85/100 · Critical
Manufactured by E.R. Squibb & Sons, L.L.C.
High Safety Concerns with Ipilimumab: Serious Adverse Events Predominate
65,125 FDA adverse event reports analyzed
Last updated: 2026-05-12
IPILIMUMAB 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 65,125 FDA adverse event reports, IPILIMUMAB 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 IPILIMUMAB include DEATH, MALIGNANT NEOPLASM PROGRESSION, DIARRHOEA, OFF LABEL USE, COLITIS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for IPILIMUMAB.
Ipilimumab 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 65,125 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, Diarrhoea. Of classified reports, 88.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Ipilimumab reports predominantly involve serious adverse events, with death and malignant neoplasm progression being the most frequent.
A wide range of reactions are reported, indicating diverse safety concerns. The majority of reports are from male patients aged 65-75 years.
Patients taking Ipilimumab should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Ipilimumab can cause severe immune-mediated adverse reactions, and patients should be monitored for signs of these conditions. Drug interactions are not well-documented, but caution is advised when used with other immunosuppressive agents. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Ipilimumab received a safety concern score of 85/100 (high concern). This is based on a 88.8% serious event ratio across 41,217 classified reports. The score accounts for 65,125 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: 22,554, Female: 12,606, Unknown: 206. The most frequently reported age groups are age 68 (1,066 reports), age 70 (991 reports), age 71 (969 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 41,217 classified reports for IPILIMUMAB:
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.
Ipilimumab can cause severe immune-mediated adverse reactions, and patients should be monitored for signs of these conditions. Drug interactions are not well-documented, but caution is advised when used with other immunosuppressive agents.
If you are taking Ipilimumab, here are important things to know. The most commonly reported side effects include death, malignant neoplasm progression, diarrhoea, off label use, colitis. 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 severe adverse reactions, including respiratory and cardiac issues. Follow the prescribed dosing regimen and report any side effects to your healthcare provider promptly. 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 Ipilimumab for safety, and updates will be provided as necessary. Healthcare providers should report any adverse events to the FDA's MedWatch program.
The FDA has received approximately 65,125 adverse event reports associated with Ipilimumab. 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 Ipilimumab include Death, Malignant Neoplasm Progression, Diarrhoea, Off Label Use, Colitis. By volume, the top reported reactions are: Death (4,177 reports), Malignant Neoplasm Progression (3,667 reports), Diarrhoea (3,053 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Ipilimumab.
Out of 41,217 classified reports, 36,587 (88.8%) were classified as serious and 4,630 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 Ipilimumab break down by patient sex as follows: Male: 22,554, Female: 12,606, Unknown: 206. 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 Ipilimumab adverse events are: age 68: 1,066 reports, age 70: 991 reports, age 71: 969 reports, age 69: 960 reports, age 72: 952 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 Ipilimumab 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 Ipilimumab include: Pyrexia, Rash, Fatigue, Nausea, Intentional Product Use Issue. 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 Ipilimumab 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.
Ipilimumab 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. Ipilimumab reports predominantly involve serious adverse events, with death and malignant neoplasm progression being the most frequent.
Key safety signals identified in Ipilimumab's adverse event data include: High incidence of death and malignant neoplasm progression.. Significant reports of immune-mediated adverse events such as enterocolitis and hepatitis.. Multiple reports of respiratory and cardiac issues, including pneumonia and myocarditis.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Ipilimumab can cause severe immune-mediated adverse reactions, and patients should be monitored for signs of these conditions. Drug interactions are not well-documented, but caution is advised when used with other immunosuppressive agents. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Ipilimumab.
Patients should be closely monitored for signs of severe adverse reactions, including respiratory and cardiac issues. Follow the prescribed dosing regimen and report any side effects to your healthcare provider promptly.
Ipilimumab has 65,125 adverse event reports on file with the FDA. A wide range of reactions are reported, indicating diverse safety concerns. The volume of reports for Ipilimumab reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Ipilimumab for safety, and updates will be provided as necessary. Healthcare providers should report any adverse events to the FDA's MedWatch program. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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