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Ustekinumab Side Effects

The most commonly reported side effects of ustekinumab include off label use, product dose omission issue, and fatigue, based on 99,352 FDA adverse event reports from 2009 to 2025. 14.5% of reports found the drug to be ineffective.

Ustekinumab side effects

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

1
Drug Ineffective14.5%14,379
2
Off Label Use12.4%12,279
3
Product Dose Omission Issue9.8%9,771
4
Fatigue6.6%6,564
5
Psoriasis6.3%6,291
6
Pain6.1%6,023
7
Crohn^s Disease5.6%5,612
8
Arthralgia5.6%5,596
9
Rash5.5%5,428
10
Product Use Issue5.3%5,314
11
Headache5.1%5,080
12
Condition Aggravated5.1%5,063
13
Infusion Related Reaction5.0%4,945
14
Rheumatoid Arthritis4.7%4,644
15
Joint Swelling4.6%4,567

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

Report severity

59.0%Serious58,582 reports
21.7%Hospitalizations21,534 reports
5.5%Fatal5,493 reports

Seriousness is determined by the reporter, not by OpenClaim.

Ustekinumab drug interactions

Other drugs that appear in adverse event reports alongside ustekinumab. 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
Adalimumab12.3%12,241
2
Methotrexate10.4%10,373
3
Infliximab10.1%10,032
4
Etanercept8.9%8,865
5
Golimumab7.1%7,013
6
Abatacept7.0%6,969
7
Leflunomide6.9%6,894
8
Certolizumab-pegol6.9%6,835
9
Prednisone6.7%6,682
10
Secukinumab6.7%6,616
11
Sulfasalazine6.6%6,601
12
Tofacitinib6.4%6,389
13
Tocilizumab6.4%6,372
14
Rituximab6.1%6,050
15
Hydroxychloroquine-sulfate6.1%6,050

Taken alongside

1
Acetaminophen4.2%4,203
2
Methotrexate3.9%3,829
3
Ergocalciferol3.8%3,817
4
Pantoprazole-sodium3.7%3,712
5
Sulfasalazine3.7%3,690
6
Prednisone3.4%3,396
7
Ibuprofen3.4%3,337
8
Lisinopril2.8%2,745
9
Folic-acid2.6%2,557
10
Tofacitinib2.6%2,549
11
Adalimumab2.4%2,351
12
Caffeine2.2%2,197
13
Lorazepam2.1%2,106
14
Levothyroxine-sodium2.1%2,089
15
Ramipril2.1%2,068

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 ustekinumab side effects

51.7% of ustekinumab adverse event reports involve female patients and 35.0% involve male patients. The largest age group is adult at 80%. These figures reflect who reports side effects, not underlying risk.

Sex

Female51.7%
Male35.0%
Unknown13.3%

Age group

< 20.4%
2–110.6%
12–172.4%
18–6479.7%
65+16.8%

What is ustekinumab used for

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

Accidental Exposure To ProductAcneAcute Febrile Neutrophilic DermatosisAcute Graft Versus Host DiseaseAdverse EventAlopecia AreataAlopecia TotalisAnal FistulaAnkylosing SpondylitisAnorectal DisorderAnovulvar FistulaArthralgiaArthritisArthritis EnteropathicArthropathy

Showing 15 of 466 indications

Ustekinumab brand names and reporting trend

Ustekinumab is sold under several brand names including Stelara, Selarsdi, Wezlana.

Brand names

Stelara14,090
Selarsdi5
Wezlana4
Yesintek2
Pyzchiva1

Quarterly reports (20092025)

200920122016202020242025

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

Taking ustekinumab with another medication?

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