Drug · FAERS side-effect profile with label screen
Apalutamide side effects: what 11,677 FDA adverse event reports show
Drug class
Androgen receptor inhibitor
FDA label, Indications wording
Brand names
Erleada
openFDA label
Who reports
11,677 reports · 62% serious · 1,506 with death outcome · 0% female
openFDA FAERS counts, all years, deduplication not applied
Used for
ERLEADA is indicated for the treatment of patients with Metastatic castration-sensitive prostate cancer (mCSPC) Non-metastatic castration-resistant prostate cancer (nmCRPC) ERLEADA is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer. ( 1 ) non-metastatic castration-resistant prostate cancer. ( 1 )
FDA label, Indications and Usage
What it is
Apalutamide, the active ingredient of ERLEADA, is an androgen receptor inhibitor. Each ERLEADA tablet contains either 60 mg or 240 mg of apalutamide.
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 7Labeled (related wording) 2Likely indication confounding 2Reporting / coding artifact 5Lab value / disease marker 6Not in label — unassessed 18
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. 957 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 |
|---|---|---|---|---|---|---|
| Prostatic specific antigen decreased | 14 | 68.6 40.2–117.0ROR 68.7 · χ² 834 / p 1e-183 | 60.9 EB05 38.5 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious n=4 | no trial data cached |
| Prostatic specific antigen abnormal | 31 | 54.8 38.3–78.3ROR 54.9 · χ² 1,536 / p <1e-300 | 51.6 EB05 38.1 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious n=21 | no trial data cached |
| Prostate cancer metastatic | 80 | 43.9 35.2–54.7ROR 44.1 · χ² 3,228 / p <1e-300 | 42.4 EB05 35.2 · IC025 +4.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=78 | no trial data cached |
| Prostatic specific antigen increased | 304 | 40.2 36.0–45.0ROR 41.3 · χ² 11,342 / p <1e-300 | 39.3 EB05 35.7 · IC025 +5.0 3/3 methods agree | Lab value / disease marker | serious PRR 35.2 | no trial data cached |
| Dermatitis exfoliative generalised | 59 | 31.3 24.2–40.5ROR 31.5 · χ² 1,672 / p <1e-300 | 30.5 EB05 24.5 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious n=58 · 95% clinician | no trial data cached |
| Hormone-refractory prostate cancer | 16 | 24.8 15.1–40.6ROR 24.8 · χ² 337 / p 1e-75 | 23.8 EB05 15.4 · IC025 +3.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=16 | no trial data cached |
| Incorrect dosage administered | 65 | 24.1 18.8–30.7ROR 24.2 · χ² 1,395 / p <1e-300 | 23.6 EB05 19.2 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious n=16 · 80% consumer | no trial data cached |
| Hot flush (hot flashes) | 884 | 21.3 20.0–22.7ROR 22.9 · χ² 16,922 / p <1e-300 | 21.0 EB05 19.9 · IC025 +4.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.5 | no trial data cached |
| Blood testosterone increased | 20 | 16.8 10.8–26.1ROR 16.8 · χ² 279 / p 8e-63 | 16.2 EB05 10.7 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious n=9 | no trial data cached |
| Blood testosterone abnormal | 10 | 16.2 8.7–30.2ROR 16.2 · χ² 127 / p 1e-29 | 14.5 EB05 7.3 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious n=5 | no trial data cached |
| Lichenoid keratosis | 18 | 14.4 9.1–22.9ROR 14.4 · χ² 210 / p 8e-48 | 13.6 EB05 8.5 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Physical deconditioning | 18 | 13.0 8.2–20.6ROR 13.0 · χ² 186 / p 1e-42 | 12.0 EB05 7.5 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Radiotherapy | 11 | 10.4 5.7–18.7ROR 10.4 · χ² 83 / p 3e-20 | 8.4 EB05 4.6 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Blood thyroid stimulating hormone increased | 47 | 9.2 6.9–12.2ROR 9.2 · χ² 333 / p 1e-74 | 8.7 EB05 6.7 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious n=21 | no trial data cached |
| Skin toxicity | 28 | 9.0 6.2–13.1ROR 9.1 · χ² 191 / p 8e-44 | 8.3 EB05 5.9 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious n=28 · 100% clinician | no trial data cached |
| Testicular pain | 14 | 8.0 4.7–13.5ROR 8.0 · χ² 78 / p 5e-19 | 6.6 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Metastases to bone | 72 | 7.9 6.3–10.0ROR 8.0 · χ² 427 / p 3e-95 | 7.6 EB05 6.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 | no trial data cached |
| Metastatic neoplasm | 18 | 7.5 4.7–11.9ROR 7.5 · χ² 95 / p 1e-22 | 6.5 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Dermatitis exfoliative | 21 | 7.5 4.9–11.5ROR 7.5 · χ² 111 / p 3e-26 | 6.6 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=21 | no trial data cached |
| Product size issue | 20 | 6.8 4.4–10.5ROR 6.8 · χ² 92 / p 4e-22 | 5.9 EB05 4.0 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious n=12 | no trial data cached |
| Hospice care | 37 | 6.8 4.9–9.3ROR 6.8 · χ² 175 / p 3e-40 | 6.3 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 | no trial data cached |
| Muscle atrophy | 47 | 6.7 5.1–9.0ROR 6.7 · χ² 223 / p 1e-50 | 6.3 EB05 4.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 · 81% consumer | no trial data cached |
| Emergency care | 10 | 6.1 3.3–11.3ROR 6.1 · χ² 37 / p 5e-10 | 4.8 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Breast enlargement | 11 | 6.0 3.3–10.9ROR 6.0 · χ² 41 / p 7e-11 | 4.9 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 48 | 5.7 4.3–7.6ROR 5.7 · χ² 182 / p 9e-42 | 5.4 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 | no trial data cached |
| Non-cardiac chest pain | 10 | 5.7 3.0–10.5ROR 5.7 · χ² 34 / p 3e-9 | 4.6 EB05 2.7 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Nocturia (night-time urination) | 38 | 5.6 4.1–7.8ROR 5.7 · χ² 140 / p 1e-32 | 5.3 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Therapy cessation | 158 | 5.6 4.8–6.5ROR 5.6 · χ² 586 / p 8e-130 | 5.5 EB05 4.8 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 3.0 | no trial data cached |
| Agranulocytosis (severe loss of white cells) | 57 | 5.5 4.3–7.2ROR 5.6 · χ² 207 / p 3e-47 | 5.3 EB05 4.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 · 98% clinician | no trial data cached |
| Taste disorder | 61 | 5.5 4.3–7.0ROR 5.5 · χ² 218 / p 1e-49 | 5.3 EB05 4.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Listless | 10 | 5.5 2.9–10.2ROR 5.5 · χ² 32 / p 7e-9 | 4.5 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Metastases to spine | 10 | 5.4 2.9–10.0ROR 5.4 · χ² 31 / p 1e-8 | 4.4 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 76 | 5.3 4.3–6.7ROR 5.4 · χ² 264 / p 1e-59 | 5.2 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 · 96% clinician | no trial data cached |
| Rash | 1,285 | 5.3 5.1–5.6ROR 5.9 · χ² 4,597 / p <1e-300 | 5.3 EB05 5.1 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 | no trial data cached |
| Hypothyroidism | 91 | 5.1 4.2–6.3ROR 5.2 · χ² 299 / p 3e-67 | 5.0 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.1 | no trial data cached |
| Drug eruption | 50 | 5.1 3.9–6.7ROR 5.1 · χ² 160 / p 5e-37 | 4.9 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.1 | no trial data cached |
| Product label issue | 19 | 5.1 3.2–8.0ROR 5.1 · χ² 58 / p 1e-14 | 4.6 EB05 3.1 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious n=9 | no trial data cached |
| Metastases to lymph nodes | 19 | 5.1 3.2–8.0ROR 5.1 · χ² 58 / p 1e-14 | 4.6 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Therapy change | 27 | 5.0 3.5–7.3ROR 5.0 · χ² 83 / p 4e-20 | 4.6 EB05 3.4 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious n=9 | no trial data cached |
| Rash maculo-papular | 62 | 5.0 3.9–6.5ROR 5.1 · χ² 196 / p 8e-45 | 4.8 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 · 95% 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 |
|---|---|---|---|---|---|---|
| Rash | 1,285 | 5.3 5.1–5.6ROR 5.9 · χ² 4,597 / p <1e-300 | 5.3 EB05 5.1 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 | no trial data cached |
| Death | 1,181 | 2.5 2.3–2.6ROR 2.6 · χ² 1,066 / p 3e-234 | 2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree | Outcome field, not a reaction | serious PRR 2.2 | no trial data cached |
| Fatigue (tiredness) | 1,177 | 2.7 2.6–2.9ROR 2.9 · χ² 1,327 / p 1e-290 | 2.7 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.9 | no trial data cached |
| Hot flush (hot flashes) | 884 | 21.3 20.0–22.7ROR 22.9 · χ² 16,922 / p <1e-300 | 21.0 EB05 19.9 · IC025 +4.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.5 | no trial data cached |
| Product dose omission issue | 444 | 2.8 2.6–3.1ROR 2.9 · χ² 518 / p 5e-115 | 2.8 EB05 2.6 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 5.0 · 73% consumer | no trial data cached |
| Asthenia (weakness) | 430 | 2.1 1.9–2.3ROR 2.1 · χ² 235 / p 2e-53 | 2.0 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 1.4 | no trial data cached |
| Diarrhoea (diarrhea) | 401 | 1.1 1.0–1.2ROR 1.1 · χ² 5 / p 0.012 | 1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.8 | no trial data cached |
| Dizziness | 366 | 1.3 1.2–1.5ROR 1.3 · χ² 29 / p 4e-8 | 1.3 EB05 1.2 · IC025 +0.2 | Not in label — unassessed | serious PRR 1.0 | no trial data cached |
| Arthralgia (joint pain) | 356 | 1.5 1.4–1.7ROR 1.6 · χ² 69 / p 6e-17 | 1.5 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.0 | no trial data cached |
| Off label use (used outside approved label) | 354 | 0.7 0.7–0.8ROR 0.7 · χ² 36 / p 1e-9 | 0.7 EB05 0.7 · IC025 -0.6 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.8 | no trial data cached |
| Fall | 337 | 1.8 1.6–2.0ROR 1.8 · χ² 125 / p 2e-29 | 1.8 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.5 | no trial data cached |
| Decreased appetite (loss of appetite) | 316 | 2.4 2.2–2.7ROR 2.5 · χ² 272 / p 2e-61 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Prostatic specific antigen increased | 304 | 40.2 36.0–45.0ROR 41.3 · χ² 11,342 / p <1e-300 | 39.3 EB05 35.7 · IC025 +5.0 3/3 methods agree | Lab value / disease marker | serious PRR 35.2 | no trial data cached |
| Incorrect dose administered | 286 | 2.3 2.0–2.6ROR 2.3 · χ² 207 / p 3e-47 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 2.1 · 82% consumer | no trial data cached |
| Pruritus (itching) | 284 | 1.3 1.2–1.5ROR 1.4 · χ² 26 / p 2e-7 | 1.3 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 2.0 | 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.
- Metastases to bone — n=72, PRR 7.9
- Dermatitis exfoliative — n=21, PRR 7.5
- Hospice care — n=37, PRR 6.8
- Muscle atrophy — n=47, PRR 6.7
- Nocturia — n=38, PRR 5.6
- Agranulocytosis — n=57, PRR 5.5
- Taste disorder — n=61, PRR 5.5
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 Apalutamide?
In FDA FAERS, the most frequently co-reported reaction terms for Apalutamide are rash, fatigue, hot flush, asthenia, diarrhoea, dizziness. 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 Apalutamide have an FDA boxed warning?
No. The FDA label retrieved for Apalutamide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Apalutamide 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 d1cda4f7-cb33-46ea-b9ac-431f6452b1a5, effective 20260702; matched on
openfda.generic_name.exact:"APALUTAMIDE") - 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, 997 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.