Drug · FAERS side-effect profile with label screen
Abiraterone side effects: what 13,532 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Abiraterone Acetate
openFDA label
Who reports
13,532 reports · 79% serious · 2,246 with death outcome · 1% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with Metastatic castration-resistant prostate cancer (CRPC) Metastatic high-risk castration-sensitive prostate cancer (CSPC) Abiraterone acetate tablets are a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC).
FDA label, Indications and Usage
What it is
Abiraterone acetate USP, the active ingredient of abiraterone acetate tablets, USP is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each abiraterone acetate tablet, USP contains either 250 mg or 500 mg of abiraterone acetate, USP.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 3Labeled (related wording) 5Likely indication confounding 4Reporting / coding artifact 1Lab value / disease marker 2Not in label — unassessed 25
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 973 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Acquired apparent mineralocorticoid excess | 27 | 1,289.1 772.6–2,150.8ROR 1,291.7 · χ² 18,156 / p <1e-300 | 467.0 EB05 337.1 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=27 · 100% clinician | no trial data cached |
| Apparent mineralocorticoid excess | 21 | 916.7 533.8–1,574.2ROR 918.1 · χ² 11,440 / p <1e-300 | 376.3 EB05 259.6 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=20 · 100% clinician | no trial data cached |
| Hormone-dependent prostate cancer | 19 | 592.4 348.9–1,005.9ROR 593.3 · χ² 7,663 / p <1e-300 | 298.7 EB05 202.1 · IC025 +4.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=19 | no trial data cached |
| Polyneuropathy in malignant disease | 17 | 405.8 237.8–692.6ROR 406.3 · χ² 5,109 / p <1e-300 | 236.0 EB05 156.0 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Brca1 gene mutation | 11 | 221.1 117.5–416.1ROR 221.3 · χ² 1,918 / p <1e-300 | 145.2 EB05 86.5 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Acute biphenotypic leukaemia | 11 | 215.5 114.6–405.0ROR 215.6 · χ² 1,874 / p <1e-300 | 142.8 EB05 85.1 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Brca2 gene mutation | 11 | 200.1 106.7–375.0ROR 200.2 · χ² 1,754 / p <1e-300 | 135.9 EB05 81.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Hormone-refractory prostate cancer | 112 | 163.6 134.7–198.6ROR 164.9 · χ² 16,203 / p <1e-300 | 144.3 EB05 123.2 · IC025 +6.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=112 · 98% clinician | no trial data cached |
| Prostate cancer metastatic | 283 | 142.9 126.7–161.3ROR 146.0 · χ² 36,350 / p <1e-300 | 129.7 EB05 117.5 · IC025 +6.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=280 | no trial data cached |
| Prostate cancer recurrent | 26 | 68.5 46.3–101.4ROR 68.6 · χ² 1,591 / p <1e-300 | 62.7 EB05 45.0 · IC025 +4.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=26 · 92% clinician | no trial data cached |
| Metastases to soft tissue | 11 | 68.0 37.2–124.4ROR 68.1 · χ² 633 / p 6e-140 | 58.9 EB05 35.1 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Hyperaldosteronism | 14 | 65.6 38.4–112.0ROR 65.7 · χ² 793 / p 8e-175 | 58.2 EB05 36.9 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Prostatic specific antigen increased | 562 | 65.5 60.3–71.1ROR 68.3 · χ² 34,186 / p <1e-300 | 62.7 EB05 58.5 · IC025 +5.8 3/3 methods agree | Lab value / disease marker | serious PRR 56.7 | no trial data cached |
| Spinal cord infarction | 15 | 54.8 32.8–91.7ROR 54.9 · χ² 714 / p 1e-157 | 49.8 EB05 32.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Prostatic specific antigen abnormal | 32 | 48.9 34.4–69.5ROR 49.0 · χ² 1,409 / p <1e-300 | 46.2 EB05 34.3 · IC025 +4.2 3/3 methods agree | Lab value / disease marker | serious n=28 | no trial data cached |
