85/100 · Critical
Manufactured by AbbVie Inc.
Venetoclax Adverse Events: High Seriousness and Diverse Reactions
98,823 FDA adverse event reports analyzed
Last updated: 2026-05-12
VENETOCLAX is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by AbbVie Inc.. Based on analysis of 98,823 FDA adverse event reports, VENETOCLAX 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 VENETOCLAX include DEATH, OFF LABEL USE, NEUTROPENIA, FEBRILE NEUTROPENIA, PLATELET COUNT DECREASED. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for VENETOCLAX.
Venetoclax 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 98,823 adverse event reports for this medication, which is primarily manufactured by Abbvie Inc..
The most commonly reported adverse events include Death, Off Label Use, Neutropenia. Of classified reports, 90.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High percentage of serious adverse events (90.2%) indicates significant safety concerns.
Neutropenia and pneumonia are among the top reactions, highlighting potential immune system impacts. A wide range of reactions, including death and sepsis, underscores the drug's broad safety profile.
Patients taking Venetoclax should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Venetoclax can cause severe hematological reactions such as neutropenia and thrombocytopenia, and patients should be monitored for signs of infection and myelosuppression. Drug interactions, particularly with other hematopoietic agents, are a concern This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Venetoclax received a safety concern score of 85/100 (high concern). This is based on a 90.2% serious event ratio across 57,829 classified reports. The score accounts for 98,823 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: 32,228, Female: 20,010, Unknown: 2. The most frequently reported age groups are age 70 (1,384 reports), age 73 (1,328 reports), age 72 (1,260 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 57,829 classified reports for VENETOCLAX:
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.
Venetoclax can cause severe hematological reactions such as neutropenia and thrombocytopenia, and patients should be monitored for signs of infection and myelosuppression. Drug interactions, particularly with other hematopoietic agents, are a concern
If you are taking Venetoclax, here are important things to know. The most commonly reported side effects include death, off label use, neutropenia, febrile neutropenia, platelet count decreased. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor patients closely for signs of infection, particularly neutropenia and pneumonia, and adjust dosing as necessary. Inform patients about the potential for severe adverse events and the importance of adhering to prescribed dosing. 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 continues to monitor Venetoclax for safety, and healthcare providers should report any adverse events. The drug is approved for specific indications and should be used with caution in patients with pre-existing conditions.
The FDA has received approximately 98,823 adverse event reports associated with Venetoclax. 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 Venetoclax include Death, Off Label Use, Neutropenia, Febrile Neutropenia, Platelet Count Decreased. By volume, the top reported reactions are: Death (9,739 reports), Off Label Use (6,503 reports), Neutropenia (3,217 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Venetoclax.
Out of 57,829 classified reports, 52,177 (90.2%) were classified as serious and 5,652 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 Venetoclax break down by patient sex as follows: Male: 32,228, Female: 20,010, Unknown: 2. 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 Venetoclax adverse events are: age 70: 1,384 reports, age 73: 1,328 reports, age 72: 1,260 reports, age 75: 1,246 reports, age 74: 1,236 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 Venetoclax adverse event reports is Abbvie Inc.. 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 Venetoclax include: Pyrexia, Pneumonia, Fatigue, Diarrhoea, Myelosuppression. 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 Venetoclax 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.
Venetoclax 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. High percentage of serious adverse events (90.2%) indicates significant safety concerns.
Key safety signals identified in Venetoclax's adverse event data include: Neutropenia and pneumonia are key safety signals, with high counts and serious nature.. Death and sepsis are critical safety signals, indicating severe adverse outcomes.. A wide variety of reactions, including hematological and respiratory issues, are reported.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Venetoclax can cause severe hematological reactions such as neutropenia and thrombocytopenia, and patients should be monitored for signs of infection and myelosuppression. Drug interactions, particularly with other hematopoietic agents, are a concern Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Venetoclax.
Monitor patients closely for signs of infection, particularly neutropenia and pneumonia, and adjust dosing as necessary. Inform patients about the potential for severe adverse events and the importance of adhering to prescribed dosing.
Venetoclax has 98,823 adverse event reports on file with the FDA. Neutropenia and pneumonia are among the top reactions, highlighting potential immune system impacts. The volume of reports for Venetoclax reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Venetoclax for safety, and healthcare providers should report any adverse events. The drug is approved for specific indications and should be used with caution in patients with pre-existing conditions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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