17
    End date: 2012-01-21

Other drugs received by patient: Maxipime; Pursennid; Amoban; Depas; Neutrogin; Magmitt; Levofloxacin; Losartan Potassium and Hydrochlorothiazide; Neutrogin



Possible Vidaza side effects in male

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-08-27

Patient: male, weighing 99.0 kg (217.8 pounds)

Reactions: Migraine With Aura

Drug(s) suspected as cause:
Thalidomide
    Dosage: 100 milligram
    Administration route: Oral

Vidaza
    Dosage: 165 milligram
    Start date: 2009-08-12

Vidaza
    Dosage: 165 milligram
    Start date: 2009-07-13
    End date: 2009-07-19



Possible Vidaza side effects in female

Reported by a physician from United States on 2012-08-27

Patient: female

Reactions: Myocardial Infarction

Adverse event resulted in: death

Drug(s) suspected as cause:
Revlimid
    Dosage: 50 milligram
    Administration route: Oral
    Start date: 2011-07-13
    End date: 2011-01-01

Revlimid
    Dosage: 5 milligram
    Administration route: Oral
    Start date: 2011-12-01
    End date: 2012-03-23

Revlimid
    Dosage: 10 milligram
    Administration route: Oral
    Start date: 2011-09-01
    End date: 2011-12-01

Vidaza
    End date: 2012-03-01



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 male

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

Patient: male

Reactions: Pneumonia, Stevens-Johnson Syndrome, Pneumonitis

Adverse event resulted in: death, life threatening event, hospitalization, disablity

Drug(s) suspected as cause:
Bactrim
    Indication: Pneumonia

Minocycline HCL
    Dosage: 4 tablet
    Administration route: Oral
    Start date: 2009-10-12
    End date: 2010-01-07

Thalidomide
    Administration route: Oral
    Start date: 2008-09-03
    End date: 2009-08-05

Vidaza
    Start date: 2010-02-02
    End date: 2010-02-08

Vidaza
    Dosage: 75 milligram/sq. meter
    Indication: Myelodysplastic Syndrome
    Start date: 2010-01-05
    End date: 2010-01-11

Other drugs received by patient: Whole Blood; Augmentin DUO Forte



Possible Vidaza side effects in 78 year old male

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

Patient: 78 year old male, weighing 71.0 kg (156.2 pounds)

Reactions: Febrile Neutropenia, Neutrophil Count Decreased

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Vidaza

Other drugs received by patient: Platelets; Flivas OD; Zolpidem; Levofloxacin; Meropenem; Gran; Gran; Meropenem; Fluconazole; Omeprazole; RED Blood Cells; Salagen



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 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 female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Vidaza

Other drugs received by patient: Aranesp; Granisetron; Neupogen



Possible Vidaza side effects in male

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

Patient: male

Reactions: Back Pain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2012-05-23
    End date: 2012-05-25

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2012-04-17
    End date: 2012-04-24



Possible Vidaza side effects in

Reported by a physician from United States on 2012-08-23

Patient:

Reactions: Anal Fistula, Constipation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Temozolomide
    Dosage: 200 mg/m2, q4weeks
    Administration route: Oral
    Indication: Sarcoma
    Start date: 2012-07-16
    End date: 2012-07-20

Vidaza
    Dosage: 75 mg/m2, q4weeks
    Indication: Sarcoma
    Start date: 2012-07-09
    End date: 2012-07-13

Other drugs received by patient: Magnesia [milk OF]



Possible Vidaza side effects in female

Reported by a physician from United States on 2012-08-23

Patient: female

Reactions: Cardiomyopathy

Drug(s) suspected as cause:
Sorafenib
    Dosage: 800 milligram
    Administration route: Oral
    Start date: 2011-11-11
    End date: 2012-02-06

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

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2012-01-20
    End date: 2012-01-26

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-12-08
    End date: 2011-12-14

Other drugs received by patient: Valtrex; Spironolactone; Carvedilol; Oxycodone HCL; Zofran; Cefpodoxime Proxetil; Zofran; Protonix; Metoprolol Tartrate; Xopenex; Bactrim DS; Levaquin; Ciprofloxacin; Fluconazole; Klor-CON; Xopenex; Lisinopril; Lasix; Amiodarone HCL; Aquaphor; Cancidas



Possible Vidaza side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: female, weighing 181.8 kg (400.0 pounds)

Reactions: Haemoglobin Decreased, Lung Disorder, Hypoxia

Drug(s) suspected as cause:
Azacitidine
    Dosage: 137 mg

Exjade
    Dosage: 250 mg, tid
    Administration route: Oral
    Indication: Haemochromatosis
    Start date: 2012-06-01

Vidaza
    Start date: 2011-02-01

Other drugs received by patient: Lasix; RED Blood Cells, Concentrated; Wydase; Lomotil; Metoprolol Tartrate; Tylenol; Folic Acid; Diphenhydramine HCL; Dexamethasone; Hydrocodone Bitartrate + Acetaminophen; Zoloft; Allopurinol; Amlodipine Besylate



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:
Thalidomide
    Dosage: 100 milligram
    Administration route: Oral

Vidaza
    Dosage: 50% dose reduction

Vidaza
    Dosage: 75 milligram/sq. meter

Other drugs received by patient: Cytarabine; Fludarabine Phosphate



Possible Vidaza side effects in 78 year old male

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

Patient: 78 year old male, weighing 115.0 kg (253.0 pounds)

Reactions: Pneumonia, Febrile Neutropenia, Bronchitis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Vidaza

Other drugs received by patient: Deferasirox; Amiodarone HCL; Imipra; Lenograstim; Formoterol Fumarate; Pregabalin; Fentanyl; Platelets; Bisoprolol Fumarate; Pantoprazole; Transfusion



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

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

Patient:

Reactions: Myelodysplastic Syndrome Transformation, Toxicity To Various Agents, Disease Progression

Drug(s) suspected as cause:
Vidaza



Possible Vidaza side effects in female

Reported by a physician from United States on 2012-08-22

Patient: female

Reactions: Angioedema

Drug(s) suspected as cause:
Vidaza

Other drugs received by patient: Prevacid



Possible Vidaza side effects in male

Reported by a physician from United States on 2012-08-22

Patient: male, weighing 99.8 kg (219.5 pounds)

Reactions: Abdominal Pain, Anal Fistula

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Temozolomide
    Dosage: 7.1429 milligram/sq. meter
    Administration route: Oral
    Indication: Sarcoma
    Start date: 2012-07-16
    End date: 2012-07-20

Vidaza
    Dosage: 2.6786 milligram/sq. meter
    Indication: Leiomyosarcoma Metastatic
    Start date: 2012-07-09
    End date: 2012-07-13

Other drugs received by patient: Milk OF Magnesia TAB



Possible Vidaza side effects in male

Reported by a physician from Japan on 2012-08-22

Patient: male, weighing 71.0 kg (156.2 pounds)

Reactions: Hypotension, Erythema, Arrhythmia

Drug(s) suspected as cause:
Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-04-15
    End date: 2011-04-21

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-05-13
    End date: 2011-05-18

Other drugs received by patient: Olmesartan Medoxomil



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 health professional (non-physician/pharmacist) from France on 2012-08-21

Patient: male

Reactions: Hepatic Neoplasm Malignant

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Vidaza



Possible Vidaza side effects in

Reported by a physician from Japan on 2012-08-21

Patient: , weighing 71.0 kg (156.2 pounds)

Reactions: Pneumonia, Sepsis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Vidaza
    Dosage: 25 milligram/sq. meter
    Start date: 2011-10-31
    End date: 2011-11-04

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-09-12
    End date: 2011-09-16

Other drugs received by patient: Meropenem; Doripenem Monohydrate; Zoloft; Purnoside; Platelets; Serotone; Raden; Meilax; Belmaton; Funguard; Bezatol SR; Firstcin; RED Blood Cells; Magmitt; Ledolper



Possible Vidaza side effects in male

Reported by a physician from Japan on 2012-08-21

Patient: male, weighing 57.0 kg (125.4 pounds)

Reactions: Blast Cell Count Increased, Sepsis, Anaemia, Platelet Count Decreased, Neutrophil Count Decreased

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Vidaza
    Dosage: 75 milligram/sq. meter
    Indication: Myelodysplastic Syndrome
    Start date: 2011-05-16
    End date: 2011-05-22

Vidaza
    Dosage: 25 milligram/sq. meter
    Start date: 2011-08-25
    End date: 2011-08-29

Vidaza
    Dosage: 25 milligram/sq. meter
    Start date: 2011-07-05
    End date: 2011-07-09

Other drugs received by patient: Olmesartan Medoxomil; Lasix; Firstcin; Belmaton; Whole Blood; Firstcin; Serotone; Calblock; Famotidine; Fosmicin-S; Funguard; Cytarabine; Serotone; Serotone; Acrasin; Urinorm; Omegacin



Possible Vidaza side effects in male

Reported by a physician from United States on 2012-08-20

Patient: male

Reactions: Electrocardiogram QT Prolonged, Atrial Fibrillation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Sorafenib
    Dosage: 400 milligram
    Administration route: Oral
    Start date: 2012-06-15
    End date: 2012-06-21

Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2012-06-15
    End date: 2012-06-21

Other drugs received by patient: Hydrocortisone; Hydrocortisone SOD Succ; Magnesium Sulfate; Ondansetron Hydrochloride; Prednisone TAB; Sennosides-Docusate Sodium; Sodium Chloride; Tramadol HCL; Diphenoxylate HCL W / Atropine Sulfate; Coreg; Sodium Chloride; Sodium Chloride; Aminocaproic Acid; Coreg; Acetaminophen; Fluconazole; Isosorbide Mononitrate; Levofloxacin; Loratadine; Piperacillin and Tazobactam; Valacyclovir Hydrochloride; Hydralazine HCL; Temazepam; Calcium Carbonate; Carvedilol; Guaifenesin and Dextromethorphan HBR; Magnesium Oxide MG Supplement; Multiple Vitamin; Oyster Shell Calcium; Amiodarone HCL; Atorvastatin Calcium; Nifedipine; Alum + MAG Hydrox-Simethicone; Pantoprazole Sodium; Triamcinolone Acetonide; Bismuth; Chlorhexidine Gluconate; Finasteride; Sennosides-Docusate Sodium; Sodium Chloride; Valacyclovir Hydrochloride



Possible Vidaza side effects in 77 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-20

Patient: 77 year old female, weighing 42.0 kg (92.4 pounds)

Reactions: Haemoglobin Decreased, White Blood Cell Count Decreased, Pneumonia, RED Blood Cell Count Decreased, Platelet Count Decreased, Neutrophil Count Decreased

Adverse event resulted in: death

Drug(s) suspected as cause:
Vidaza
    Dosage: 75 milligram/sq. meter
    Start date: 2011-07-28
    End date: 2011-08-03

Vidaza
    Dosage: 25 milligram/sq. meter
    Start date: 2012-06-12
    End date: 2012-06-18

Vidaza
    Dosage: 25 milligram/sq. meter
    Start date: 2012-02-20
    End date: 2012-02-26

Vidaza
    Dosage: 25 milligram/sq. meter
    Start date: 2011-12-17
    End date: 2011-12-23

Vidaza
    Dosage: 25 milligram/sq. meter
    Start date: 2011-11-03
    End date: 2011-11-09

Other drugs received by patient: Itraconazole; Olopatadine HCL; Bactrim; Gascon; Morphine Hydrochloride Hydrate; Ticlopidine HCL; Gasmotin; Maglax; Aspirin; Gasmotin; Vfend; Hanp; Vfend; Lansoprazole; Polymyxin B Sulfate; Vfend; Serotone; Firstcin; Levofloxacin; Serotone



Possible Vidaza side effects in

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-20

Patient:

Reactions: Pneumonia, Gastrointestinal Disorder, Sepsis, Cardiac Disorder

Adverse event resulted in: death

Drug(s) suspected as cause:
Vidaza



Possible Vidaza side effects in male

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

Patient: male

Reactions: Abdominal Pain, Atrial Flutter, Diarrhoea, Febrile Neutropenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Everolimus
    Dosage: 10 milligram
    Start date: 2010-12-24

Everolimus
    Dosage: 2.5 milligram

Vidaza
    Dosage: 158 milligram
    Start date: 2012-07-30
    End date: 2012-08-02

Vidaza
    Dosage: 165 milligram
    Start date: 2010-12-20



Possible Vidaza side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-20

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Vidaza

Other drugs received by patient: Ondansetron



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



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