This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Vidaza (Azacitidine Subcutaneous) 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 (1313)
Death (728)
Life Threatening Events (223)
Disability (29)
Reports by Reaction Type
Pneumonia (173),
Febrile Neutropenia (165),
Sepsis (163),
Death (148),
Acute Myeloid Leukaemia (135),
Thrombocytopenia (102),
Pyrexia (99),
Platelet Count Decreased (91),
Neutropenia (84),
White Blood Cell Count Decreased (75),
Neutrophil Count Decreased (74),
Anaemia (66)
Below are a few examples of reports where side effects / adverse reactions may be related to Vidaza (Azacitidine Subcutaneous). For a complete list or a specific selection of reports, please use the links above.
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 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 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 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 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
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 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 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 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 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 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
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
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