Abiraterone side effects: what 40,903 FDA adverse event reports show

Abiraterone Acetate · Abiraterone Acetate · 1,104 reaction terms · 89,912 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Brand names

Abiraterone Acetate

openFDA label

Who reports

40,903 reports · 69% serious · 8,375 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 2Labeled (related wording) 4Likely indication confounding 6Reporting / coding artifact 3Lab value / disease marker 3Not in label — unassessed 22

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. 1,064 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Acquired apparent mineralocorticoid excess	29	488.0 292.9–812.9ROR 488.3 · χ² 6,920 / p <1e-300	213.7 EB05 156.1 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious n=29 · 100% clinician	no trial arm names this drug
Apparent mineralocorticoid excess	23	351.8 206.6–599.1ROR 352.0 · χ² 4,537 / p <1e-300	177.4 EB05 124.5 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=22 · 100% clinician	no trial arm names this drug
Hormone-dependent prostate cancer	20	210.3 124.9–354.4ROR 210.4 · χ² 2,795 / p <1e-300	130.5 EB05 89.2 · IC025 +4.3 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=20	no trial arm names this drug
Polyneuropathy in malignant disease	17	134.1 78.6–228.9ROR 134.1 · χ² 1,671 / p <1e-300	95.1 EB05 62.9 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=17	no trial arm names this drug
Prostate cancer metastatic	656	124.9 114.7–135.9ROR 126.9 · χ² 64,535 / p <1e-300	100.0 EB05 93.8 · IC025 +6.4 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=652	no trial arm names this drug
Neuroendocrine carcinoma of prostate	12	116.5 62.2–218.2ROR 116.5 · χ² 1,024 / p 4e-225	82.8 EB05 50.5 · IC025 +3.3 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=12	no trial arm names this drug
Prostatic specific antigen increased	2,013	87.2 83.2–91.3ROR 91.6 · χ² 146,231 / p <1e-300	74.4 EB05 71.7 · IC025 +6.1 3/3 methods agree	Lab value / disease marker	serious PRR 61.0	no trial arm names this drug
Hormone-refractory prostate cancer	150	75.1 63.3–89.2ROR 75.4 · χ² 9,485 / p <1e-300	65.0 EB05 56.7 · IC025 +5.5 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=150 · 95% clinician	no trial arm names this drug
Brca1 gene mutation	11	73.1 38.8–137.5ROR 73.1 · χ² 621 / p 2e-137	57.9 EB05 34.5 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=11	no trial arm names this drug
Brca2 gene mutation	12	73.0 39.8–133.7ROR 73.0 · χ² 683 / p 9e-151	58.3 EB05 35.5 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=12	no trial arm names this drug
Acute biphenotypic leukaemia	11	71.2 37.9–133.8ROR 71.2 · χ² 607 / p 3e-134	56.7 EB05 33.8 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=11	no trial arm names this drug
Prostatic specific antigen decreased	38	56.9 40.7–79.6ROR 57.0 · χ² 1,826 / p <1e-300	50.0 EB05 38.1 · IC025 +4.4 3/3 methods agree	Lab value / disease marker	serious n=14 · 71% consumer	no trial arm names this drug
Prostatic specific antigen abnormal	103	56.0 45.7–68.6ROR 56.1 · χ² 4,957 / p <1e-300	50.0 EB05 42.4 · IC025 +5.0 3/3 methods agree	Lab value / disease marker	serious n=64	no trial arm names this drug
Hyperaldosteronism	25	40.1 26.7–60.2ROR 40.1 · χ² 846 / p 2e-186	36.3 EB05 25.8 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=25 · 100% clinician	no trial arm names this drug
Prostate cancer recurrent	39	34.7 25.1–48.0ROR 34.8 · χ² 1,164 / p 2e-255	32.1 EB05 24.5 · IC025 +4.0 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=39	no trial arm names this drug
Metastases to soft tissue	12	24.6 13.8–44.0ROR 24.6 · χ² 237 / p 8e-54	22.6 EB05 13.5 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious n=12	no trial arm names this drug
Product difficult to swallow	44	22.9 16.9–30.9ROR 22.9 · χ² 859 / p 4e-189	21.7 EB05 16.8 · IC025 +3.6 3/3 methods agree	Reporting / coding artifact	–	no trial arm names this drug
Acquired haemophilia	34	18.2 13.0–25.7ROR 18.3 · χ² 518 / p 5e-115	17.4 EB05 13.0 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=33 · 100% clinician	no trial arm names this drug
