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Sarilumab Side Effects

The most commonly reported side effects of sarilumab include pain, arthralgia, and rheumatoid arthritis, based on 23,695 FDA adverse event reports from 2015 to 2025. 23.6% of reports found the drug to be ineffective.

Sarilumab side effects

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

1
Drug Ineffective23.6%5,592
2
Pain22.4%5,313
3
Arthralgia19.7%4,659
4
Rheumatoid Arthritis18.5%4,395
5
Joint Swelling18.4%4,365
6
Condition Aggravated15.1%3,581
7
Fatigue14.1%3,334
8
Rash13.6%3,212
9
Alopecia12.5%2,969
10
Abdominal Discomfort12.3%2,906
11
Hepatic Enzyme Increased12.1%2,858
12
Systemic Lupus Erythematosus11.7%2,780
13
Pemphigus11.5%2,721
14
Hand Deformity11.2%2,643
15
Glossodynia11.1%2,625

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

Report severity

43.0%Serious10,193 reports
17.1%Hospitalizations4,050 reports
9.8%Fatal2,314 reports

Seriousness is determined by the reporter, not by OpenClaim.

Sarilumab drug interactions

Other drugs that appear in adverse event reports alongside sarilumab. 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
Methotrexate19.0%4,496
2
Abatacept17.8%4,216
3
Hydroxychloroquine-sulfate17.3%4,096
4
Leflunomide17.1%4,054
5
Etanercept16.8%3,974
6
Adalimumab16.6%3,940
7
Prednisone16.5%3,912
8
Tocilizumab16.3%3,873
9
Sulfasalazine15.7%3,711
10
Diclofenac15.6%3,708
11
Folic-acid15.4%3,639
12
Certolizumab-pegol15.3%3,634
13
Rituximab15.2%3,605
14
Desoximetasone15.1%3,589
15
Cetirizine-hydrochloride15.1%3,589

Taken alongside

1
Ergocalciferol9.9%2,356
2
Acetaminophen9.8%2,321
3
Prednisone9.1%2,156
4
Sulfasalazine8.9%2,115
5
Ibuprofen7.7%1,826
6
Pantoprazole-sodium7.6%1,802
7
Lisinopril7.3%1,724
8
Methotrexate6.8%1,604
9
Tofacitinib6.7%1,587
10
Caffeine5.7%1,362
11
Lorazepam5.1%1,220
12
Hydroxychloroquine-sulfate5.1%1,201
13
Calcium4.7%1,124
14
Levothyroxine-sodium4.7%1,121
15
Folic-acid4.7%1,104

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 sarilumab side effects

75.9% of sarilumab adverse event reports involve female patients and 14.6% involve male patients. The largest age group is adult at 73%. These figures reflect who reports side effects, not underlying risk.

Sex

Female75.9%
Male14.6%
Unknown9.5%

Age group

< 20.2%
2–11<0.1%
12–17<0.1%
18–6472.6%
65+27.2%

What is sarilumab used for

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

Adjuvant TherapyAmyotrophic Lateral SclerosisAnaemiaAnaemia Vitamin B12 DeficiencyAnkylosing SpondylitisAntiretroviral TherapyArteritisArthralgiaArthritisArthritis EnteropathicArthropathyAutoimmune DisorderAutoimmune ThyroiditisAcquired Attr AmyloidosisAdrenal Insufficiency

Showing 15 of 372 indications

Sarilumab brand names and reporting trend

Sarilumab is sold under the brand name Kevzara.

Brand names

Kevzara2,551

Quarterly reports (20152025)

2015202020242025

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

Taking sarilumab with another medication?

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