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Dacogen Side Effects

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Common Dacogen Side Effects


The most commonly reported Dacogen side effects (click to view or check a box to report):

Off Label Use (38)
Platelet Count Decreased (34)
Febrile Neutropenia (29)
White Blood Cell Count Decreased (24)
Pneumonia (22)
Pyrexia (22)
Haemoglobin Decreased (22)
Asthenia (18)
Infection (15)
Pancytopenia (14)
Dyspnoea (13)
Thrombocytopenia (13)
Neutropenia (12)
Anaemia (11)
Bone Marrow Failure (11)
Peritonitis (11)
Sepsis (11)
Pleural Effusion (10)
Joint Swelling (9)
Fatigue (9)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Dacogen Side Effects Reported to FDA



Dacogen Side Effect Report#9913643
Rhinorrhoea, Oropharyngeal Pain, Asthenia, Myalgia
This is a report of a 88-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: acute myeloid leukaemia, who was treated with Dacogen (dosage: Qdx10; 28 Day Cycle, start time:
Oct 04, 2013), combined with:
  • Acetaminophen
  • Acyclovir
  • Amlodipine Besylate
  • Ciprofloxacin Hcl
  • Famotidine
  • Metoprolol Succinate Er
  • Prochlorperazine Maleate
  • Tramadol Hci
and developed a serious reaction and side effect(s): Rhinorrhoea, Oropharyngeal Pain, Asthenia, Myalgia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Dacogen treatment in female patients, resulting in Rhinorrhoea side effect. The patient was hospitalized.
Dacogen Side Effect Report#9913635
Oropharyngeal Pain, Dysphagia, Cough, Dyspnoea, Pain, Neutrophil Count Decreased
This report suggests a potential Dacogen Oropharyngeal Pain side effect(s) that can have serious consequences. A 64-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: acute myeloid leukaemia and used Dacogen (dosage: Qdx10; 28 Day Cycle) starting
Oct 04, 2013. After starting Dacogen the patient began experiencing various side effects, including: Oropharyngeal Pain, Dysphagia, Cough, Dyspnoea, Pain, Neutrophil Count DecreasedAdditional drugs used concurrently:
  • Acyclovir
  • Famotidine
  • Fluconazole
The patient was hospitalized. Although Dacogen demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Oropharyngeal Pain, may still occur.
Dacogen Side Effect Report#9869734
Anal Fistula, Rectal Abscess
This Anal Fistula problem was reported by a physician from US. A 71-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Dacogen (dosage: NA). The following drugs were being taken at the same time:
  • Sapacitabine
When using Dacogen, the patient experienced the following unwanted symptoms/side effects: Anal Fistula, Rectal AbscessAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Anal Fistula, may become evident only after a product is in use by the general population.
Dacogen Side Effect Report#9867160
Rash Maculo-papular, Oropharyngeal Pain, Oedema Peripheral, Condition Aggravated, Pyrexia, Neutropenia, Lung Infection
This Rash Maculo-papular side effect was reported by a consumer or non-health professional from US. A 58-year-old female patient (weight:NA) experienced the following symptoms/conditions: myelodysplastic syndrome.The patient was prescribed Dacogen (drug dosage: Qdx10; 28 Day Cycl), which was initiated on
Nov 11, 2013. Concurrently used drugs:
  • Acyclovir
  • Ciprofloxacin
  • Posaconazole
  • Multivitamin
.After starting to take Dacogen the consumer reported adverse symptoms, such as: Rash Maculo-papular, Oropharyngeal Pain, Oedema Peripheral, Condition Aggravated, Pyrexia, Neutropenia, Lung InfectionThese side effects may potentially be related to Dacogen. The patient was hospitalized.
Dacogen Side Effect Report#9819192
Off Label Use, Weight Decreased, Asthenia, Epistaxis, Thrombocytopenia, Anaemia, Malnutrition
This is a report of a 74-year-old male patient (weight: NA) from FR, suffering from the following health symptoms/conditions: chronic myelomonocytic leukaemia, who was treated with Dacogen (dosage: NA, start time:
Jun 05, 2013), combined with:
  • Becilan (pyridoxine Hydrochloride) Tablet
  • Bevitine (thiamine Hydrochloride) Tablet
  • Duragesic (fentanyl) Patch
  • Oramorph (morphine Sulfate) Solution
  • Paracetamol (paracetamol) Tablet