Spinal cord infarction	15	18.1 10.8–30.3ROR 18.1 · χ² 218 / p 1e-49	16.8 EB05 10.3 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious n=15	no trial arm names this drug
Gastroduodenal ulcer	13	16.4 9.4–28.4ROR 16.4 · χ² 167 / p 2e-38	14.9 EB05 8.4 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious n=13	no trial arm names this drug
Therapy cessation	1,563	16.1 15.4–17.0ROR 16.8 · χ² 21,561 / p <1e-300	15.7 EB05 15.0 · IC025 +3.9 3/3 methods agree	Reporting / coding artifact	serious PRR 3.5 · 75% consumer	no trial arm names this drug
Nephrostomy	10	16.1 8.6–30.3ROR 16.1 · χ² 123 / p 6e-29	14.1 EB05 7.0 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious n=10	no trial arm names this drug
Retroperitoneal lymphadenopathy	16	16.0 9.7–26.4ROR 16.0 · χ² 204 / p 1e-46	14.8 EB05 9.1 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious n=16	no trial arm names this drug
Hydroureter	11	15.5 8.5–28.2ROR 15.5 · χ² 131 / p 1e-30	13.6 EB05 7.1 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious n=11	no trial arm names this drug
Metastases to bone	450	14.5 13.2–15.9ROR 14.6 · χ² 5,478 / p <1e-300	14.1 EB05 13.0 · IC025 +3.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 11.5	no trial arm names this drug
Bone cancer metastatic	14	13.9 8.2–23.7ROR 13.9 · χ² 151 / p 5e-35	12.4 EB05 7.1 · IC025 +2.3 3/3 methods agree	Labeled (related wording) related wording	serious n=13	no trial arm names this drug
Chemotherapy	97	13.8 11.2–16.8ROR 13.8 · χ² 1,105 / p 2e-242	13.3 EB05 11.2 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious n=95 · 75% consumer	no trial arm names this drug
Hospice care	252	13.4 11.9–15.2ROR 13.5 · χ² 2,814 / p <1e-300	13.1 EB05 11.8 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 5.9	no trial arm names this drug
Metabolic alkalosis	40	13.2 9.6–18.0ROR 13.2 · χ² 426 / p 5e-95	12.5 EB05 9.4 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=40 · 100% clinician	no trial arm names this drug
Metastases to spine	84	13.2 10.6–16.3ROR 13.2 · χ² 908 / p 1e-199	12.7 EB05 10.5 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=82	no trial arm names this drug
Transurethral prostatectomy	12	12.6 7.1–22.4ROR 12.7 · χ² 114 / p 5e-27	10.8 EB05 5.8 · IC025 +2.1 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=12	no trial arm names this drug
Product size issue	125	12.3 10.3–14.7ROR 12.4 · χ² 1,258 / p 6e-276	12.0 EB05 10.3 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	serious n=38	no trial arm names this drug
Radiotherapy	43	11.8 8.7–15.9ROR 11.8 · χ² 403 / p 6e-90	11.1 EB05 8.4 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=39	no trial arm names this drug
Metastases to bone marrow	11	11.4 6.3–20.8ROR 11.4 · χ² 92 / p 4e-22	9.3 EB05 5.0 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious n=11	no trial arm names this drug
Soft tissue mass	10	11.3 6.0–21.2ROR 11.3 · χ² 82 / p 6e-20	9.0 EB05 4.7 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious n=10	no trial arm names this drug
Urinary tract obstruction	49	10.9 8.2–14.4ROR 10.9 · χ² 420 / p 2e-93	10.3 EB05 8.0 · IC025 +2.8 3/3 methods agree	Labeled (related wording) related wording	serious n=49	no trial arm names this drug
Hot flush (hot flashes)	1,490	10.3 9.8–10.9ROR 10.7 · χ² 12,322 / p <1e-300	10.1 EB05 9.7 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.6	no trial arm names this drug
Spinal cord compression	77	10.3 8.2–12.9ROR 10.3 · χ² 623 / p 8e-138	9.8 EB05 8.1 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=76	no trial arm names this drug
Metastases to pelvis	12	9.9 5.6–17.6ROR 9.9 · χ² 86 / p 1e-20	8.0 EB05 4.6 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious n=12	no trial arm names this drug
Cancer pain	43	8.7 6.4–11.8ROR 8.7 · χ² 281 / p 2e-63	8.1 EB05 6.2 · IC025 +2.5 3/3 methods agree	Labeled (related wording) related wording	serious n=40	no trial arm names this drug

Trial evidence (ClinicalTrials.gov)

No completed trial with posted adverse-event results was found on ClinicalTrials.gov for Abiraterone (searched ABIRATERONE).

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	6,189	3.7 3.6–3.8ROR 4.2 · χ² 12,640 / p <1e-300	3.7 EB05 3.6 · IC025 +1.8 3/3 methods agree	Outcome field, not a reaction	serious PRR 3.1	no trial arm names this drug
Fatigue (tiredness)	2,676	1.8 1.7–1.8ROR 1.8 · χ² 924 / p 3e-203	1.8 EB05 1.7 · IC025 +0.8	Labeled adverse reaction exact term	serious PRR 1.4	no trial arm names this drug
Prostatic specific antigen increased	2,013	87.2 83.2–91.3ROR 91.6 · χ² 146,231 / p <1e-300	74.4 EB05 71.7 · IC025 +6.1 3/3 methods agree	Lab value / disease marker	serious PRR 61.0	no trial arm names this drug
Drug ineffective (drug did not work)	1,989	0.8 0.7–0.8ROR 0.8 · χ² 140 / p 2e-32	0.8 EB05 0.7 · IC025 -0.4 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious PRR 1.2	no trial arm names this drug
Therapy cessation	1,563	16.1 15.4–17.0ROR 16.8 · χ² 21,561 / p <1e-300	15.7 EB05 15.0 · IC025 +3.9 3/3 methods agree	Reporting / coding artifact	serious PRR 3.5 · 75% consumer	no trial arm names this drug
Hot flush (hot flashes)	1,490	10.3 9.8–10.9ROR 10.7 · χ² 12,322 / p <1e-300	10.1 EB05 9.7 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.6	no trial arm names this drug
Asthenia (weakness)	1,317	1.8 1.7–1.9ROR 1.8 · χ² 473 / p 5e-105	1.8 EB05 1.7 · IC025 +0.8	Not in label — unassessed	serious PRR 1.5	no trial arm names this drug
Disease progression	1,221	5.4 5.1–5.7ROR 5.5 · χ² 4,296 / p <1e-300	5.3 EB05 5.1 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 3.5	no trial arm names this drug
Hospitalisation	1,085	3.7 3.5–3.9ROR 3.7 · χ² 2,104 / p <1e-300	3.6 EB05 3.5 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious PRR 3.0	no trial arm names this drug
Off label use (used outside approved label)	1,076	0.6 0.6–0.7ROR 0.6 · χ² 235 / p 3e-53	0.6 EB05 0.6 · IC025 -0.8 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious PRR 0.6	no trial arm names this drug
Nausea	1,020	0.7 0.6–0.7ROR 0.7 · χ² 182 / p 9e-42	0.7 EB05 0.6 · IC025 -0.7 PRR-only: not supported by EBGM or IC	Labeled adverse reaction exact term	serious PRR 0.7	no trial arm names this drug
Diarrhoea (diarrhea)	980	0.8 0.7–0.8ROR 0.8 · χ² 62 / p 2e-15	0.8 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC	Labeled adverse reaction exact term	serious PRR 0.7	no trial arm names this drug
Fall	950	1.5 1.4–1.6ROR 1.5 · χ² 142 / p 5e-33	1.5 EB05 1.4 · IC025 +0.4	Labeled adverse reaction exact term	serious PRR 1.2	no trial arm names this drug
Prostate cancer	891	5.7 5.3–6.1ROR 5.8 · χ² 3,402 / p <1e-300	5.6 EB05 5.3 · IC025 +2.4 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 4.4	no trial arm names this drug
Dizziness	839	0.9 0.8–0.9ROR 0.9 · χ² 18 / p 9e-6	0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC	Not in label — unassessed	serious PRR 0.8	no trial arm names this drug

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=29, PRR 488.0
Apparent mineralocorticoid excess — n=23, PRR 351.8
Hyperaldosteronism — n=25, PRR 40.1
Acquired haemophilia — n=34, PRR 18.2
Hospice care — n=252, PRR 13.4
Metabolic alkalosis — n=40, PRR 13.2
Metastases to spine — n=84, PRR 13.2
Radiotherapy — n=43, PRR 11.8
Spinal cord compression — n=77, PRR 10.3

✓ A hand-written Bradford Hill causality assessment exists for this drug: Medroxyprogesterone acetate ↔ Meningioma.

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, prostatic specific antigen increased, hot flush, asthenia, nausea, diarrhoea. 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, field patient.drug.openfda.generic_name.exact, 1,104 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
ClinicalTrials.gov API v2 (query ABIRATERONE, results-bearing studies sorted by enrollment)

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.