72/100 · Elevated
Manufactured by AbbVie Inc.
Adalimumab Adverse Events: Pain and Fatigue Predominate, with Serious Reactions Notably High
1,482,766 FDA adverse event reports analyzed
Last updated: 2026-05-12
ADALIMUMAB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by AbbVie Inc.. Based on analysis of 1,482,766 FDA adverse event reports, ADALIMUMAB 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 include DRUG INEFFECTIVE, PAIN, ARTHRALGIA, INJECTION SITE PAIN, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ADALIMUMAB.
Adalimumab 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 1,482,766 adverse event reports for this medication, which is primarily manufactured by Abbvie Inc..
The most commonly reported adverse events include Drug Ineffective, Pain, Arthralgia. Of classified reports, 50.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Pain and fatigue are the most frequently reported adverse events, with pain being the most common.
Serious adverse events account for nearly 51% of all reports, indicating a significant risk. Injection site reactions and gastrointestinal issues are also commonly reported.
Patients taking Adalimumab should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Adalimumab can cause injection site reactions and may interact with other drugs, leading to adverse effects. Patients should be monitored for signs of infection and respiratory issues. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Adalimumab received a safety concern score of 72/100 (elevated concern). This is based on a 50.6% serious event ratio across 695,797 classified reports. The score accounts for 1,482,766 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: 446,644, Male: 209,784, Unknown: 1,947. The most frequently reported age groups are age 60 (9,357 reports), age 59 (9,171 reports), age 58 (9,079 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 695,797 classified reports for ADALIMUMAB:
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 can cause injection site reactions and may interact with other drugs, leading to adverse effects. Patients should be monitored for signs of infection and respiratory issues.
If you are taking Adalimumab, here are important things to know. The most commonly reported side effects include drug ineffective, pain, arthralgia, injection site 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 promptly. Follow prescribed dosing instructions carefully to minimize the risk of adverse events. 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 adalimumab for safety, and updates are regularly issued based on new data.
The FDA has received approximately 1,482,766 adverse event reports associated with Adalimumab. 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 include Drug Ineffective, Pain, Arthralgia, Injection Site Pain, Fatigue. By volume, the top reported reactions are: Drug Ineffective (90,709 reports), Pain (49,059 reports), Arthralgia (48,039 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.
Out of 695,797 classified reports, 352,416 (50.6%) were classified as serious and 343,381 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 break down by patient sex as follows: Female: 446,644, Male: 209,784, Unknown: 1,947. 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 adverse events are: age 60: 9,357 reports, age 59: 9,171 reports, age 58: 9,079 reports, age 57: 8,823 reports, age 61: 8,740 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 adverse event reports is Abbvie 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 include: Rheumatoid Arthritis, Headache, Nausea, Diarrhoea, Rash. 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 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 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. Pain and fatigue are the most frequently reported adverse events, with pain being the most common.
Key safety signals identified in Adalimumab's adverse event data include: Pain (including injection site pain) is the most frequent adverse event.. Fatigue is the second most common adverse event.. Serious adverse events, particularly infections and respiratory issues, are notable.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Adalimumab can cause injection site reactions and may interact with other drugs, leading to adverse effects. Patients should be monitored for signs of infection and respiratory issues. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Adalimumab.
Patients should report any new or worsening symptoms to their healthcare provider promptly. Follow prescribed dosing instructions carefully to minimize the risk of adverse events.
Adalimumab has 1,482,766 adverse event reports on file with the FDA. Serious adverse events account for nearly 51% of all reports, indicating a significant risk. The volume of reports for Adalimumab reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor adalimumab for safety, and updates are regularly issued based on new data. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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