85/100 · Critical
Manufactured by Novartis Pharmaceuticals Corporation
High Safety Concerns with Everolimus, Particularly for Serious Reactions
106,093 FDA adverse event reports analyzed
Last updated: 2026-05-12
EVEROLIMUS is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Novartis Pharmaceuticals Corporation. Based on analysis of 106,093 FDA adverse event reports, EVEROLIMUS 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 EVEROLIMUS include DEATH, MALIGNANT NEOPLASM PROGRESSION, DIARRHOEA, FATIGUE, STOMATITIS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for EVEROLIMUS.
Everolimus 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 106,093 adverse event reports for this medication, which is primarily manufactured by Novartis Pharmaceuticals Corporation.
The most commonly reported adverse events include Death, Malignant Neoplasm Progression, Diarrhoea. Of classified reports, 76.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Everolimus has a high incidence of serious adverse reactions, with death and malignant neoplasm progression being the most frequent.
The drug is associated with a wide range of gastrointestinal and systemic symptoms, indicating a broad safety profile. There is a notable increase in serious reactions, accounting for 76.6% of all reported outcomes.
Patients taking Everolimus should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Everolimus has warnings for drug interactions, including potential effects on blood pressure and kidney function, and it is important to monitor these parameters closely. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Everolimus received a safety concern score of 85/100 (high concern). This is based on a 76.6% serious event ratio across 49,681 classified reports. The score accounts for 106,093 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: 27,021, Male: 18,427, Unknown: 293. The most frequently reported age groups are age 65 (897 reports), age 64 (885 reports), age 60 (859 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 49,681 classified reports for EVEROLIMUS:
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.
Everolimus has warnings for drug interactions, including potential effects on blood pressure and kidney function, and it is important to monitor these parameters closely.
If you are taking Everolimus, here are important things to know. The most commonly reported side effects include death, malignant neoplasm progression, diarrhoea, fatigue, stomatitis. 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 immediately. Regular monitoring of vital signs and laboratory parameters is crucial, especially for patients with pre-existing conditions. 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 closely monitors Everolimus for safety, and healthcare providers should be vigilant about serious adverse events and follow the drug's labeling for specific warnings and precautions.
The FDA has received approximately 106,093 adverse event reports associated with Everolimus. 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 Everolimus include Death, Malignant Neoplasm Progression, Diarrhoea, Fatigue, Stomatitis. By volume, the top reported reactions are: Death (6,301 reports), Malignant Neoplasm Progression (4,591 reports), Diarrhoea (3,999 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Everolimus.
Out of 49,681 classified reports, 38,039 (76.6%) were classified as serious and 11,642 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 Everolimus break down by patient sex as follows: Female: 27,021, Male: 18,427, Unknown: 293. 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 Everolimus adverse events are: age 65: 897 reports, age 64: 885 reports, age 60: 859 reports, age 62: 852 reports, age 63: 820 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 Everolimus 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 Everolimus include: Nausea, Dyspnoea, Drug Ineffective, Pyrexia, Vomiting. 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 Everolimus 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.
Everolimus 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. Everolimus has a high incidence of serious adverse reactions, with death and malignant neoplasm progression being the most frequent.
Key safety signals identified in Everolimus's adverse event data include: High frequency of serious reactions (38,039 out of 49,681, or 76.6%). Multiple reports of malignancy progression and death. A wide variety of reactions, including respiratory, gastrointestinal, and hematological issues. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Everolimus has warnings for drug interactions, including potential effects on blood pressure and kidney function, and it is important to monitor these parameters closely. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Everolimus.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Regular monitoring of vital signs and laboratory parameters is crucial, especially for patients with pre-existing conditions.
Everolimus has 106,093 adverse event reports on file with the FDA. The drug is associated with a wide range of gastrointestinal and systemic symptoms, indicating a broad safety profile. The volume of reports for Everolimus reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Everolimus for safety, and healthcare providers should be vigilant about serious adverse events and follow the drug's labeling for specific warnings and precautions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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