  • Transipeg (macrogol) Sachet
and developed a serious reaction and side effect(s): Off Label Use, Weight Decreased, Asthenia, Epistaxis, Thrombocytopenia, Anaemia, Malnutrition after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Dacogen treatment in male patients, resulting in Off Label Use side effect. The patient was hospitalized.
Dacogen Side Effect Report#9786259
Aneurysm
This report suggests a potential Dacogen (decitabine) Lyophilized Powder Aneurysm side effect(s) that can have serious consequences. A 66-year-old female patient (weight: NA) from HK was diagnosed with the following symptoms/conditions: myelodysplastic syndrome and used Dacogen (decitabine) Lyophilized Powder (dosage: NA) starting NS. After starting Dacogen (decitabine) Lyophilized Powder the patient began experiencing various side effects, including: AneurysmAdditional drugs used concurrently: NA.The patient was hospitalized. Although Dacogen (decitabine) Lyophilized Powder demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Aneurysm, may still occur.
Dacogen Side Effect Report#9767356
Pneumonia, Respiratory Acidosis, Arrhythmia, Platelet Count Decreased
This Pneumonia problem was reported by a health professional from CO. A 79-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: myelodysplastic syndrome. On
Sep 06, 2013 this consumer started treatment with Dacogen (dosage: NA). The following drugs were being taken at the same time: NA. When using Dacogen, the patient experienced the following unwanted symptoms/side effects: Pneumonia, Respiratory Acidosis, Arrhythmia, Platelet Count DecreasedThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pneumonia, may become evident only after a product is in use by the general population.
Dacogen Side Effect Report#9759977
Haemolytic Anaemia, Gastric Haemorrhage, Frequent Bowel Movements
This Haemolytic Anaemia side effect was reported by a health professional from FR. A 59-year-old male patient (weight:NA) experienced the following symptoms/conditions: acute myeloid leukaemia.The patient was prescribed Dacogen (drug dosage: NA), which was initiated on
Sep 02, 2013. Concurrently used drugs:
  • Augmentin
  • Midostaurin
  • Speciafoldine (folic Acid)
  • Lexomil (bromazepam)
  • Zophren (ondansetron Hydrochloride)
  • Verapamil Hydrochloride (verapamil Hydrochloride)
  • Vitamine C (ascorbic Acid)
  • Orocal D3 (lekovit Ca)
.After starting to take Dacogen the consumer reported adverse symptoms, such as: Haemolytic Anaemia, Gastric Haemorrhage, Frequent Bowel MovementsThese side effects may potentially be related to Dacogen. The patient was hospitalized.
Dacogen Side Effect Report#9759864
White Blood Cell Count Increased, Thrombocytopenia, Disseminated Intravascular Coagulation, Hypertension, Haemorrhage, Oral Herpes, Encephalopathy
This is a report of a 77-year-old female patient (weight: NA) from KZ, suffering from the following health symptoms/conditions: acute myeloid leukaemia, who was treated with Dacogen (decitabine) Lyophilized Powder (dosage: NA, start time:
Nov 15, 2013), combined with:
  • Potassium Chloride
  • Nebilet (nebivolol Hydrochloride)
  • Acyclovir (aciclovir)
  • Lexatumumab (monoclonal Antibodies)
  • Hydrea (hydroxycarbamide)
  • Cytarabine (cytarabine)
  • Methotrexate (methotrexate)
  • Acyclovir (aciclovir)
and developed a serious reaction and side effect(s): White Blood Cell Count Increased, Thrombocytopenia, Disseminated Intravascular Coagulation, Hypertension, Haemorrhage, Oral Herpes, Encephalopathy after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Dacogen (decitabine) Lyophilized Powder treatment in female patients, resulting in White Blood Cell Count Increased side effect.
Dacogen Side Effect Report#9735105
Abdominal Pain Lower, Appendicitis, Pyrexia, Colitis, Appendix Disorder
This report suggests a potential Dacogen Abdominal Pain Lower side effect(s) that can have serious consequences. A 83-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: myelodysplastic syndrome and used Dacogen (dosage: 1 Day) starting
Sep 09, 2013. After starting Dacogen the patient began experiencing various side effects, including: Abdominal Pain Lower, Appendicitis, Pyrexia, Colitis, Appendix DisorderAdditional drugs used concurrently:
  • Omeprazole
  • Latanoprost
  • Dorzolamide
  • Ondansetron
  • Senna (senna Alexandrina)
  • Cyclizine
  • Augmentin
The patient was hospitalized. Although Dacogen demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Abdominal Pain Lower, may still occur.
Dacogen Side Effect Report#9716535
Convulsion, Neutropenia, Sepsis, Lower Respiratory Tract Infection, Pneumonia, White Blood Cell Count Decreased
This Convulsion problem was reported by a physician from GB. A 81-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: myelodysplastic syndrome. On
Sep 16, 2013 this consumer started treatment with Dacogen (dosage: NA). The following drugs were being taken at the same time:
  • Allopurinol
  • Aciclovir (aciclovir)
  • Ondansetron (ondansetron)
  • Fluconazole (fluconazole)
  • Bisoprolol (bisoprolol)
  • Aspirin (acetylsalicylic Acid)
  • Simvastatin (simvastatin)
  • Gliclazide (gliclazide)
When using Dacogen, the patient experienced the following unwanted symptoms/side effects: Convulsion, Neutropenia, Sepsis, Lower Respiratory Tract Infection, Pneumonia, White Blood Cell Count DecreasedThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Convulsion, may become evident only after a product is in use by the general population.
Dacogen Side Effect Report#9697853
Aspergillus Infection, Abscess, Neutropenia, Infection, Renal Cyst, Left Ventricular Hypertrophy, Diastolic Dysfunction, Tricuspid Valve Incompetence, Mitral Valve Incompetence
This Aspergillus Infection side effect was reported by a physician from DE. A 75-year-old male patient (weight:NA) experienced the following symptoms/conditions: myelodysplastic syndrome.The patient was prescribed Dacogen (drug dosage: NA), which was initiated on
Aug 08, 2013. Concurrently used drugs: NA..After starting to take Dacogen the consumer reported adverse symptoms, such as: Aspergillus Infection, Abscess, Neutropenia, Infection, Renal Cyst, Left Ventricular Hypertrophy, Diastolic Dysfunction, Tricuspid Valve Incompetence, Mitral Valve IncompetenceThese side effects may potentially be related to Dacogen. The patient was hospitalized.
Dacogen Side Effect Report#9689056
Febrile Neutropenia, Pancytopenia, Electrocardiogram St Segment Elevation, Cardiomegaly, Pericardial Effusion, Hepatitis Acute
This is a report of a 53-year-old male patient (weight: NA) from KR, suffering from the following health symptoms/conditions: myelodysplastic syndrome, who was treated with Dacogen (dosage: NA, start time:
Oct 14, 2013), combined with:
  • Metoclopramide Hydrochloride (metoclopramide Hydrochloride)
and developed a serious reaction and side effect(s): Febrile Neutropenia, Pancytopenia, Electrocardiogram St Segment Elevation, Cardiomegaly, Pericardial Effusion, Hepatitis Acute after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Dacogen treatment in male patients, resulting in Febrile Neutropenia side effect. The patient was hospitalized.
Dacogen Side Effect Report#9688773
Necrosis, Panniculitis, Nodule, Skin Necrosis, Breast Necrosis, Fatigue, Lower Respiratory Tract Infection, Pain, Septal Panniculitis
This report suggests a potential Dacogen Necrosis side effect(s) that can have serious consequences. A 78-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: acute myeloid leukaemia and used Dacogen (dosage: 40 Mg, 1 In 1 Day) starting
May 20, 2013. After starting Dacogen the patient began experiencing various side effects, including: Necrosis, Panniculitis, Nodule, Skin Necrosis, Breast Necrosis, Fatigue, Lower Respiratory Tract Infection, Pain, Septal PanniculitisAdditional drugs used concurrently:
  • Ondansetron Hcl (ondansetron Hydrochloride)
  • Oxycodone Hcl (oxycodone Hydrochloride)
  • Mucinex
  • Drotaverin (drotaverine)
  • Tylenol (paracetamol)
  • Zofran (ondansetron)
  • Norvasc (amlodipine Besilate)
  • Toprol (metoprolol Succinate)
The patient was hospitalized. Although Dacogen demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Necrosis, may still occur.
Dacogen Side Effect Report#9686301
Abscess Limb, Disseminated Intravascular Coagulation, Sepsis
