82/100 · Critical
Manufactured by Pfizer Laboratories Div Pfizer Inc
Sunitinib Malate Adverse Events: High Serious Reaction Rate
93,209 FDA adverse event reports analyzed
Last updated: 2026-05-12
SUNITINIB MALATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Pfizer Laboratories Div Pfizer Inc. Based on analysis of 93,209 FDA adverse event reports, SUNITINIB MALATE has a safety score of 82 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 SUNITINIB MALATE include DEATH, DIARRHOEA, FATIGUE, DISEASE PROGRESSION, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for SUNITINIB MALATE.
Sunitinib Malate has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 93,209 adverse event reports for this medication, which is primarily manufactured by Pfizer Laboratories Div Pfizer Inc.
The most commonly reported adverse events include Death, Diarrhoea, Fatigue. Of classified reports, 77.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High incidence of serious reactions, particularly death and disease progression.
Significant gastrointestinal and hematological adverse events reported. Common reactions include fatigue, nausea, and decreased appetite.
Patients taking Sunitinib Malate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Sunitinib Malate can cause significant hematological and gastrointestinal side effects, and patients should be monitored closely for these issues. Drug interactions, particularly with other hematological agents, should be considered. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Sunitinib Malate received a safety concern score of 82/100 (high concern). This is based on a 77.1% serious event ratio across 38,962 classified reports. The score accounts for 93,209 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: 23,228, Female: 12,429, Unknown: 271. The most frequently reported age groups are age 65 (1,045 reports), age 68 (984 reports), age 66 (968 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 38,962 classified reports for SUNITINIB MALATE:
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.
Sunitinib Malate can cause significant hematological and gastrointestinal side effects, and patients should be monitored closely for these issues. Drug interactions, particularly with other hematological agents, should be considered.
If you are taking Sunitinib Malate, here are important things to know. The most commonly reported side effects include death, diarrhoea, fatigue, disease progression, 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 are recommended to monitor hematological parameters. 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 has issued warnings regarding the serious nature of adverse events associated with Sunitinib Malate. Healthcare providers should closely monitor patients and adjust dosing as necessary.
The FDA has received approximately 93,209 adverse event reports associated with Sunitinib Malate. 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 Sunitinib Malate include Death, Diarrhoea, Fatigue, Disease Progression, Nausea. By volume, the top reported reactions are: Death (7,365 reports), Diarrhoea (4,413 reports), Fatigue (4,186 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Sunitinib Malate.
Out of 38,962 classified reports, 30,040 (77.1%) were classified as serious and 8,922 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 Sunitinib Malate break down by patient sex as follows: Male: 23,228, Female: 12,429, Unknown: 271. 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 Sunitinib Malate adverse events are: age 65: 1,045 reports, age 68: 984 reports, age 66: 968 reports, age 70: 968 reports, age 67: 951 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 Sunitinib Malate adverse event reports is Pfizer Laboratories Div Pfizer 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 Sunitinib Malate include: Asthenia, Decreased Appetite, Vomiting, Neoplasm Progression, Hypertension. 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 Sunitinib Malate 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.
Sunitinib Malate has a safety concern score of 82 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 incidence of serious reactions, particularly death and disease progression.
Key safety signals identified in Sunitinib Malate's adverse event data include: Death and disease progression are among the most serious reactions.. Hematological issues such as decreased platelet count and thrombocytopenia are frequent.. Gastrointestinal symptoms like diarrhea and vomiting are commonly reported.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Sunitinib Malate can cause significant hematological and gastrointestinal side effects, and patients should be monitored closely for these issues. Drug interactions, particularly with other hematological agents, should be considered. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Sunitinib Malate.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Regular blood tests are recommended to monitor hematological parameters.
Sunitinib Malate has 93,209 adverse event reports on file with the FDA. Significant gastrointestinal and hematological adverse events reported. The volume of reports for Sunitinib Malate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA has issued warnings regarding the serious nature of adverse events associated with Sunitinib Malate. Healthcare providers should closely monitor patients and adjust dosing as necessary. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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