OpenClaim

Guselkumab Side Effects

The most commonly reported side effects of guselkumab include product dose omission issue, accidental exposure to product, and psoriasis, based on 31,204 FDA adverse event reports from 2016 to 2025. 7.2% of reports found the drug to be ineffective.

Guselkumab side effects

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

1
Product Dose Omission Issue32.1%10,013
2
Accidental Exposure To Product10.1%3,138
3
Drug Ineffective7.2%2,243
4
Psoriasis6.6%2,070
5
Needle Issue6.6%2,054
6
Device Issue5.6%1,748
7
Device Malfunction4.7%1,480
8
Off Label Use4.3%1,328
9
Product Storage Error3.6%1,121
10
Device Deployment Issue3.1%973
11
Inappropriate Schedule Of Product Administration2.9%898
12
Arthralgia2.7%843
13
Device Leakage2.5%791
14
Pneumonia2.5%788
15
Product Leakage2.3%733

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

Report severity

25.7%Serious8,009 reports
7.5%Hospitalizations2,355 reports
1.3%Fatal405 reports

Seriousness is determined by the reporter, not by OpenClaim.

Guselkumab drug interactions

Other drugs that appear in adverse event reports alongside guselkumab. 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
Adalimumab1.3%413
2
Secukinumab1.2%389
3
Apremilast1.2%374
4
Methotrexate1.0%321
5
Ustekinumab0.8%256
6
Etanercept0.7%206
7
Ixekizumab0.7%204
8
Dupilumab0.6%197
9
Risankizumab-rzaa0.6%185
10
Certolizumab-pegol0.6%176
11
Infliximab0.4%136
12
Upadacitinib0.4%113
13
Bimekizumab-bkzx0.3%93
14
Ibuprofen0.2%73
15
Tofacitinib0.2%69

Taken alongside

1
Methotrexate1.1%339
2
Ergocalciferol1.0%302
3
Metformin1.0%297
4
Atorvastatin-calcium0.9%280
5
Levothyroxine-sodium0.9%273
6
Clobetasol-propionate0.8%251
7
Omeprazole0.8%248
8
Aspirin0.8%246
9
Prednisone0.8%243
10
Amlodipine0.8%242
11
Lisinopril0.7%230
12
Acetaminophen0.7%228
13
Albuterol0.7%207
14
Pantoprazole-sodium0.6%199
15
Metoprolol0.6%181

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 guselkumab side effects

47.2% of guselkumab adverse event reports involve female patients and 33.3% involve male patients. The largest age group is adult at 80%. These figures reflect who reports side effects, not underlying risk.

Sex

Female47.2%
Male33.3%
Unknown19.5%

Age group

< 20.1%
2–11<0.1%
12–170.2%
18–6479.8%
65+19.9%

What is guselkumab used for

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

Accidental Exposure To ProductAcne ConglobataAdenomatous Polyposis ColiAngiogramAnkylosing SpondylitisAnxietyArthralgiaArthritisArthropathyAccidental Exposure To ProductAcneAdverse Drug ReactionAlcoholismAlopecia ScarringAnal Fistula

Showing 15 of 188 indications

Guselkumab brand names and reporting trend

Guselkumab is sold under the brand name Tremfya.

Brand names

Tremfya2,177

Quarterly reports (20162025)

2016202020242025

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

Taking guselkumab with another medication?

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