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Satralizumab Side Effects

The most commonly reported side effects of satralizumab include neuromyelitis optica spectrum disorder, off label use, and urinary tract infection, based on 1,467 FDA adverse event reports from 2020 to 2025.

Satralizumab side effects

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

1
Neuromyelitis Optica Spectrum Disorder17.2%252
2
Off Label Use9.7%142
3
Urinary Tract Infection8.0%118
4
Pneumonia6.3%93
5
Covid-194.2%62
6
No Adverse Event4.0%59
7
Fatigue4.0%59
8
Hypoaesthesia3.3%49
9
Pain3.3%48
10
Headache3.1%45
11
Arthralgia2.8%41
12
Infection2.8%41
13
Muscular Weakness2.7%40
14
Optic Neuritis2.5%36
15
Fall2.2%33

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

Report severity

76.4%Serious1,121 reports
38.5%Hospitalizations565 reports
5.4%Fatal79 reports

Seriousness is determined by the reporter, not by OpenClaim.

Satralizumab drug interactions

Other drugs that appear in adverse event reports alongside satralizumab. 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
Rituximab10.4%153
2
Prednisolone5.7%84
3
Mycophenolate4.4%65
4
Prednisone4.2%62
5
Azathioprine2.2%32
6
Tocilizumab1.5%22
7
Inebilizumab-cdon1.4%20
8
Tacrolimus1.2%18
9
Ocrelizumab0.7%11
10
Eculizumab0.7%11
11
Ravulizumab-cwvz0.7%11
12
Cyclosporine0.4%6
13
Methoxy-polyethylene-glycol-epoetin-beta0.3%4
14
Methylprednisolone0.3%4
15
Carbamazepine0.3%4

Taken alongside

1
Prednisolone6.7%99
2
Prednisone6.3%92
3
Pregabalin3.6%53
4
Azathioprine2.7%40
5
Gabapentin2.7%40
6
Tacrolimus2.0%29
7
Baclofen1.8%27
8
Lansoprazole1.7%25
9
Ergocalciferol1.7%25
10
Omeprazole1.6%23
11
Duloxetine-hydrochloride1.6%23
12
Methylprednisolone1.6%23
13
Carbamazepine1.5%22
14
Acetaminophen1.4%21
15
Levothyroxine-sodium1.4%21

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 satralizumab side effects

77.7% of satralizumab adverse event reports involve female patients and 12.0% involve male patients. The largest age group is adult at 67%. These figures reflect who reports side effects, not underlying risk.

Sex

Female77.7%
Male12.0%
Unknown10.3%

Age group

< 20.3%
2–110.3%
12–171.9%
18–6467.2%
65+30.4%

What is satralizumab used for

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

Anti-aquaporin-4 Antibody PositiveAutoimmune DisorderCutaneous Lupus ErythematosusCystoid Macular OedemaDemyelinationEncephalitis AutoimmuneImmunomodulatory TherapyMultiple SclerosisMyelitisMultiple SclerosisMyasthenia GravisMyelin Oligodendrocyte Glycoprotein Antibody-associated DiseaseMyelitisMyelitis TransverseNeuromyelitis Optica Spectrum Disorder

Showing 15 of 25 indications

Satralizumab brand names and reporting trend

Satralizumab is sold under the brand name Enspryng.

Brand names

Enspryng345

Quarterly reports (20202025)

2020202220242025

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

Taking satralizumab with another medication?

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