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Siltuximab Side Effects

The most commonly reported side effects of siltuximab include off label use, cytokine release syndrome, and immune effector cell-associated neurotoxicity syndrome, based on 582 FDA adverse event reports from 2013 to 2025. 15.8% of reports found the drug to be ineffective.

Siltuximab side effects

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

1
Off Label Use21.1%123
2
Drug Ineffective15.8%92
3
Cytokine Release Syndrome8.4%49
4
Immune Effector Cell-associated Neurotoxicity Syndrome6.9%40
5
Hypertension6.7%39
6
Disease Progression6.0%35
7
Death5.5%32
8
Cataract5.2%30
9
Drug Effective For Unapproved Indication5.2%30
10
Hepatic Steatosis5.0%29
11
Cushingoid4.8%28
12
Osteopenia4.8%28
13
Short Stature4.8%28
14
Product Use In Unapproved Indication4.5%26
15
Acute Kidney Injury3.8%22

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

Report severity

81.4%Serious474 reports
32.1%Hospitalizations187 reports
20.4%Fatal119 reports

Seriousness is determined by the reporter, not by OpenClaim.

Siltuximab drug interactions

Other drugs that appear in adverse event reports alongside siltuximab. 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
Tocilizumab19.1%111
2
Dexamethasone15.1%88
3
Cyclophosphamide12.9%75
4
Anakinra11.7%68
5
Methylprednisolone10.8%63
6
Rituximab8.1%47
7
Methotrexate6.4%37
8
Prednisone5.8%34
9
Fludarabine-phosphate5.5%32
10
Infliximab4.5%26
11
Canakinumab4.3%25
12
Vincristine-sulfate4.1%24
13
Tofacitinib3.8%22
14
Ruxolitinib3.8%22
15
Lenalidomide3.6%21

Taken alongside

1
Fludarabine-phosphate8.8%51
2
Methylprednisolone6.7%39
3
Tocilizumab6.7%39
4
Cyclophosphamide6.4%37
5
Ondansetron6.0%35
6
Levetiracetam6.0%35
7
Dexamethasone5.7%33
8
Acyclovir4.6%27
9
Anakinra4.6%27
10
Acetaminophen4.1%24
11
Rituximab4.0%23
12
Furosemide3.8%22
13
Filgrastim3.8%22
14
Busulfan3.8%22
15
Prednisone3.4%20

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 siltuximab side effects

25.3% of siltuximab adverse event reports involve female patients and 31.6% involve male patients. The largest age group is adult at 49%. These figures reflect who reports side effects, not underlying risk.

Sex

Female25.3%
Male31.6%
Unknown43.1%

Age group

< 20.7%
2–1110.3%
12–178.5%
18–6449.4%
65+31.0%

What is siltuximab used for

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

Acute Lymphocytic LeukaemiaAcneAcute Lymphocytic LeukaemiaAnaemiaAstheniaBlood Pressure AbnormalBicytopeniaC-reactive Protein AbnormalCastleman^s DiseaseCovid-19Covid-19 PneumoniaCytokine Release SyndromeCastleman^s DiseaseCentral Nervous System LymphomaCerebral Infarction

Showing 15 of 65 indications

Siltuximab brand names and reporting trend

Siltuximab is sold under the brand name Sylvant.

Brand names

Sylvant440

Quarterly reports (20132025)

20132016202020242025

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

Taking siltuximab with another medication?

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