78/100 · Elevated
Manufactured by UCB, Inc.
Certolizumab Pegol Adverse Events Show High Seriousness and Diverse Reactions
552,144 FDA adverse event reports analyzed
Last updated: 2026-05-12
CERTOLIZUMAB PEGOL is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by UCB, Inc.. Based on analysis of 552,144 FDA adverse event reports, CERTOLIZUMAB PEGOL has a safety score of 78 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 CERTOLIZUMAB PEGOL include DRUG INEFFECTIVE, RHEUMATOID ARTHRITIS, PAIN, FATIGUE, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CERTOLIZUMAB PEGOL.
Certolizumab Pegol has a safety concern score of 78 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 552,144 adverse event reports for this medication, which is primarily manufactured by Ucb, Inc..
The most commonly reported adverse events include Drug Ineffective, Rheumatoid Arthritis, Pain. Of classified reports, 64.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High percentage of serious adverse events (64.6%) indicates significant safety concerns.
A wide range of reactions, including infections, gastrointestinal issues, and musculoskeletal problems, are reported. The drug is frequently reported to be ineffective or have decreased therapeutic effect.
Patients taking Certolizumab Pegol should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Interactions and warnings include contraindications with other products and potential for systemic lupus erythematosus and pemphigus. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Certolizumab Pegol received a safety concern score of 78/100 (high concern). This is based on a 64.6% serious event ratio across 112,944 classified reports. The score accounts for 552,144 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: Female: 83,571, Male: 20,495, Unknown: 180. The most frequently reported age groups are age 44 (2,726 reports), age 43 (2,655 reports), age 40 (1,754 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 112,944 classified reports for CERTOLIZUMAB PEGOL:
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.
Interactions and warnings include contraindications with other products and potential for systemic lupus erythematosus and pemphigus.
If you are taking Certolizumab Pegol, here are important things to know. The most commonly reported side effects include drug ineffective, rheumatoid arthritis, pain, fatigue, off label use. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for signs of serious infections and gastrointestinal issues, as these are common and can be severe. Report any unexpected or severe side effects to healthcare providers 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 the safety of certolizumab pegol, with ongoing reviews of adverse event reports.
The FDA has received approximately 552,144 adverse event reports associated with Certolizumab Pegol. 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 Certolizumab Pegol include Drug Ineffective, Rheumatoid Arthritis, Pain, Fatigue, Off Label Use. By volume, the top reported reactions are: Drug Ineffective (26,532 reports), Rheumatoid Arthritis (19,136 reports), Pain (15,508 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Certolizumab Pegol.
Out of 112,944 classified reports, 72,975 (64.6%) were classified as serious and 39,969 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 Certolizumab Pegol break down by patient sex as follows: Female: 83,571, Male: 20,495, Unknown: 180. 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 Certolizumab Pegol adverse events are: age 44: 2,726 reports, age 43: 2,655 reports, age 40: 1,754 reports, age 59: 1,581 reports, age 60: 1,504 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 Certolizumab Pegol adverse event reports is Ucb, 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 Certolizumab Pegol include: Rash, Arthralgia, Alopecia, Joint Swelling, Abdominal Discomfort. 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 Certolizumab Pegol 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.
Certolizumab Pegol has a safety concern score of 78 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 percentage of serious adverse events (64.6%) indicates significant safety concerns.
Key safety signals identified in Certolizumab Pegol's adverse event data include: High number of serious adverse events (72,975 out of 112,944, 64.6%). Diverse reactions including infections, gastrointestinal issues, and musculoskeletal problems. Frequent reports of drug ineffectiveness and decreased therapeutic effect. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Interactions and warnings include contraindications with other products and potential for systemic lupus erythematosus and pemphigus. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Certolizumab Pegol.
Monitor for signs of serious infections and gastrointestinal issues, as these are common and can be severe. Report any unexpected or severe side effects to healthcare providers promptly.
Certolizumab Pegol has 552,144 adverse event reports on file with the FDA. A wide range of reactions, including infections, gastrointestinal issues, and musculoskeletal problems, are reported. The volume of reports for Certolizumab Pegol reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of certolizumab pegol, with ongoing reviews of adverse event reports. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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