35/100 · Moderate
Manufactured by Eli Lilly and Company
Ixequizumab Adverse Events: Injection Site Reactions and Mild to Moderate Symptoms Predominate
50,855 FDA adverse event reports analyzed
Last updated: 2026-05-12
IXEKIZUMAB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Eli Lilly and Company. Based on analysis of 50,855 FDA adverse event reports, IXEKIZUMAB has a safety score of 35 out of 100. This lower score reflects a significant number of adverse event reports, suggesting that patients should discuss potential risks carefully with their healthcare provider. The most commonly reported adverse reactions for IXEKIZUMAB include INJECTION SITE PAIN, DRUG INEFFECTIVE, PSORIASIS, INJECTION SITE ERYTHEMA, INJECTION SITE REACTION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for IXEKIZUMAB.
Ixekizumab has a safety concern score of 35 out of 100, placing it in the moderate concern category based on analysis of FDA adverse event data. The FDA has received approximately 50,855 adverse event reports for this medication, which is primarily manufactured by Eli Lilly And Company.
The most commonly reported adverse events include Injection Site Pain, Drug Ineffective, Psoriasis. Of classified reports, 20.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The majority of adverse events are mild to moderate in nature, with injection site reactions being the most common.
Serious adverse events account for approximately 21% of all reports, with infections being a notable concern. The reaction diversity is high, with over 100 distinct reactions reported, indicating a broad safety profile.
Patients taking Ixekizumab should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Ixequizumab can cause injection site reactions, and patients should be monitored for signs of infection. Drug interactions have not been extensively studied. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Ixekizumab received a safety concern score of 35/100 (moderate concern). This is based on a 20.9% serious event ratio across 35,883 classified reports. The score accounts for 50,855 total adverse event reports and 100 distinct reaction types. This moderate score is typical for widely prescribed medications with established safety profiles.
Adverse event reports by sex: Female: 19,946, Male: 12,771, Unknown: 12. The most frequently reported age groups are age 60 (644 reports), age 55 (641 reports), age 56 (622 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 35,883 classified reports for IXEKIZUMAB:
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.
Ixequizumab can cause injection site reactions, and patients should be monitored for signs of infection. Drug interactions have not been extensively studied.
If you are taking Ixekizumab, here are important things to know. The most commonly reported side effects include injection site pain, drug ineffective, psoriasis, injection site erythema, injection site reaction. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for injection site reactions and signs of infection, especially in the first few weeks of treatment. Report any serious adverse events to your healthcare provider 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.
The FDA continues to monitor the safety of Ixequizumab. Patients should report any adverse events to their healthcare provider.
The FDA has received approximately 50,855 adverse event reports associated with Ixekizumab. 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 Ixekizumab include Injection Site Pain, Drug Ineffective, Psoriasis, Injection Site Erythema, Injection Site Reaction. By volume, the top reported reactions are: Injection Site Pain (3,851 reports), Drug Ineffective (3,177 reports), Psoriasis (3,159 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Ixekizumab.
Out of 35,883 classified reports, 7,501 (20.9%) were classified as serious and 28,382 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 Ixekizumab break down by patient sex as follows: Female: 19,946, Male: 12,771, Unknown: 12. 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 Ixekizumab adverse events are: age 60: 644 reports, age 55: 641 reports, age 56: 622 reports, age 58: 595 reports, age 63: 589 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 Ixekizumab adverse event reports is Eli Lilly And Company. 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 Ixekizumab include: Injection Site Swelling, Incorrect Dose Administered, Product Dose Omission Issue, Covid-19, Pain. 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 Ixekizumab 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.
Ixekizumab has a safety concern score of 35 out of 100 (moderate 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 adverse events are mild to moderate in nature, with injection site reactions being the most common.
Key safety signals identified in Ixekizumab's adverse event data include: Injection site reactions (pain, erythema, swelling) are the most frequently reported adverse events.. Infections, particularly respiratory and skin infections, are notable safety signals.. There are reports of serious adverse events, including pneumonia and death, though these are less frequent.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Ixequizumab can cause injection site reactions, and patients should be monitored for signs of infection. Drug interactions have not been extensively studied. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Ixekizumab.
Monitor for injection site reactions and signs of infection, especially in the first few weeks of treatment. Report any serious adverse events to your healthcare provider immediately.
Ixekizumab has 50,855 adverse event reports on file with the FDA. Serious adverse events account for approximately 21% of all reports, with infections being a notable concern. The volume of reports for Ixekizumab reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety of Ixequizumab. Patients should report any adverse events to their healthcare provider. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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