What the label lists and what reports show
Isatuximab side effects
Isatuximab's FDA label: “The most common adverse reactions (≥20%) are upper respiratory tract infection, infusion-related reactions, pneumonia, and diarrhea.” FAERS holds 5,605 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 neutropenia (524 reports).
- No generic listed
Check it at the source: the isatuximab FDA label on DailyMed (effective July 7, 2026); 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 SARCLISA?SARCLISA may cause serious side effects including: Infusion reactions. Infusion reactions are common with SARCLISA and can sometimes be severe or life threatening. Your healthcare provider will prescribe medicines before each infusion of SARCLISA to help decrease your risk for infusion reactions or to help make any infusion reaction less severe. You will be monitored for infusion reactions during each infusion of SARCLISA. Your healthcare provider may slow down or stop your infusion, or completely stop treatment with SARCLISA if you have an infusion reaction. […]
Source: FDA drug label, Sanofi-Aventis U.S. LLC, effective July 7, 2026 (SPL set a0473462-6f9d-4eca-a5bf-8620aea68e8a), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥20%) are upper respiratory tract infection, infusion-related reactions, pneumonia, and diarrhea.
Table 8: Adverse Reactions (≥ 20%) in Patients Receiving SARCLISA, Bortezomib, Lenalidomide, and Dexamethasone in IMROZ
| Reaction | All Grades (%) | Grade 3 or 4 (%) | All Grades (%) | Grade 3 or 4 (%) |
|---|---|---|---|---|
| Upper respiratory tract infection Includes other related terms | 65 | 4.6 | 57 Includes 1 patient (0.6%) with fatal URTI. | 6 |
| COVID-19 COVID-19 includes COVID-19 infections other than COVID-19 pneumonia. | 22 | 0.8 | 17 Includes 2 patients (1.1%) with fatal COVID-19. | 1.7 |
| Fatigue Fatigue includes Fatigue, Asthenia, or Malaise. | 55 | 11 | 50 | 9 |
| Edema peripheral | 33 | 0 | 33 | 1.1 |
| Infusion-related reaction | 24 | 0.4 | 1.1 | 0 |
| Diarrhea | 55 | 8 | 49 | 8 |
| Constipation | 36 | 2.3 | 41 | 1.7 |
| Peripheral sensory neuropathy | 54 | 7 | 61 | 6 |
| Cataract | 38 | 16 | 25 | 11 |
| Musculoskeletal pain | 38 | 4.2 | 33 | 3.3 |
| Rash Rash includes Dermatitis, Dermatitis acneiform, Dermatitis allergic, Dermatitis… | 32 | 5 | 34 | 5 |
| Insomnia | 22 | 3.8 | 24 | 2.2 |
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 from SARCLISA are also described in other sections of the labeling: Infusion-Related Reactions [see Warnings and Precautions (5.1) ] Infections [see Warnings and Precautions (5.2) ] Neutropenia [see Warnings and Precautions (5.3) ] Second Primary Malignancies [see Warnings and Precautions (5.4) ] In combination with pomalidomide and dexamethasone: The most common adverse reactions (≥20%) are upper respiratory tract infection, infusion-related reactions, pneumonia, and diarrhea. The most common hematology laboratory abnormalities (≥80%) are decreased hemoglobin, decreased neutrophils, decreased lymphocytes, and decreased platelets. ( 6.1 ) In combination with carfilzomib and dexamethasone: The most common adverse reactions (≥20%) are upper respiratory tract infection, infusion-related reactions, fatigue, hypertension, diarrhea, pneumonia, dyspnea, insomnia, bronchitis, cough, and back pain. The most common hematology laboratory abnormalities (≥80%) are decreased hemoglobin, decreased lymphocytes, and decreased platelets. …
Source: FDA drug label, Sanofi-Aventis U.S. LLC, effective July 7, 2026 (SPL set a0473462-6f9d-4eca-a5bf-8620aea68e8a), via openFDA; the full label on DailyMed
What do FAERS reports show?
5,605 reports list isatuximab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 742 are coded as a death and 2,875 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. Reports rose sharply in 2023 (1,313, against a median of 353 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 21 reactions below, 15 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?
- Isatuximab: 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