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Dacogen Side Effects

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)

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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.

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.

Dacogen Side Effects Reported to FDA

The following 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.


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.
Rhinorrhoea, Oropharyngeal Pain, Asthenia, Myalgia
This is a report of a 88-year-old female patient (weight: NA) from US, suffering from the following 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). The consumer presented with:
  • Rhinorrhoea
  • Oropharyngeal Pain
  • Asthenia
  • Myalgia
which developed 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.

Oropharyngeal Pain, Dysphagia, Cough, Dyspnoea, Neutrophil Count Decreased
This report suggests a potential Dacogen Oropharyngeal Pain, Dysphagia, Cough, Dyspnoea, Neutrophil Count Decreased 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. Soon after starting Dacogen the patient began experiencing various side effects, including:
  • Oropharyngeal Pain
  • Dysphagia
  • Cough
  • Dyspnoea
  • Neutrophil Count Decreased
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.

Anal Fistula, Rectal Abscess
This Anal Fistula, Rectal Abscess 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 commencing Dacogen, the patient experienced the following unwanted symptoms/side effects:
  • Anal Fistula
  • Rectal Abscess
Although 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.

Rash Maculo-papular, Oropharyngeal Pain, Oedema Peripheral, Condition Aggravated, Pyrexia, Neutropenia, Lung Infection
This is a report of a 58-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: myelodysplastic syndrome and was treated with Dacogen (dosage: Qdx10; 28 Day Cycl) starting Nov 11, 2013. Concurrently used drugs:
  • Acyclovir
  • Ciprofloxacin
  • Posaconazole
  • Multivitamin
Soon after that, the consumer experienced the following side effects:
  • Rash Maculo-papular
  • Oropharyngeal Pain
  • Oedema Peripheral
  • Condition Aggravated
  • Pyrexia
  • Neutropenia
  • Lung Infection
The patient was hospitalized. This opens a possibility that Dacogen treatment could cause the above reactions, including rash maculo-papular, and some female subjects may be more susceptible.


Off Label Use, Weight Decreased, Asthenia, Epistaxis, Thrombocytopenia, Anaemia, Malnutrition
A 74-year-old male patient (weight: NA) from FR with the following symptoms/conditions: chronic myelomonocytic leukaemia started Dacogen treatment (dosage: NA) on Jun 05, 2013. Soon after starting Dacogen treatment, the subject experienced various side effects, including:
  • Off Label Use
  • Weight Decreased
  • Asthenia
  • Epistaxis
  • Thrombocytopenia
  • Anaemia
  • Malnutrition
Concurrently used drugs:
  • Becilan (pyridoxine Hydrochloride) Tablet
  • Bevitine (thiamine Hydrochloride) Tablet
  • Duragesic (fentanyl) Patch
  • Oramorph (morphine Sulfate) Solution
  • Paracetamol (paracetamol) Tablet
  • Transipeg (macrogol) Sachet
The patient was hospitalized. This finding indicates that some male patients could be more vulnerable to Dacogen.

Aneurysm
A 66-year-old female patient from HK (weight: NA) experienced symptoms, such as: myelodysplastic syndrome and was treated with Dacogen (decitabine) Lyophilized Powder(dosage: NA). The treatment was initiated on NS. After that a consumer reported the following side effect(s):
  • Aneurysm
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Dacogen (decitabine) Lyophilized Powder efficacy: NA.The patient was hospitalized.

Pneumonia, Respiratory Acidosis, Arrhythmia, Platelet Count Decreased
In this report, Dacogen was administered for the following condition: myelodysplastic syndrome.A 79-year-old male consumer from CO (weight: NA) started Dacogen treatment (dosage: NA) on Sep 06, 2013.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Pneumonia
  • Respiratory Acidosis
  • Arrhythmia
  • Platelet Count Decreased
A possible interaction with other drugs could have contributed to this reaction: NA.The patient was hospitalized.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Dacogen treatment could be related to the listed above side effect(s).

Haemolytic Anaemia, Gastric Haemorrhage, Frequent Bowel Movements
This is a report of the following Dacogen side effect(s):
  • Haemolytic Anaemia
  • Gastric Haemorrhage
  • Frequent Bowel Movements
A 59-year-old male patient from FR (weight: NA) presented with the following condition: acute myeloid leukaemia and received a treatment with Dacogen (dosage: NA) starting: Sep 02, 2013.The following concurrently used drugs could have generated interactions:
  • Augmentin
  • Midostaurin
  • Speciafoldine (folic Acid)
  • Lexomil (bromazepam)
  • Zophren (ondansetron Hydrochloride)
  • Verapamil Hydrochloride (verapamil Hydrochloride)
  • Vitamine C (ascorbic Acid)
  • Orocal D3 (lekovit Ca)
The patient was hospitalized.This report suggests that a Dacogen treatment could be associated with the listed above side effect(s).

White Blood Cell Count Increased, Thrombocytopenia, Disseminated Intravascular Coagulation, Hypertension, Haemorrhage, Oral Herpes, Encephalopathy
This Dacogen (decitabine) Lyophilized Powder report was submitted by a 77-year-old female consumer from KZ (weight: NA). The patient was diagnosed with: acute myeloid leukaemia and Dacogen (decitabine) Lyophilized Powder was administered (dosage: NA) starting: Nov 15, 2013. The consumer developed a set of symptoms:
  • White Blood Cell Count Increased
  • Thrombocytopenia
  • Disseminated Intravascular Coagulation
  • Hypertension
  • Haemorrhage
  • Oral Herpes
  • Encephalopathy
Other drugs used simultaneously:
  • Potassium Chloride
  • Nebilet (nebivolol Hydrochloride)
  • Acyclovir (aciclovir)
  • Lexatumumab (monoclonal Antibodies)
  • Hydrea (hydroxycarbamide)
  • Cytarabine (cytarabine)
  • Methotrexate (methotrexate)
  • Acyclovir (aciclovir)
Those unexpected symptoms could be linked to a Dacogen (decitabine) Lyophilized Powder treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Abdominal Pain Lower, Appendicitis, Pyrexia, Colitis, Appendix Disorder
This is a report of a possible correlation between Dacogen use and the following symptoms/side effect(s):
  • Abdominal Pain Lower
  • Appendicitis
  • Pyrexia
  • Colitis
  • Appendix Disorder
which could contribute to an assessment of Dacogen risk profile.A 83-year-old male consumer from GB (weight: NA) was suffering from myelodysplastic syndrome and was treated with Dacogen (dosage: 1 Day) starting Sep 09, 2013.Other concurrent medications:
  • Omeprazole
  • Latanoprost
  • Dorzolamide
  • Ondansetron
  • Senna (senna Alexandrina)
  • Cyclizine
  • Augmentin
The patient was hospitalized.

Convulsion, Neutropenia, Sepsis, Lower Respiratory Tract Infection, Pneumonia, White Blood Cell Count Decreased
A 81-year-old male patient from GB (weight: NA) presented with the following symptoms: myelodysplastic syndrome and after a treatment with Dacogen (dosage: NA) experienced the following side effect(s):
  • Convulsion
  • Neutropenia
  • Sepsis
  • Lower Respiratory Tract Infection
  • Pneumonia
  • White Blood Cell Count Decreased
The treatment was started on Sep 16, 2013. Dacogen was used in combination with the following drugs:
  • Allopurinol
  • Aciclovir (aciclovir)
  • Ondansetron (ondansetron)
  • Fluconazole (fluconazole)
  • Bisoprolol (bisoprolol)
  • Aspirin (acetylsalicylic Acid)
  • Simvastatin (simvastatin)
  • Gliclazide (gliclazide)
The patient was hospitalized.This report could alert potential Dacogen consumers.

Aspergillus Infection, Abscess, Neutropenia, Renal Cyst, Left Ventricular Hypertrophy, Diastolic Dysfunction, Tricuspid Valve Incompetence, Mitral Valve Incompetence
In this report, a 75-year-old male patient from DE (weight: NA) was affected by a possible Dacogen side effect.The patient was diagnosed with myelodysplastic syndrome. After a treatment with Dacogen (dosage: NA, start date: Aug 08, 2013), the patient experienced the following side effect(s):
  • Aspergillus Infection
  • Abscess
  • Neutropenia
  • Renal Cyst
  • Left Ventricular Hypertrophy
  • Diastolic Dysfunction
  • Tricuspid Valve Incompetence
  • Mitral Valve Incompetence
The following simultaneously used drugs could have led to this reaction: NA.The patient was hospitalized.The findings here stress that side effects should be taken into consideration when evaluating a Dacogen treatment.

