DECITABINE

N/A

Manufactured by Accord Healthcare Inc.

8,659 FDA adverse event reports analyzed

Last updated: 2026-04-15

About DECITABINE

DECITABINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Accord Healthcare Inc.. The most commonly reported adverse reactions for DECITABINE include OFF LABEL USE, FEBRILE NEUTROPENIA, DRUG INEFFECTIVE, PNEUMONIA, MYELOSUPPRESSION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DECITABINE.

Top Adverse Reactions

OFF LABEL USE479 reports
FEBRILE NEUTROPENIA448 reports
DRUG INEFFECTIVE333 reports
PNEUMONIA308 reports
MYELOSUPPRESSION281 reports
NEUTROPENIA279 reports
DEATH277 reports
PYREXIA249 reports
ACUTE MYELOID LEUKAEMIA236 reports
THROMBOCYTOPENIA234 reports
PRODUCT USE IN UNAPPROVED INDICATION215 reports
SEPSIS202 reports
DISEASE PROGRESSION185 reports
NAUSEA178 reports
INFECTION175 reports
ANAEMIA163 reports
PANCYTOPENIA152 reports
PLATELET COUNT DECREASED146 reports
DIARRHOEA131 reports
FATIGUE130 reports
WHITE BLOOD CELL COUNT DECREASED119 reports
DYSPNOEA116 reports
ASTHENIA112 reports
RESPIRATORY FAILURE111 reports
BONE MARROW FAILURE109 reports
HAEMOGLOBIN DECREASED91 reports
THERAPY NON RESPONDER90 reports
MYELODYSPLASTIC SYNDROME86 reports
VOMITING86 reports
SEPTIC SHOCK84 reports
MUCOSAL INFLAMMATION73 reports
MALIGNANT NEOPLASM PROGRESSION71 reports
CARDIAC FAILURE69 reports
CONSTIPATION69 reports
CYTOPENIA66 reports
HYPOTENSION66 reports
DECREASED APPETITE64 reports
PRODUCT USE ISSUE63 reports
BACTERAEMIA62 reports
ACUTE MYELOID LEUKAEMIA RECURRENT61 reports
NEUTROPHIL COUNT DECREASED60 reports
GASTROINTESTINAL HAEMORRHAGE59 reports
ACUTE KIDNEY INJURY54 reports
HAEMATOTOXICITY54 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION53 reports
ATRIAL FIBRILLATION49 reports
COUGH48 reports
DIZZINESS48 reports
RASH47 reports
THERAPY PARTIAL RESPONDER47 reports
URINARY TRACT INFECTION47 reports
ABDOMINAL PAIN44 reports
DISEASE RECURRENCE43 reports
FALL42 reports
LUNG INFECTION42 reports
CONDITION AGGRAVATED40 reports
PLEURAL EFFUSION40 reports
TUMOUR LYSIS SYNDROME40 reports
GENERAL PHYSICAL HEALTH DETERIORATION39 reports
LEUKOPENIA39 reports
TREATMENT FAILURE37 reports
ALANINE AMINOTRANSFERASE INCREASED36 reports
CHILLS36 reports
FUNGAL INFECTION36 reports
GASTROINTESTINAL DISORDER36 reports
HYPOXIA36 reports
NEOPLASM PROGRESSION36 reports
PAIN36 reports
PNEUMONIA FUNGAL36 reports
HAEMORRHAGE35 reports
RENAL FAILURE35 reports
ASPERGILLUS INFECTION34 reports
CARDIAC ARREST34 reports
CONFUSIONAL STATE34 reports
DRUG RESISTANCE34 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME34 reports
TOXICITY TO VARIOUS AGENTS32 reports
COLITIS31 reports
HYPERBILIRUBINAEMIA31 reports
CHRONIC GRAFT VERSUS HOST DISEASE30 reports
COVID 1930 reports
DRUG INTERACTION30 reports
ESCHERICHIA BACTERAEMIA30 reports
HEADACHE30 reports
OEDEMA PERIPHERAL30 reports
BACTERIAL INFECTION29 reports
BRONCHOPULMONARY ASPERGILLOSIS29 reports
PULMONARY OEDEMA29 reports
RED BLOOD CELL COUNT DECREASED29 reports
BACK PAIN28 reports
CELLULITIS28 reports
HYPOKALAEMIA28 reports
ACUTE RESPIRATORY FAILURE27 reports
AGRANULOCYTOSIS27 reports
ARTHRALGIA27 reports
INTENTIONAL PRODUCT USE ISSUE27 reports
LEUKOCYTOSIS27 reports
PNEUMONITIS27 reports
PSEUDOMONAS INFECTION27 reports
THERAPEUTIC RESPONSE DECREASED27 reports

Report Outcomes

Out of 4,048 classified reports for DECITABINE:

Serious 94.8%Non-Serious 5.2%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Male1,943 (57.0%)
Female1,426 (41.9%)
Unknown38 (1.1%)

Reports by Age

Age 73124 reports
Age 7197 reports
Age 7094 reports
Age 7280 reports
Age 6779 reports
Age 6978 reports
Age 7776 reports
Age 7575 reports
Age 7474 reports
Age 6871 reports
Age 6568 reports
Age 6466 reports
Age 7666 reports
Age 6064 reports
Age 6363 reports
Age 6162 reports
Age 7862 reports
Age 7961 reports
Age 5957 reports
Age 5756 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with DECITABINE?

This profile reflects 8,659 FDA FAERS reports that mention DECITABINE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for DECITABINE?

Frequently reported terms in FAERS include OFF LABEL USE, FEBRILE NEUTROPENIA, DRUG INEFFECTIVE, PNEUMONIA, MYELOSUPPRESSION, NEUTROPENIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures DECITABINE?

Labeling and FAERS entries often list Accord Healthcare Inc. in connection with DECITABINE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.