85/100 · Critical
Manufactured by Takeda Pharmaceuticals America, Inc.
High Safety Concerns with Bortezomib, Particularly for Serious Adverse Events
141,037 FDA adverse event reports analyzed
Last updated: 2026-05-12
BORTEZOMIB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Takeda Pharmaceuticals America, Inc.. Based on analysis of 141,037 FDA adverse event reports, BORTEZOMIB 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 BORTEZOMIB include PLASMA CELL MYELOMA, NEUROPATHY PERIPHERAL, OFF LABEL USE, DIARRHOEA, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BORTEZOMIB.
Bortezomib 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 141,037 adverse event reports for this medication, which is primarily manufactured by Takeda Pharmaceuticals America, Inc..
The most commonly reported adverse events include Plasma Cell Myeloma, Neuropathy Peripheral, Off Label Use. Of classified reports, 83.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Bortezomib is associated with a high number of serious adverse events, including death and pneumonia.
Peripheral neuropathy and thrombocytopenia are common side effects, affecting a significant portion of users. The drug is frequently reported to be ineffective, leading to disease progression and therapy non-responder status.
Patients taking Bortezomib should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Bortezomib can cause severe drug interactions, including with other chemotherapy agents, and warnings are issued for its use in unapproved indications. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Bortezomib received a safety concern score of 85/100 (high concern). This is based on a 83.7% serious event ratio across 86,281 classified reports. The score accounts for 141,037 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: 38,879, Female: 31,457, Unknown: 1,583. The most frequently reported age groups are age 65 (2,039 reports), age 68 (2,034 reports), age 69 (1,991 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 86,281 classified reports for BORTEZOMIB:
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.
Bortezomib can cause severe drug interactions, including with other chemotherapy agents, and warnings are issued for its use in unapproved indications.
If you are taking Bortezomib, here are important things to know. The most commonly reported side effects include plasma cell myeloma, neuropathy peripheral, off label use, diarrhoea, fatigue. 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 peripheral neuropathy and thrombocytopenia, and any symptoms should be reported to their healthcare provider immediately. Avoid using Bortezomib in unapproved indications as it may be ineffective and increase the risk of serious adverse events. 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 Bortezomib due to its high rate of serious adverse events, particularly in elderly patients.
The FDA has received approximately 141,037 adverse event reports associated with Bortezomib. 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 Bortezomib include Plasma Cell Myeloma, Neuropathy Peripheral, Off Label Use, Diarrhoea, Fatigue. By volume, the top reported reactions are: Plasma Cell Myeloma (8,874 reports), Neuropathy Peripheral (6,256 reports), Off Label Use (6,143 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Bortezomib.
Out of 86,281 classified reports, 72,190 (83.7%) were classified as serious and 14,091 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 Bortezomib break down by patient sex as follows: Male: 38,879, Female: 31,457, Unknown: 1,583. 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 Bortezomib adverse events are: age 65: 2,039 reports, age 68: 2,034 reports, age 69: 1,991 reports, age 70: 1,914 reports, age 67: 1,858 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 Bortezomib adverse event reports is Takeda Pharmaceuticals America, 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 Bortezomib include: Death, Pneumonia, Drug Ineffective, Thrombocytopenia, Nausea. 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 Bortezomib 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.
Bortezomib 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. Bortezomib is associated with a high number of serious adverse events, including death and pneumonia.
Key safety signals identified in Bortezomib's adverse event data include: Death is one of the most serious adverse events reported, with 4,100 reports.. Peripheral neuropathy and thrombocytopenia are key safety signals, with 6,256 and 3,577 reports respectively.. The drug is often reported as ineffective, with 3,584 reports of drug ineffectiveness.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Bortezomib can cause severe drug interactions, including with other chemotherapy agents, and warnings are issued for its use in unapproved indications. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Bortezomib.
Patients should be closely monitored for signs of peripheral neuropathy and thrombocytopenia, and any symptoms should be reported to their healthcare provider immediately. Avoid using Bortezomib in unapproved indications as it may be ineffective and increase the risk of serious adverse events.
Bortezomib has 141,037 adverse event reports on file with the FDA. Peripheral neuropathy and thrombocytopenia are common side effects, affecting a significant portion of users. The volume of reports for Bortezomib reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Bortezomib due to its high rate of serious adverse events, particularly in elderly patients. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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