85/100 · Critical
Manufactured by ImClone LLC
Cetuximab Adverse Events: High Serious Reaction Rate
51,547 FDA adverse event reports analyzed
Last updated: 2026-05-12
CETUXIMAB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ImClone LLC. Based on analysis of 51,547 FDA adverse event reports, CETUXIMAB 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 CETUXIMAB include RASH, DIARRHOEA, OFF LABEL USE, NAUSEA, VOMITING. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CETUXIMAB.
Cetuximab 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 51,547 adverse event reports for this medication, which is primarily manufactured by Imclone Llc.
The most commonly reported adverse events include Rash, Diarrhoea, Off Label Use. Of classified reports, 84.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Cetuximab has a high rate of serious adverse events, particularly skin and gastrointestinal issues.
The most common reactions include rash, diarrhea, and nausea, which are often reported. Serious reactions such as death, malignant neoplasm progression, and sepsis are also frequently reported.
Patients taking Cetuximab should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Cetuximab can cause severe skin reactions and gastrointestinal issues, and patients should be monitored closely for these and other serious adverse events. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Cetuximab received a safety concern score of 85/100 (high concern). This is based on a 84.9% serious event ratio across 30,413 classified reports. The score accounts for 51,547 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: 17,208, Female: 8,723, Unknown: 251. The most frequently reported age groups are age 66 (765 reports), age 67 (749 reports), age 70 (744 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 30,413 classified reports for CETUXIMAB:
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.
Cetuximab can cause severe skin reactions and gastrointestinal issues, and patients should be monitored closely for these and other serious adverse events.
If you are taking Cetuximab, here are important things to know. The most commonly reported side effects include rash, diarrhoea, off label use, nausea, vomiting. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor patients for signs of severe skin reactions and gastrointestinal issues, and report any adverse events to healthcare providers promptly. Follow strict guidelines for administration to minimize infusion-related reactions. 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 oversight is ongoing, with cetuximab requiring close monitoring and management of adverse events, especially in elderly patients.
The FDA has received approximately 51,547 adverse event reports associated with Cetuximab. 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 Cetuximab include Rash, Diarrhoea, Off Label Use, Nausea, Vomiting. By volume, the top reported reactions are: Rash (2,235 reports), Diarrhoea (1,987 reports), Off Label Use (1,798 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Cetuximab.
Out of 30,413 classified reports, 25,829 (84.9%) were classified as serious and 4,584 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 Cetuximab break down by patient sex as follows: Male: 17,208, Female: 8,723, Unknown: 251. 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 Cetuximab adverse events are: age 66: 765 reports, age 67: 749 reports, age 70: 744 reports, age 65: 732 reports, age 68: 717 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 Cetuximab adverse event reports is Imclone Llc. 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 Cetuximab include: Dyspnoea, Neutropenia, Pyrexia, Dehydration, Infusion Related Reaction. 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 Cetuximab 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.
Cetuximab 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. Cetuximab has a high rate of serious adverse events, particularly skin and gastrointestinal issues.
Key safety signals identified in Cetuximab's adverse event data include: High rate of serious adverse events (84.9%). Common skin reactions like rash and dermatitis. Gastrointestinal issues such as diarrhea and nausea are frequent. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Cetuximab can cause severe skin reactions and gastrointestinal issues, and patients should be monitored closely for these and other serious adverse events. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Cetuximab.
Monitor patients for signs of severe skin reactions and gastrointestinal issues, and report any adverse events to healthcare providers promptly. Follow strict guidelines for administration to minimize infusion-related reactions.
Cetuximab has 51,547 adverse event reports on file with the FDA. The most common reactions include rash, diarrhea, and nausea, which are often reported. The volume of reports for Cetuximab reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with cetuximab requiring close monitoring and management of adverse events, especially in elderly patients. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
The following drugs share commonly reported adverse reactions with CETUXIMAB:
Drugs related to CETUXIMAB based on therapeutic use, drug class, or shared indications: