Drug · FAERS side-effect profile with label screen
Radium Ra 223 Dichloride side effects: what 5,023 FDA adverse event reports show
Drug class
Alpha particle-emitting radioactive therapeutic agent
FDA label, Indications wording
Brand names
Xofigo
openFDA label
Who reports
5,023 reports · 89% serious · 1,027 with death outcome · 1% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. Xofigo is an alpha particle-emitting radioactive therapeutic agent indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. ( 1 )
FDA label, Indications and Usage
What it is
Radium Ra 223 dichloride, an alpha particle-emitting pharmaceutical, is a radiotherapeutic drug. Xofigo is supplied as a clear, colorless, isotonic, and sterile solution to be administered intravenously with pH between 6 and 8.
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) 5Likely indication confounding 2Reporting / coding artifact 5Lab value / disease marker 6Not in label — unassessed 15
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. 48 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 | 479 | 149.5 137.1–163.1ROR 165.2 · χ² 68,098 / p <1e-300 | 143.5 EB05 133.0 · IC025 +6.8 3/3 methods agree | Lab value / disease marker | serious PRR 139.9 | no trial data cached |
| Metastases to bone | 328 | 85.4 76.8–94.9ROR 91.3 · χ² 26,744 / p <1e-300 | 83.3 EB05 76.0 · IC025 +6.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 55.0 | no trial data cached |
| Metastases to liver | 178 | 42.8 37.0–49.5ROR 44.3 · χ² 7,157 / p <1e-300 | 42.2 EB05 37.2 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 27.7 | no trial data cached |
| Metastases to lung | 65 | 23.6 18.6–30.1ROR 23.9 · χ² 1,379 / p <1e-300 | 23.4 EB05 19.0 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 15.4 | no trial data cached |
| Blood count abnormal | 68 | 18.5 14.6–23.5ROR 18.8 · χ² 1,107 / p 6e-243 | 18.4 EB05 15.0 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious PRR 15.3 | no trial data cached |
| Blood test abnormal | 53 | 15.8 12.1–20.7ROR 16.0 · χ² 718 / p 1e-158 | 15.6 EB05 12.3 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 15.1 | no trial data cached |
| Osteonecrosis of jaw (jawbone death) | 90 | 15.1 12.3–18.6ROR 15.4 · χ² 1,170 / p 9e-257 | 15.0 EB05 12.5 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 | no trial data cached |
| Bone marrow failure | 73 | 14.9 11.9–18.8ROR 15.2 · χ² 933 / p 3e-205 | 14.8 EB05 12.1 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.7 | no trial data cached |
| Haematotoxicity | 33 | 14.9 10.6–21.0ROR 15.0 · χ² 413 / p 4e-92 | 14.6 EB05 10.7 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 | no trial data cached |
| Metastases to central nervous system | 36 | 11.8 8.5–16.3ROR 11.8 · χ² 343 / p 7e-77 | 11.3 EB05 8.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | no trial data cached |
| Laboratory test abnormal | 82 | 11.6 9.4–14.4ROR 11.8 · χ² 786 / p 3e-173 | 11.4 EB05 9.4 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 16.8 | no trial data cached |
| Prostate cancer | 220 | 11.3 10.0–12.9ROR 11.8 · χ² 2,065 / p <1e-300 | 11.2 EB05 10.0 · IC025 +3.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 7.4 | no trial data cached |
| General physical health deterioration | 309 | 11.3 10.1–12.5ROR 11.9 · χ² 2,885 / p <1e-300 | 11.2 EB05 10.2 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 8.4 | no trial data cached |
| Blood alkaline phosphatase increased | 64 | 10.8 8.4–13.7ROR 10.9 · χ² 556 / p 3e-123 | 10.5 EB05 8.4 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious PRR 7.9 | no trial data cached |
| Bone pain | 145 | 10.3 8.8–12.1ROR 10.6 · χ² 1,215 / p 2e-266 | 10.2 EB05 8.9 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.3 | no trial data cached |
| Transfusion | 25 | 9.9 6.7–14.7ROR 10.0 · χ² 192 / p 6e-44 | 9.1 EB05 6.3 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.8 | no trial data cached |
| Haemoglobin decreased | 243 | 9.9 8.7–11.2ROR 10.3 · χ² 1,935 / p <1e-300 | 9.8 EB05 8.8 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.2 | no trial data cached |
| Full blood count abnormal | 22 | 8.7 5.7–13.2ROR 8.8 · χ² 143 / p 4e-33 | 7.8 EB05 5.3 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious PRR 7.5 · 95% clinician | no trial data cached |
| Pancytopenia (all blood cells low) | 115 | 8.6 7.2–10.3ROR 8.8 · χ² 769 / p 2e-169 | 8.4 EB05 7.2 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 | no trial data cached |
| Disease progression | 223 | 7.9 7.0–9.0ROR 8.2 · χ² 1,344 / p 2e-294 | 7.8 EB05 7.0 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 5.8 | no trial data cached |
| Platelet count decreased | 186 | 7.3 6.3–8.4ROR 7.5 · χ² 1,008 / p 1e-221 | 7.2 EB05 6.4 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.8 | no trial data cached |
| Spinal pain | 19 | 6.8 4.3–10.6ROR 6.8 · χ² 88 / p 3e-21 | 5.9 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Malignant neoplasm progression | 156 | 6.4 5.5–7.5ROR 6.6 · χ² 708 / p 3e-156 | 6.3 EB05 5.5 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 4.2 | no trial data cached |
| Anaemia (low red blood cells) | 283 | 6.2 5.5–6.9ROR 6.5 · χ² 1,238 / p 2e-271 | 6.1 EB05 5.6 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.4 | no trial data cached |
| Disseminated intravascular coagulation | 20 | 5.9 3.8–9.2ROR 5.9 · χ² 77 / p 9e-19 | 5.3 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 · 95% clinician | no trial data cached |
| Fracture | 26 | 5.7 3.9–8.4ROR 5.8 · χ² 97 / p 3e-23 | 5.2 EB05 3.8 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.9 | no trial data cached |
| Haematocrit decreased | 24 | 5.0 3.4–7.5ROR 5.0 · χ² 73 / p 5e-18 | 4.6 EB05 3.3 · IC025 +1.5 3/3 methods agree | Lab value / disease marker | serious PRR 3.1 | no trial data cached |
| Urosepsis | 11 | 5.0 2.8–9.0ROR 5.0 · χ² 31 / p 1e-8 | 4.2 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Subdural haematoma | 17 | 4.9 3.1–7.9ROR 5.0 · χ² 50 / p 9e-13 | 4.4 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Thrombocytopenia (low platelets) | 131 | 4.9 4.1–5.8ROR 5.0 · χ² 406 / p 2e-90 | 4.8 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 | no trial data cached |
| Myelosuppression | 38 | 4.7 3.4–6.4ROR 4.7 · χ² 106 / p 4e-25 | 4.4 EB05 3.4 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.0 | no trial data cached |
| Haematuria (blood in urine) | 38 | 4.6 3.4–6.4ROR 4.7 · χ² 105 / p 8e-25 | 4.4 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Red blood cell count decreased | 31 | 4.5 3.2–6.4ROR 4.5 · χ² 82 / p 8e-20 | 4.3 EB05 3.1 · IC025 +1.5 3/3 methods agree | Lab value / disease marker | serious PRR 3.6 | no trial data cached |
| Bedridden | 14 | 4.5 2.6–7.5ROR 4.5 · χ² 34 / p 3e-9 | 3.9 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Hypercalcaemia | 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 | Not in label — unassessed | serious PRR 3.1 | no trial data cached |
| Central nervous system lesion | 14 | 4.2 2.5–7.1ROR 4.2 · χ² 31 / p 1e-8 | 3.8 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Femur fracture | 31 | 4.2 2.9–5.9ROR 4.2 · χ² 72 / p 1e-17 | 3.9 EB05 2.9 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.7 | no trial data cached |
| Neutrophil count decreased | 40 | 4.1 3.0–5.6ROR 4.1 · χ² 92 / p 5e-22 | 3.9 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.8 | no trial data cached |
| Musculoskeletal chest pain | 15 | 4.0 2.4–6.7ROR 4.1 · χ² 31 / p 1e-8 | 3.6 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Myelodysplastic syndrome | 14 | 4.0 2.4–6.8ROR 4.0 · χ² 29 / p 4e-8 | 3.6 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 | 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 |
