85/100 · Critical
Manufactured by E.R. Squibb & Sons, L.L.C.
High Safety Concerns with Nivolumab, Particularly for Serious Reactions
139,909 FDA adverse event reports analyzed
Last updated: 2026-05-12
NIVOLUMAB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by E.R. Squibb & Sons, L.L.C.. Based on analysis of 139,909 FDA adverse event reports, NIVOLUMAB 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 NIVOLUMAB include DEATH, MALIGNANT NEOPLASM PROGRESSION, 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 NIVOLUMAB.
Nivolumab 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 139,909 adverse event reports for this medication, which is primarily manufactured by E.R. Squibb & Sons, L.L.C..
The most commonly reported adverse events include Death, Malignant Neoplasm Progression, Off Label Use. Of classified reports, 89.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Nivolumab reports a high percentage of serious adverse events, with death and malignant neoplasm progression being the most frequent.
The drug is associated with a wide range of immune-mediated reactions, including colitis, pneumonitis, and interstitial lung disease. Significant gastrointestinal and respiratory issues are reported, with diarrhea, pneumonia, and colitis being common.
Patients taking Nivolumab should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Nivolumab can cause immune-mediated adverse events, and patients should be monitored for signs of colitis, pneumonitis, and interstitial lung disease. Drug interactions are not well-documented, but caution is advised when used with other immunosuppre This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Nivolumab received a safety concern score of 85/100 (high concern). This is based on a 89.7% serious event ratio across 92,260 classified reports. The score accounts for 139,909 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: 52,001, Female: 27,815, Unknown: 6. The most frequently reported age groups are age 68 (2,395 reports), age 70 (2,356 reports), age 69 (2,330 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 92,260 classified reports for NIVOLUMAB:
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.
Nivolumab can cause immune-mediated adverse events, and patients should be monitored for signs of colitis, pneumonitis, and interstitial lung disease. Drug interactions are not well-documented, but caution is advised when used with other immunosuppre
If you are taking Nivolumab, here are important things to know. The most commonly reported side effects include death, malignant neoplasm progression, 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 report any new or worsening symptoms to their healthcare provider immediately. Regular monitoring for immune-mediated adverse events is crucial, especially for gastrointestinal and respiratory symptoms. 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 the safety profile of Nivolumab and has issued several safety alerts, particularly regarding immune-mediated adverse events. Healthcare providers should be vigilant in managing these risks.
The FDA has received approximately 139,909 adverse event reports associated with Nivolumab. 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 Nivolumab include Death, Malignant Neoplasm Progression, Off Label Use, Diarrhoea, Fatigue. By volume, the top reported reactions are: Death (11,508 reports), Malignant Neoplasm Progression (9,599 reports), Off Label Use (5,881 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Nivolumab.
Out of 92,260 classified reports, 82,741 (89.7%) were classified as serious and 9,519 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 Nivolumab break down by patient sex as follows: Male: 52,001, Female: 27,815, Unknown: 6. 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 Nivolumab adverse events are: age 68: 2,395 reports, age 70: 2,356 reports, age 69: 2,330 reports, age 71: 2,224 reports, age 67: 2,221 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 Nivolumab adverse event reports is E.R. Squibb & Sons, L.L.C.. 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 Nivolumab include: Pyrexia, Intentional Product Use Issue, Nausea, Rash, Decreased Appetite. 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 Nivolumab 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.
Nivolumab 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. Nivolumab reports a high percentage of serious adverse events, with death and malignant neoplasm progression being the most frequent.
Key safety signals identified in Nivolumab's adverse event data include: High incidence of immune-mediated adverse events, including colitis, pneumonitis, and interstitial lung disease.. Significant number of serious adverse events, with death and malignant neoplasm progression being the most common.. Widespread impact on multiple organ systems, including gastrointestinal, respiratory, and cardiovascular.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Nivolumab can cause immune-mediated adverse events, and patients should be monitored for signs of colitis, pneumonitis, and interstitial lung disease. Drug interactions are not well-documented, but caution is advised when used with other immunosuppre Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Nivolumab.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Regular monitoring for immune-mediated adverse events is crucial, especially for gastrointestinal and respiratory symptoms.
Nivolumab has 139,909 adverse event reports on file with the FDA. The drug is associated with a wide range of immune-mediated reactions, including colitis, pneumonitis, and interstitial lung disease. The volume of reports for Nivolumab reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety profile of Nivolumab and has issued several safety alerts, particularly regarding immune-mediated adverse events. Healthcare providers should be vigilant in managing these risks. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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