85/100 · Critical
Manufactured by Takeda Pharmaceuticals America, Inc.
High Safety Concerns with Ixazomib, Particularly for Serious Adverse Events
55,273 FDA adverse event reports analyzed
Last updated: 2026-05-12
IXAZOMIB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Takeda Pharmaceuticals America, Inc.. Based on analysis of 55,273 FDA adverse event reports, IXAZOMIB 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 IXAZOMIB include PLASMA CELL MYELOMA, DEATH, DIARRHOEA, OFF LABEL USE, PNEUMONIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for IXAZOMIB.
Ixazomib 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 55,273 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, Death, Diarrhoea. Of classified reports, 74.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Ixazomib has a high incidence of serious adverse events, with death being one of the most reported.
Neurological and hematological side effects are common, including peripheral neuropathy and thrombocytopenia. The drug is associated with a significant number of infections, particularly pneumonia and sepsis.
Patients taking Ixazomib should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Ixazomib is contraindicated in patients with severe renal impairment and caution is advised in patients with cardiac failure or peripheral edema. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Ixazomib received a safety concern score of 85/100 (high concern). This is based on a 74.2% serious event ratio across 28,422 classified reports. The score accounts for 55,273 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: 14,089, Female: 12,893. The most frequently reported age groups are age 73 (602 reports), age 74 (602 reports), age 71 (596 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 28,422 classified reports for IXAZOMIB:
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.
Ixazomib is contraindicated in patients with severe renal impairment and caution is advised in patients with cardiac failure or peripheral edema.
If you are taking Ixazomib, here are important things to know. The most commonly reported side effects include plasma cell myeloma, death, diarrhoea, off label use, pneumonia. 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 serious adverse events, especially neurological and hematological issues. Regular blood tests are recommended to check for hematological abnormalities. 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.
Regulatory authorities have issued warnings regarding the serious adverse events associated with Ixazomib, particularly in elderly patients.
The FDA has received approximately 55,273 adverse event reports associated with Ixazomib. 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 Ixazomib include Plasma Cell Myeloma, Death, Diarrhoea, Off Label Use, Pneumonia. By volume, the top reported reactions are: Plasma Cell Myeloma (3,635 reports), Death (3,297 reports), Diarrhoea (3,142 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Ixazomib.
Out of 28,422 classified reports, 21,097 (74.2%) were classified as serious and 7,325 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 Ixazomib break down by patient sex as follows: Male: 14,089, Female: 12,893. 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 Ixazomib adverse events are: age 73: 602 reports, age 74: 602 reports, age 71: 596 reports, age 70: 595 reports, age 72: 582 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 Ixazomib 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 Ixazomib include: Fatigue, Nausea, Neuropathy Peripheral, Vomiting, Rash. 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 Ixazomib 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.
Ixazomib 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. Ixazomib has a high incidence of serious adverse events, with death being one of the most reported.
Key safety signals identified in Ixazomib's adverse event data include: High rate of serious adverse events (74.2%). Multiple hematological issues including thrombocytopenia and neutropenia. Frequent respiratory issues, including pneumonia and respiratory tract infections. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Ixazomib is contraindicated in patients with severe renal impairment and caution is advised in patients with cardiac failure or peripheral edema. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Ixazomib.
Patients should be closely monitored for signs of serious adverse events, especially neurological and hematological issues. Regular blood tests are recommended to check for hematological abnormalities.
Ixazomib has 55,273 adverse event reports on file with the FDA. Neurological and hematological side effects are common, including peripheral neuropathy and thrombocytopenia. The volume of reports for Ixazomib reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory authorities have issued warnings regarding the serious adverse events associated with Ixazomib, 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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