82/100 · Critical
Manufactured by Novartis Pharmaceuticals Corporation
High Serious Adverse Event Rate for Nilotinib
60,790 FDA adverse event reports analyzed
Last updated: 2026-05-12
NILOTINIB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Novartis Pharmaceuticals Corporation. Based on analysis of 60,790 FDA adverse event reports, NILOTINIB has a safety score of 82 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 NILOTINIB include DEATH, FATIGUE, RASH, NAUSEA, HEADACHE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for NILOTINIB.
Nilotinib has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 60,790 adverse event reports for this medication, which is primarily manufactured by Novartis Pharmaceuticals Corporation.
The most commonly reported adverse events include Death, Fatigue, Rash. Of classified reports, 73.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. The most common serious adverse events include death, myocardial infarction, and pleural effusion.
Fatigue, rash, and nausea are among the most frequently reported non-serious adverse events. The adverse event profile is diverse, with over 100 distinct reactions reported.
Patients taking Nilotinib should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Nilotinib can cause significant drug interactions, including QT prolongation and increased risk of arrhythmias. Patients should avoid certain drugs that can affect the heart rhythm. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Nilotinib received a safety concern score of 82/100 (high concern). This is based on a 73.5% serious event ratio across 28,903 classified reports. The score accounts for 60,790 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: Male: 13,728, Female: 12,449, Unknown: 128. The most frequently reported age groups are age 60 (402 reports), age 65 (383 reports), age 70 (351 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 28,903 classified reports for NILOTINIB:
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.
Nilotinib can cause significant drug interactions, including QT prolongation and increased risk of arrhythmias. Patients should avoid certain drugs that can affect the heart rhythm.
If you are taking Nilotinib, here are important things to know. The most commonly reported side effects include death, fatigue, rash, nausea, headache. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor closely for signs of serious adverse events such as chest pain, shortness of breath, and unexplained weight loss. Follow prescribed dosing instructions and do not alter the schedule without consulting a healthcare provider. 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 regular safety updates. Patients should report any adverse events to their healthcare provider immediately.
The FDA has received approximately 60,790 adverse event reports associated with Nilotinib. 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 Nilotinib include Death, Fatigue, Rash, Nausea, Headache. By volume, the top reported reactions are: Death (3,200 reports), Fatigue (2,081 reports), Rash (1,631 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Nilotinib.
Out of 28,903 classified reports, 21,234 (73.5%) were classified as serious and 7,669 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 Nilotinib break down by patient sex as follows: Male: 13,728, Female: 12,449, Unknown: 128. 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 Nilotinib adverse events are: age 60: 402 reports, age 65: 383 reports, age 70: 351 reports, age 55: 340 reports, age 64: 336 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 Nilotinib 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 Nilotinib include: Dyspnoea, Pain, Diarrhoea, Drug Ineffective, Malaise. 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 Nilotinib 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.
Nilotinib has a safety concern score of 82 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. The most common serious adverse events include death, myocardial infarction, and pleural effusion.
Key safety signals identified in Nilotinib's adverse event data include: Death. Myocardial infarction. Pleural effusion. Drug intolerance. Pain. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Nilotinib can cause significant drug interactions, including QT prolongation and increased risk of arrhythmias. Patients should avoid certain drugs that can affect the heart rhythm. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Nilotinib.
Monitor closely for signs of serious adverse events such as chest pain, shortness of breath, and unexplained weight loss. Follow prescribed dosing instructions and do not alter the schedule without consulting a healthcare provider.
Nilotinib has 60,790 adverse event reports on file with the FDA. Fatigue, rash, and nausea are among the most frequently reported non-serious adverse events. The volume of reports for Nilotinib reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with the FDA requiring regular safety updates. Patients should report any adverse events to their healthcare provider immediately. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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