72/100 · Elevated
Manufactured by Biocon Biologics Inc
Adalimumab-FKJP Safety Profile: Common Reactions and Warnings
281,217 FDA adverse event reports analyzed
Last updated: 2026-05-12
ADALIMUMAB FKJP is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Biocon Biologics Inc. Based on analysis of 281,217 FDA adverse event reports, ADALIMUMAB FKJP has a safety score of 72 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 FKJP include DRUG INEFFECTIVE, OFF LABEL USE, RHEUMATOID ARTHRITIS, PAIN, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ADALIMUMAB FKJP.
Adalimumab-Fkjp has a safety concern score of 72 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 281,217 adverse event reports for this medication, which is primarily manufactured by Biocon Biologics Inc.
The most commonly reported adverse events include Drug Ineffective, Off Label Use, Rheumatoid Arthritis. Of classified reports, 95.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The most common reactions include pain, fatigue, and rash, indicating a broad range of potential side effects.
Serious reactions such as systemic lupus erythematosus and pericarditis are reported, but occur less frequently. Drug intolerance and treatment failure are significant concerns, affecting a substantial portion of users.
Patients taking Adalimumab-Fkjp should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Adalimumab-FKJP may interact with other immunosuppressants, and patients should be monitored for signs of infection and other adverse reactions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Adalimumab-Fkjp received a safety concern score of 72/100 (elevated concern). This is based on a 95.4% serious event ratio across 42,143 classified reports. The score accounts for 281,217 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: 21,551, Male: 10,432, Unknown: 86. The most frequently reported age groups are age 43 (1,604 reports), age 44 (1,410 reports), age 40 (1,127 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 42,143 classified reports for ADALIMUMAB FKJP:
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-FKJP may interact with other immunosuppressants, and patients should be monitored for signs of infection and other adverse reactions.
If you are taking Adalimumab-Fkjp, here are important things to know. The most commonly reported side effects include drug ineffective, off label use, rheumatoid arthritis, pain, fatigue. 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. Regular monitoring for signs of infection and other serious adverse reactions is recommended. 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 adalimumab-FKJP, and updates will be provided based on ongoing studies and reports.
The FDA has received approximately 281,217 adverse event reports associated with Adalimumab-Fkjp. 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-Fkjp include Drug Ineffective, Off Label Use, Rheumatoid Arthritis, Pain, Fatigue. By volume, the top reported reactions are: Drug Ineffective (10,138 reports), Off Label Use (7,909 reports), Rheumatoid Arthritis (5,480 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-Fkjp.
Out of 42,143 classified reports, 40,186 (95.4%) were classified as serious and 1,957 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-Fkjp break down by patient sex as follows: Female: 21,551, Male: 10,432, Unknown: 86. 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-Fkjp adverse events are: age 43: 1,604 reports, age 44: 1,410 reports, age 40: 1,127 reports, age 59: 685 reports, age 56: 560 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-Fkjp adverse event reports is Biocon Biologics 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-Fkjp 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-Fkjp 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-Fkjp has a safety concern score of 72 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 most common reactions include pain, fatigue, and rash, indicating a broad range of potential side effects.
Key safety signals identified in Adalimumab-Fkjp's adverse event data include: Systemic lupus erythematosus and pericarditis are key safety signals, though less common.. Drug intolerance and treatment failure are notable safety signals, affecting a significant number of patients.. Infections, particularly pneumonia and lower respiratory tract infections, are frequent but generally non-serious.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Adalimumab-FKJP may interact with other immunosuppressants, and patients should be monitored for signs of infection and other adverse reactions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Adalimumab-Fkjp.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Regular monitoring for signs of infection and other serious adverse reactions is recommended.
Adalimumab-Fkjp has 281,217 adverse event reports on file with the FDA. Serious reactions such as systemic lupus erythematosus and pericarditis are reported, but occur less frequently. The volume of reports for Adalimumab-Fkjp reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of adalimumab-FKJP, 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.
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