|---|---|---|---|---|---|---|
| Prostatic specific antigen increased | 479 | 149.5 137.1–163.1ROR 165.2 · χ² 68,098 / p <1e-300 | 143.5 EB05 133.0 · IC025 +6.8 3/3 methods agree | Lab value / disease marker | serious PRR 139.9 | no trial data cached |
| Death | 445 | 2.2 2.0–2.4ROR 2.3 · χ² 287 / p 1e-64 | 2.2 EB05 2.0 · IC025 +1.0 | Outcome field, not a reaction | serious PRR 1.4 | no trial data cached |
| Metastases to bone | 328 | 85.4 76.8–94.9ROR 91.3 · χ² 26,744 / p <1e-300 | 83.3 EB05 76.0 · IC025 +6.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 55.0 | no trial data cached |
| General physical health deterioration | 309 | 11.3 10.1–12.5ROR 11.9 · χ² 2,885 / p <1e-300 | 11.2 EB05 10.2 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 8.4 | no trial data cached |
| Anaemia (low red blood cells) | 283 | 6.2 5.5–6.9ROR 6.5 · χ² 1,238 / p 2e-271 | 6.1 EB05 5.6 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.4 | no trial data cached |
| Haemoglobin decreased | 243 | 9.9 8.7–11.2ROR 10.3 · χ² 1,935 / p <1e-300 | 9.8 EB05 8.8 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.2 | no trial data cached |
| Disease progression | 223 | 7.9 7.0–9.0ROR 8.2 · χ² 1,344 / p 2e-294 | 7.8 EB05 7.0 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 5.8 | no trial data cached |
| Prostate cancer | 220 | 11.3 10.0–12.9ROR 11.8 · χ² 2,065 / p <1e-300 | 11.2 EB05 10.0 · IC025 +3.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 7.4 | no trial data cached |
| Malaise (feeling unwell) | 203 | 1.9 1.7–2.2ROR 2.0 · χ² 92 / p 5e-22 | 1.9 EB05 1.7 · IC025 +0.7 | Not in label — unassessed | serious PRR 2.0 | no trial data cached |
| Asthenia (weakness) | 196 | 2.2 1.9–2.5ROR 2.2 · χ² 126 / p 2e-29 | 2.2 EB05 1.9 · IC025 +0.9 | Not in label — unassessed | serious PRR 1.8 | no trial data cached |
| Platelet count decreased | 186 | 7.3 6.3–8.4ROR 7.5 · χ² 1,008 / p 1e-221 | 7.2 EB05 6.4 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.8 | no trial data cached |
| Metastases to liver | 178 | 42.8 37.0–49.5ROR 44.3 · χ² 7,157 / p <1e-300 | 42.2 EB05 37.2 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 27.7 | no trial data cached |
| Decreased appetite (loss of appetite) | 175 | 3.2 2.7–3.7ROR 3.2 · χ² 258 / p 2e-58 | 3.1 EB05 2.8 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 | no trial data cached |
| Malignant neoplasm progression | 156 | 6.4 5.5–7.5ROR 6.6 · χ² 708 / p 3e-156 | 6.3 EB05 5.5 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 4.2 | no trial data cached |
| Bone pain | 145 | 10.3 8.8–12.1ROR 10.6 · χ² 1,215 / p 2e-266 | 10.2 EB05 8.9 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.3 | 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 liver — n=178, PRR 42.8
- Metastases to lung — n=65, PRR 23.6
- Osteonecrosis of jaw — n=90, PRR 15.1
- Haematotoxicity — n=33, PRR 14.9
- Metastases to central nervous system — n=36, PRR 11.8
- Disseminated intravascular coagulation — n=20, PRR 5.9
- Haematuria — n=38, PRR 4.6
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 Radium Ra 223 Dichloride?
In FDA FAERS, the most frequently co-reported reaction terms for Radium Ra 223 Dichloride are prostatic specific antigen increased, metastases to bone, anaemia, haemoglobin decreased, prostate cancer, malaise. 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 Radium Ra 223 Dichloride have an FDA boxed warning?
No. The FDA label retrieved for Radium Ra 223 Dichloride has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Radium Ra 223 Dichloride 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 a398400e-bd31-41a9-9696-4f7c06569ede, effective 20260302; matched on
openfda.generic_name.exact:"RADIUM RA 223 DICHLORIDE") - 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, 88 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.