85/100 · Critical
Manufactured by Celgene Corporation
High Safety Concerns with Azacitidine, Particularly for Serious Reactions
50,397 FDA adverse event reports analyzed
Last updated: 2026-05-12
AZACITIDINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Celgene Corporation. Based on analysis of 50,397 FDA adverse event reports, AZACITIDINE has a safety score of 85 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for AZACITIDINE include DEATH, FEBRILE NEUTROPENIA, ACUTE MYELOID LEUKAEMIA, PNEUMONIA, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for AZACITIDINE.
Azacitidine has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 50,397 adverse event reports for this medication, which is primarily manufactured by Celgene Corporation.
The most commonly reported adverse events include Death, Febrile Neutropenia, Acute Myeloid Leukaemia. Of classified reports, 95.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Azacitidine is associated with a high number of serious adverse reactions, including death, sepsis, and pneumonia.
The drug shows a significant risk of hematological toxicity, including anemia, neutropenia, and thrombocytopenia. There is a notable risk of infections and sepsis, which are among the most frequently reported adverse events.
Patients taking Azacitidine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Azacitidine can cause severe hematological and infectious complications, and patients should be monitored closely for signs of these adverse events. Drug interactions are not well-documented, but caution is advised when used with other hematological This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Azacitidine received a safety concern score of 85/100 (high concern). This is based on a 95.3% serious event ratio across 28,019 classified reports. The score accounts for 50,397 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Male: 14,796, Female: 9,536, Unknown: 226. The most frequently reported age groups are age 72 (896 reports), age 71 (886 reports), age 70 (849 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 28,019 classified reports for AZACITIDINE:
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 reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Azacitidine can cause severe hematological and infectious complications, and patients should be monitored closely for signs of these adverse events. Drug interactions are not well-documented, but caution is advised when used with other hematological
If you are taking Azacitidine, here are important things to know. The most commonly reported side effects include death, febrile neutropenia, acute myeloid leukaemia, pneumonia, off label use. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should be closely monitored for signs of severe infections, anemia, and neutropenia. Regular blood tests are essential to detect early signs of hematological toxicity. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA closely monitors the safety of Azacitidine, and any new or worsening symptoms should be reported to healthcare providers immediately. Regular blood tests are recommended to monitor for hematological toxicity.
The FDA has received approximately 50,397 adverse event reports associated with Azacitidine. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Azacitidine include Death, Febrile Neutropenia, Acute Myeloid Leukaemia, Pneumonia, Off Label Use. By volume, the top reported reactions are: Death (3,212 reports), Febrile Neutropenia (2,840 reports), Acute Myeloid Leukaemia (2,117 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Azacitidine.
Out of 28,019 classified reports, 26,701 (95.3%) were classified as serious and 1,318 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Azacitidine break down by patient sex as follows: Male: 14,796, Female: 9,536, Unknown: 226. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Azacitidine adverse events are: age 72: 896 reports, age 71: 886 reports, age 70: 849 reports, age 73: 844 reports, age 74: 836 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Azacitidine adverse event reports is Celgene Corporation. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Azacitidine include: Neutropenia, Pyrexia, Thrombocytopenia, Myelosuppression, Anaemia. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Azacitidine to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Azacitidine has a safety concern score of 85 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Azacitidine is associated with a high number of serious adverse reactions, including death, sepsis, and pneumonia.
Key safety signals identified in Azacitidine's adverse event data include: Death and sepsis are the most serious reactions reported, with a high frequency of occurrence.. Hematological toxicity, including anemia and neutropenia, is a key safety signal.. Infections and sepsis are frequently reported, indicating a significant risk of severe infections.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Azacitidine can cause severe hematological and infectious complications, and patients should be monitored closely for signs of these adverse events. Drug interactions are not well-documented, but caution is advised when used with other hematological Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Azacitidine.
Patients should be closely monitored for signs of severe infections, anemia, and neutropenia. Regular blood tests are essential to detect early signs of hematological toxicity.
Azacitidine has 50,397 adverse event reports on file with the FDA. The drug shows a significant risk of hematological toxicity, including anemia, neutropenia, and thrombocytopenia. The volume of reports for Azacitidine reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors the safety of Azacitidine, and any new or worsening symptoms should be reported to healthcare providers immediately. Regular blood tests are recommended to monitor for hematological toxicity. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by Celgene Corporation and compare their safety profiles:
The following drugs share commonly reported adverse reactions with AZACITIDINE:
Drugs related to AZACITIDINE based on therapeutic use, drug class, or shared indications: