65/100 · Elevated
Manufactured by Novartis Pharmaceuticals Corporation
Secukinumab Adverse Events: Moderate Safety Concerns
482,303 FDA adverse event reports analyzed
Last updated: 2026-05-12
SECUKINUMAB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Novartis Pharmaceuticals Corporation. Based on analysis of 482,303 FDA adverse event reports, SECUKINUMAB has a safety score of 65 out of 100. This moderate score indicates a notable volume of adverse event reports that patients and providers should be aware of. The most commonly reported adverse reactions for SECUKINUMAB include DRUG INEFFECTIVE, PSORIASIS, PAIN, ARTHRALGIA, FATIGUE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for SECUKINUMAB.
Secukinumab has a safety concern score of 65 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 482,303 adverse event reports for this medication, which is primarily manufactured by Novartis Pharmaceuticals Corporation.
The most commonly reported adverse events include Drug Ineffective, Psoriasis, Pain. Of classified reports, 39.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Pain and musculoskeletal issues are common, with arthralgia and joint swelling reported frequently.
Infections, particularly respiratory and gastrointestinal, are notable, with pneumonia and diarrhea reported. Serious adverse events, including pneumonia and liver injury, account for nearly 40% of reports.
Patients taking Secukinumab should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Secukinumab may interact with other drugs, and patients should be monitored for potential side effects such as infections and musculoskeletal issues. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Secukinumab received a safety concern score of 65/100 (elevated concern). This is based on a 39.5% serious event ratio across 157,194 classified reports. The score accounts for 482,303 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: 90,501, Male: 55,361, Unknown: 10. The most frequently reported age groups are age 43 (2,783 reports), age 44 (2,295 reports), age 40 (2,131 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 157,194 classified reports for SECUKINUMAB:
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.
Secukinumab may interact with other drugs, and patients should be monitored for potential side effects such as infections and musculoskeletal issues.
If you are taking Secukinumab, here are important things to know. The most commonly reported side effects include drug ineffective, psoriasis, pain, arthralgia, fatigue. 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 respiratory and gastrointestinal issues, and report any symptoms to healthcare providers. Follow prescribed dosing instructions 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.
Regulatory oversight is ongoing, with a focus on monitoring for serious adverse events and ensuring proper dosing and administration.
The FDA has received approximately 482,303 adverse event reports associated with Secukinumab. 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 Secukinumab include Drug Ineffective, Psoriasis, Pain, Arthralgia, Fatigue. By volume, the top reported reactions are: Drug Ineffective (28,717 reports), Psoriasis (22,567 reports), Pain (16,136 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Secukinumab.
Out of 157,194 classified reports, 62,054 (39.5%) were classified as serious and 95,140 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 Secukinumab break down by patient sex as follows: Female: 90,501, Male: 55,361, Unknown: 10. 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 Secukinumab adverse events are: age 43: 2,783 reports, age 44: 2,295 reports, age 40: 2,131 reports, age 59: 1,881 reports, age 58: 1,783 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 Secukinumab adverse event reports is Novartis Pharmaceuticals Corporation. 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 Secukinumab include: Psoriatic Arthropathy, Pruritus, Malaise, Rash, Condition Aggravated. 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 Secukinumab 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.
Secukinumab has a safety concern score of 65 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 musculoskeletal issues are common, with arthralgia and joint swelling reported frequently.
Key safety signals identified in Secukinumab's adverse event data include: Frequent reports of musculoskeletal pain and joint swelling.. High incidence of infections, especially respiratory and gastrointestinal.. Significant number of serious adverse events, including pneumonia and liver injury.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Secukinumab may interact with other drugs, and patients should be monitored for potential side effects such as infections and musculoskeletal issues. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Secukinumab.
Monitor for signs of infection, particularly respiratory and gastrointestinal issues, and report any symptoms to healthcare providers. Follow prescribed dosing instructions to minimize the risk of adverse events.
Secukinumab has 482,303 adverse event reports on file with the FDA. Infections, particularly respiratory and gastrointestinal, are notable, with pneumonia and diarrhea reported. The volume of reports for Secukinumab reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with a focus on monitoring for serious adverse events and ensuring proper dosing and administration. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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