Drug · FAERS side-effect profile with label screen
Lutetium Lu 177 Vipivotide Tetraxetan side effects: what 13,100 FDA adverse event reports show
Drug class
Radioligand Therapeutic Agent
FDA label (Established Pharmacologic Class)
Brand names
Pluvicto
openFDA label
Who reports
13,100 reports · 24% serious · 1,631 with death outcome · 1% female
openFDA FAERS counts, all years, deduplication not applied
Used for
PLUVICTO is a radioligand therapeutic agent indicated: Metastatic Androgen Pathway Modulation-Naïve or -Sensitive (mAPMN/S) Prostate Cancer in combination with androgen receptor pathway inhibitor (ARPI) therapy for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer.
FDA label, Indications and Usage
What it is
PLUVICTO (lutetium Lu 177 vipivotide tetraxetan) is a radioligand therapeutic agent. Lutetium Lu 177 vipivotide tetraxetan is a PSMA-binding ligand bound to a DOTA chelator radiolabeled with lutetium-177.
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 37 strongest signals
Labeled adverse reaction 6Labeled (related wording) 3Likely indication confounding 3Reporting / coding artifact 6Lab value / disease marker 7Outcome field, not a reaction 1Not in label — unassessed 11
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.
- Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
- 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. 421 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 |
|---|---|---|---|---|---|---|
| Hormone-refractory prostate cancer | 150 | 234.9 198.1–278.6ROR 237.6 · χ² 30,210 / p <1e-300 | 199.4 EB05 174.1 · IC025 +6.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=150 | no trial data cached |
| Ill-defined disorder | 3,636 | 101.8 98.9–104.8ROR 140.6 · χ² 341,958 / p <1e-300 | 95.7 EB05 93.1 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious PRR 31.3 · 99% clinician | no trial data cached |
| General physical health deterioration | 6,138 | 90.4 88.6–92.1ROR 169.1 · χ² 515,782 / p <1e-300 | 85.5 EB05 83.7 · IC025 +6.4 3/3 methods agree | Reporting / coding artifact | serious PRR 15.8 · 100% clinician | no trial data cached |
| Prostatic specific antigen decreased | 15 | 65.8 39.3–110.2ROR 65.8 · χ² 857 / p 9e-189 | 58.7 EB05 37.8 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious n=5 | no trial data cached |
| Prostate cancer metastatic | 79 | 38.6 30.9–48.2ROR 38.8 · χ² 2,790 / p <1e-300 | 37.4 EB05 31.0 · IC025 +4.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=79 | no trial data cached |
| Prostatic specific antigen abnormal | 24 | 37.6 25.1–56.3ROR 37.7 · χ² 799 / p 3e-176 | 35.8 EB05 25.3 · IC025 +3.7 3/3 methods agree | Lab value / disease marker | serious n=12 | no trial data cached |
| Prostatic specific antigen increased | 268 | 31.6 28.0–35.6ROR 32.2 · χ² 7,751 / p <1e-300 | 30.9 EB05 27.9 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious PRR 57.0 | no trial data cached |
| Acquired haemophilia | 14 | 23.0 13.6–39.0ROR 23.0 · χ² 269 / p 9e-61 | 22.0 EB05 13.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Laboratory test abnormal | 260 | 14.2 12.6–16.1ROR 14.5 · χ² 3,162 / p <1e-300 | 14.1 EB05 12.7 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 10.1 · 98% clinician | no trial data cached |
| Sars-cov-2 test positive | 112 | 13.5 11.2–16.3ROR 13.6 · χ² 1,277 / p 6e-280 | 13.3 EB05 11.4 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious n=1 · 100% clinician | no trial data cached |
| Metastases to spine | 21 | 10.1 6.6–15.5ROR 10.1 · χ² 162 / p 2e-37 | 9.0 EB05 6.0 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=21 | no trial data cached |
| Metastases to bone | 95 | 9.3 7.6–11.4ROR 9.4 · χ² 696 / p 1e-153 | 9.1 EB05 7.6 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 22.2 | no trial data cached |
| Cancer pain | 11 | 6.9 3.8–12.4ROR 6.9 · χ² 49 / p 1e-12 | 5.5 EB05 3.3 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious n=11 | no trial data cached |
| Peptic ulcer | 14 | 6.8 4.0–11.4ROR 6.8 · χ² 63 / p 1e-15 | 5.7 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Malignant neoplasm progression | 315 | 5.0 4.4–5.5ROR 5.1 · χ² 994 / p 2e-218 | 4.9 EB05 4.5 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 11.9 | no trial data cached |
| Disease progression | 340 | 4.6 4.2–5.1ROR 4.7 · χ² 965 / p 3e-212 | 4.6 EB05 4.2 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 6.3 · 95% clinician | no trial data cached |
| Spinal cord compression | 11 | 4.5 2.5–8.2ROR 4.5 · χ² 27 / p 1e-7 | 3.9 EB05 2.3 · IC025 +0.9 3/3 methods agree | Labeled adverse reaction exact term | serious n=11 | no trial data cached |
| Haematotoxicity | 26 | 4.5 3.1–6.6ROR 4.5 · χ² 67 / p 1e-16 | 4.2 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 10.1 · 92% clinician | no trial data cached |
| Loss of libido | 25 | 4.5 3.0–6.6ROR 4.5 · χ² 64 / p 7e-16 | 4.1 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 1.1 · 96% consumer | no trial data cached |
| Bone lesion | 10 | 4.4 2.4–8.3ROR 4.4 · χ² 23 / p 7e-7 | 3.8 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Full blood count decreased | 55 | 4.4 3.4–5.7ROR 4.4 · χ² 140 / p 2e-32 | 4.2 EB05 3.4 · IC025 +1.6 3/3 methods agree | Lab value / disease marker | serious PRR 3.8 | no trial data cached |
| Metastases to lymph nodes | 17 | 4.1 2.5–6.5ROR 4.1 · χ² 36 / p 9e-10 | 3.7 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Metastases to liver | 43 | 3.9 2.9–5.3ROR 3.9 · χ² 91 / p 7e-22 | 3.8 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 | no trial data cached |
| Blood test abnormal | 31 | 3.5 2.5–5.0ROR 3.5 · χ² 54 / p 1e-13 | 3.4 EB05 2.5 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 3.3 | no trial data cached |
| Cytopenia | 26 | 3.5 2.4–5.1ROR 3.5 · χ² 44 / p 2e-11 | 3.3 EB05 2.4 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.5 | no trial data cached |
| Hydronephrosis | 14 | 3.0 1.8–5.1ROR 3.0 · χ² 17 / p 2e-5 | 2.8 EB05 1.8 · IC025 +0.6 | Not in label — unassessed | serious PRR 7.2 | no trial data cached |
| Full blood count abnormal | 19 | 2.9 1.8–4.5ROR 2.9 · χ² 22 / p 2e-6 | 2.7 EB05 1.9 · IC025 +0.7 | Lab value / disease marker | serious PRR 1.4 | no trial data cached |
| Prostate cancer | 130 | 2.6 2.2–3.0ROR 2.6 · χ² 123 / p 8e-29 | 2.5 EB05 2.2 · IC025 +1.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 6.1 | no trial data cached |
| Illness | 156 | 2.5 2.1–2.9ROR 2.5 · χ² 138 / p 4e-32 | 2.5 EB05 2.2 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 3.4 · 90% clinician | no trial data cached |
| Death | 1,298 | 2.4 2.3–2.5ROR 2.6 · χ² 1,119 / p 1e-245 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree | Outcome field, not a reaction | serious PRR 5.7 · 94% clinician | no trial data cached |
| Platelet count decreased | 159 | 2.4 2.0–2.8ROR 2.4 · χ² 128 / p 6e-30 | 2.4 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.9 | no trial data cached |
| Glomerular filtration rate decreased | 18 | 2.4 1.5–3.8ROR 2.4 · χ² 13 / p 2e-4 | 2.3 EB05 1.5 · IC025 +0.4 | Lab value / disease marker | serious PRR 4.2 | no trial data cached |
| Haemoglobin decreased | 146 | 2.3 1.9–2.7ROR 2.3 · χ² 103 / p 2e-24 | 2.3 EB05 2.0 · IC025 +0.9 | Labeled (related wording) related wording | serious PRR 3.4 | no trial data cached |
| Myelosuppression | 48 | 2.3 1.7–3.0ROR 2.3 · χ² 32 / p 6e-9 | 2.2 EB05 1.8 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 5.3 | no trial data cached |
| Dry mouth | 113 | 2.2 1.9–2.7ROR 2.2 · χ² 76 / p 1e-18 | 2.2 EB05 1.9 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 5.2 | no trial data cached |
| Thrombocytopenia (low platelets) | 143 | 2.1 1.7–2.4ROR 2.1 · χ² 77 / p 1e-18 | 2.0 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 5.0 · 94% clinician | no trial data cached |
| Pancytopenia (all blood cells low) | 71 | 2.0 1.6–2.6ROR 2.0 · χ² 37 / p 7e-10 | 2.0 EB05 1.7 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 4.9 | 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 |
|---|---|---|---|---|---|---|
| General physical health deterioration | 6,138 | 90.4 88.6–92.1ROR 169.1 · χ² 515,782 / p <1e-300 | 85.5 EB05 83.7 · IC025 +6.4 3/3 methods agree | Reporting / coding artifact | serious PRR 15.8 · 100% clinician | no trial data cached |
| Ill-defined disorder | 3,636 | 101.8 98.9–104.8ROR 140.6 · χ² 341,958 / p <1e-300 | 95.7 EB05 93.1 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious PRR 31.3 · 99% clinician | no trial data cached |
| Death | 1,298 | 2.4 2.3–2.5ROR 2.6 · χ² 1,119 / p 1e-245 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree | Outcome field, not a reaction | serious PRR 5.7 · 94% clinician | no trial data cached |
| Disease progression | 340 | 4.6 4.2–5.1ROR 4.7 · χ² 965 / p 3e-212 | 4.6 EB05 4.2 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 6.3 · 95% clinician | no trial data cached |
| Malignant neoplasm progression | 315 | 5.0 4.4–5.5ROR 5.1 · χ² 994 / p 2e-218 | 4.9 EB05 4.5 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 11.9 | no trial data cached |
| Prostatic specific antigen increased | 268 | 31.6 28.0–35.6ROR 32.2 · χ² 7,751 / p <1e-300 | 30.9 EB05 27.9 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious PRR 57.0 | no trial data cached |
| Laboratory test abnormal | 260 | 14.2 12.6–16.1ROR 14.5 · χ² 3,162 / p <1e-300 | 14.1 EB05 12.7 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 10.1 · 98% clinician | no trial data cached |
| Fatigue (tiredness) | 229 | 0.5 0.4–0.5ROR 0.5 · χ² 140 / p 1e-32 | 0.5 EB05 0.4 · IC025 -1.3 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.1 | no trial data cached |
| Anaemia (low red blood cells) | 191 | 1.6 1.4–1.8ROR 1.6 · χ² 43 / p 3e-11 | 1.6 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 3.6 | no trial data cached |
| Platelet count decreased | 159 | 2.4 2.0–2.8ROR 2.4 · χ² 128 / p 6e-30 | 2.4 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.9 | no trial data cached |
| Illness | 156 | 2.5 2.1–2.9ROR 2.5 · χ² 138 / p 4e-32 | 2.5 EB05 2.2 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 3.4 · 90% clinician | no trial data cached |
| Hormone-refractory prostate cancer | 150 | 234.9 198.1–278.6ROR 237.6 · χ² 30,210 / p <1e-300 | 199.4 EB05 174.1 · IC025 +6.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=150 | no trial data cached |
| Haemoglobin decreased | 146 | 2.3 1.9–2.7ROR 2.3 · χ² 103 / p 2e-24 | 2.3 EB05 2.0 · IC025 +0.9 | Labeled (related wording) related wording | serious PRR 3.4 | no trial data cached |
| Covid-19 | 144 | 1.3 1.1–1.5ROR 1.3 · χ² 10 / p 8e-4 | 1.3 EB05 1.1 · IC025 +0.1 | Labeled adverse reaction exact term | serious PRR 0.5 · 97% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 143 | 2.1 1.7–2.4ROR 2.1 · χ² 77 / p 1e-18 | 2.0 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 5.0 · 94% 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.
- Ill-defined disorder — n=3,636, PRR 101.8
- Metastases to spine — n=21, PRR 10.1
- Metastases to bone — n=95, PRR 9.3
- Haematotoxicity — n=26, PRR 4.5
- Loss of libido — n=25, PRR 4.5
- Metastases to liver — n=43, PRR 3.9
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 Lutetium Lu 177 Vipivotide Tetraxetan?
In FDA FAERS, the most frequently co-reported reaction terms for Lutetium Lu 177 Vipivotide Tetraxetan are ill-defined disorder, prostatic specific antigen increased, fatigue, anaemia, platelet count decreased, hormone-refractory prostate cancer. 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 Lutetium Lu 177 Vipivotide Tetraxetan have an FDA boxed warning?
No. The FDA label retrieved for Lutetium Lu 177 Vipivotide Tetraxetan has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Lutetium Lu 177 Vipivotide Tetraxetan 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 14908037-2892-4d98-a053-253ce35afb1a, effective 20260812; matched on
openfda.generic_name.exact:"LUTETIUM LU 177 VIPIVOTIDE TETRAXETAN") - 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, 458 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.