72/100 · Elevated
Manufactured by Janssen Biotech, Inc.
High Fatigue and Prostate Cancer-Related Reactions with Abiraterone Acetate
56,299 FDA adverse event reports analyzed
Last updated: 2026-05-12
ABIRATERONE ACETATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Janssen Biotech, Inc.. Based on analysis of 56,299 FDA adverse event reports, ABIRATERONE ACETATE has a safety score of 72 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 ABIRATERONE ACETATE include DEATH, FATIGUE, PROSTATIC SPECIFIC ANTIGEN INCREASED, DRUG INEFFECTIVE, THERAPY CESSATION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ABIRATERONE ACETATE.
Abiraterone Acetate has a safety concern score of 72 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 56,299 adverse event reports for this medication, which is primarily manufactured by Janssen Biotech, Inc..
The most commonly reported adverse events include Death, Fatigue, Prostatic Specific Antigen Increased. Of classified reports, 68.7% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Fatigue and prostatic specific antigen increased are the most common reactions.
Serious adverse events, particularly death, are prevalent. Prostate cancer progression and disease progression are significant concerns.
Patients taking Abiraterone Acetate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Abiraterone acetate can cause drug interactions, including those with anticoagulants and diuretics, and warnings are provided for these interactions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Abiraterone Acetate received a safety concern score of 72/100 (elevated concern). This is based on a 68.7% serious event ratio across 40,026 classified reports. The score accounts for 56,299 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Male: 37,196, Female: 212, Unknown: 64. The most frequently reported age groups are age 78 (937 reports), age 80 (886 reports), age 74 (885 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 40,026 classified reports for ABIRATERONE ACETATE:
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.
Abiraterone acetate can cause drug interactions, including those with anticoagulants and diuretics, and warnings are provided for these interactions.
If you are taking Abiraterone Acetate, here are important things to know. The most commonly reported side effects include death, fatigue, prostatic specific antigen increased, drug ineffective, therapy cessation. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor patients closely for signs of fatigue and changes in prostate-specific antigen levels. Be aware of potential serious adverse events and follow up with healthcare providers if symptoms worsen. 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 safety and efficacy.
The FDA has received approximately 56,299 adverse event reports associated with Abiraterone Acetate. 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 Abiraterone Acetate include Death, Fatigue, Prostatic Specific Antigen Increased, Drug Ineffective, Therapy Cessation. By volume, the top reported reactions are: Death (6,122 reports), Fatigue (2,592 reports), Prostatic Specific Antigen Increased (1,989 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Abiraterone Acetate.
Out of 40,026 classified reports, 27,478 (68.7%) were classified as serious and 12,548 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 Abiraterone Acetate break down by patient sex as follows: Male: 37,196, Female: 212, Unknown: 64. 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 Abiraterone Acetate adverse events are: age 78: 937 reports, age 80: 886 reports, age 74: 885 reports, age 76: 879 reports, age 79: 876 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 Abiraterone Acetate adverse event reports is Janssen Biotech, 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 Abiraterone Acetate include: Hot Flush, Asthenia, Disease Progression, Hospitalisation, Off Label Use. 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 Abiraterone Acetate 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.
Abiraterone Acetate has a safety concern score of 72 out of 100 (elevated 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 prostatic specific antigen increased are the most common reactions.
Key safety signals identified in Abiraterone Acetate's adverse event data include: High frequency of death reports. Significant number of serious adverse events. Common reactions include fatigue and increased prostatic specific antigen. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Abiraterone acetate can cause drug interactions, including those with anticoagulants and diuretics, and warnings are provided for these interactions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Abiraterone Acetate.
Monitor patients closely for signs of fatigue and changes in prostate-specific antigen levels. Be aware of potential serious adverse events and follow up with healthcare providers if symptoms worsen.
Abiraterone Acetate has 56,299 adverse event reports on file with the FDA. Serious adverse events, particularly death, are prevalent. The volume of reports for Abiraterone Acetate 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 safety and efficacy. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by Janssen Biotech, Inc. and compare their safety profiles:
The following drugs share commonly reported adverse reactions with ABIRATERONE ACETATE:
Drugs related to ABIRATERONE ACETATE based on therapeutic use, drug class, or shared indications: