AZACITIDINE FOR

N/A

Manufactured by Accord Healthcare Inc.

29,877 FDA adverse event reports analyzed

Last updated: 2026-04-14

About AZACITIDINE FOR

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

Top Adverse Reactions

FEBRILE NEUTROPENIA1,887 reports
DEATH1,740 reports
OFF LABEL USE1,421 reports
ACUTE MYELOID LEUKAEMIA1,224 reports
NEUTROPENIA1,220 reports
MYELOSUPPRESSION1,203 reports
PNEUMONIA998 reports
DRUG INEFFECTIVE959 reports
PYREXIA927 reports
THROMBOCYTOPENIA891 reports
ANAEMIA738 reports
INFECTION627 reports
SEPSIS626 reports
PANCYTOPENIA600 reports
PLATELET COUNT DECREASED542 reports
NAUSEA449 reports
WHITE BLOOD CELL COUNT DECREASED439 reports
CYTOPENIA428 reports
ACUTE MYELOID LEUKAEMIA RECURRENT415 reports
DIARRHOEA413 reports
NEUTROPHIL COUNT DECREASED406 reports
DISEASE PROGRESSION390 reports
SEPTIC SHOCK368 reports
FATIGUE328 reports
MYELODYSPLASTIC SYNDROME324 reports
ASTHENIA300 reports
TUMOUR LYSIS SYNDROME287 reports
VOMITING266 reports
ACUTE KIDNEY INJURY249 reports
COVID 19249 reports
HAEMOGLOBIN DECREASED244 reports
RESPIRATORY FAILURE244 reports
DYSPNOEA235 reports
GENERAL PHYSICAL HEALTH DETERIORATION220 reports
PRODUCT USE IN UNAPPROVED INDICATION211 reports
MALIGNANT NEOPLASM PROGRESSION197 reports
CONSTIPATION196 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME190 reports
HYPOTENSION189 reports
PRODUCT USE ISSUE182 reports
BRONCHOPULMONARY ASPERGILLOSIS173 reports
PNEUMONITIS172 reports
FALL165 reports
BACTERAEMIA159 reports
LEUKOPENIA158 reports
PLEURAL EFFUSION158 reports
CONDITION AGGRAVATED154 reports
ATRIAL FIBRILLATION152 reports
DECREASED APPETITE146 reports
PNEUMONIA FUNGAL143 reports
RASH143 reports
CARDIAC FAILURE142 reports
THERAPY NON RESPONDER142 reports
BONE MARROW FAILURE140 reports
HAEMATOTOXICITY134 reports
RENAL FAILURE133 reports
URINARY TRACT INFECTION131 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE128 reports
AGRANULOCYTOSIS127 reports
DIZZINESS127 reports
OEDEMA PERIPHERAL124 reports
TREATMENT FAILURE123 reports
COUGH120 reports
ABDOMINAL PAIN119 reports
CELLULITIS119 reports
EPISTAXIS117 reports
MALAISE117 reports
HYPOKALAEMIA115 reports
GASTROINTESTINAL HAEMORRHAGE114 reports
TOXICITY TO VARIOUS AGENTS113 reports
NEUTROPENIC SEPSIS110 reports
DRUG INTERACTION108 reports
FULL BLOOD COUNT DECREASED108 reports
LEUKOCYTOSIS107 reports
SYNCOPE104 reports
CEREBRAL HAEMORRHAGE103 reports
HYPOXIA103 reports
PAIN98 reports
BLOOD CREATININE INCREASED96 reports
COLITIS96 reports
HOSPITALISATION96 reports
PERICARDITIS95 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION92 reports
FUNGAL INFECTION92 reports
CARDIAC ARREST88 reports
DISEASE RECURRENCE87 reports
GRAFT VERSUS HOST DISEASE87 reports
PERICARDIAL EFFUSION87 reports
SUBDURAL HAEMATOMA86 reports
C REACTIVE PROTEIN INCREASED85 reports
CONFUSIONAL STATE85 reports
HAEMORRHAGE85 reports
ASPERGILLUS INFECTION82 reports
HEADACHE82 reports
RENAL IMPAIRMENT82 reports
WEIGHT DECREASED82 reports
BACK PAIN81 reports
MUCOSAL INFLAMMATION81 reports
INTENTIONAL PRODUCT USE ISSUE80 reports
TRANSFUSION79 reports

Report Outcomes

Out of 16,885 classified reports for AZACITIDINE FOR:

Serious 96.9%Non-Serious 3.1%

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

Male8,778 (60.1%)
Female5,824 (39.9%)
Unknown12 (0.1%)

Reports by Age

Age 72583 reports
Age 71572 reports
Age 73568 reports
Age 74530 reports
Age 70526 reports
Age 75517 reports
Age 76471 reports
Age 77463 reports
Age 79436 reports
Age 80420 reports
Age 78413 reports
Age 69409 reports
Age 68399 reports
Age 65362 reports
Age 81342 reports
Age 67333 reports
Age 62280 reports
Age 64266 reports
Age 66259 reports
Age 82235 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 AZACITIDINE FOR?

This profile reflects 29,877 FDA FAERS reports that mention AZACITIDINE FOR. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for AZACITIDINE FOR?

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

Who manufactures AZACITIDINE FOR?

Labeling and FAERS entries often list Accord Healthcare Inc. in connection with AZACITIDINE FOR. 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.