Reported signals
abiraterone
Registration status unknownDrugalgemeen
40,471
reports (FAERS)
68.7%
reported as serious
6,560
fatal reports (16.2%)
17
signals above threshold
2026-07
last updated
Signal ranking · ROR
What stands out in the reports.
On the labelNew signalUnknown & frequent
Symptom
0.1110100
ROR [95% CI]
Prostate cancer metastatic
127.9 [117.3–139.4]
Prostatic specific antigen increased
91.8 [87.4–96.3]
Therapy cessation
16.9 [16.0–17.8]
Metastases to bone
14.3 [13.0–15.7]
Hot flush
10.6 [10.0–11.1]
Hypokalaemia
8.6 [8.0–9.3]
Prostate cancer
5.7 [5.3–6.1]
Disease progression
5.5 [5.1–5.8]
Therapy interrupted
4.3 [4.0–4.7]
Death
4.2 [4.1–4.3]
Malignant neoplasm progression
4.0 [3.7–4.3]
Hospitalisation
3.8 [3.6–4.0]
Dysphagia
2.4 [2.2–2.6]
Adverse event
2.3 [2.1–2.6]
Oedema peripheral
2.3 [2.1–2.5]
ROR = reporting odds ratio (log scale). A value above 1 means the symptom is reported more often for this product than for all other products combined. This measures how much it stands out in reports — not cause, not risk.
Interpretation
Summary not yet available — will be auto-generated.
Label versus report
On the label
No signals currently mapped to the label.
Newly reported
Prostate cancer metastatic
Prostatic specific antigen increased
Therapy cessation
Metastases to bone
Hot flush
Hypokalaemia
Prostate cancer
Disease progression
Recall history · 0 on record
No recalls on record.
Compare within ALGEMEEN
Source & citation
HealthProves. abiraterone — reported signals. Retrieved 2026-07-05. Source: openFDA (FAERS). healthproves.com/abiraterone/
FAERS40,471 records
Retrieved2026-07-05
MethodROR / disproportionality