78/100 · Elevated
Manufactured by E.R. Squibb & Sons, L.L.C.
Abatacept Adverse Events: High Seriousness and Diverse Reactions
665,237 FDA adverse event reports analyzed
Last updated: 2026-05-12
ABATACEPT 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 665,237 FDA adverse event reports, ABATACEPT 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 ABATACEPT include DRUG INEFFECTIVE, RHEUMATOID ARTHRITIS, PAIN, ARTHRALGIA, JOINT SWELLING. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ABATACEPT.
Abatacept 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 665,237 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 Drug Ineffective, Rheumatoid Arthritis, Pain. Of classified reports, 61.1% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High percentage of serious adverse events (61.1%) indicates significant safety concerns.
A wide range of reactions reported, including infections, musculoskeletal issues, and skin disorders. Drug ineffectiveness and off-label use are common, suggesting potential misuse or inefficacy.
Patients taking Abatacept should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Abatacept is contraindicated in patients with active infections and should be used with caution in patients with a history of malignancy or immunodeficiency. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Abatacept received a safety concern score of 78/100 (high concern). This is based on a 61.1% serious event ratio across 132,930 classified reports. The score accounts for 665,237 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: 102,148, Male: 17,902, Unknown: 301. The most frequently reported age groups are age 63 (2,798 reports), age 44 (2,752 reports), age 60 (2,659 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 132,930 classified reports for ABATACEPT:
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.
Abatacept is contraindicated in patients with active infections and should be used with caution in patients with a history of malignancy or immunodeficiency.
If you are taking Abatacept, here are important things to know. The most commonly reported side effects include drug ineffective, rheumatoid arthritis, pain, arthralgia, joint swelling. 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 report any symptoms to your healthcare provider immediately. Follow prescribed dosing and use only as directed by your healthcare provider. 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 abatacept and has not issued any new warnings or restrictions based on this data.
The FDA has received approximately 665,237 adverse event reports associated with Abatacept. 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 Abatacept include Drug Ineffective, Rheumatoid Arthritis, Pain, Arthralgia, Joint Swelling. By volume, the top reported reactions are: Drug Ineffective (38,612 reports), Rheumatoid Arthritis (23,596 reports), Pain (21,295 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Abatacept.
Out of 132,930 classified reports, 81,179 (61.1%) were classified as serious and 51,751 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 Abatacept break down by patient sex as follows: Female: 102,148, Male: 17,902, Unknown: 301. 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 Abatacept adverse events are: age 63: 2,798 reports, age 44: 2,752 reports, age 60: 2,659 reports, age 59: 2,627 reports, age 43: 2,623 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 Abatacept 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 Abatacept include: Fatigue, Contraindicated Product Administered, Drug Intolerance, Rash, Off Label Use. 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 Abatacept 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.
Abatacept 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 (61.1%) indicates significant safety concerns.
Key safety signals identified in Abatacept's adverse event data include: High number of serious adverse events (81,179 out of 132,930, 61.1%). Diverse reactions including infections, musculoskeletal issues, and skin disorders. Common reactions like fatigue, pain, and joint swelling. Reports of drug intolerance and contraindicated product administration. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Abatacept is contraindicated in patients with active infections and should be used with caution in patients with a history of malignancy or immunodeficiency. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Abatacept.
Monitor for signs of serious infections and report any symptoms to your healthcare provider immediately. Follow prescribed dosing and use only as directed by your healthcare provider.
Abatacept has 665,237 adverse event reports on file with the FDA. A wide range of reactions reported, including infections, musculoskeletal issues, and skin disorders. The volume of reports for Abatacept reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of abatacept and has not issued any new warnings or restrictions based on this data. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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