Drug · FAERS side-effect profile with label screen
Elotuzumab side effects: what 5,136 FDA adverse event reports show
Drug class
SLAMF7-directed Immunostimulatory Antibody
FDA label (Established Pharmacologic Class)
Brand names
Empliciti
openFDA label
Who reports
5,136 reports · 81% serious · 918 with death outcome · 45% female
openFDA FAERS counts, all years, deduplication not applied
Used for
• EMPLICITI is indicated in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received one to three prior therapies. • EMPLICITI is indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
FDA label, Indications and Usage
What it is
Elotuzumab is a humanized recombinant monoclonal antibody directed to SLAMF7, a cell surface glycoprotein. Elotuzumab consists of the complementary determining regions (CDR) of the mouse antibody, MuLuc63, grafted onto human IgG1 heavy and kappa light chain frameworks.
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 6Labeled (related wording) 5Likely indication confounding 1Reporting / coding artifact 4Lab value / disease marker 3Not in label — unassessed 21
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. 85 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 |
|---|---|---|---|---|---|---|
| Plasma cell myeloma | 564 | 59.7 55.2–64.6ROR 67.0 · χ² 32,102 / p <1e-300 | 58.8 EB05 54.8 · IC025 +5.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 42.7 · 96% clinician | no trial data cached |
| Cytopenia | 35 | 12.0 8.6–16.7ROR 12.1 · χ² 341 / p 2e-76 | 11.5 EB05 8.4 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.7 · 97% clinician | no trial data cached |
| Pneumocystis jirovecii pneumonia | 25 | 10.2 6.9–15.1ROR 10.3 · χ² 199 / p 2e-45 | 9.4 EB05 6.4 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 · ♀ 17% (drug 45%) · 100% clinician | no trial data cached |
| Malignant neoplasm progression | 254 | 10.2 9.0–11.5ROR 10.7 · χ² 2,104 / p <1e-300 | 10.1 EB05 9.1 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 7.3 · 94% clinician | no trial data cached |
| Bacteraemia | 28 | 9.7 6.7–14.1ROR 9.8 · χ² 210 / p 6e-48 | 9.0 EB05 6.3 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 · ♀ 24% (drug 45%) · 96% clinician | no trial data cached |
| Lymphocyte count decreased | 40 | 9.2 6.8–12.6ROR 9.3 · χ² 286 / p 2e-64 | 8.7 EB05 6.6 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious PRR 7.8 · ♀ 66% (drug 45%) · 95% clinician | no trial data cached |
| Cytomegalovirus infection | 37 | 9.1 6.6–12.5ROR 9.2 · χ² 258 / p 2e-58 | 8.5 EB05 6.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 · ♀ 69% (drug 45%) · 100% clinician | no trial data cached |
| Cytokine release syndrome | 39 | 8.4 6.1–11.4ROR 8.4 · χ² 245 / p 1e-55 | 7.8 EB05 5.9 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 · 97% clinician | no trial data cached |
| Covid-19 pneumonia | 24 | 8.3 5.5–12.3ROR 8.3 · χ² 146 / p 8e-34 | 7.4 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · ♀ 23% (drug 45%) · 96% clinician | no trial data cached |
| Hypercalcaemia | 23 | 7.6 5.1–11.5ROR 7.7 · χ² 126 / p 2e-29 | 6.8 EB05 4.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 · 96% clinician | no trial data cached |
| Therapy partial responder | 27 | 7.3 5.0–10.7ROR 7.4 · χ² 141 / p 8e-33 | 6.6 EB05 4.7 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 6.0 · 100% clinician | no trial data cached |
| Myelodysplastic syndrome | 25 | 7.1 4.8–10.4ROR 7.1 · χ² 124 / p 4e-29 | 6.3 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 · 100% clinician | no trial data cached |
| Basal cell carcinoma | 26 | 6.8 4.6–10.0ROR 6.8 · χ² 123 / p 7e-29 | 6.1 EB05 4.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · ♀ 16% (drug 45%) · 96% clinician | no trial data cached |
| Full blood count decreased | 33 | 6.7 4.8–9.4ROR 6.7 · χ² 154 / p 1e-35 | 6.2 EB05 4.6 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 4.6 | no trial data cached |
| Neutrophil count decreased | 66 | 6.7 5.2–8.5ROR 6.7 · χ² 312 / p 4e-70 | 6.4 EB05 5.2 · IC025 +2.3 3/3 methods agree | Lab value / disease marker | serious PRR 5.2 · 97% clinician | no trial data cached |
| Acute myeloid leukaemia | 25 | 6.6 4.4–9.7ROR 6.6 · χ² 112 / p 2e-26 | 5.9 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · ♀ 13% (drug 45%) · 96% clinician | no trial data cached |
| Febrile neutropenia | 95 | 5.9 4.8–7.2ROR 6.0 · χ² 379 / p 1e-84 | 5.7 EB05 4.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 · 97% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 192 | 5.8 5.0–6.7ROR 6.0 · χ² 760 / p 1e-167 | 5.7 EB05 5.1 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 · 96% clinician | no trial data cached |
| Clostridium difficile colitis | 15 | 5.8 3.5–9.6ROR 5.8 · χ² 54 / p 8e-14 | 5.0 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Septic shock | 57 | 5.4 4.2–7.0ROR 5.4 · χ² 200 / p 1e-45 | 5.2 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 · 98% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 147 | 5.4 4.6–6.3ROR 5.5 · χ² 523 / p 5e-116 | 5.3 EB05 4.6 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.9 · 96% clinician | no trial data cached |
| Lymphopenia | 18 | 5.2 3.3–8.3ROR 5.2 · χ² 57 / p 2e-14 | 4.6 EB05 3.1 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 | no trial data cached |
| Platelet count decreased | 134 | 5.1 4.3–6.1ROR 5.3 · χ² 444 / p 6e-99 | 5.0 EB05 4.4 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.9 | no trial data cached |
| Neuropathy peripheral (nerve damage in hands/feet) | 114 | 4.9 4.1–5.9ROR 5.0 · χ² 354 / p 3e-79 | 4.8 EB05 4.1 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.5 | no trial data cached |
| Urosepsis | 11 | 4.9 2.7–8.8ROR 4.9 · χ² 30 / p 2e-8 | 4.1 EB05 2.5 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Acute respiratory failure | 22 | 4.7 3.1–7.1ROR 4.7 · χ² 60 / p 4e-15 | 4.3 EB05 3.0 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.3 · 100% clinician | no trial data cached |
| Pneumonitis | 31 | 4.7 3.3–6.7ROR 4.7 · χ² 86 / p 8e-21 | 4.4 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 · 97% clinician | no trial data cached |
| Malignant melanoma | 15 | 4.6 2.8–7.6ROR 4.6 · χ² 38 / p 3e-10 | 4.1 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Hypocalcaemia (low calcium) | 21 | 4.5 3.0–7.0ROR 4.6 · χ² 55 / p 8e-14 | 4.2 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 · 95% clinician | no trial data cached |
| Sepsis (blood infection) | 124 | 4.5 3.8–5.4ROR 4.6 · χ² 340 / p 3e-76 | 4.5 EB05 3.8 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.2 · 96% clinician | no trial data cached |
| Laboratory test abnormal | 32 | 4.4 3.1–6.3ROR 4.5 · χ² 82 / p 8e-20 | 4.2 EB05 3.1 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 0.9 | no trial data cached |
| Squamous cell carcinoma | 10 | 4.3 2.3–8.1ROR 4.3 · χ² 22 / p 1e-6 | 3.7 EB05 2.2 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Pancytopenia (all blood cells low) | 55 | 4.0 3.1–5.2ROR 4.1 · χ² 123 / p 9e-29 | 3.9 EB05 3.1 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.9 · 100% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 27 | 4.0 2.7–5.8ROR 4.0 · χ² 57 / p 3e-14 | 3.7 EB05 2.7 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 2.8 · 93% clinician | no trial data cached |
| Product preparation error | 20 | 3.9 2.5–6.1ROR 4.0 · χ² 41 / p 7e-11 | 3.6 EB05 2.5 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | 100% clinician | no trial data cached |
| Electrolyte imbalance | 11 | 3.9 2.2–7.1ROR 3.9 · χ² 21 / p 2e-6 | 3.4 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 | no trial data cached |
| Lung infection | 15 | 3.9 2.3–6.4ROR 3.9 · χ² 29 / p 3e-8 | 3.5 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 | no trial data cached |
| Pneumonia (lung infection) | 304 | 3.8 3.4–4.3ROR 4.0 · χ² 646 / p 1e-142 | 3.8 EB05 3.5 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 · 92% clinician | no trial data cached |
| Infusion related reaction (reaction during infusion) | 62 | 3.8 3.0–4.9ROR 3.9 · χ² 127 / p 8e-30 | 3.7 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.5 | no trial data cached |
| Anaemia (low red blood cells) | 173 | 3.7 3.2–4.3ROR 3.8 · χ² 341 / p 2e-76 | 3.7 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 · 96% 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 |
|---|---|---|---|---|---|---|
| Plasma cell myeloma | 564 | 59.7 55.2–64.6ROR 67.0 · χ² 32,102 / p <1e-300 | 58.8 EB05 54.8 · IC025 +5.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 42.7 · 96% clinician | no trial data cached |
| Pneumonia (lung infection) | 304 | 3.8 3.4–4.3ROR 4.0 · χ² 646 / p 1e-142 | 3.8 EB05 3.5 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 · 92% clinician | no trial data cached |
| Death | 298 | 1.4 1.3–1.6ROR 1.4 · χ² 37 / p 6e-10 | 1.4 EB05 1.3 · IC025 +0.3 | Outcome field, not a reaction | serious PRR 1.0 | no trial data cached |
| Malignant neoplasm progression | 254 | 10.2 9.0–11.5ROR 10.7 · χ² 2,104 / p <1e-300 | 10.1 EB05 9.1 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 7.3 · 94% clinician | no trial data cached |
| Pyrexia (fever) | 221 | 2.6 2.3–3.0ROR 2.7 · χ² 221 / p 3e-50 | 2.6 EB05 2.3 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.1 · 91% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 192 | 5.8 5.0–6.7ROR 6.0 · χ² 760 / p 1e-167 | 5.7 EB05 5.1 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 · 96% clinician | no trial data cached |
| Anaemia (low red blood cells) | 173 | 3.7 3.2–4.3ROR 3.8 · χ² 341 / p 2e-76 | 3.7 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 · 96% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 147 | 5.4 4.6–6.3ROR 5.5 · χ² 523 / p 5e-116 | 5.3 EB05 4.6 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.9 · 96% clinician | no trial data cached |
| Platelet count decreased | 134 | 5.1 4.3–6.1ROR 5.3 · χ² 444 / p 6e-99 | 5.0 EB05 4.4 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.9 | no trial data cached |
| Sepsis (blood infection) | 124 | 4.5 3.8–5.4ROR 4.6 · χ² 340 / p 3e-76 | 4.5 EB05 3.8 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.2 · 96% clinician | no trial data cached |
| Neuropathy peripheral (nerve damage in hands/feet) | 114 | 4.9 4.1–5.9ROR 5.0 · χ² 354 / p 3e-79 | 4.8 EB05 4.1 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.5 | no trial data cached |
| White blood cell count decreased | 98 | 3.7 3.0–4.5ROR 3.7 · χ² 190 / p 1e-43 | 3.6 EB05 3.1 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.3 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 95 | 2.5 2.1–3.1ROR 2.6 · χ² 88 / p 3e-21 | 2.5 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 1.8 · 96% clinician | no trial data cached |
| Febrile neutropenia | 95 | 5.9 4.8–7.2ROR 6.0 · χ² 379 / p 1e-84 | 5.7 EB05 4.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 · 97% clinician | no trial data cached |
| Infection | 85 | 2.4 1.9–3.0ROR 2.4 · χ² 69 / p 5e-17 | 2.4 EB05 2.0 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.0 · 99% 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.
- Pneumocystis jirovecii pneumonia — n=25, PRR 10.2
- Bacteraemia — n=28, PRR 9.7
- Cytomegalovirus infection — n=37, PRR 9.1
- Cytokine release syndrome — n=39, PRR 8.4
- Covid-19 pneumonia — n=24, PRR 8.3
- Hypercalcaemia — n=23, PRR 7.6
- Myelodysplastic syndrome — n=25, PRR 7.1
- Basal cell carcinoma — n=26, PRR 6.8
- Acute myeloid leukaemia — n=25, PRR 6.6
- Febrile neutropenia — n=95, PRR 5.9
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 Elotuzumab?
In FDA FAERS, the most frequently co-reported reaction terms for Elotuzumab are plasma cell myeloma, pneumonia, pyrexia, neutropenia, anaemia, thrombocytopenia. 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 Elotuzumab have an FDA boxed warning?
No. The FDA label retrieved for Elotuzumab has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Elotuzumab 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 80686b7e-f6f4-4154-b5c0-c846425e2d91, effective 20220322; matched on
openfda.generic_name.exact:"ELOTUZUMAB") - 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, 125 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.