85/100 · Critical
Manufactured by Novartis Pharmaceuticals Corporation
High Safety Concerns with RIBOCICLIB, Particularly for Serious Adverse Reactions
86,238 FDA adverse event reports analyzed
Last updated: 2026-05-12
RIBOCICLIB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Novartis Pharmaceuticals Corporation. Based on analysis of 86,238 FDA adverse event reports, RIBOCICLIB 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 RIBOCICLIB include NEUTROPENIA, NAUSEA, FATIGUE, MALIGNANT NEOPLASM PROGRESSION, DEATH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for RIBOCICLIB.
Ribociclib 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 86,238 adverse event reports for this medication, which is primarily manufactured by Novartis Pharmaceuticals Corporation.
The most commonly reported adverse events include Neutropenia, Nausea, Fatigue. Of classified reports, 82.5% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Neutropenia and anemia are the most common serious adverse reactions, with a significant number of reports of death.
The drug is associated with a high rate of serious adverse events, particularly in the elderly. There is a notable increase in liver and kidney function abnormalities.
Patients taking Ribociclib should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. RIBOCICLIB can cause severe hematological and hepatic adverse reactions, and patients should be monitored closely for these conditions. Drug interactions, particularly with other hematological agents, should be carefully managed. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Ribociclib received a safety concern score of 85/100 (high concern). This is based on a 82.5% serious event ratio across 28,966 classified reports. The score accounts for 86,238 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: 26,518, Male: 405, Unknown: 6. The most frequently reported age groups are age 60 (415 reports), age 63 (413 reports), age 62 (412 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 28,966 classified reports for RIBOCICLIB:
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.
RIBOCICLIB can cause severe hematological and hepatic adverse reactions, and patients should be monitored closely for these conditions. Drug interactions, particularly with other hematological agents, should be carefully managed.
If you are taking Ribociclib, here are important things to know. The most commonly reported side effects include neutropenia, nausea, fatigue, malignant neoplasm progression, death. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should be closely monitored for signs of neutropenia, anemia, and liver or kidney dysfunction. Follow the prescribed dosing regimen and report any adverse reactions to healthcare providers promptly. 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 RIBOCICLIB, and the drug is subject to ongoing review. Healthcare providers should be vigilant in managing patient safety and reporting adverse events.
The FDA has received approximately 86,238 adverse event reports associated with Ribociclib. 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 Ribociclib include Neutropenia, Nausea, Fatigue, Malignant Neoplasm Progression, Death. By volume, the top reported reactions are: Neutropenia (3,730 reports), Nausea (3,543 reports), Fatigue (3,502 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Ribociclib.
Out of 28,966 classified reports, 23,895 (82.5%) were classified as serious and 5,071 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 Ribociclib break down by patient sex as follows: Female: 26,518, Male: 405, Unknown: 6. 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 Ribociclib adverse events are: age 60: 415 reports, age 63: 413 reports, age 62: 412 reports, age 68: 412 reports, age 57: 391 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 Ribociclib 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 Ribociclib include: Vomiting, Diarrhoea, White Blood Cell Count Decreased, Pain, Metastases To Bone. 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 Ribociclib 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.
Ribociclib 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. Neutropenia and anemia are the most common serious adverse reactions, with a significant number of reports of death.
Key safety signals identified in Ribociclib's adverse event data include: Neutropenia and anemia are key safety signals, with a high frequency of reports.. Death is a significant safety concern, with 2,430 reports.. Liver and kidney function abnormalities are also critical safety signals.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
RIBOCICLIB can cause severe hematological and hepatic adverse reactions, and patients should be monitored closely for these conditions. Drug interactions, particularly with other hematological agents, should be carefully managed. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Ribociclib.
Patients should be closely monitored for signs of neutropenia, anemia, and liver or kidney dysfunction. Follow the prescribed dosing regimen and report any adverse reactions to healthcare providers promptly.
Ribociclib has 86,238 adverse event reports on file with the FDA. The drug is associated with a high rate of serious adverse events, particularly in the elderly. The volume of reports for Ribociclib reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor the safety profile of RIBOCICLIB, and the drug is subject to ongoing review. Healthcare providers should be vigilant in managing patient safety and reporting adverse events. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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