Drug · FAERS side-effect profile with label screen
Darolutamide side effects: what 5,493 FDA adverse event reports show
Drug class
No validated FDA label found
Who reports
5,493 reports · 69% serious · 670 with death outcome · 0% female
openFDA FAERS counts, all years, deduplication not applied
Used for
—
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
Reporting / coding artifact 3Lab value / disease marker 7No label text to screen 30
What the badges mean
- 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.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
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. 160 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 increased | 230 | 64.3 56.6–73.1ROR 67.1 · χ² 14,049 / p <1e-300 | 63.0 EB05 56.4 · IC025 +5.6 3/3 methods agree | Lab value / disease marker | serious PRR 68.0 | no trial data cached |
| Metastases to bone | 137 | 32.2 27.3–38.0ROR 33.0 · χ² 4,077 / p <1e-300 | 31.8 EB05 27.6 · IC025 +4.6 3/3 methods agree | No label text to screen | serious PRR 26.8 | no trial data cached |
| Hot flush (hot flashes) | 622 | 31.7 29.4–34.2ROR 35.6 · χ² 18,379 / p <1e-300 | 31.4 EB05 29.4 · IC025 +4.8 3/3 methods agree | No label text to screen | serious PRR 23.7 · 90% consumer | no trial data cached |
| Brain fog | 45 | 11.8 8.8–15.8ROR 11.9 · χ² 433 / p 2e-96 | 11.4 EB05 8.7 · IC025 +2.9 3/3 methods agree | No label text to screen | serious PRR 9.2 · 91% consumer | no trial data cached |
| Nocturia (night-time urination) | 32 | 10.1 7.1–14.3ROR 10.1 · χ² 253 / p 3e-57 | 9.4 EB05 6.8 · IC025 +2.6 3/3 methods agree | No label text to screen | serious PRR 4.9 · 100% consumer | no trial data cached |
| Neuropathy peripheral (nerve damage in hands/feet) | 189 | 7.6 6.6–8.8ROR 7.9 · χ² 1,086 / p 2e-238 | 7.5 EB05 6.6 · IC025 +2.7 3/3 methods agree | No label text to screen | serious PRR 7.3 | no trial data cached |
| Product dose omission in error | 52 | 7.4 5.6–9.7ROR 7.5 · χ² 281 / p 2e-63 | 7.0 EB05 5.5 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 13.0 · 96% consumer | no trial data cached |
| Interstitial lung disease | 85 | 6.7 5.4–8.3ROR 6.8 · χ² 408 / p 5e-91 | 6.5 EB05 5.4 · IC025 +2.3 3/3 methods agree | No label text to screen | serious PRR 5.6 · 95% clinician | no trial data cached |
| Prostate cancer | 131 | 6.2 5.2–7.3ROR 6.3 · χ² 562 / p 2e-124 | 6.0 EB05 5.2 · IC025 +2.3 3/3 methods agree | No label text to screen | serious PRR 5.1 | no trial data cached |
| Muscle atrophy | 20 | 6.1 3.9–9.4ROR 6.1 · χ² 80 / p 2e-19 | 5.4 EB05 3.7 · IC025 +1.7 3/3 methods agree | No label text to screen | serious PRR 3.2 | no trial data cached |
| Neutrophil count decreased | 63 | 5.9 4.6–7.6ROR 6.0 · χ² 254 / p 2e-57 | 5.7 EB05 4.6 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 5.3 · 94% clinician | no trial data cached |
| Pollakiuria (frequent urination) | 63 | 5.8 4.5–7.4ROR 5.8 · χ² 244 / p 3e-55 | 5.5 EB05 4.5 · IC025 +2.1 3/3 methods agree | No label text to screen | serious PRR 3.9 · 100% consumer | no trial data cached |
| Myelosuppression | 50 | 5.6 4.3–7.4ROR 5.7 · χ² 185 / p 2e-42 | 5.3 EB05 4.2 · IC025 +2.0 3/3 methods agree | No label text to screen | serious PRR 4.7 · 96% clinician | no trial data cached |
| Therapy interrupted | 99 | 5.5 4.5–6.7ROR 5.6 · χ² 358 / p 3e-80 | 5.3 EB05 4.5 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 3.0 · 91% consumer | no trial data cached |
| Metastases to liver | 24 | 5.2 3.5–7.8ROR 5.2 · χ² 78 / p 6e-19 | 4.8 EB05 3.4 · IC025 +1.6 3/3 methods agree | No label text to screen | serious PRR 4.4 | no trial data cached |
| Taste disorder | 27 | 5.1 3.5–7.5ROR 5.2 · χ² 86 / p 9e-21 | 4.7 EB05 3.4 · IC025 +1.6 3/3 methods agree | No label text to screen | serious PRR 6.0 · 70% consumer | no trial data cached |
| Urinary retention | 43 | 4.9 3.7–6.6ROR 5.0 · χ² 131 / p 1e-30 | 4.7 EB05 3.6 · IC025 +1.7 3/3 methods agree | No label text to screen | serious PRR 3.8 | no trial data cached |
| Blood sodium decreased | 24 | 4.9 3.3–7.3ROR 4.9 · χ² 70 / p 3e-17 | 4.5 EB05 3.2 · IC025 +1.5 3/3 methods agree | Lab value / disease marker | serious PRR 4.0 · 71% consumer | no trial data cached |
| Liver function test increased | 27 | 4.8 3.3–7.0ROR 4.8 · χ² 78 / p 5e-19 | 4.5 EB05 3.2 · IC025 +1.5 3/3 methods agree | No label text to screen | serious PRR 3.7 | no trial data cached |
| Urosepsis | 11 | 4.6 2.5–8.2ROR 4.6 · χ² 27 / p 1e-7 | 3.9 EB05 2.3 · IC025 +1.0 3/3 methods agree | No label text to screen | serious PRR 3.8 | no trial data cached |
| Blood calcium decreased | 13 | 4.4 2.6–7.6ROR 4.4 · χ² 31 / p 1e-8 | 3.9 EB05 2.4 · IC025 +1.0 3/3 methods agree | Lab value / disease marker | serious PRR 3.5 | no trial data cached |
| Night sweats | 37 | 4.4 3.2–6.0ROR 4.4 · χ² 93 / p 2e-22 | 4.2 EB05 3.2 · IC025 +1.5 3/3 methods agree | No label text to screen | serious PRR 3.0 · 86% consumer | no trial data cached |
| Red blood cell count decreased | 32 | 4.3 3.0–6.0ROR 4.3 · χ² 77 / p 1e-18 | 4.0 EB05 3.0 · IC025 +1.4 3/3 methods agree | Lab value / disease marker | serious PRR 3.1 · 88% consumer | no trial data cached |
| Fatigue (tiredness) | 829 | 4.1 3.8–4.3ROR 4.6 · χ² 1,989 / p <1e-300 | 4.1 EB05 3.8 · IC025 +1.9 3/3 methods agree | No label text to screen | serious PRR 3.2 · 82% consumer | no trial data cached |
| Blood urine present | 20 | 4.0 2.6–6.2ROR 4.0 · χ² 42 / p 4e-11 | 3.7 EB05 2.5 · IC025 +1.1 3/3 methods agree | Lab value / disease marker | serious PRR 2.8 · 75% consumer | no trial data cached |
| Metastases to lung | 12 | 4.0 2.3–7.0ROR 4.0 · χ² 24 / p 6e-7 | 3.5 EB05 2.2 · IC025 +0.8 3/3 methods agree | No label text to screen | serious PRR 3.3 | no trial data cached |
| Pneumonitis | 28 | 4.0 2.7–5.7ROR 4.0 · χ² 59 / p 9e-15 | 3.7 EB05 2.7 · IC025 +1.3 3/3 methods agree | No label text to screen | serious PRR 3.4 · 100% clinician | no trial data cached |
| Bone pain | 58 | 3.8 2.9–4.9ROR 3.8 · χ² 116 / p 3e-27 | 3.7 EB05 2.9 · IC025 +1.4 3/3 methods agree | No label text to screen | serious PRR 3.9 · 81% consumer | no trial data cached |
| Libido decreased (lower sex drive) | 12 | 3.7 2.1–6.5ROR 3.7 · χ² 21 / p 2e-6 | 3.3 EB05 2.0 · IC025 +0.8 3/3 methods agree | No label text to screen | serious PRR 3.2 | no trial data cached |
| Gait inability | 32 | 3.7 2.6–5.2ROR 3.7 · χ² 60 / p 5e-15 | 3.5 EB05 2.6 · IC025 +1.2 3/3 methods agree | No label text to screen | serious PRR 3.7 · 88% consumer | no trial data cached |
| Cytokine release syndrome | 18 | 3.6 2.3–5.7ROR 3.6 · χ² 31 / p 1e-8 | 3.3 EB05 2.3 · IC025 +1.0 3/3 methods agree | No label text to screen | serious PRR 3.0 | no trial data cached |
| Incontinence | 10 | 3.6 1.9–6.7ROR 3.6 · χ² 16 / p 3e-5 | 3.2 EB05 1.9 · IC025 +0.6 | No label text to screen | serious PRR 2.0 | no trial data cached |
| Febrile neutropenia | 62 | 3.6 2.8–4.6ROR 3.6 · χ² 112 / p 1e-26 | 3.5 EB05 2.8 · IC025 +1.4 3/3 methods agree | No label text to screen | serious PRR 3.0 · 97% clinician | no trial data cached |
| Asthenia (weakness) | 352 | 3.6 3.2–4.0ROR 3.7 · χ² 660 / p 7e-146 | 3.6 EB05 3.3 · IC025 +1.7 3/3 methods agree | No label text to screen | serious PRR 2.5 · 78% consumer | no trial data cached |
| Decreased activity | 10 | 3.6 1.9–6.6ROR 3.6 · χ² 16 / p 3e-5 | 3.1 EB05 1.9 · IC025 +0.6 | No label text to screen | serious PRR 3.1 | no trial data cached |
| Blood iron decreased | 11 | 3.6 2.0–6.4ROR 3.6 · χ² 18 / p 1e-5 | 3.2 EB05 1.9 · IC025 +0.7 | Lab value / disease marker | serious PRR 2.9 | no trial data cached |
| Incorrect dose administered | 208 | 3.5 3.1–4.0ROR 3.6 · χ² 378 / p 2e-84 | 3.5 EB05 3.1 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 4.3 · 90% consumer | no trial data cached |
| Dysuria (painful urination) | 34 | 3.5 2.5–4.9ROR 3.5 · χ² 59 / p 8e-15 | 3.4 EB05 2.5 · IC025 +1.2 3/3 methods agree | No label text to screen | serious PRR 2.5 · 85% consumer | no trial data cached |
| Renal impairment | 74 | 3.4 2.7–4.2ROR 3.4 · χ² 122 / p 1e-28 | 3.3 EB05 2.7 · IC025 +1.3 3/3 methods agree | No label text to screen | serious PRR 2.9 | no trial data cached |
| Ageusia (loss of taste) | 22 | 3.4 2.2–5.1ROR 3.4 · χ² 34 / p 3e-9 | 3.2 EB05 2.2 · IC025 +1.0 3/3 methods agree | No label text to screen | serious PRR 3.1 · 95% consumer | 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 |
|---|---|---|---|---|---|---|
| Fatigue (tiredness) | 829 | 4.1 3.8–4.3ROR 4.6 · χ² 1,989 / p <1e-300 | 4.1 EB05 3.8 · IC025 +1.9 3/3 methods agree | No label text to screen | serious PRR 3.2 · 82% consumer | no trial data cached |
| Hot flush (hot flashes) | 622 | 31.7 29.4–34.2ROR 35.6 · χ² 18,379 / p <1e-300 | 31.4 EB05 29.4 · IC025 +4.8 3/3 methods agree | No label text to screen | serious PRR 23.7 · 90% consumer | no trial data cached |
| Death | 441 | 2.0 1.8–2.1ROR 2.0 · χ² 213 / p 2e-48 | 2.0 EB05 1.8 · IC025 +0.8 | Outcome field, not a reaction | serious PRR 1.6 | no trial data cached |
