72/100 · Elevated
Manufactured by AbbVie Inc.
Upadacitinib Adverse Events: Pain and Infections Most Common
110,317 FDA adverse event reports analyzed
Last updated: 2026-05-12
UPADACITINIB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by AbbVie Inc.. Based on analysis of 110,317 FDA adverse event reports, UPADACITINIB 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 UPADACITINIB include PAIN, ARTHRALGIA, DRUG INEFFECTIVE, COVID-19, RHEUMATOID ARTHRITIS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for UPADACITINIB.
Upadacitinib 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 110,317 adverse event reports for this medication, which is primarily manufactured by Abbvie Inc..
The most commonly reported adverse events include Pain, Arthralgia, Drug Ineffective. Of classified reports, 66.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Pain-related reactions are the most frequent, with arthralgia and pain in extremities being the top complaints.
Serious adverse events, particularly infections and falls, are concerning, making up over 66% of reports. The majority of reactions are non-serious, but the diversity of reactions indicates a broad safety profile.
Patients taking Upadacitinib should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Upadacitinib is associated with various musculoskeletal and gastrointestinal side effects, and patients should be monitored for signs of infection and falls. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Upadacitinib received a safety concern score of 72/100 (elevated concern). This is based on a 66.3% serious event ratio across 72,777 classified reports. The score accounts for 110,317 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: 48,021, Male: 20,013, Unknown: 11. The most frequently reported age groups are age 63 (1,240 reports), age 60 (1,218 reports), age 61 (1,215 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 72,777 classified reports for UPADACITINIB:
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.
Upadacitinib is associated with various musculoskeletal and gastrointestinal side effects, and patients should be monitored for signs of infection and falls.
If you are taking Upadacitinib, here are important things to know. The most commonly reported side effects include pain, arthralgia, drug ineffective, covid-19, rheumatoid arthritis. 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 infection, particularly in elderly patients. Report any serious adverse events to healthcare providers immediately. 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 the FDA requiring post-marketing studies to further evaluate the safety profile of upadacitinib.
The FDA has received approximately 110,317 adverse event reports associated with Upadacitinib. 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 Upadacitinib include Pain, Arthralgia, Drug Ineffective, Covid-19, Rheumatoid Arthritis. By volume, the top reported reactions are: Pain (4,942 reports), Arthralgia (4,342 reports), Drug Ineffective (4,175 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Upadacitinib.
Out of 72,777 classified reports, 48,271 (66.3%) were classified as serious and 24,506 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 Upadacitinib break down by patient sex as follows: Female: 48,021, Male: 20,013, Unknown: 11. 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 Upadacitinib adverse events are: age 63: 1,240 reports, age 60: 1,218 reports, age 61: 1,215 reports, age 62: 1,212 reports, age 64: 1,201 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 Upadacitinib 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 Upadacitinib include: Pain In Extremity, Fatigue, Fall, Surgery, Headache. 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 Upadacitinib 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.
Upadacitinib 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-related reactions are the most frequent, with arthralgia and pain in extremities being the top complaints.
Key safety signals identified in Upadacitinib's adverse event data include: Pain and arthralgia are the most reported reactions.. Serious events such as pneumonia, death, and falls are notable.. A wide range of reactions, including infections, falls, and musculoskeletal issues, are reported.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Upadacitinib is associated with various musculoskeletal and gastrointestinal side effects, and patients should be monitored for signs of infection and falls. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Upadacitinib.
Monitor for signs of infection, particularly in elderly patients. Report any serious adverse events to healthcare providers immediately.
Upadacitinib has 110,317 adverse event reports on file with the FDA. Serious adverse events, particularly infections and falls, are concerning, making up over 66% of reports. The volume of reports for Upadacitinib reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with the FDA requiring post-marketing studies to further evaluate the safety profile of upadacitinib. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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