What the label lists and what reports show
Elotuzumab side effects
Elotuzumab's FDA label: “Most common adverse reactions (20% or higher) • with lenalidomide and dexamethasone are fatigue, diarrhea, pyrexia, constipation, cough, peripheral neuropathy, nasopharyngitis, upper respiratory tract infection, decreased appetite, pneumonia.” FAERS holds 5,137 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is plasma cell myeloma (564 reports).
- No generic listed
Check it at the source: the elotuzumab FDA label on DailyMed (effective March 22, 2022, E.R. Squibb & Sons, L.L.C.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of EMPLICITI?EMPLICITI may cause serious side effects, including: • Infusion reactions. Infusion reactions can happen during your infusion or within 24 hours after your infusion of EMPLICITI. Your healthcare provider will give you medicines before each infusion of EMPLICITI to help reduce the risk of an infusion reaction. If you have an infusion reaction while receiving EMPLICITI, your healthcare provider will slow or stop your infusion and treat your reaction. If you have a severe infusion reaction, your healthcare provider may stop your treatment completely. Tell your healthcare provider or get medical help right away if you have any of these symptoms after your infusion with EMPLICITI: o fever o chills o rash o chest pain o trouble breathing o dizziness o light-headedness • Infections. […]
Source: FDA drug label, E.R. Squibb & Sons, L.L.C., effective March 22, 2022 (SPL set 80686b7e-f6f4-4154-b5c0-c846425e2d91), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (20% or higher) • with lenalidomide and dexamethasone are fatigue, diarrhea, pyrexia, constipation, cough, peripheral neuropathy, nasopharyngitis, upper respiratory tract infection, decreased appetite, pneumonia.
Table 6: ELOQUENT-2: Adverse Reactions with a 10% or Higher Incidence for EMPLICITI-Treated Patients and a 5% or Higher Incidence than Lenalidomide and Dexamethasone-Treated Patients [All Grades]
| Primary Term | All Grades | Grade 3/4 | All Grades | Grade 3/4 |
|---|---|---|---|---|
| Fatigue | 62 | 13 | 52 | 12 |
| Diarrhea | 47 | 5.0 | 36 | 4.1 |
| Pyrexia | 37 | 2.5 | 25 | 2.8 |
| Constipation | 36 | 1.3 | 27 | 0.3 |
| Cough | 34 | 0.3 | 19 | 0 |
| Peripheral Neuropathy | 27 | 3.8 | 21 | 2.2 |
| Nasopharyngitis | 25 | 0 | 19 | 0 |
| Upper Respiratory Tract Infection | 23 | 0.6 | 17 | 1.3 |
| Decreased Appetite | 21 | 1.6 | 13 | 1.3 |
| Pneumonia | 20 | 14 | 14 | 9 |
| Pain in Extremities | 16 | 0.9 | 10 | 0.3 |
| Headache | 15 | 0.3 | 8 | 0.3 |
| Vomiting | 14 | 0.3 | 9 | 0.9 |
| Weight Decreased | 14 | 1.3 | 6 | 0 |
| Lymphopenia | 13 | 9 | 7 | 3.2 |
| Cataracts | 12 | 6 | 6 | 2.8 |
| Oropharyngeal Pain | 10 | 0 | 4 | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described in detail in other sections of the label: • Infusion reaction [see Warnings and Precautions (5.1) ]. • Infections [see Warnings and Precautions (5.2) ]. • Second Primary Malignancies [ see Warnings and Precautions (5.3) ]. • Hepatotoxicity [see Warnings and Precautions (5.4) ]. • Interference with determination of complete response [see Warnings and Precautions (5.5) ]. Most common adverse reactions (20% or higher) • with lenalidomide and dexamethasone are fatigue, diarrhea, pyrexia, constipation, cough, peripheral neuropathy, nasopharyngitis, upper respiratory tract infection, decreased appetite, pneumonia. (6.1) • with pomalidomide and dexamethasone are constipation and hyperglycemia. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …
Source: FDA drug label, E.R. Squibb & Sons, L.L.C., effective March 22, 2022 (SPL set 80686b7e-f6f4-4154-b5c0-c846425e2d91), via openFDA; the full label on DailyMed
What do FAERS reports show?
5,137 reports list elotuzumab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 918 are coded as a death and 2,010 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 12 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Elotuzumab: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions