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Rilonacept Side Effects

The most commonly reported side effects of rilonacept include injection site erythema, chest pain, and product dose omission issue, based on 944 FDA adverse event reports from 2009 to 2025. 6.8% of reports found the drug to be ineffective.

Rilonacept side effects

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

1
Injection Site Erythema12.2%115
2
Chest Pain10.8%102
3
Product Dose Omission Issue10.0%94
4
Off Label Use8.2%77
5
Injection Site Pain8.1%76
6
Fatigue7.9%75
7
Pain6.9%65
8
Drug Ineffective6.8%64
9
Pericarditis6.8%64
10
Injection Site Pruritus6.3%59
11
Injection Site Rash6.0%57
12
Injection Site Reaction5.7%54
13
Dyspnoea5.6%53
14
Arthralgia4.9%46
15
Nausea4.7%44

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

Report severity

23.2%Serious219 reports
11.3%Hospitalizations107 reports
2.1%Fatal20 reports

Seriousness is determined by the reporter, not by OpenClaim.

Rilonacept drug interactions

Other drugs that appear in adverse event reports alongside rilonacept. 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
Prednisone3.7%35
2
Anakinra3.5%33
3
Canakinumab3.1%29
4
Tocilizumab2.8%26
5
Colchicine2.2%21
6
Cyclosporine1.8%17
7
Methotrexate1.4%13
8
Tofacitinib1.4%13
9
Cyclophosphamide1.2%11
10
Mycophenolate1.1%10
11
Adalimumab1.1%10
12
Infliximab1.1%10
13
Etanercept1.0%9
14
Ibuprofen0.8%8
15
Naproxen0.7%7

Taken alongside

1
Colchicine9.5%90
2
Prednisone7.8%74
3
Ibuprofen4.4%42
4
Metoprolol2.1%20
5
Naproxen2.0%19
6
Aspirin1.9%18
7
Anakinra1.7%16
8
Levothyroxine-sodium1.7%16
9
Pantoprazole-sodium1.7%16
10
Acetaminophen1.6%15
11
Ergocalciferol1.6%15
12
Omeprazole1.5%14
13
Atorvastatin-calcium1.4%13
14
Indomethacin1.3%12
15
Canakinumab1.3%12

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 rilonacept side effects

59.9% of rilonacept adverse event reports involve female patients and 27.6% involve male patients. The largest age group is adult at 68%. These figures reflect who reports side effects, not underlying risk.

Sex

Female59.9%
Male27.6%
Unknown12.5%

Age group

< 20.8%
2–113.3%
12–172.6%
18–6467.8%
65+25.5%

What is rilonacept used for

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

Autoinflammatory DiseaseAutoimmune PericarditisAutoinflammatory DiseaseBehcet^s SyndromeBursitisBlau SyndromeChronic Inflammatory Demyelinating PolyradiculoneuropathyConnective Tissue DisorderCovid-19Cryopyrin Associated Periodic SyndromeCryopyrin Associated Periodic SyndromeDepressionFamilial AmyloidosisFamilial Cold Autoinflammatory SyndromeFamilial Mediterranean Fever

Showing 15 of 58 indications

Rilonacept brand names and reporting trend

Rilonacept is sold under the brand name Arcalyst.

Brand names

Arcalyst115

Quarterly reports (20092025)

20092012201620242025

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

Taking rilonacept with another medication?

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