Febrile Neutropenia, Pancytopenia, Electrocardiogram St Segment Elevation, Cardiomegaly, Pericardial Effusion, Hepatitis Acute
This is a report of a 53-year-old male patient from KR (weight: NA), who used Dacogen (dosage: NA) for a treatment of myelodysplastic syndrome. After starting a treatment on Oct 14, 2013, the patient experienced the following side effect(s):
  • Febrile Neutropenia
  • Pancytopenia
  • Electrocardiogram St Segment Elevation
  • Cardiomegaly
  • Pericardial Effusion
  • Hepatitis Acute
The following drugs could possibly have interacted with the Dacogen treatment
  • Metoclopramide Hydrochloride (metoclopramide Hydrochloride)
The patient was hospitalized.Taken together, these observations suggest that a Dacogen treatment could be related to side effect(s), such as Febrile Neutropenia, Pancytopenia, Electrocardiogram St Segment Elevation, Cardiomegaly, Pericardial Effusion, Hepatitis Acute.

Necrosis, Panniculitis, Nodule, Skin Necrosis, Breast Necrosis, Fatigue, Lower Respiratory Tract Infection, Pain, Septal Panniculitis
This necrosis side effect was reported by a health professional from US. A 78-year-old female patient (weight:NA) experienced the following symptoms/conditions: acute myeloid leukaemia. The patient was prescribed Dacogen (dosage: 40 Mg, 1 In 1 Day), which was started on May 20, 2013. Concurrently used drugs:
  • Ondansetron Hcl (ondansetron Hydrochloride)
  • Oxycodone Hcl (oxycodone Hydrochloride)
  • Mucinex
  • Drotaverin (drotaverine)
  • Tylenol (paracetamol)
  • Zofran (ondansetron)
  • Norvasc (amlodipine Besilate)
  • Toprol (metoprolol Succinate)
When starting to take Dacogen the consumer reported the following symptoms:
  • Necrosis
  • Panniculitis
  • Nodule
  • Skin Necrosis
  • Breast Necrosis
  • Fatigue
  • Lower Respiratory Tract Infection
  • Pain
  • Septal Panniculitis
The patient was hospitalized. These side effects may potentially be related to Dacogen.

Abscess Limb, Disseminated Intravascular Coagulation, Sepsis
This is a Dacogen side effect report of a 69-year-old male patient (weight:NA) from KR, suffering from the following symptoms/conditions: myelodysplastic syndrome, who was treated with Dacogen (dosage:NA, start time: Mar 19, 2011), combined with: NA., and developed a serious reaction and a abscess limb side effect. The patient presented with:
  • Abscess Limb
  • Disseminated Intravascular Coagulation
  • Sepsis
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Dacogen treatment in male patients suffering from myelodysplastic syndrome, resulting in abscess limb.

Infection, Disease Complication, Pneumonia, No Therapeutic Response
This report suggests a potential Dacogen (decitabine) Lyophilized Powder infection side effect(s) that can have serious consequences. A 75-year-old male patient from SG (weight:NA) was diagnosed with the following health condition(s): myelodysplastic syndrome and used Dacogen (decitabine) Lyophilized Powder (dosage: Almost 2 Years) starting NS. Soon after starting Dacogen (decitabine) Lyophilized Powder the patient began experiencing various side effects, including:
  • Infection
  • Disease Complication
  • Pneumonia
  • No Therapeutic Response
Drugs used concurrently:NA. Although Dacogen (decitabine) Lyophilized Powder demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as infection, may still occur.

Infection, Haemoglobin Decreased, Disease Progression, Candiduria, Myelodysplastic Syndrome, Fall, Arthralgia
This infection problem was reported by a physician from GB. A 68-year-old female patient (weight: NA) was diagnosed with the following medical condition(s): myelodysplastic syndrome.On Feb 18, 2013 a consumer started treatment with Dacogen (decitabine) Lyophilized Powder (dosage: 31 Mg, 1 In 1 Day, Intravenous). The following drugs/medications were being taken at the same time: NA. When commencing Dacogen (decitabine) Lyophilized Powder, the patient experienced the following unwanted symptoms /side effects:
  • Infection
  • Haemoglobin Decreased
  • Disease Progression
  • Candiduria
  • Myelodysplastic Syndrome
  • Fall
  • Arthralgia
The patient was hospitalized. Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as infection, may become evident only after a product is in use by the general population.