This Abscess Limb problem was reported by a health professional from KR. A 69-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: myelodysplastic syndrome. On
Mar 19, 2011 this consumer started treatment with Dacogen (dosage: NA). The following drugs were being taken at the same time: NA. When using Dacogen, the patient experienced the following unwanted symptoms/side effects: Abscess Limb, Disseminated Intravascular Coagulation, SepsisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Abscess Limb, may become evident only after a product is in use by the general population.
Dacogen Side Effect Report#9670359
Infection, Disease Complication, Pneumonia, No Therapeutic Response
This Infection side effect was reported by a physician from SG. A 75-year-old male patient (weight:NA) experienced the following symptoms/conditions: myelodysplastic syndrome.The patient was prescribed Dacogen (decitabine) Lyophilized Powder (drug dosage: Almost 2 Years), which was initiated on NS. Concurrently used drugs: NA..After starting to take Dacogen (decitabine) Lyophilized Powder the consumer reported adverse symptoms, such as: Infection, Disease Complication, Pneumonia, No Therapeutic ResponseThese side effects may potentially be related to Dacogen (decitabine) Lyophilized Powder.
Dacogen Side Effect Report#9657928
Infection, Haemoglobin Decreased, Disease Progression, Candiduria, Myelodysplastic Syndrome, Fall, Arthralgia
This is a report of a 68-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: myelodysplastic syndrome, who was treated with Dacogen (decitabine) Lyophilized Powder (dosage: 31 Mg, 1 In 1 Day, Intravenous, start time:
Feb 18, 2013), combined with: NA. and developed a serious reaction and side effect(s): Infection, Haemoglobin Decreased, Disease Progression, Candiduria, Myelodysplastic Syndrome, Fall, Arthralgia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Dacogen (decitabine) Lyophilized Powder treatment in female patients, resulting in Infection side effect. The patient was hospitalized.
Dacogen Side Effect Report#9657767
Erythema, Pancytopenia, C-reactive Protein Increased, Papule, Haemorrhage
This report suggests a potential Dacogen (decitabine) Lyophilized Powder Erythema side effect(s) that can have serious consequences. A 63-year-old male patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: acute myeloid leukaemia and used Dacogen (decitabine) Lyophilized Powder (dosage: NA) starting
Sep 19, 2013. After starting Dacogen (decitabine) Lyophilized Powder the patient began experiencing various side effects, including: Erythema, Pancytopenia, C-reactive Protein Increased, Papule, HaemorrhageAdditional drugs used concurrently:
  • Deferasirox
  • Cyklokapron (tranexamic Acid)
  • Lyrica (pregabalin)
  • Saroten (amitriptyline Hydrochloride)
  • Pantoprazole
  • Linezolid
The patient was hospitalized. Although Dacogen (decitabine) Lyophilized Powder demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Erythema, may still occur.
Dacogen Side Effect Report#9602138
Oesophageal Cancer Metastatic, Haematemesis, Gastrointestinal Haemorrhage
This Oesophageal Cancer Metastatic problem was reported by a physician from CN. A 61-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: myelodysplastic syndrome. On
Apr 08, 2010 this consumer started treatment with Dacogen (decitabine) Lyophilized Powder (dosage: NA). The following drugs were being taken at the same time: NA. When using Dacogen (decitabine) Lyophilized Powder, the patient experienced the following unwanted symptoms/side effects: Oesophageal Cancer Metastatic, Haematemesis, Gastrointestinal HaemorrhageAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Oesophageal Cancer Metastatic, may become evident only after a product is in use by the general population.
Dacogen Side Effect Report#9592858
Chest Pain, Haemoglobin Decreased, Breath Sounds Abnormal, Cardio-respiratory Arrest
This Chest Pain side effect was reported by a health professional from CO. A 68-year-old male patient (weight:NA) experienced the following symptoms/conditions: myelodysplastic syndrome.The patient was prescribed Dacogen (decitabine) Lyophilized Powder (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Dacogen (decitabine) Lyophilized Powder the consumer reported adverse symptoms, such as: Chest Pain, Haemoglobin Decreased, Breath Sounds Abnormal, Cardio-respiratory ArrestThese side effects may potentially be related to Dacogen (decitabine) Lyophilized Powder.
Dacogen Side Effect Report#9548275
Bone Marrow Failure
This is a report of a patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Dacogen (decitabine) Lyophilized Powder (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Bone Marrow Failure after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Dacogen (decitabine) Lyophilized Powder treatment in patients, resulting in Bone Marrow Failure side effect.
Dacogen Side Effect Report#9548259
Thrombocytopenia, Pulmonary Embolism, Leukopenia
This report suggests a potential Dacogen (decitabine) Lyophilized Powder Thrombocytopenia side effect(s) that can have serious consequences. A 77-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: myelodysplastic syndrome and used Dacogen (decitabine) Lyophilized Powder (dosage: 20 Mg, 1 In 6 Week, Intravenous) starting
Dec 08, 2006. After starting Dacogen (decitabine) Lyophilized Powder the patient began experiencing various side effects, including: Thrombocytopenia, Pulmonary Embolism, LeukopeniaAdditional drugs used concurrently: NA.The patient was hospitalized. Although Dacogen (decitabine) Lyophilized Powder demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Thrombocytopenia, may still occur.
Dacogen Side Effect Report#9449030
Platelet Count Decreased, Haematuria, Pneumonia, Dyspnoea, Pulmonary Oedema, Cardiac Arrest
This Platelet Count Decreased problem was reported by a consumer or non-health professional from CO. A 78-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: myelodysplastic syndrome. On
Jul 04, 2013 this consumer started treatment with Dacogen (decitabine) Lyophilized Powder (dosage: NA). The following drugs were being taken at the same time: NA. When using Dacogen (decitabine) Lyophilized Powder, the patient experienced the following unwanted symptoms/side effects: Platelet Count Decreased, Haematuria, Pneumonia, Dyspnoea, Pulmonary Oedema, Cardiac ArrestThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Platelet Count Decreased, may become evident only after a product is in use by the general population.
Dacogen Side Effect Report#9425371
Pancytopenia, Haemorrhage, Pyrexia
This Pancytopenia side effect was reported by a physician from KZ. A 19-year-old female patient (weight:NA) experienced the following symptoms/conditions: myelodysplastic syndrome.The patient was prescribed Dacogen (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Dacogen the consumer reported adverse symptoms, such as: Pancytopenia, Haemorrhage, PyrexiaThese side effects may potentially be related to Dacogen.
Dacogen Side Effect Report#9422850
Vomiting, Diarrhoea, Abdominal Pain, Tachypnoea, Tachycardia, Hypotension, Respiratory Failure, Renal Failure Acute, Occult Blood Positive
This is a report of a female patient (weight: NA) from US, suffering from the following health symptoms/conditions: acute myeloid leukaemia, who was treated with Dacogen (decitabine) Lyophilized Powder (dosage: NA, start time:
Feb 25, 2013), combined with:
  • Bortezomib
and developed a serious reaction and side effect(s): Vomiting, Diarrhoea, Abdominal Pain, Tachypnoea, Tachycardia, Hypotension, Respiratory Failure, Renal Failure Acute, Occult Blood Positive after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Dacogen (decitabine) Lyophilized Powder treatment in female patients, resulting in Vomiting side effect. The patient was hospitalized.


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The appearance of Dacogen on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.


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  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Dacogen reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Side Effects reported to FDA: 305

    Dacogen safety alerts: No

    Reported deaths: 95

    Reported hospitalizations: 131

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