85/100 · Critical
Manufactured by Allergan, Inc.
Cylosporine Adverse Events: High Seriousness and Diverse Reactions
190,279 FDA adverse event reports analyzed
Last updated: 2026-05-12
CYCLOSPORINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Allergan, Inc.. Based on analysis of 190,279 FDA adverse event reports, CYCLOSPORINE has a safety score of 85 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 CYCLOSPORINE include DRUG INEFFECTIVE, OFF LABEL USE, EYE IRRITATION, PRODUCT USE IN UNAPPROVED INDICATION, PYREXIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CYCLOSPORINE.
Cyclosporine has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 190,279 adverse event reports for this medication, which is primarily manufactured by Allergan, Inc..
The most commonly reported adverse events include Drug Ineffective, Off Label Use, Eye Irritation. Of classified reports, 68.2% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Cylosporine reports show a high percentage of serious adverse events (68.2%).
The most common reactions include eye irritation, nausea, and fatigue. Renal impairment and infections are significant concerns, with multiple reports of renal failure and sepsis.
Patients taking Cyclosporine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Cylosporine can interact with other drugs, leading to adverse effects. Warnings include interactions with immunosuppressants and antifungals. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Cyclosporine received a safety concern score of 85/100 (high concern). This is based on a 68.2% serious event ratio across 106,432 classified reports. The score accounts for 190,279 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 57,702, Male: 36,340, Unknown: 623. The most frequently reported age groups are age 63 (1,743 reports), age 60 (1,468 reports), age 64 (1,404 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 106,432 classified reports for CYCLOSPORINE:
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.
Cylosporine can interact with other drugs, leading to adverse effects. Warnings include interactions with immunosuppressants and antifungals.
If you are taking Cyclosporine, here are important things to know. The most commonly reported side effects include drug ineffective, off label use, eye irritation, product use in unapproved indication, pyrexia. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor patients for signs of renal impairment and infections, especially in elderly patients. Ensure proper dosing and administration to avoid drug ineffectiveness and intolerance. 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 Cylosporine for safety, with ongoing reviews of serious adverse events and drug interactions.
The FDA has received approximately 190,279 adverse event reports associated with Cyclosporine. 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 Cyclosporine include Drug Ineffective, Off Label Use, Eye Irritation, Product Use In Unapproved Indication, Pyrexia. By volume, the top reported reactions are: Drug Ineffective (12,344 reports), Off Label Use (8,709 reports), Eye Irritation (7,786 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Cyclosporine.
Out of 106,432 classified reports, 72,576 (68.2%) were classified as serious and 33,856 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 Cyclosporine break down by patient sex as follows: Female: 57,702, Male: 36,340, Unknown: 623. 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 Cyclosporine adverse events are: age 63: 1,743 reports, age 60: 1,468 reports, age 64: 1,404 reports, age 55: 1,367 reports, age 62: 1,360 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 Cyclosporine adverse event reports is Allergan, 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 Cyclosporine include: Eye Pain, Nausea, Diarrhoea, Headache, Fatigue. 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 Cyclosporine 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.
Cyclosporine has a safety concern score of 85 out of 100 (high 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. Cylosporine reports show a high percentage of serious adverse events (68.2%).
Key safety signals identified in Cyclosporine's adverse event data include: Renal impairment and failure are key safety signals, with 2085 and 1849 reports respectively.. Infections, including pneumonia and sepsis, are frequent and serious.. Drug interactions and ineffective drug use are also notable safety signals.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Cylosporine can interact with other drugs, leading to adverse effects. Warnings include interactions with immunosuppressants and antifungals. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Cyclosporine.
Monitor patients for signs of renal impairment and infections, especially in elderly patients. Ensure proper dosing and administration to avoid drug ineffectiveness and intolerance.
Cyclosporine has 190,279 adverse event reports on file with the FDA. The most common reactions include eye irritation, nausea, and fatigue. The volume of reports for Cyclosporine reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor Cylosporine for safety, with ongoing reviews of serious adverse events and drug interactions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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