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Isatuximab Side Effects

The most commonly reported side effects of isatuximab include neutropenia, pneumonia, and plasma cell myeloma, based on 5,134 FDA adverse event reports from 2017 to 2025. 2.6% of reports found the drug to be ineffective.

Isatuximab side effects

Percentages show how often each reaction appears relative to total reports for isatuximab.

1
Neutropenia9.4%482
2
Pneumonia6.8%351
3
Plasma Cell Myeloma6.5%336
4
Thrombocytopenia5.6%285
5
Covid-195.4%278
6
Pyrexia4.9%250
7
Anaemia4.9%250
8
Infusion Related Reaction4.8%247
9
Diarrhoea4.3%222
10
Off Label Use3.7%191
11
Dyspnoea3.6%183
12
Nausea3.0%152
13
Acute Kidney Injury2.8%145
14
Death2.7%141
15
Febrile Neutropenia2.6%135

These are voluntary reports and do not establish that isatuximab caused these reactions.

Report severity

92.7%Serious4,760 reports
53.4%Hospitalizations2,740 reports
12.7%Fatal654 reports

Seriousness is determined by the reporter, not by OpenClaim.

Isatuximab drug interactions

Other drugs that appear in adverse event reports alongside isatuximab. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Dexamethasone67.9%3,488
2
Lenalidomide43.0%2,209
3
Carfilzomib37.8%1,943
4
Pomalidomide31.3%1,609
5
Bortezomib20.7%1,064
6
Cyclophosphamide7.3%375
7
Daratumumab3.1%160
8
Melphalan2.9%150
9
Doxorubicin-hydrochloride2.5%130
10
Thalidomide2.3%116
11
Etoposide2.1%106
12
Ixazomib-citrate1.4%71
13
Elotuzumab1.3%66
14
Cisplatin1.2%62
15
Filgrastim0.8%42

Taken alongside

1
Acyclovir25.2%1,292
2
Acetaminophen19.1%983
3
Dexamethasone19.0%975
4
Aspirin12.0%615
5
Pantoprazole-sodium10.1%519
6
Sulfamethoxazole9.8%505
7
Trimethoprim9.5%488
8
Omeprazole8.3%424
9
Apixaban6.4%330
10
Furosemide5.6%288
11
Zoledronic-acid5.4%279
12
Amoxicillin5.3%273
13
Allopurinol5.2%269
14
Montelukast-sodium5.2%266
15
Pomalidomide5.0%258

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports isatuximab side effects

38.6% of isatuximab adverse event reports involve female patients and 47.0% involve male patients. The largest age group is elderly at 55%. These figures reflect who reports side effects, not underlying risk.

Sex

Female38.6%
Male47.0%
Unknown14.5%

Age group

< 2<0.1%
2–110.6%
12–170.2%
18–6444.3%
65+54.9%

What is isatuximab used for

Conditions and purposes for which patients were taking isatuximab when the adverse event was reported.

Acute Myeloid LeukaemiaAdult T-cell Lymphoma/leukaemiaAmyloidosisAngioimmunoblastic T-cell LymphomaAcute Lymphocytic LeukaemiaAcute Lymphocytic Leukaemia RecurrentAcute Myeloid LeukaemiaAcute Myeloid Leukaemia RefractoryAmyloidosisAplasia Pure Red CellAutologous Haematopoietic Stem Cell TransplantB-cell Type Acute LeukaemiaB-cell Type Acute LeukaemiaBreast CancerColorectal Cancer Metastatic

Showing 15 of 75 indications

Isatuximab brand names and reporting trend

Isatuximab is sold under the brand name Sarclisa.

Brand names

Sarclisa10,725

Quarterly reports (20172025)

20182020202220242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking isatuximab with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.