This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Dacogen (Decitabine) 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 (48)
Death (13)
Life Threatening Events (2)
Disability (1)
Reports by Reaction Type
Toxicity To Various Agents (10),
Colitis (7),
Pyrexia (6),
Febrile Neutropenia (5),
Oedema Peripheral (4),
Hypotension (4),
Mucosal Inflammation (4),
Cardiac Failure (4),
Productive Cough (3),
Lung Infection (3),
Hypokalaemia (3),
Hypocalcaemia (3)
Below are a few examples of reports where side effects / adverse reactions may be related to Dacogen (Decitabine). For a complete list or a specific selection of reports, please use the links above.
Possible Dacogen side effects in 72 year old male
Reported by a physician from Germany on 2012-08-06
Patient: 72 year old male, weighing 109.0 kg (239.8 pounds)
Reactions: Pneumonia, Febrile Neutropenia, Asthenia, Aspergillus Test Positive, Pulmonary Mycosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Bactrim
Dosage: 960 mg, 3 in 1 week, oral
Administration route: Oral
Indication: Antiviral Prophylaxis
Start date: 2012-05-04
Dacogen
Dosage: 46 mg, in 1 day, intravenous, 46 mg, in 1 day, intravenous, 40 mg, in 1 day, intravenous
Indication: Acute Myeloid Leukaemia
Start date: 2012-06-04
End date: 2012-06-08
Dacogen
Dosage: 46 mg, in 1 day, intravenous, 46 mg, in 1 day, intravenous, 40 mg, in 1 day, intravenous
Indication: Acute Myeloid Leukaemia
Start date: 2012-07-02
End date: 2012-07-06
Dacogen
Dosage: 46 mg, in 1 day, intravenous, 46 mg, in 1 day, intravenous, 40 mg, in 1 day, intravenous
Indication: Acute Myeloid Leukaemia
Start date: 2012-05-04
End date: 2012-05-09
Other drugs received by patient: Cefixime Chewable; Ramipril; Pantoprazole Sodium; Cotrim Forte (Bactrim); Ampho Moronal (Amphotericin B); Esidrix; Ciprofloxacin; Acyclovir Sodium; Vfend
Possible Dacogen side effects in
Reported by a physician from United States on 2012-07-24
Patient:
Reactions: Systemic Mastocytosis, Eosinophilia
Drug(s) suspected as cause:
Dacogen
Possible Dacogen side effects in 75 year old male
Reported by a physician from Iran (Islamic Republic OF) on 2012-07-20
Patient: 75 year old male
Reactions: Ventricular Extrasystoles, Supraventricular Extrasystoles
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Dacogen
Dosage: 20 mg/m2, 1 in 1 cyclical, intravenous, 20 mg/m2, 1 in 1 cyclical, intravenous, 1 in 1 cyclical, int
Indication: Acute Myeloid Leukaemia
Start date: 2012-06-03
Dacogen
Dosage: 20 mg/m2, 1 in 1 cyclical, intravenous, 20 mg/m2, 1 in 1 cyclical, intravenous, 1 in 1 cyclical, int
Indication: Acute Myeloid Leukaemia
Start date: 2012-05-05
Cytosar-U
Indication: Acute Myeloid Leukaemia
Idarubicin HCL
Indication: Acute Myeloid Leukaemia
Possible Dacogen side effects in 71 year old female
Reported by a physician from France on 2012-07-10
Patient: 71 year old female
Reactions: Malaise, Cardiac Failure, Pulmonary Embolism, Atrial Fibrillation, Respiratory Distress, Cardiogenic Shock
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Dacogen
Other drugs received by patient: Isoptin
Possible Dacogen side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-06
Patient:
Reactions: Bone Marrow Failure, Haematotoxicity, Infection
Drug(s) suspected as cause:
Dacogen
Possible Dacogen side effects in 60 year old female
Reported by a physician from United States on 2012-07-03
Patient: 60 year old female, weighing 62.0 kg (136.4 pounds)
Reactions: Pneumonia Fungal, Blood Alkaline Phosphatase Increased, Dyspnoea, Acute Myeloid Leukaemia, Hypotension, Lung Infection, Febrile Neutropenia, Muscular Weakness, Neoplasm Progression, Acidosis, Hypokalaemia, Dehydration, Hypoalbuminaemia, Hypoxia, Pulmonary Oedema, Asthenia, Renal Failure Acute
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Dacogen
Dosage: 20 mg/m2, intravenous
Indication: Acute Myeloid Leukaemia
Start date: 2012-02-27
End date: 2012-05-06
Bortezomib
Dosage: 1.3 mg/m2, subcutaneous
Indication: Acute Myeloid Leukaemia
Start date: 2012-02-27
End date: 2012-05-06
Possible Dacogen side effects in 75 year old male
Reported by a physician from Iran (Islamic Republic OF) on 2012-06-21
Patient: 75 year old male
Reactions: Ventricular Extrasystoles, Supraventricular Extrasystoles
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Dacogen
Dosage: 20 mg/m2, 1 in 1 cyclical, intravenous
Indication: Acute Myeloid Leukaemia
Start date: 2012-05-05
Cytosar-U
Indication: Product Used FOR Unknown Indication
Idarubicin HCL
Indication: Product Used FOR Unknown Indication
Possible Dacogen side effects in 68 year old male
Reported by a physician from China on 2012-06-12
Patient: 68 year old male
Reactions: Productive Cough, Haemoptysis, Lung Infection, Myelodysplastic Syndrome, Coronary Artery Disease, Cardiac Failure, Myocardial Infarction, Hypertension, Cough
Adverse event resulted in: death
Drug(s) suspected as cause:
Colony Stimulating Factor (Colony Stimulating Factors)
Dosage: unknown
Indication: Myelodysplastic Syndrome
Aclarubicin (Aclarubicin)
Dosage: 24 mg, 1 in 1 day, intravenous
Indication: Myelodysplastic Syndrome
Start date: 2012-05-26
Unknown Medication (All Other Therapeutic Products)
Dosage: other leukopenic treatments
Cytarabine
Dosage: 15 mg, 1 in 12 hour, subcutaneous
Indication: Myelodysplastic Syndrome
Dacogen
Dosage: 24 mg, 1 in 1 d, intravenous
Indication: Myelodysplastic Syndrome
Start date: 2012-05-26
End date: 2012-05-30
Other drugs received by patient: Metoprolol Succinate; Atorvastatin; Trimetazidine Hydrochloride (Trimetazidine Hydrochloride); Felodipine
Possible Dacogen side effects in 68 year old male
Reported by a physician from China on 2012-06-12
Patient: 68 year old male
Reactions: Productive Cough, Cardiac Failure, Haemoptysis, Myocardial Infarction, Cardiac Disorder, Cough
Adverse event resulted in: death
Drug(s) suspected as cause:
Aclarubicin (Aclarubicin) Unspecified
Dosage: 10 mg, 1 in 1 day, intravenous
Indication: Myelodysplastic Syndrome
Start date: 2012-05-26
Colony Stimulating Factor (Colony Stimulating Factors) Unspecified
Indication: Myelodysplastic Syndrome
Dacogen
Dosage: 24 mg, 1 in 1 day, intravenous
Indication: Myelodysplastic Syndrome
Start date: 2012-05-26
End date: 2012-05-30
Unknown Medication (All Other Therapeutic Products) Unspecified
Dosage: other leukopenic treatments unknown
Indication: Myelodysplastic Syndrome
Cytarabine
Dosage: 15 mg, 1 in 12 hour, subcutaneous
Indication: Myelodysplastic Syndrome
Start date: 2012-05-26
Other drugs received by patient: Atorvastatin (Atorvastatin) Unspecified; Metoprolol Succinate; Felodipine (Felodipine) Sustained Release Tablets; Trimetazidine Hydrochloride (Trimetazidine Hydrochloride) Unspecified
Possible Dacogen side effects in 68 year old male
Reported by a physician from China on 2012-06-12
Patient: 68 year old male
Reactions: Productive Cough, Haemoptysis, Lung Infection, Coronary Artery Disease, Myelodysplastic Syndrome, Cardiac Disorder, Respiratory Failure, Cardiac Failure, Myocardial Infarction, Hypertension, Cough
Adverse event resulted in: death
Drug(s) suspected as cause:
Dacogen
Dosage: 24 mg, 1 in 1 day, intravenous
Indication: Myelodysplastic Syndrome
Start date: 2012-05-26
End date: 2012-05-30
Colony Stimulating Factor (Colony Stimulating Factors) Unspecified
Indication: Myelodysplastic Syndrome
Unknown Medication (All Other Therapeutic Products) Unspecified
Dosage: other leukopenic treatments unknown
Indication: Myelodysplastic Syndrome
Cytarabine
Dosage: 15 mg, 1 in 12 hour, subcutaneous
Indication: Myelodysplastic Syndrome
Start date: 2012-05-26
Aclarubicin (Aclarubicin) Unspecified
Dosage: 10 mg, 1 in 1 day, intravenous
Indication: Myelodysplastic Syndrome
Start date: 2012-05-26
Other drugs received by patient: Felodipine (Felodipine) Sustained Release Tablets; Metoprolol Succinate; Atorvastatin (Atorvastatin) Unspecified; Trimetazidine Hydrochloride (Trimetazidine
Possible Dacogen side effects in 71 year old female
Reported by a physician from Korea, Republic of on 2012-06-12
Patient: 71 year old female, weighing 56.0 kg (123.2 pounds)
Reactions: Upper Respiratory Tract Infection, Pharyngeal Abscess, Febrile Neutropenia, Oropharyngeal Pain, Pyrexia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Dacogen
Dosage: 20 mg/m2, in 1 day, intravenous
Indication: Myelodysplastic Syndrome
Start date: 2011-04-11
End date: 2011-04-12
Dacogen
Dosage: 20 mg/m2, in 1 day, intravenous
Indication: Myelodysplastic Syndrome
Start date: 2011-05-23
End date: 2011-05-27
Other drugs received by patient: Citopcin (Ciprofloxacin Hdyrochloride); Furazolidon (Furazolidone); Vivir (Aciclovir)
Possible Dacogen side effects in 77 year old male
Reported by a pharmacist from United States on 2012-05-29
Patient: 77 year old male
Reactions: Blood Urine Present
Drug(s) suspected as cause:
Dacogen
Possible Dacogen side effects in 60 year old male
Reported by a pharmacist from Colombia on 2012-05-29
Patient: 60 year old male
Reactions: Pulmonary Hypertension, Off Label Use, Blood Creatinine Increased, Aortic Valve Incompetence
Adverse event resulted in: death
Drug(s) suspected as cause:
Dacogen
Possible Dacogen side effects in female
Reported by a health professional (non-physician/pharmacist) from Colombia on 2012-05-21
Patient: female
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Dacogen
Possible Dacogen side effects in 84 year old female
Reported by a health professional (non-physician/pharmacist) from Colombia on 2012-05-09
Patient: 84 year old female
Reactions: Extravasation
Drug(s) suspected as cause:
Dacogen
Other drugs received by patient: Erythropoietin (Erythropoietin); Danazol
Possible Dacogen side effects in male
Reported by a physician from China on 2012-05-02
Patient: male, weighing 60.0 kg (132.0 pounds)
Reactions: Infection
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Dacogen
Dosage: 40 mg, in 1 day, intravenous
Indication: Myeloid Leukaemia
Start date: 2011-03-24
End date: 2011-03-24
Dacogen
Dosage: 40 mg, in 1 day, intravenous
Indication: Myeloid Leukaemia
Start date: 2011-03-27
End date: 2011-03-27
Possible Dacogen side effects in 64 year old male
Reported by a physician from Korea, Republic of on 2012-05-02
Patient: 64 year old male, weighing 68.5 kg (150.7 pounds)
Reactions: Myocardial Ischaemia, Oedema Peripheral, Sepsis, Pancytopenia, Cardiac Failure Congestive, Pyelonephritis
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Dacogen
Dosage: 20 mg/m2, in 1 cyclical, intravenous
Indication: Myelodysplastic Syndrome
Start date: 2011-03-23
End date: 2011-03-27
Dacogen
Dosage: 20 mg/m2, in 1 cyclical, intravenous
Indication: Myelodysplastic Syndrome
Start date: 2011-06-13
End date: 2011-06-17
Dacogen
Dosage: 20 mg/m2, in 1 cyclical, intravenous
Indication: Myelodysplastic Syndrome
Start date: 2011-05-02
End date: 2011-05-06
Other drugs received by patient: Amlodipine Besylate and Olmesartan Medoxomil; Beecom-Hexa (B-Komplex); Sigmart (Nicorandil); Bisoprolol Fumarate; Janumet; Humulin R; Piperacillin and Tazobactam; Kanitron (Granisetron); Kalitake (Calcium Polystyrene Sulfonate); Duphalac; Dextrose and Sodium Chloride Injection (Dextrose and Sodium Chloride I; Chlorpheniramine Maleate; Lasix; Folic Acid; Nitroglycerin; Sporanox; Flasinyl (Metronidazole); Taspen ER (Paracetamol); Lidocain (Lidocaine Hydrochloride); Megace; Vastinan (Trimetazidine Hydrochloride); Citopcin (Ciprofloxacin Hydrochloride); Hibitan (Chlorhexidine Gluconate)
Possible Dacogen side effects in male
Reported by a pharmacist from Colombia on 2012-04-23
Patient: male
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Dacogen
Possible Dacogen side effects in 70 year old
Reported by a physician from Germany on 2012-03-28
Patient: 70 year old
Reactions: Blood Bilirubin Increased, Blood Alkaline Phosphatase Increased, Hyperglycaemia, Hypoglycaemia, Blood Creatine Increased, Hypercalcaemia, Activated Partial Thromboplastin Time Prolonged, Blood Fibrinogen Decreased, Aspartate Aminotransferase Increased, Bone Marrow Failure, Prothrombin Time Shortened, Hypocalcaemia
Drug(s) suspected as cause:
Dacogen
Dosage: 15 mg/m2, 1 in 1 day, intravenous
Indication: Acute Myeloid Leukaemia
Tretinoin
Indication: Acute Myeloid Leukaemia
Possible Dacogen side effects in 77 year old female
Reported by a pharmacist from United States on 2012-03-26
Patient: 77 year old female, weighing 83.0 kg (182.6 pounds)
Reactions: Hospitalisation
Adverse event resulted in: death
Drug(s) suspected as cause:
Dacogen
Other drugs received by patient: Received Blood Products
Possible Dacogen side effects in 77 year old male
Reported by a physician from Korea, Republic of on 2012-03-01
Patient: 77 year old male, weighing 58.0 kg (127.6 pounds)
Reactions: Coronary Artery Stenosis, Coronary Artery Occlusion, Colitis, Antibiotic Resistant Staphylococcus Test Positive, Asthenia, Lobar Pneumonia, Decreased Appetite
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Dacogen
Dosage: 20 mg/m2, 1 in 1 day, intravenous
Indication: Myelodysplastic Syndrome
Start date: 2011-11-05
End date: 2011-11-09
Dacogen
Dosage: 20 mg/m2, 1 in 1 day, intravenous
Indication: Myelodysplastic Syndrome
Start date: 2011-10-10
End date: 2011-10-10
Dacogen
Dosage: 20 mg/m2, 1 in 1 day, intravenous
Indication: Myelodysplastic Syndrome
Start date: 2011-10-05
End date: 2011-10-08
Other drugs received by patient: Sporanox; Targocid; Colchicine; Tylenol ER (Paracetamol); Mucomyst; Tranexamic Acid; Kalimate Granules (Calcium Polystyrene Sulfonate); Ganaton (Itopride Hydrochloride); Tamsulosin HCL; Cimetidine; Grasin (Filgrastim); Feroba YOU SR (Ferrous Sulfate); Mucosta (Rebamipide); Bactrim; Exoperin (Eperisone); Famotidine; Methylon (Methylprednisolone); Exjade; Meiact (Cefditoren Pivoxil); Globulin-S (Normal Human Immunoglobulin); Recomide (Rebamipide); Maxipime; Norzyme (Pancreatin); Ultracet; Q-Zyme (Digestives, Incl Enzymes); Atrovent UDV (Ipratropium Bromide); Macperan (Metoclopramide Hydrochloride); Magnesium Oxide; Allopurinol; Fluconazole; Magnesium; Danazol; Legalon (Silybum Marianum); Albumin (Human); Levobact (Levofloxacin); Macperan (Metoclopramide Hydrochloride); Adcal (Lekovit CA); Flomax; Lasix
Possible Dacogen side effects in
Reported by a physician from United States on 2012-02-16
Patient:
Reactions: Balance Disorder, Parkinson's Disease, Musculoskeletal Stiffness, Bradykinesia, Muscle Rigidity, Tremor
Drug(s) suspected as cause:
Dacogen
Possible Dacogen side effects in 73 year old male
Reported by a physician from United States on 2012-02-09
Patient: 73 year old male
Reactions: Faecal Vomiting, Ileus, Febrile Neutropenia, Constipation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Dacogen
Possible Dacogen side effects in 44 year old female
Reported by a physician from China on 2012-02-07
Patient: 44 year old female
Reactions: Acute Myeloid Leukaemia, Neoplasm Progression, Haematotoxicity
Adverse event resulted in: death
Drug(s) suspected as cause:
Dacogen
Possible Dacogen side effects in 73 year old male
Reported by a physician from United States on 2012-01-09
Patient: 73 year old male
Reactions: Ileus, Febrile Neutropenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Dacogen
Possible Dacogen side effects in 62 year old male
Reported by a physician from Turkey on 2011-12-20
Patient: 62 year old male
Reactions: Haemoglobin Decreased, Sudden Cardiac Death, Blood Albumin Decreased, Ventricular Fibrillation, Cardiac Arrest, Arrhythmia
Adverse event resulted in: death
Drug(s) suspected as cause:
Dacogen
Other drugs received by patient: Moxifloxacin HCL; Acyclovir; Digoxin; Furosemide; Valproate Sodium; Granisetron; Fluconazole
Possible Dacogen side effects in female
Reported by a physician from United States on 2011-11-29
Patient: female
Reactions: Blood Bilirubin Increased, Pancytopenia, Rash
Adverse event resulted in: life threatening event, disablity
Drug(s) suspected as cause:
Revlimid
Dosage: 5mg alternating with 10mg
Administration route: Oral
Start date: 2011-06-03
End date: 2011-06-14
Revlimid
Dosage: 5 milligram
Administration route: Oral
Start date: 2011-05-27
Dacogen
Revlimid
Dosage: 10 milligram
Administration route: Oral
Start date: 2011-05-11
End date: 2011-05-01
Revlimid
Dosage: 2.5 milligram
Administration route: Oral
Start date: 2011-06-16
End date: 2011-07-05
Revlimid
Dosage: 5 milligram
Administration route: Oral
Start date: 2011-05-20
Other drugs received by patient: Valsartan; Ondansetron Hydrochloride; Prochlorperazine Maleate; Voriconazole; Cyanocobalamin; Metformin HCL; Cholecalciferol; Potassium Chloride; Glyburide; Levothyroxine Sodium; Magnesium Oxide; Insulin Glargine; Ginger; Acyclovir
Possible Dacogen side effects in
Reported by a physician from United States on 2011-11-22
Patient:
Reactions: Haemolytic Anaemia
Drug(s) suspected as cause:
Dacogen
Possible Dacogen side effects in 69 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-16
Patient: 69 year old female, weighing 107.3 kg (236.1 pounds)
Reactions: Dyspnoea, Interstitial Lung Disease, Body Temperature Increased, Hypotension, Blood Culture Positive, Bacterial Infection, Feeling Cold
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Dacogen
Possible Dacogen side effects in 45 year old male
Reported by a physician from United States on 2011-11-10
Patient: 45 year old male, weighing 65.7 kg (144.5 pounds)
Reactions: Confusional State, Citrobacter Test Positive, Pyrexia, Hyperhidrosis, Tumour Haemorrhage, Hypokalaemia, Oedema Peripheral, Proteinuria, Hypocalcaemia, Culture Wound Positive, Electrolyte Imbalance, Serratia Test Positive, Bacterial Test Positive, Blood Creatinine Increased, Enterobacter Test Positive, Hydronephrosis, Hypotension, Urinary Tract Infection, Anaemia, Bacteraemia, Systemic Inflammatory Response Syndrome, Klebsiella Test Positive, Deep Vein Thrombosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Dacogen
Dosage: see image
Indication: Colorectal Cancer Metastatic
Start date: 2011-09-16
End date: 2011-09-16
Dacogen
Dosage: see image
Indication: Colorectal Cancer Metastatic
Start date: 2011-09-28
End date: 2011-09-28
Dacogen
Dosage: see image
Indication: Colorectal Cancer Metastatic
Start date: 2011-10-21
End date: 2011-10-21
Dacogen
Dosage: see image
Indication: Colorectal Cancer Metastatic
Start date: 2011-09-02
End date: 2011-09-02
Dacogen
Dosage: see image
Indication: Colorectal Cancer Metastatic
Start date: 2011-07-29
End date: 2011-07-29
Panitumumab (Panitumumab) Unspecified
Dosage: see image
Indication: Colorectal Cancer Metastatic
Start date: 2011-10-14
End date: 2011-10-14
Panitumumab (Panitumumab) Unspecified
Dosage: see image
Indication: Colorectal Cancer Metastatic
Start date: 2011-09-09
End date: 2011-09-09
Panitumumab (Panitumumab) Unspecified
Dosage: see image
Indication: Colorectal Cancer Metastatic
Start date: 2011-08-26
End date: 2011-08-26
Panitumumab (Panitumumab) Unspecified
Dosage: see image
Indication: Colorectal Cancer Metastatic
Start date: 2011-09-23
End date: 2011-09-23
Panitumumab (Panitumumab) Unspecified
Dosage: see image
Indication: Colorectal Cancer Metastatic
Start date: 2011-08-05
End date: 2011-08-05
Other drugs received by patient: Actiq; Senna S (Senokot-S); Ritalin; Gabapentin; Cymbalta; Trazodone HCL; Ambien
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