| Gastroduodenal ulcer | 11 | 41.7 22.9–75.9ROR 41.7 · χ² 387 / p 2e-86 | 38.2 EB05 22.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Soft tissue mass | 10 | 34.3 18.3–64.1ROR 34.3 · χ² 284 / p 5e-64 | 31.7 EB05 18.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Metabolic alkalosis | 29 | 28.7 19.9–41.4ROR 28.7 · χ² 734 / p 8e-162 | 27.7 EB05 20.2 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=29 · 100% clinician | no trial data cached |
| Metastases to bone | 261 | 25.1 22.2–28.3ROR 25.6 · χ² 5,924 / p <1e-300 | 24.7 EB05 22.3 · IC025 +4.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 17.9 | no trial data cached |
| Hospice care | 146 | 23.3 19.8–27.4ROR 23.5 · χ² 3,048 / p <1e-300 | 22.9 EB05 19.9 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Allodynia | 16 | 22.3 13.6–36.6ROR 22.4 · χ² 301 / p 1e-67 | 21.5 EB05 13.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Metastases to spine | 42 | 19.6 14.5–26.6ROR 19.7 · χ² 716 / p 6e-158 | 19.2 EB05 14.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=41 | no trial data cached |
| Spinal cord compression | 46 | 18.4 13.8–24.6ROR 18.5 · χ² 732 / p 1e-161 | 18.1 EB05 14.1 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=45 | no trial data cached |
| Radiation injury | 12 | 17.7 10.0–31.2ROR 17.7 · χ² 170 / p 3e-39 | 16.5 EB05 9.2 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Metastases to lymph nodes | 69 | 16.1 12.7–20.4ROR 16.2 · χ² 952 / p 2e-209 | 15.8 EB05 12.9 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=68 | no trial data cached |
| Long qt syndrome | 23 | 14.9 9.9–22.5ROR 14.9 · χ² 282 / p 1e-63 | 14.3 EB05 9.7 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious n=23 · 100% clinician | no trial data cached |
| Hot flush (hot flashes) | 717 | 14.9 13.8–16.0ROR 15.6 · χ² 9,205 / p <1e-300 | 14.7 EB05 13.8 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.0 · 78% consumer | no trial data cached |
| Urinary tract obstruction | 20 | 13.2 8.5–20.6ROR 13.3 · χ² 212 / p 2e-48 | 12.4 EB05 8.0 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious n=20 | no trial data cached |
| Secondary adrenocortical insufficiency | 12 | 12.5 7.1–22.1ROR 12.5 · χ² 115 / p 4e-27 | 10.8 EB05 5.9 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious n=12 | no trial data cached |
| Hypokalaemia (low potassium) | 361 | 12.3 11.1–13.6ROR 12.6 · χ² 3,706 / p <1e-300 | 12.2 EB05 11.1 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.0 · 96% clinician | no trial data cached |
| Urinary bladder haemorrhage | 15 | 11.1 6.7–18.4ROR 11.1 · χ² 127 / p 1e-29 | 9.7 EB05 5.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Haemorrhage urinary tract | 18 | 11.0 7.0–17.6ROR 11.1 · χ² 154 / p 1e-35 | 9.9 EB05 6.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Cancer pain | 18 | 10.9 6.9–17.4ROR 10.9 · χ² 152 / p 4e-35 | 9.8 EB05 6.1 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious n=16 | no trial data cached |
| Metastases to lung | 80 | 10.8 8.7–13.5ROR 10.9 · χ² 697 / p 5e-154 | 10.5 EB05 8.7 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | no trial data cached |
| Hydronephrosis | 51 | 10.7 8.1–14.0ROR 10.7 · χ² 434 / p 1e-96 | 10.2 EB05 8.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 | no trial data cached |
| Therapy interrupted | 466 | 10.5 9.6–11.5ROR 10.9 · χ² 3,995 / p <1e-300 | 10.4 EB05 9.7 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 11.2 | no trial data cached |
| Acute coronary syndrome | 53 | 9.9 7.6–13.0ROR 9.9 · χ² 413 / p 5e-92 | 9.5 EB05 7.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 · 92% clinician | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 260 | 9.7 8.6–11.0ROR 9.9 · χ² 2,020 / p <1e-300 | 9.6 EB05 8.7 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.1 · 98% clinician | no trial data cached |
