Drug · FAERS side-effect profile with label screen
Lutetium Lu 177 Dotatate side effects: what 5,683 FDA adverse event reports show
Drug class
Radiolabeled somatostatin analog
FDA label, Indications wording
Brand names
Lutathera
openFDA label
Who reports
5,683 reports · 41% serious · 704 with death outcome · 48% female
openFDA FAERS counts, all years, deduplication not applied
Used for
LUTATHERA is indicated for the treatment of adult and pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors. LUTAT.
FDA label, Indications and Usage
What it is
Lutetium Lu 177 dotatate is a radiolabeled somatostatin analog. The drug substance lutetium Lu 177 dotatate is a cyclic peptide linked with the covalently bound chelator 1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid to a radionuclide.
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) 3Reporting / coding artifact 6Lab value / disease marker 9Not 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.
- 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. 55 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 |
|---|---|---|---|---|---|---|
| Ill-defined disorder | 1,541 | 96.0 91.9–100.2ROR 131.3 · χ² 141,412 / p <1e-300 | 93.4 EB05 89.6 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious PRR 21.4 · 95% clinician | no trial data cached |
| General physical health deterioration | 1,200 | 38.9 37.0–41.0ROR 49.1 · χ² 44,096 / p <1e-300 | 38.5 EB05 36.7 · IC025 +5.2 3/3 methods agree | Reporting / coding artifact | serious PRR 6.2 · 98% clinician | no trial data cached |
| Laboratory test abnormal | 172 | 21.6 18.7–25.1ROR 22.3 · χ² 3,352 / p <1e-300 | 21.5 EB05 18.9 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 9.6 · 93% clinician | no trial data cached |
| Metastases to liver | 101 | 21.4 17.6–25.9ROR 21.7 · χ² 1,931 / p <1e-300 | 21.2 EB05 17.9 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 30.0 | no trial data cached |
| Sars-cov-2 test positive | 64 | 17.8 13.9–22.7ROR 18.0 · χ² 991 / p 7e-218 | 17.6 EB05 14.2 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious n=4 · 97% clinician | no trial data cached |
| Malignant neoplasm progression | 349 | 12.7 11.5–14.0ROR 13.4 · χ² 3,749 / p <1e-300 | 12.6 EB05 11.5 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 18.1 | no trial data cached |
| Metastases to bone | 48 | 10.9 8.2–14.4ROR 10.9 · χ² 419 / p 2e-93 | 10.5 EB05 8.1 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 15.3 · 92% clinician | no trial data cached |
| Lymphocyte count decreased | 46 | 9.6 7.2–12.8ROR 9.7 · χ² 346 / p 2e-77 | 9.2 EB05 7.0 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious PRR 15.4 · 96% clinician | no trial data cached |
| Platelet count decreased | 229 | 7.9 7.0–9.0ROR 8.2 · χ² 1,388 / p <1e-300 | 7.8 EB05 7.0 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.9 | no trial data cached |
| Myelodysplastic syndrome | 29 | 7.4 5.1–10.7ROR 7.4 · χ² 154 / p 1e-35 | 6.7 EB05 4.9 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.5 · ♀ 75% (drug 48%) · 93% clinician | no trial data cached |
| Ascites | 56 | 7.0 5.4–9.1ROR 7.1 · χ² 284 / p 6e-64 | 6.7 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 | no trial data cached |
| Lymphopenia | 24 | 6.3 4.2–9.4ROR 6.3 · χ² 102 / p 3e-24 | 5.7 EB05 4.0 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.7 · 96% clinician | no trial data cached |
| Illness | 166 | 6.1 5.3–7.1ROR 6.3 · χ² 706 / p 9e-156 | 6.0 EB05 5.3 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 4.5 | no trial data cached |
| Acute myeloid leukaemia | 25 | 5.9 4.0–8.8ROR 6.0 · χ² 98 / p 3e-23 | 5.4 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 · 92% clinician | no trial data cached |
| Glomerular filtration rate decreased | 19 | 5.8 3.7–9.1ROR 5.8 · χ² 71 / p 2e-17 | 5.1 EB05 3.5 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.5 | no trial data cached |
| Haematotoxicity | 14 | 5.6 3.3–9.4ROR 5.6 · χ² 48 / p 2e-12 | 4.8 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Disease progression | 173 | 5.4 4.7–6.3ROR 5.6 · χ² 622 / p 2e-137 | 5.3 EB05 4.7 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 6.7 | no trial data cached |
| Full blood count decreased | 28 | 5.1 3.5–7.4ROR 5.1 · χ² 89 / p 2e-21 | 4.7 EB05 3.5 · IC025 +1.6 3/3 methods agree | Lab value / disease marker | serious PRR 2.6 | no trial data cached |
| Blood urea increased | 22 | 4.8 3.2–7.3ROR 4.8 · χ² 63 / p 1e-15 | 4.4 EB05 3.1 · IC025 +1.4 3/3 methods agree | Lab value / disease marker | serious PRR 7.1 · 91% clinician | no trial data cached |
| Small intestinal obstruction | 16 | 4.8 3.0–7.9ROR 4.8 · χ² 45 / p 1e-11 | 4.3 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Disseminated intravascular coagulation | 18 | 4.7 3.0–7.5ROR 4.7 · χ² 49 / p 1e-12 | 4.2 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Neutrophil count increased | 12 | 4.3 2.4–7.6ROR 4.3 · χ² 27 / p 9e-8 | 3.8 EB05 2.3 · IC025 +0.9 3/3 methods agree | Lab value / disease marker | serious PRR 6.6 | no trial data cached |
| Leukaemia | 11 | 4.3 2.4–7.8ROR 4.3 · χ² 25 / p 3e-7 | 3.7 EB05 2.2 · IC025 +0.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.1 | no trial data cached |
| Thrombocytopenia (low platelets) | 128 | 4.2 3.6–5.0ROR 4.3 · χ² 315 / p 9e-71 | 4.2 EB05 3.6 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.1 · 95% clinician | no trial data cached |
| Metastases to lung | 13 | 4.2 2.4–7.2ROR 4.2 · χ² 28 / p 6e-8 | 3.7 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Blood pressure systolic increased | 22 | 4.1 2.7–6.3ROR 4.2 · χ² 49 / p 1e-12 | 3.8 EB05 2.7 · IC025 +1.2 3/3 methods agree | Lab value / disease marker | serious PRR 6.0 | no trial data cached |
| Covid-19 | 198 | 4.1 3.6–4.7ROR 4.2 · χ² 471 / p 1e-104 | 4.1 EB05 3.6 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 0.8 · 95% clinician | no trial data cached |
| Flank pain | 10 | 3.9 2.1–7.3ROR 4.0 · χ² 19 / p 6e-6 | 3.4 EB05 2.0 · IC025 +0.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 | no trial data cached |
| Intestinal obstruction | 40 | 3.9 2.9–5.4ROR 4.0 · χ² 85 / p 2e-20 | 3.8 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Blood test abnormal | 14 | 3.7 2.2–6.2ROR 3.7 · χ² 25 / p 3e-7 | 3.3 EB05 2.1 · IC025 +0.8 3/3 methods agree | Reporting / coding artifact | serious PRR 3.4 | no trial data cached |
| Red blood cell count decreased | 28 | 3.6 2.5–5.2ROR 3.6 · χ² 50 / p 7e-13 | 3.4 EB05 2.5 · IC025 +1.2 3/3 methods agree | Lab value / disease marker | serious PRR 5.7 | no trial data cached |
| Pancytopenia (all blood cells low) | 54 | 3.6 2.7–4.7ROR 3.6 · χ² 98 / p 2e-23 | 3.5 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.9 | no trial data cached |
| Hypoglycaemia (low blood sugar) | 47 | 3.6 2.7–4.8ROR 3.6 · χ² 85 / p 2e-20 | 3.5 EB05 2.7 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 | no trial data cached |
| Haematocrit decreased | 19 | 3.5 2.2–5.5ROR 3.5 · χ² 32 / p 9e-9 | 3.3 EB05 2.2 · IC025 +1.0 3/3 methods agree | Lab value / disease marker | serious PRR 5.0 | no trial data cached |
| Full blood count abnormal | 10 | 3.5 1.9–6.5ROR 3.5 · χ² 15 / p 4e-5 | 3.1 EB05 1.8 · IC025 +0.6 | Lab value / disease marker | serious PRR 2.6 | no trial data cached |
| Ileus | 11 | 3.3 1.8–6.0ROR 3.3 · χ² 15 / p 4e-5 | 3.0 EB05 1.8 · IC025 +0.6 | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Hepatic failure | 27 | 3.3 2.3–4.8ROR 3.3 · χ² 41 / p 8e-11 | 3.2 EB05 2.3 · IC025 +1.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.6 | no trial data cached |
| Cytopenia | 10 | 3.1 1.7–5.7ROR 3.1 · χ² 12 / p 3e-4 | 2.8 EB05 1.7 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 4.5 | no trial data cached |
| Neoplasm progression | 29 | 3.0 2.1–4.4ROR 3.1 · χ² 38 / p 4e-10 | 2.9 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Generalised oedema | 10 | 3.0 1.6–5.6ROR 3.0 · χ² 11 / p 4e-4 | 2.7 EB05 1.6 · IC025 +0.4 | Not in label — unassessed | serious PRR 4.7 | 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 |
|---|---|---|---|---|---|---|
| Ill-defined disorder | 1,541 | 96.0 91.9–100.2ROR 131.3 · χ² 141,412 / p <1e-300 | 93.4 EB05 89.6 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious PRR 21.4 · 95% clinician | no trial data cached |
| General physical health deterioration | 1,200 | 38.9 37.0–41.0ROR 49.1 · χ² 44,096 / p <1e-300 | 38.5 EB05 36.7 · IC025 +5.2 3/3 methods agree | Reporting / coding artifact | serious PRR 6.2 · 98% clinician | no trial data cached |
| Death | 439 | 1.9 1.7–2.1ROR 2.0 · χ² 188 / p 4e-43 | 1.9 EB05 1.7 · IC025 +0.8 | Outcome field, not a reaction | serious PRR 2.6 | no trial data cached |
| Malignant neoplasm progression | 349 | 12.7 11.5–14.0ROR 13.4 · χ² 3,749 / p <1e-300 | 12.6 EB05 11.5 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 18.1 | no trial data cached |
| Platelet count decreased | 229 | 7.9 7.0–9.0ROR 8.2 · χ² 1,388 / p <1e-300 | 7.8 EB05 7.0 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.9 | no trial data cached |
| Covid-19 | 198 | 4.1 3.6–4.7ROR 4.2 · χ² 471 / p 1e-104 | 4.1 EB05 3.6 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 0.8 · 95% clinician | no trial data cached |
| Disease progression | 173 | 5.4 4.7–6.3ROR 5.6 · χ² 622 / p 2e-137 | 5.3 EB05 4.7 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 6.7 | no trial data cached |
| Laboratory test abnormal | 172 | 21.6 18.7–25.1ROR 22.3 · χ² 3,352 / p <1e-300 | 21.5 EB05 18.9 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 9.6 · 93% clinician | no trial data cached |
| Illness | 166 | 6.1 5.3–7.1ROR 6.3 · χ² 706 / p 9e-156 | 6.0 EB05 5.3 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 4.5 | no trial data cached |
| Abdominal pain | 137 | 2.2 1.8–2.6ROR 2.2 · χ² 87 / p 6e-21 | 2.2 EB05 1.9 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 3.5 | no trial data cached |
| Thrombocytopenia (low platelets) | 128 | 4.2 3.6–5.0ROR 4.3 · χ² 315 / p 9e-71 | 4.2 EB05 3.6 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.1 · 95% clinician | no trial data cached |
| Metastases to liver | 101 | 21.4 17.6–25.9ROR 21.7 · χ² 1,931 / p <1e-300 | 21.2 EB05 17.9 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 30.0 | no trial data cached |
| Sars-cov-2 test positive | 64 | 17.8 13.9–22.7ROR 18.0 · χ² 991 / p 7e-218 | 17.6 EB05 14.2 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious n=4 · 97% clinician | no trial data cached |
| White blood cell count decreased | 62 | 2.1 1.6–2.7ROR 2.1 · χ² 35 / p 1e-9 | 2.1 EB05 1.7 · IC025 +0.6 | Labeled (related wording) related wording | serious PRR 3.2 | no trial data cached |
| Inappropriate schedule of product administration | 60 | 1.3 1.0–1.6ROR 1.3 · χ² 3 / p 0.046 | 1.3 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 4.0 | 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.
- Ill-defined disorder — n=1,541, PRR 96.0
- Metastases to liver — n=101, PRR 21.4
- Metastases to bone — n=48, PRR 10.9
- Ascites — n=56, PRR 7.0
- Acute myeloid leukaemia — n=25, PRR 5.9
- Covid-19 — n=198, PRR 4.1
- Intestinal obstruction — n=40, PRR 3.9
- Neoplasm progression — n=29, PRR 3.0
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 Dotatate?
In FDA FAERS, the most frequently co-reported reaction terms for Lutetium Lu 177 Dotatate are ill-defined disorder, platelet count decreased, covid-19, abdominal pain, thrombocytopenia, metastases to liver. 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 Dotatate have an FDA boxed warning?
No. The FDA label retrieved for Lutetium Lu 177 Dotatate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Lutetium Lu 177 Dotatate 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 72d1a024-00b7-418a-b36e-b2cb48f2ab55, effective 20260115; matched on
openfda.generic_name.exact:"LUTETIUM LU 177 DOTATATE") - 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, 95 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.