Erythema, Pancytopenia, C-reactive Protein Increased, Papule, Haemorrhage
This is a Dacogen (decitabine) Lyophilized Powder side effect report of a 63-year-old male patient (weight: NA) from DE. The patient developed the following symptoms/conditions: acute myeloid leukaemia and was treated with Dacogen (decitabine) Lyophilized Powder (dosage: NA) starting Sep 19, 2013. Concurrently used drugs:
  • Deferasirox
  • Cyklokapron (tranexamic Acid)
  • Lyrica (pregabalin)
  • Saroten (amitriptyline Hydrochloride)
  • Pantoprazole
  • Linezolid
Soon after that, the consumer experienced the following of symptoms:
  • Erythema
  • Pancytopenia
  • C-reactive Protein Increased
  • Papule
  • Haemorrhage
The patient was hospitalized. This opens a possibility that Dacogen (decitabine) Lyophilized Powder could cause erythema and that some male patients may be more susceptible.

Oesophageal Cancer Metastatic, Haematemesis, Gastrointestinal Haemorrhage
A 61-year-old female patient (weight: NA) from CN with the following symptoms: myelodysplastic syndrome started Dacogen (decitabine) Lyophilized Powder treatment (dosage: NA) on Apr 08, 2010. Soon after starting Dacogen (decitabine) Lyophilized Powder treatment, the consumer experienced several side effects, including:
  • Oesophageal Cancer Metastatic
  • Haematemesis
  • Gastrointestinal Haemorrhage
. Concurrently used drugs: NA. This finding indicates that some patients can be more vulnerable to developing Dacogen (decitabine) Lyophilized Powder side effects, such as oesophageal cancer metastatic.

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 (dosage: NA), which was started on NS. Concurrently used drugs: NA..When starting to take Dacogen (decitabine) Lyophilized Powder the consumer reported symptoms, such as:
  • Chest Pain
  • Haemoglobin Decreased
  • Breath Sounds Abnormal
  • Cardio-respiratory Arrest
These side effects may potentially be related to Dacogen (decitabine) Lyophilized Powder.

Bone Marrow Failure
This is a report of a patient (weight: NA) from US, suffering from the following 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). The consumer presented with:
  • Bone Marrow Failure
which developed 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.

Thrombocytopenia, Pulmonary Embolism, Leukopenia
This report suggests a potential Dacogen (decitabine) Lyophilized Powder Thrombocytopenia, Pulmonary Embolism, Leukopenia 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. Soon after starting Dacogen (decitabine) Lyophilized Powder the patient began experiencing various side effects, including:
  • Thrombocytopenia
  • Pulmonary Embolism
  • Leukopenia
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.

Platelet Count Decreased, Haematuria, Pneumonia, Dyspnoea, Pulmonary Oedema, Cardiac Arrest
This Platelet Count Decreased, Haematuria, Pneumonia, Dyspnoea, Pulmonary Oedema, Cardiac Arrest 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 commencing Dacogen (decitabine) Lyophilized Powder, the patient experienced the following unwanted symptoms/side effects:
  • Platelet Count Decreased
  • Haematuria
  • Pneumonia
  • Dyspnoea
  • Pulmonary Oedema
  • Cardiac Arrest
The 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.

Pancytopenia, Haemorrhage, Pyrexia
This is a report of a 19-year-old female patient (weight: NA) from KZ. The patient developed the following symptoms/conditions: myelodysplastic syndrome and was treated with Dacogen (dosage: NA) starting NS. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Pancytopenia
  • Haemorrhage
  • Pyrexia
This opens a possibility that Dacogen treatment could cause the above reactions, including pancytopenia, and some female subjects may be more susceptible.

Vomiting, Diarrhoea, Abdominal Pain, Tachypnoea, Tachycardia, Hypotension, Respiratory Failure, Renal Failure Acute, Occult Blood Positive
A female patient (weight: NA) from US with the following symptoms/conditions: acute myeloid leukaemia started Dacogen (decitabine) Lyophilized Powder treatment (dosage: NA) on Feb 25, 2013. Soon after starting Dacogen (decitabine) Lyophilized Powder treatment, the subject experienced various side effects, including:
  • Vomiting
  • Diarrhoea
  • Abdominal Pain
  • Tachypnoea
  • Tachycardia
  • Hypotension
  • Respiratory Failure
  • Renal Failure Acute
  • Occult Blood Positive
Concurrently used drugs:
  • Bortezomib
The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Dacogen (decitabine) Lyophilized Powder.

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Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • 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

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    Side Effects reported to FDA: 305

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    Reported deaths: 95

    Reported hospitalizations: 131

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