| Pyelonephritis acute | 12 | 9.6 5.4–16.9ROR 9.6 · χ² 83 / p 4e-20 | 7.8 EB05 4.5 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Bone lesion | 22 | 9.5 6.2–14.4ROR 9.5 · χ² 158 / p 2e-36 | 8.5 EB05 5.7 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=22 · 100% clinician | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Death | 1,454 | 2.6 2.5–2.7ROR 2.8 · χ² 1,512 / p <1e-300 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree | Outcome field, not a reaction | serious PRR 1.8 | no trial data cached |
| Fatigue (tiredness) | 1,096 | 2.2 2.1–2.3ROR 2.3 · χ² 731 / p 2e-161 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Hot flush (hot flashes) | 717 | 14.9 13.8–16.0ROR 15.6 · χ² 9,205 / p <1e-300 | 14.7 EB05 13.8 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.0 · 78% consumer | no trial data cached |
| Asthenia (weakness) | 597 | 2.5 2.3–2.7ROR 2.5 · χ² 525 / p 1e-116 | 2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.0 | no trial data cached |
| Disease progression | 592 | 7.8 7.2–8.5ROR 8.1 · χ² 3,511 / p <1e-300 | 7.7 EB05 7.2 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 4.1 | no trial data cached |
| Prostatic specific antigen increased | 562 | 65.5 60.3–71.1ROR 68.3 · χ² 34,186 / p <1e-300 | 62.7 EB05 58.5 · IC025 +5.8 3/3 methods agree | Lab value / disease marker | serious PRR 56.7 | no trial data cached |
| Drug ineffective (drug did not work) | 495 | 0.6 0.5–0.6ROR 0.6 · χ² 158 / p 2e-36 | 0.6 EB05 0.5 · IC025 -0.9 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.9 | no trial data cached |
| Therapy interrupted | 466 | 10.5 9.6–11.5ROR 10.9 · χ² 3,995 / p <1e-300 | 10.4 EB05 9.7 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 11.2 | no trial data cached |
| Fall | 446 | 2.1 1.9–2.3ROR 2.1 · χ² 253 / p 3e-57 | 2.1 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 1.6 | no trial data cached |
| Anaemia (low red blood cells) | 437 | 3.6 3.2–3.9ROR 3.6 · χ² 805 / p 3e-177 | 3.5 EB05 3.3 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.7 · 91% clinician | no trial data cached |
| Malignant neoplasm progression | 413 | 6.3 5.7–6.9ROR 6.5 · χ² 1,839 / p <1e-300 | 6.2 EB05 5.8 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 4.4 | no trial data cached |
| Diarrhoea (diarrhea) | 408 | 1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.370 | 1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.0 | no trial data cached |
| Nausea | 367 | 0.7 0.7–0.8ROR 0.7 · χ² 41 / p 8e-11 | 0.7 EB05 0.7 · IC025 -0.6 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.8 | no trial data cached |
| Prostate cancer | 365 | 7.0 6.3–7.7ROR 7.2 · χ² 1,866 / p <1e-300 | 6.9 EB05 6.3 · IC025 +2.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 4.5 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 364 | 3.7 3.4–4.1ROR 3.8 · χ² 721 / p 4e-159 | 3.7 EB05 3.4 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 · 96% clinician | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Acquired apparent mineralocorticoid excess — n=27, PRR 1,289.1
- Apparent mineralocorticoid excess — n=21, PRR 916.7
- Metabolic alkalosis — n=29, PRR 28.7
- Hospice care — n=146, PRR 23.3
- Metastases to spine — n=42, PRR 19.6
- Spinal cord compression — n=46, PRR 18.4
- Metastases to lymph nodes — n=69, PRR 16.1
- Metastases to lung — n=80, PRR 10.8
- Hydronephrosis — n=51, PRR 10.7
- Acute coronary syndrome — n=53, PRR 9.9
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Abiraterone?
In FDA FAERS, the most frequently co-reported reaction terms for Abiraterone are fatigue, hot flush, asthenia, prostatic specific antigen increased, fall, anaemia. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Abiraterone have an FDA boxed warning?
No. The FDA label retrieved for Abiraterone has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Abiraterone causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID c9eb9b46-f847-40a8-802c-a51b40406d5a, effective 20230814; matched on
openfda.generic_name.exact:"ABIRATERONE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,013 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.