65/100 · Elevated
Manufactured by AbbVie Inc.
Moderate Safety Concerns with RISANKIZUMAB-RZAA
92,878 FDA adverse event reports analyzed
Last updated: 2026-05-12
RISANKIZUMAB RZAA is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by AbbVie Inc.. Based on analysis of 92,878 FDA adverse event reports, RISANKIZUMAB RZAA 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 RISANKIZUMAB RZAA include PSORIASIS, DRUG INEFFECTIVE, PAIN, FATIGUE, ARTHRALGIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for RISANKIZUMAB RZAA.
Risankizumab-Rzaa 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 92,878 adverse event reports for this medication, which is primarily manufactured by Abbvie Inc..
The most commonly reported adverse events include Psoriasis, Drug Ineffective, Pain. Of classified reports, 64.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Serious adverse events, including death and cardiovascular issues, account for over 64% of reports.
Pain and fatigue are among the most frequently reported symptoms, indicating potential long-term discomfort. There is a notable presence of malignancies and infections, suggesting potential risks for these conditions. The drug is associated with a range of gastrointestinal issues, including diarrhea and abdominal pain. Some reports indicate potential drug ineffectiveness, which could impact treatment outcomes.
Patients taking Risankizumab-Rzaa should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. No specific drug interactions are listed, but patients should be monitored for potential exacerbation of malignancies and infections, as well as cardiovascular events. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Risankizumab-Rzaa received a safety concern score of 65/100 (elevated concern). This is based on a 64.3% serious event ratio across 71,836 classified reports. The score accounts for 92,878 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: 38,865, Male: 29,632, Unknown: 4. The most frequently reported age groups are age 62 (1,006 reports), age 60 (1,002 reports), age 61 (981 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 71,836 classified reports for RISANKIZUMAB RZAA:
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.
No specific drug interactions are listed, but patients should be monitored for potential exacerbation of malignancies and infections, as well as cardiovascular events.
If you are taking Risankizumab-Rzaa, here are important things to know. The most commonly reported side effects include psoriasis, drug ineffective, pain, fatigue, arthralgia. 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. Regular follow-ups are recommended to monitor for potential serious adverse events, especially cardiovascular and malignancy risks. 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 profile of RISANKIZUMAB-RZAA, and healthcare providers should be vigilant for serious adverse events and consider alternative treatments if necessary.
The FDA has received approximately 92,878 adverse event reports associated with Risankizumab-Rzaa. 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 Risankizumab-Rzaa include Psoriasis, Drug Ineffective, Pain, Fatigue, Arthralgia. By volume, the top reported reactions are: Psoriasis (7,313 reports), Drug Ineffective (3,225 reports), Pain (2,847 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Risankizumab-Rzaa.
Out of 71,836 classified reports, 46,221 (64.3%) were classified as serious and 25,615 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 Risankizumab-Rzaa break down by patient sex as follows: Female: 38,865, Male: 29,632, Unknown: 4. 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 Risankizumab-Rzaa adverse events are: age 62: 1,006 reports, age 60: 1,002 reports, age 61: 981 reports, age 67: 968 reports, age 65: 946 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 Risankizumab-Rzaa 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 Risankizumab-Rzaa include: Pruritus, Covid-19, Surgery, Fall, Death. 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 Risankizumab-Rzaa 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.
Risankizumab-Rzaa 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. Serious adverse events, including death and cardiovascular issues, account for over 64% of reports.
Key safety signals identified in Risankizumab-Rzaa's adverse event data include: Death and serious infections are key safety signals, with a significant number of reports.. Cardiovascular events, including myocardial infarction and cerebrovascular accidents, are also notable.. Malignancies, particularly skin cancer, are a concern given the drug's mechanism of action.. Gastrointestinal issues, such as diarrhea and abdominal pain, are frequently reported.. Drug ineffectiveness and therapeutic response issues are also significant safety signals.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
No specific drug interactions are listed, but patients should be monitored for potential exacerbation of malignancies and infections, as well as cardiovascular events. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Risankizumab-Rzaa.
Patients should report any new or worsening symptoms to their healthcare provider promptly. Regular follow-ups are recommended to monitor for potential serious adverse events, especially cardiovascular and malignancy risks.
Risankizumab-Rzaa has 92,878 adverse event reports on file with the FDA. Pain and fatigue are among the most frequently reported symptoms, indicating potential long-term discomfort. The volume of reports for Risankizumab-Rzaa reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety profile of RISANKIZUMAB-RZAA, and healthcare providers should be vigilant for serious adverse events and consider alternative treatments if necessary. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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