| Asthenia (weakness) | 352 | 3.6 3.2–4.0ROR 3.7 · χ² 660 / p 7e-146 | 3.6 EB05 3.3 · IC025 +1.7 3/3 methods agree | No label text to screen | serious PRR 2.5 · 78% consumer | no trial data cached |
| Dizziness | 236 | 1.8 1.6–2.0ROR 1.8 · χ² 86 / p 8e-21 | 1.8 EB05 1.6 · IC025 +0.6 | No label text to screen | serious PRR 1.7 · 78% consumer | no trial data cached |
| Arthralgia (joint pain) | 235 | 2.2 1.9–2.5ROR 2.2 · χ² 149 / p 2e-34 | 2.2 EB05 1.9 · IC025 +0.9 | No label text to screen | serious PRR 1.9 · 76% consumer | no trial data cached |
| Prostatic specific antigen increased | 230 | 64.3 56.6–73.1ROR 67.1 · χ² 14,049 / p <1e-300 | 63.0 EB05 56.4 · IC025 +5.6 3/3 methods agree | Lab value / disease marker | serious PRR 68.0 | no trial data cached |
| Incorrect dose administered | 208 | 3.5 3.1–4.0ROR 3.6 · χ² 378 / p 2e-84 | 3.5 EB05 3.1 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 4.3 · 90% consumer | no trial data cached |
| Product dose omission issue | 204 | 2.7 2.4–3.1ROR 2.8 · χ² 225 / p 3e-51 | 2.7 EB05 2.4 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 4.7 · 87% consumer | no trial data cached |
| Neuropathy peripheral (nerve damage in hands/feet) | 189 | 7.6 6.6–8.8ROR 7.9 · χ² 1,086 / p 2e-238 | 7.5 EB05 6.6 · IC025 +2.7 3/3 methods agree | No label text to screen | serious PRR 7.3 | no trial data cached |
| Pain in extremity | 170 | 2.2 1.9–2.5ROR 2.2 · χ² 111 / p 3e-26 | 2.2 EB05 1.9 · IC025 +0.9 | No label text to screen | serious PRR 2.2 · 83% consumer | no trial data cached |
| Constipation | 162 | 2.9 2.5–3.3ROR 2.9 · χ² 195 / p 1e-44 | 2.8 EB05 2.5 · IC025 +1.2 3/3 methods agree | No label text to screen | serious PRR 2.9 · 75% consumer | no trial data cached |
| Decreased appetite (loss of appetite) | 150 | 2.5 2.1–2.9ROR 2.5 · χ² 131 / p 1e-30 | 2.5 EB05 2.1 · IC025 +1.0 3/3 methods agree | No label text to screen | serious PRR 2.4 | no trial data cached |
| Metastases to bone | 137 | 32.2 27.3–38.0ROR 33.0 · χ² 4,077 / p <1e-300 | 31.8 EB05 27.6 · IC025 +4.6 3/3 methods agree | No label text to screen | serious PRR 26.8 | no trial data cached |
| Prostate cancer | 131 | 6.2 5.2–7.3ROR 6.3 · χ² 562 / p 2e-124 | 6.0 EB05 5.2 · IC025 +2.3 3/3 methods agree | No label text to screen | serious PRR 5.1 | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
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 Darolutamide?
In FDA FAERS, the most frequently co-reported reaction terms for Darolutamide are fatigue, hot flush, asthenia, dizziness, arthralgia, prostatic specific antigen increased. 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 Darolutamide have an FDA boxed warning?
No validated FDA label could be retrieved for this product name, so this page cannot say.
Do FAERS signals prove that Darolutamide 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
- No FDA label passed the name-validation check for this product string, so label-based screening was skipped
- 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, 200 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.