85/100 · Critical
Manufactured by Genentech, Inc.
Bevacizumab Adverse Events: High Seriousness and Diverse Reactions
204,762 FDA adverse event reports analyzed
Last updated: 2026-05-12
BEVACIZUMAB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Genentech, Inc.. Based on analysis of 204,762 FDA adverse event reports, BEVACIZUMAB 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 BEVACIZUMAB include OFF LABEL USE, DEATH, DISEASE PROGRESSION, DIARRHOEA, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BEVACIZUMAB.
Bevacizumab 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 204,762 adverse event reports for this medication, which is primarily manufactured by Genentech, Inc..
The most commonly reported adverse events include Off Label Use, Death, Disease Progression. Of classified reports, 91.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Bevacizumab reports include a high percentage of serious adverse events, with death being one of the most common.
The drug is associated with a wide range of reactions, including gastrointestinal, hematological, and respiratory issues. Fatigue, nausea, and diarrhea are among the most frequently reported non-serious adverse events.
Patients taking Bevacizumab should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Bevacizumab can cause severe hematological and respiratory adverse events, and patients should be monitored closely for these conditions. Drug interactions are not well-documented, but caution is advised when used with other hematological or respirat This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Bevacizumab received a safety concern score of 85/100 (high concern). This is based on a 91.1% serious event ratio across 118,680 classified reports. The score accounts for 204,762 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: Female: 52,772, Male: 44,624, Unknown: 1,166. The most frequently reported age groups are age 65 (2,331 reports), age 70 (2,209 reports), age 60 (2,134 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 118,680 classified reports for BEVACIZUMAB:
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.
Bevacizumab can cause severe hematological and respiratory adverse events, and patients should be monitored closely for these conditions. Drug interactions are not well-documented, but caution is advised when used with other hematological or respirat
If you are taking Bevacizumab, here are important things to know. The most commonly reported side effects include off label use, death, disease progression, diarrhoea, nausea. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any new or worsening symptoms to their healthcare provider immediately. Regular blood tests and monitoring of vital signs are recommended to detect potential adverse events early. 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 Bevacizumab for safety, and updates are regularly issued based on new data. Healthcare providers should stay informed about the latest safety information and guidelines.
The FDA has received approximately 204,762 adverse event reports associated with Bevacizumab. 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 Bevacizumab include Off Label Use, Death, Disease Progression, Diarrhoea, Nausea. By volume, the top reported reactions are: Off Label Use (13,542 reports), Death (12,987 reports), Disease Progression (7,200 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Bevacizumab.
Out of 118,680 classified reports, 108,109 (91.1%) were classified as serious and 10,571 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 Bevacizumab break down by patient sex as follows: Female: 52,772, Male: 44,624, Unknown: 1,166. 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 Bevacizumab adverse events are: age 65: 2,331 reports, age 70: 2,209 reports, age 60: 2,134 reports, age 63: 2,119 reports, age 67: 2,086 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 Bevacizumab adverse event reports is Genentech, 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 Bevacizumab include: Fatigue, Hypertension, Vomiting, Anaemia, Pyrexia. 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 Bevacizumab 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.
Bevacizumab 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. Bevacizumab reports include a high percentage of serious adverse events, with death being one of the most common.
Key safety signals identified in Bevacizumab's adverse event data include: High percentage of serious adverse events (91.1%). Multiple hematological issues like anemia, neutropenia, and thrombocytopenia. Significant respiratory issues including dyspnea and interstitial lung disease. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Bevacizumab can cause severe hematological and respiratory adverse events, and patients should be monitored closely for these conditions. Drug interactions are not well-documented, but caution is advised when used with other hematological or respirat Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Bevacizumab.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Regular blood tests and monitoring of vital signs are recommended to detect potential adverse events early.
Bevacizumab has 204,762 adverse event reports on file with the FDA. The drug is associated with a wide range of reactions, including gastrointestinal, hematological, and respiratory issues. The volume of reports for Bevacizumab reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Bevacizumab for safety, and updates are regularly issued based on new data. Healthcare providers should stay informed about the latest safety information and guidelines. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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