82/100 · Critical
Manufactured by Incyte Corporation
Ruxolitinib Adverse Events: High Seriousness and Diverse Reactions
126,373 FDA adverse event reports analyzed
Last updated: 2026-05-12
RUXOLITINIB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Incyte Corporation. Based on analysis of 126,373 FDA adverse event reports, RUXOLITINIB 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 RUXOLITINIB include OFF LABEL USE, DEATH, FATIGUE, ANAEMIA, HAEMOGLOBIN DECREASED. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for RUXOLITINIB.
Ruxolitinib 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 126,373 adverse event reports for this medication, which is primarily manufactured by Incyte Corporation.
The most commonly reported adverse events include Off Label Use, Death, Fatigue. Of classified reports, 48.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High percentage of serious adverse events (48.7%) indicates significant safety concerns.
Diverse range of reactions including hematological, gastrointestinal, and respiratory issues. Frequent reports of hematological abnormalities such as anemia and thrombocytopenia.
Patients taking Ruxolitinib should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Ruxolitinib has warnings for hematological abnormalities and infections. Patients should be monitored closely for these conditions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Ruxolitinib received a safety concern score of 82/100 (high concern). This is based on a 48.7% serious event ratio across 67,152 classified reports. The score accounts for 126,373 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: 10,394, Female: 9,730, Unknown: 179. The most frequently reported age groups are age 70 (541 reports), age 74 (518 reports), age 71 (505 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 67,152 classified reports for RUXOLITINIB:
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.
Ruxolitinib has warnings for hematological abnormalities and infections. Patients should be monitored closely for these conditions.
If you are taking Ruxolitinib, here are important things to know. The most commonly reported side effects include off label use, death, fatigue, anaemia, haemoglobin decreased. 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 hematological abnormalities and infections, especially in elderly patients. Follow prescribed dosing instructions to avoid dose-related issues. 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 bodies are closely monitoring the safety profile of Ruxolitinib, with ongoing reviews and updates to the labeling.
The FDA has received approximately 126,373 adverse event reports associated with Ruxolitinib. 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 Ruxolitinib include Off Label Use, Death, Fatigue, Anaemia, Haemoglobin Decreased. By volume, the top reported reactions are: Off Label Use (13,321 reports), Death (6,150 reports), Fatigue (5,848 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Ruxolitinib.
Out of 67,152 classified reports, 32,693 (48.7%) were classified as serious and 34,459 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 Ruxolitinib break down by patient sex as follows: Male: 10,394, Female: 9,730, Unknown: 179. 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 Ruxolitinib adverse events are: age 70: 541 reports, age 74: 518 reports, age 71: 505 reports, age 68: 491 reports, age 73: 483 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 Ruxolitinib adverse event reports is Incyte 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 Ruxolitinib include: Platelet Count Decreased, Diarrhoea, Asthenia, Dizziness, Headache. 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 Ruxolitinib 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.
Ruxolitinib 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. High percentage of serious adverse events (48.7%) indicates significant safety concerns.
Key safety signals identified in Ruxolitinib's adverse event data include: High number of serious adverse events (32,693 out of 67,152 total outcomes).. Multiple hematological abnormalities reported, including anemia and thrombocytopenia.. Significant reports of infections, particularly pneumonia and sepsis.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Ruxolitinib has warnings for hematological abnormalities and infections. Patients should be monitored closely for these conditions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Ruxolitinib.
Monitor patients for signs of hematological abnormalities and infections, especially in elderly patients. Follow prescribed dosing instructions to avoid dose-related issues.
Ruxolitinib has 126,373 adverse event reports on file with the FDA. Diverse range of reactions including hematological, gastrointestinal, and respiratory issues. The volume of reports for Ruxolitinib reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory bodies are closely monitoring the safety profile of Ruxolitinib, with ongoing reviews and updates to the labeling. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
The following drugs share commonly reported adverse reactions with RUXOLITINIB:
Drugs related to RUXOLITINIB based on therapeutic use, drug class, or shared indications: