abiraterone Side Effects
Also known as: Zytiga
Analysis of 12,794 adverse event reports submitted to the FDA from 2010 to 2025.
Total Reports
12,794
Death-Related
2,176
17.0% of reports
Hospitalizations
4,866
38.0% of reports
Top Indication
Prostate Cancer
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 2,176 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 1,344 |
| PROSTATE CANCER | 110 |
| OFF LABEL USE | 96 |
| ANAEMIA | 85 |
| MALIGNANT NEOPLASM PROGRESSION | 85 |
| DISEASE PROGRESSION | 79 |
| PROSTATE CANCER METASTATIC | 76 |
| DRUG INEFFECTIVE | 72 |
| FATIGUE | 64 |
| DECREASED APPETITE | 56 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 53 |
| SEPSIS | 51 |
| DIARRHOEA | 49 |
| PNEUMONIA | 49 |
| ASTHENIA | 47 |
| METASTASES TO BONE | 46 |
| THROMBOCYTOPENIA | 43 |
| ACUTE KIDNEY INJURY | 41 |
| PROSTATIC SPECIFIC ANTIGEN INCREASED | 41 |
| CONSTIPATION | 37 |
Reactions in Hospitalization Reports
Top reactions in 4,866 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| FALL | 290 |
| ACUTE KIDNEY INJURY | 286 |
| PNEUMONIA | 262 |
| ASTHENIA | 254 |
| THERAPY INTERRUPTED | 250 |
| FATIGUE | 236 |
| URINARY TRACT INFECTION | 236 |
| HOSPITALISATION | 212 |
| DRUG INTERACTION | 206 |
| HYPOKALAEMIA | 206 |
| RHABDOMYOLYSIS | 203 |
| ANAEMIA | 193 |
| DYSPNOEA | 180 |
| ATRIAL FIBRILLATION | 157 |
| NAUSEA | 154 |
| SEPSIS | 152 |
| DIARRHOEA | 149 |
| VOMITING | 144 |
| DEHYDRATION | 140 |
| DIZZINESS | 128 |
Nearby — Related Medications
What the FAERS Data Reveals About abiraterone Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 12,794 voluntary reports linked to abiraterone and its brand equivalents (Zytiga), spanning 2010 through 2025. Of those, 2,176 (17.0%) listed death as an outcome and 4,866 (38.0%) involved hospitalization. The most common indication reported alongside adverse events was Prostate Cancer.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 1% were female and 99% male; age distribution skews toward 75+, with 4,055 reports in that bracket. The single most reported reaction is death with 1,390 submissions, followed by fatigue and hot flush.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.