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Dacogen (Decitabine) - Side Effect Reports to FDA

 
 



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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