82/100 · Critical
Manufactured by Astellas Pharma US, Inc.
Enzalutamide Adverse Events: High Serious Reaction Rate
117,902 FDA adverse event reports analyzed
Last updated: 2026-05-12
ENZALUTAMIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Astellas Pharma US, Inc.. Based on analysis of 117,902 FDA adverse event reports, ENZALUTAMIDE 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 ENZALUTAMIDE include FATIGUE, DEATH, MALIGNANT NEOPLASM PROGRESSION, PROSTATIC SPECIFIC ANTIGEN INCREASED, ASTHENIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ENZALUTAMIDE.
Enzalutamide 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 117,902 adverse event reports for this medication, which is primarily manufactured by Astellas Pharma Us, Inc..
The most commonly reported adverse events include Fatigue, Death, Malignant Neoplasm Progression. Of classified reports, 61.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Fatigue and asthenia are the most common adverse events, with over 10,000 reports each.
Serious adverse events, including death and malignant neoplasm progression, account for 61.4% of all reports. The most frequent serious reactions include death, malignant neoplasm progression, and heart-related issues.
Patients taking Enzalutamide should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Enzalutamide can interact with other drugs, leading to adverse effects. Patients should inform their healthcare providers of all medications they are taking. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Enzalutamide received a safety concern score of 82/100 (high concern). This is based on a 61.4% serious event ratio across 57,602 classified reports. The score accounts for 117,902 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: 54,925, Female: 361, Unknown: 83. The most frequently reported age groups are age 78 (1,378 reports), age 75 (1,320 reports), age 79 (1,309 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 57,602 classified reports for ENZALUTAMIDE:
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.
Enzalutamide can interact with other drugs, leading to adverse effects. Patients should inform their healthcare providers of all medications they are taking.
If you are taking Enzalutamide, here are important things to know. The most commonly reported side effects include fatigue, death, malignant neoplasm progression, prostatic specific antigen increased, asthenia. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for signs of fatigue and weakness, which are common and can be severe. Report any serious adverse events immediately to your 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 post-marketing studies to further evaluate long-term safety and efficacy.
The FDA has received approximately 117,902 adverse event reports associated with Enzalutamide. 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 Enzalutamide include Fatigue, Death, Malignant Neoplasm Progression, Prostatic Specific Antigen Increased, Asthenia. By volume, the top reported reactions are: Fatigue (10,159 reports), Death (7,667 reports), Malignant Neoplasm Progression (5,409 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Enzalutamide.
Out of 57,602 classified reports, 35,395 (61.4%) were classified as serious and 22,207 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 Enzalutamide break down by patient sex as follows: Male: 54,925, Female: 361, Unknown: 83. 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 Enzalutamide adverse events are: age 78: 1,378 reports, age 75: 1,320 reports, age 79: 1,309 reports, age 77: 1,293 reports, age 74: 1,264 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 Enzalutamide adverse event reports is Astellas Pharma Us, 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 Enzalutamide include: Drug Ineffective, Hot Flush, Decreased Appetite, Nausea, Dizziness. 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 Enzalutamide 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.
Enzalutamide 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. Fatigue and asthenia are the most common adverse events, with over 10,000 reports each.
Key safety signals identified in Enzalutamide's adverse event data include: Death and malignant neoplasm progression are the most critical safety signals.. Heart-related issues, including myocardial infarction and atrial fibrillation, are also significant.. Drug ineffectiveness and underdose are common, indicating potential dosing issues.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Enzalutamide can interact with other drugs, leading to adverse effects. Patients should inform their healthcare providers of all medications they are taking. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Enzalutamide.
Monitor for signs of fatigue and weakness, which are common and can be severe. Report any serious adverse events immediately to your healthcare provider.
Enzalutamide has 117,902 adverse event reports on file with the FDA. Serious adverse events, including death and malignant neoplasm progression, account for 61.4% of all reports. The volume of reports for Enzalutamide reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is ongoing, with the FDA requiring post-marketing studies to further evaluate long-term safety and efficacy. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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