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Spesolimab Side Effects

The most commonly reported side effects of spesolimab include generalised pustular psoriasis, off label use, and pustular psoriasis, based on 287 FDA adverse event reports from 2022 to 2025. 13.2% of reports found the drug to be ineffective.

Spesolimab side effects

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

1
Generalised Pustular Psoriasis14.6%42
2
Drug Ineffective13.2%38
3
Off Label Use6.6%19
4
Pustular Psoriasis6.3%18
5
Pruritus5.6%16
6
Rash4.9%14
7
Psoriasis4.2%12
8
Maternal Exposure During Pregnancy4.2%12
9
Fatigue3.8%11
10
Pustule3.8%11
11
Pyrexia3.8%11
12
Therapeutic Product Effect Incomplete3.1%9
13
Stress3.1%9
14
Headache2.8%8
15
Urinary Tract Infection2.8%8

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

Report severity

54.4%Serious156 reports
23.3%Hospitalizations67 reports
7.3%Fatal21 reports

Seriousness is determined by the reporter, not by OpenClaim.

Spesolimab drug interactions

Other drugs that appear in adverse event reports alongside spesolimab. 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
Adalimumab4.5%13
2
Ixekizumab3.5%10
3
Prednisolone3.1%9
4
Guselkumab3.1%9
5
Risankizumab-rzaa2.8%8
6
Certolizumab-pegol2.8%8
7
Etanercept2.4%7
8
Golimumab2.4%7
9
Bimekizumab-bkzx1.7%5
10
Cyclosporine1.4%4
11
Apremilast1.4%4
12
Rituximab1.0%3
13
Mycophenolate1.0%3
14
Canakinumab1.0%3
15
Triamcinolone0.7%2

Taken alongside

1
Prednisone6.6%19
2
Methylprednisolone5.6%16
3
Cyclosporine3.5%10
4
Bimekizumab-bkzx3.1%9
5
Clobetasol-propionate2.8%8
6
Metformin2.4%7
7
Triamcinolone2.4%7
8
Infliximab2.4%7
9
Anakinra2.4%7
10
Isotretinoin2.4%7
11
Deucravacitinib2.4%7
12
Secukinumab2.4%7
13
Methotrexate2.1%6
14
Acetaminophen2.1%6
15
Levothyroxine-sodium2.1%6

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 spesolimab side effects

59.6% of spesolimab adverse event reports involve female patients and 27.2% involve male patients. The largest age group is adult at 64%. These figures reflect who reports side effects, not underlying risk.

Sex

Female59.6%
Male27.2%
Unknown13.2%

Age group

< 20.0%
2–111.1%
12–170.0%
18–6464.3%
65+34.6%

What is spesolimab used for

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

Acute Generalised Exanthematous PustulosisBehcet^s SyndromeDrug EruptionGeneralised Pustular PsoriasisHidradenitisHypertensionNeutrophil Function DisorderPalmoplantar PustulosisProduct Used For Unknown IndicationPsoriasisPustular PsoriasisPyoderma GangrenosumThrombosis

Spesolimab brand names and reporting trend

Spesolimab is sold under the brand name Spevigo.

Brand names

Spevigo81

Quarterly reports (20222025)

202220242025

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

Taking spesolimab with another medication?

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