65/100 · Elevated
Manufactured by CELLTRION USA, Inc.
Adverse Reactions to Adalimumab-AATY: Mostly Non-Serious but Diverse
280,977 FDA adverse event reports analyzed
Last updated: 2026-05-12
ADALIMUMAB AATY is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by CELLTRION USA, Inc.. Based on analysis of 280,977 FDA adverse event reports, ADALIMUMAB AATY has a safety score of 65 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for ADALIMUMAB AATY include DRUG INEFFECTIVE, OFF LABEL USE, RHEUMATOID ARTHRITIS, FATIGUE, PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ADALIMUMAB AATY.
Adalimumab-Aaty has a safety concern score of 65 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 280,977 adverse event reports for this medication, which is primarily manufactured by Celltrion Usa, Inc..
The most commonly reported adverse events include Drug Ineffective, Off Label Use, Rheumatoid Arthritis. Of classified reports, 94.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of reported reactions are non-serious, but the diversity of reactions is high.
Fatigue, pain, and rash are among the most commonly reported side effects. Serious reactions, though less frequent, include infections and liver injury. The drug is often used off-label, which may contribute to the reported adverse events. There is a notable gender imbalance, with more female reports than male.
Patients taking Adalimumab-Aaty should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Adalimumab-AATY is contraindicated in patients with known hypersensitivity to the drug. It should be used with caution in patients with a history of serious infections. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Adalimumab-Aaty received a safety concern score of 65/100 (elevated concern). This is based on a 94.9% serious event ratio across 42,334 classified reports. The score accounts for 280,977 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 20,965, Male: 10,017, Unknown: 85. The most frequently reported age groups are age 43 (1,594 reports), age 44 (1,406 reports), age 40 (1,118 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 42,334 classified reports for ADALIMUMAB AATY:
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.
Adalimumab-AATY is contraindicated in patients with known hypersensitivity to the drug. It should be used with caution in patients with a history of serious infections.
If you are taking Adalimumab-Aaty, here are important things to know. The most commonly reported side effects include drug ineffective, off label use, rheumatoid arthritis, fatigue, pain. 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 promptly. Follow the prescribed treatment plan and do not alter the dosage without medical advice. 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 Adalimumab-AATY, and updates will be provided based on ongoing studies and reports.
The FDA has received approximately 280,977 adverse event reports associated with Adalimumab-Aaty. 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 Adalimumab-Aaty include Drug Ineffective, Off Label Use, Rheumatoid Arthritis, Fatigue, Pain. By volume, the top reported reactions are: Drug Ineffective (10,014 reports), Off Label Use (7,675 reports), Rheumatoid Arthritis (5,448 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Adalimumab-Aaty.
Out of 42,334 classified reports, 40,159 (94.9%) were classified as serious and 2,175 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 Adalimumab-Aaty break down by patient sex as follows: Female: 20,965, Male: 10,017, Unknown: 85. 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 Adalimumab-Aaty adverse events are: age 43: 1,594 reports, age 44: 1,406 reports, age 40: 1,118 reports, age 59: 671 reports, age 56: 549 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 Adalimumab-Aaty adverse event reports is Celltrion Usa, 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 Adalimumab-Aaty include: Arthralgia, Rash, Condition Aggravated, Drug Intolerance, Systemic Lupus Erythematosus. 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 Adalimumab-Aaty 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.
Adalimumab-Aaty has a safety concern score of 65 out of 100 (elevated 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. The majority of reported reactions are non-serious, but the diversity of reactions is high.
Key safety signals identified in Adalimumab-Aaty's adverse event data include: High diversity of reactions reported, including systemic lupus erythematosus and pneumonia.. Serious reactions such as pericarditis and liver injury are reported but less frequently.. Off-label use is common, which may increase the risk of adverse events.. Gender imbalance in reporting, with more female reports than male.. Infections are a significant concern, with multiple types reported.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Adalimumab-AATY is contraindicated in patients with known hypersensitivity to the drug. It should be used with caution in patients with a history of serious infections. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Adalimumab-Aaty.
Patients should report any new or worsening symptoms to their healthcare provider promptly. Follow the prescribed treatment plan and do not alter the dosage without medical advice.
Adalimumab-Aaty has 280,977 adverse event reports on file with the FDA. Fatigue, pain, and rash are among the most commonly reported side effects. The volume of reports for Adalimumab-Aaty reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety profile of Adalimumab-AATY, and updates will be provided based on ongoing studies and reports. 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 ADALIMUMAB AATY:
Drugs related to ADALIMUMAB AATY based on therapeutic use, drug class, or shared indications: