85/100 · Critical
Manufactured by Cordavis Limited
Adalimumab-Adaz Reports Show High Serious Event Rate
305,491 FDA adverse event reports analyzed
Last updated: 2026-05-12
ADALIMUMAB ADAZ is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Cordavis Limited. Based on analysis of 305,491 FDA adverse event reports, ADALIMUMAB ADAZ 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 ADALIMUMAB ADAZ include DRUG INEFFECTIVE, OFF LABEL USE, FATIGUE, RHEUMATOID ARTHRITIS, PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ADALIMUMAB ADAZ.
Adalimumab-Adaz 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 305,491 adverse event reports for this medication, which is primarily manufactured by Cordavis Limited.
The most commonly reported adverse events include Drug Ineffective, Off Label Use, Fatigue. Of classified reports, 93.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High percentage of serious adverse events (93.2%) indicates significant safety concerns.
A wide range of reactions reported, including infections, gastrointestinal issues, and musculoskeletal problems. The majority of reports (32,640) are non-serious, but the serious event rate is very high. Fatigue, rash, and pain are among the most frequently reported symptoms.
Patients taking Adalimumab-Adaz should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Interactions with other drugs, especially those affecting the immune system, should be monitored. Adalimumab-Adaz is contraindicated in patients with certain conditions and should be used with caution. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Adalimumab-Adaz received a safety concern score of 85/100 (high concern). This is based on a 93.2% serious event ratio across 47,730 classified reports. The score accounts for 305,491 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: 25,459, Male: 12,501, Unknown: 89. The most frequently reported age groups are age 43 (1,919 reports), age 44 (1,519 reports), age 40 (1,332 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 47,730 classified reports for ADALIMUMAB ADAZ:
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 with other drugs, especially those affecting the immune system, should be monitored. Adalimumab-Adaz is contraindicated in patients with certain conditions and should be used with caution.
If you are taking Adalimumab-Adaz, here are important things to know. The most commonly reported side effects include drug ineffective, off label use, fatigue, rheumatoid arthritis, 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 immediately. Follow all prescribed dosing instructions and do not discontinue treatment 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.
Regulatory oversight is ongoing, with a focus on monitoring serious adverse events and ensuring patient safety.
The FDA has received approximately 305,491 adverse event reports associated with Adalimumab-Adaz. 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-Adaz include Drug Ineffective, Off Label Use, Fatigue, Rheumatoid Arthritis, Pain. By volume, the top reported reactions are: Drug Ineffective (10,718 reports), Off Label Use (8,473 reports), Fatigue (5,832 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-Adaz.
Out of 47,730 classified reports, 44,466 (93.2%) were classified as serious and 3,264 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-Adaz break down by patient sex as follows: Female: 25,459, Male: 12,501, Unknown: 89. 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-Adaz adverse events are: age 43: 1,919 reports, age 44: 1,519 reports, age 40: 1,332 reports, age 59: 760 reports, age 56: 640 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-Adaz adverse event reports is Cordavis Limited. 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-Adaz include: Arthralgia, Rash, Condition Aggravated, Diarrhoea, Drug Intolerance. 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-Adaz 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-Adaz 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. High percentage of serious adverse events (93.2%) indicates significant safety concerns.
Key safety signals identified in Adalimumab-Adaz's adverse event data include: High rate of serious events (44,466 out of 47,730, 93.2%). Infections and gastrointestinal disorders are common. Musculoskeletal issues like arthralgia and joint swelling are frequently reported. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Interactions with other drugs, especially those affecting the immune system, should be monitored. Adalimumab-Adaz is contraindicated in patients with certain conditions and should be used with caution. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Adalimumab-Adaz.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Follow all prescribed dosing instructions and do not discontinue treatment without medical advice.
Adalimumab-Adaz has 305,491 adverse event reports on file with the FDA. A wide range of reactions reported, including infections, gastrointestinal issues, and musculoskeletal problems. The volume of reports for Adalimumab-Adaz reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with a focus on monitoring serious adverse events and ensuring patient safety. 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 ADAZ:
Drugs related to ADALIMUMAB ADAZ based on therapeutic use, drug class, or shared indications: