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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

ABIRATERONE\ABIRATERONE: 104 Adverse Event Reports & Safety Profile

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104
Total FAERS Reports
22 (21.2%)
Deaths Reported
27
Hospitalizations
104
As Primary/Secondary Suspect
3
Life-Threatening

Active Ingredient: ABIRATERONE\ABIRATERONE ACETATE ·

First Report: 20221014 · Latest Report: 20241230

What Are the Most Common ABIRATERONE\ABIRATERONE Side Effects?

#1 Most Reported
Drug ineffective
21 reports (20.2%)
#2 Most Reported
Fatigue
12 reports (11.5%)
#3 Most Reported
Hot flush
10 reports (9.6%)

All ABIRATERONE\ABIRATERONE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 21 20.2% 9 3
Fatigue 12 11.5% 1 3
Hot flush 10 9.6% 0 0
Death 9 8.7% 9 1
Disease progression 7 6.7% 1 1
Atrioventricular block complete 6 5.8% 0 6
Long qt syndrome 6 5.8% 0 6
Prostatic specific antigen increased 6 5.8% 3 1
Syncope 6 5.8% 0 6
Anaemia 5 4.8% 3 0
Arthralgia 5 4.8% 1 0
Asthenia 5 4.8% 0 2
Atrial fibrillation 5 4.8% 2 1
Diarrhoea 5 4.8% 3 2
Dyspnoea 5 4.8% 1 2
Hypertension 5 4.8% 1 1
Hypokalaemia 5 4.8% 1 0
Malignant neoplasm progression 5 4.8% 3 2
Neutropenia 5 4.8% 0 0
Oedema peripheral 5 4.8% 1 1

Who Reports ABIRATERONE\ABIRATERONE Side Effects? Age & Gender Data

Gender: 3.2% female, 96.8% male. Average age: 72.3 years. Most reports from: US. View detailed demographics →

Is ABIRATERONE\ABIRATERONE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2022 1 1 0
2023 4 1 2
2024 33 4 14

View full timeline →

What Is ABIRATERONE\ABIRATERONE Used For?

IndicationReports
Prostate cancer 36
Prostate cancer metastatic 25
Hormone-refractory prostate cancer 14
Product used for unknown indication 12

ABIRATERONE\ABIRATERONE vs Alternatives: Which Is Safer?

ABIRATERONE\ABIRATERONE vs ABOBOTULINUMTOXINA ABIRATERONE\ABIRATERONE vs ABRAXANE ABIRATERONE\ABIRATERONE vs ABROCITINIB ABIRATERONE\ABIRATERONE vs ACALABRUTINIB ABIRATERONE\ABIRATERONE vs ACAMPROSATE ABIRATERONE\ABIRATERONE vs ACARBOSE ABIRATERONE\ABIRATERONE vs ACCUTANE ABIRATERONE\ABIRATERONE vs ACEBUTOLOL ABIRATERONE\ABIRATERONE vs ACECLOFENAC ABIRATERONE\ABIRATERONE vs ACEMETACIN

Official FDA Label for ABIRATERONE\ABIRATERONE

Official prescribing information from the FDA-approved drug label.