Drug · FAERS side-effect profile with label screen
Guselkumab side effects: what 35,198 FDA adverse event reports show
Brand names
Tremfya
openFDA label
Who reports
35,198 reports · 26% serious · 458 with death outcome · 59% female
openFDA FAERS counts, all years, deduplication not applied
Used for
TREMFYA is an interleukin-23 antagonist indicated for the treatment of: adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with moderate-to-severe plaque psoriasis and who are candidates for systemic therapy or phototherapy. ( 1.1 ) adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with active psoriatic arthritis.
FDA label, Indications and Usage
What it is
Guselkumab, an interleukin-23 antagonist, is a human immunoglobulin G1 lambda (IgG1λ) monoclonal antibody. Guselkumab is produced in a mammalian cell line using recombinant DNA technology and has an approximate molecular weight of approximately 147 kDa.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled (related wording) 1Likely indication confounding 7Reporting / coding artifact 16Lab value / disease marker 2Not in label — unassessed 14
What the badges mean
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 986 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Product leakage | 875 | 115.8 107.8–124.5ROR 118.7 · χ² 82,982 / p <1e-300 | 96.5 EB05 91.3 · IC025 +6.4 3/3 methods agree | Reporting / coding artifact | serious n=24 | not reported in cached trials |
| Drug delivery system malfunction | 737 | 100.7 93.2–108.8ROR 102.8 · χ² 61,914 / p <1e-300 | 85.8 EB05 80.7 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=37 | not reported in cached trials |
| Device deployment issue | 1,495 | 83.9 79.6–88.5ROR 87.5 · χ² 106,997 / p <1e-300 | 73.4 EB05 70.3 · IC025 +6.1 3/3 methods agree | Reporting / coding artifact | serious n=43 | not reported in cached trials |
| Needle issue | 2,305 | 51.7 49.6–53.8ROR 55.2 · χ² 105,249 / p <1e-300 | 47.5 EB05 45.9 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=52 | not reported in cached trials |
| Delusion of parasitosis | 10 | 47.2 24.8–90.0ROR 47.2 · χ² 377 / p 3e-84 | 40.6 EB05 23.6 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Device defective | 997 | 38.7 36.3–41.2ROR 39.8 · χ² 34,302 / p <1e-300 | 36.3 EB05 34.5 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious n=33 | not reported in cached trials |
| Product storage issue | 98 | 33.9 27.6–41.5ROR 34.0 · χ² 2,923 / p <1e-300 | 31.9 EB05 26.9 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious n=4 | not reported in cached trials |
| Product information content complaint | 10 | 30.1 15.9–56.8ROR 30.1 · χ² 240 / p 2e-54 | 27.2 EB05 15.6 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | – | not reported in cached trials |
| Lung adenocarcinoma stage iv | 18 | 29.3 18.2–47.0ROR 29.3 · χ² 442 / p 2e-98 | 27.2 EB05 18.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Generalised pustular psoriasis | 11 | 26.2 14.3–47.9ROR 26.2 · χ² 231 / p 1e-52 | 24.0 EB05 14.0 · IC025 +2.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=11 | not reported in cached trials |
| Product dose omission issue | 11,426 | 24.6 24.2–25.0ROR 35.8 · χ² 251,847 / p <1e-300 | 23.7 EB05 23.3 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious PRR 8.0 | not reported in cached trials |
| Angioimmunoblastic t-cell lymphoma | 11 | 21.5 11.8–39.3ROR 21.5 · χ² 188 / p 4e-43 | 19.8 EB05 11.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Accidental exposure to product | 3,518 | 21.5 20.8–22.2ROR 23.7 · χ² 66,597 / p <1e-300 | 20.8 EB05 20.2 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious PRR 17.9 | not reported in cached trials |
| Liquid product physical issue | 236 | 20.4 17.9–23.2ROR 20.5 · χ² 4,179 / p <1e-300 | 19.7 EB05 17.7 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Product label issue | 220 | 20.0 17.5–22.8ROR 20.1 · χ² 3,817 / p <1e-300 | 19.3 EB05 17.3 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious n=20 · 89% consumer | not reported in cached trials |
| Syringe issue | 514 | 17.8 16.3–19.4ROR 18.0 · χ² 7,894 / p <1e-300 | 17.3 EB05 16.1 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Product outer packaging issue | 22 | 15.3 10.0–23.3ROR 15.3 · χ² 272 / p 2e-61 | 14.4 EB05 9.7 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | 82% consumer | not reported in cached trials |
| Device malfunction | 1,655 | 14.9 14.2–15.6ROR 15.5 · χ² 20,930 / p <1e-300 | 14.5 EB05 13.9 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 5.3 | not reported in cached trials |
| Device issue | 1,980 | 13.7 13.1–14.3ROR 14.4 · χ² 22,804 / p <1e-300 | 13.4 EB05 12.9 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 4.9 | not reported in cached trials |
| Device leakage | 921 | 13.1 12.3–14.0ROR 13.4 · χ² 10,070 / p <1e-300 | 12.8 EB05 12.1 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious n=22 | not reported in cached trials |
| Paternal exposure during pregnancy | 18 | 12.6 7.9–20.1ROR 12.6 · χ² 177 / p 1e-40 | 11.4 EB05 7.1 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Physical product label issue | 24 | 12.4 8.3–18.5ROR 12.4 · χ² 235 / p 3e-53 | 11.5 EB05 7.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Blood uric acid decreased | 10 | 12.3 6.6–23.1ROR 12.3 · χ² 91 / p 7e-22 | 10.1 EB05 5.1 · IC025 +1.9 3/3 methods agree | Lab value / disease marker | serious n=10 | not reported in cached trials |
| Product temperature excursion issue | 97 | 12.3 10.0–15.0ROR 12.3 · χ² 974 / p 5e-214 | 11.9 EB05 10.0 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious n=5 | not reported in cached trials |
| Nail psoriasis | 12 | 11.7 6.6–20.6ROR 11.7 · χ² 104 / p 8e-25 | 9.7 EB05 5.4 · IC025 +2.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=7 | not reported in cached trials |
| Erythrodermic psoriasis | 15 | 11.0 6.6–18.3ROR 11.0 · χ² 124 / p 4e-29 | 9.5 EB05 5.6 · IC025 +2.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=12 | not reported in cached trials |
| Psoriatic arthropathy | 723 | 10.8 10.0–11.6ROR 11.0 · χ² 6,300 / p <1e-300 | 10.6 EB05 9.9 · IC025 +3.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 29.0 | not reported in cached trials |
| Product knowledge deficit | 10 | 10.6 5.7–19.9ROR 10.6 · χ² 77 / p 1e-18 | 8.4 EB05 4.4 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | – | not reported in cached trials |
| Mycobacterium tuberculosis complex test positive | 42 | 10.6 7.8–14.4ROR 10.6 · χ² 351 / p 1e-78 | 10.0 EB05 7.6 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious n=7 | not reported in cached trials |
| Psoriasis | 2,239 | 10.3 9.9–10.7ROR 10.9 · χ² 18,492 / p <1e-300 | 10.1 EB05 9.7 · IC025 +3.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 17.8 | NCT04033445: 1/23 (4.3%) on Guselkumab; 1/295 (0.3%) control |
| Drug delivery system issue | 30 | 9.5 6.7–13.7ROR 9.5 · χ² 217 / p 2e-49 | 8.7 EB05 6.2 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=4 | not reported in cached trials |
| Latent tuberculosis | 33 | 9.5 6.7–13.3ROR 9.5 · χ² 237 / p 8e-54 | 8.7 EB05 6.3 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious n=20 · 94% clinician | not reported in cached trials |
| Product design issue | 10 | 8.8 4.7–16.4ROR 8.8 · χ² 61 / p 4e-15 | 6.8 EB05 3.8 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | – | not reported in cached trials |
| Product storage error | 1,212 | 8.4 7.9–8.8ROR 8.6 · χ² 7,771 / p <1e-300 | 8.2 EB05 7.9 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 9.8 | not reported in cached trials |
| Dactylitis | 13 | 7.9 4.6–13.7ROR 7.9 · χ² 71 / p 2e-17 | 6.4 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious n=7 | not reported in cached trials |
| Guttate psoriasis | 10 | 7.2 3.9–13.5ROR 7.2 · χ² 47 / p 4e-12 | 5.6 EB05 3.2 · IC025 +1.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=6 | not reported in cached trials |
| Pustular psoriasis | 41 | 7.1 5.2–9.6ROR 7.1 · χ² 206 / p 6e-47 | 6.6 EB05 5.0 · IC025 +2.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=28 | not reported in cached trials |
| Injection related reaction | 18 | 6.7 4.2–10.6ROR 6.7 · χ² 80 / p 2e-19 | 5.7 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious n=8 | not reported in cached trials |
| Dermatitis exfoliative generalised | 38 | 6.6 4.8–9.1ROR 6.6 · χ² 172 / p 1e-39 | 6.1 EB05 4.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=38 · ♀ 33% (drug 59%) · 92% clinician | not reported in cached trials |
| Cutaneous t-cell lymphoma | 13 | 6.5 3.8–11.3ROR 6.5 · χ² 55 / p 7e-14 | 5.4 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Guselkumab as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (1 of 40 signal terms matched).
- NCT03466411 — A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Di (N=1409, PHASE2, PHASE3; 112 AE terms posted; arms: GALAXI 1 (Group 1) Guselkumab 1200 mg IV; GALAXI 1 (Group 2) Guselkumab 600 mg IV ; GALAXI 1 (Group 3) Guselkumab 200 mg IV ; GALAXI 1 (Group 4) Ustekinumab 6 mg/kg I)
- NCT04033445 — A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis (N=1064, PHASE2, PHASE3; 120 AE terms posted; arms: IS-1: Period 1: Placebo IV at Weeks I-0,; IS-1: Period 1: Guselkumab 200 mg IV at ; IS-1: Period 1: Guselkumab 400 mg IV at ; IS-1: Period 2: Guselkumab 200 mg IV at )
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Product dose omission issue | 11,426 | 24.6 24.2–25.0ROR 35.8 · χ² 251,847 / p <1e-300 | 23.7 EB05 23.3 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious PRR 8.0 | not reported in cached trials |
| Accidental exposure to product | 3,518 | 21.5 20.8–22.2ROR 23.7 · χ² 66,597 / p <1e-300 | 20.8 EB05 20.2 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious PRR 17.9 | not reported in cached trials |
| Drug ineffective (drug did not work) | 2,460 | 1.1 1.1–1.1ROR 1.1 · χ² 25 / p 3e-7 | 1.1 EB05 1.1 · IC025 +0.1 | Reporting / coding artifact | serious PRR 1.6 | not reported in cached trials |
| Needle issue | 2,305 | 51.7 49.6–53.8ROR 55.2 · χ² 105,249 / p <1e-300 | 47.5 EB05 45.9 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=52 | not reported in cached trials |
| Psoriasis | 2,239 | 10.3 9.9–10.7ROR 10.9 · χ² 18,492 / p <1e-300 | 10.1 EB05 9.7 · IC025 +3.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 17.8 | NCT04033445: 1/23 (4.3%) on Guselkumab; 1/295 (0.3%) control |
| Device issue | 1,980 | 13.7 13.1–14.3ROR 14.4 · χ² 22,804 / p <1e-300 | 13.4 EB05 12.9 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 4.9 | not reported in cached trials |
| Device malfunction | 1,655 | 14.9 14.2–15.6ROR 15.5 · χ² 20,930 / p <1e-300 | 14.5 EB05 13.9 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 5.3 | not reported in cached trials |
| Off label use (used outside approved label) | 1,536 | 1.0 1.0–1.1ROR 1.0 · χ² 3 / p 0.044 | 1.0 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.2 | not reported in cached trials |
| Device deployment issue | 1,495 | 83.9 79.6–88.5ROR 87.5 · χ² 106,997 / p <1e-300 | 73.4 EB05 70.3 · IC025 +6.1 3/3 methods agree | Reporting / coding artifact | serious n=43 | not reported in cached trials |
| Product storage error | 1,212 | 8.4 7.9–8.8ROR 8.6 · χ² 7,771 / p <1e-300 | 8.2 EB05 7.9 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 9.8 | not reported in cached trials |
| Inappropriate schedule of product administration | 1,028 | 3.4 3.2–3.7ROR 3.5 · χ² 1,784 / p <1e-300 | 3.4 EB05 3.3 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 2.5 | not reported in cached trials |
| Device defective | 997 | 38.7 36.3–41.2ROR 39.8 · χ² 34,302 / p <1e-300 | 36.3 EB05 34.5 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious n=33 | not reported in cached trials |
| Arthralgia (joint pain) | 956 | 1.4 1.3–1.4ROR 1.4 · χ² 93 / p 3e-22 | 1.4 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.3 | NCT03466411: 9/148 (6.1%) on Guselkumab; 4/70 (5.7%) control |
| Device leakage | 921 | 13.1 12.3–14.0ROR 13.4 · χ² 10,070 / p <1e-300 | 12.8 EB05 12.1 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious n=22 | not reported in cached trials |
| Product leakage | 875 | 115.8 107.8–124.5ROR 118.7 · χ² 82,982 / p <1e-300 | 96.5 EB05 91.3 · IC025 +6.4 3/3 methods agree | Reporting / coding artifact | serious n=24 | not reported in cached trials |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Drug delivery system malfunction — n=737, PRR 100.7
- Needle issue — n=2,305, PRR 51.7
- Liquid product physical issue — n=236, PRR 20.4
- Syringe issue — n=514, PRR 17.8
- Physical product label issue — n=24, PRR 12.4
- Drug delivery system issue — n=30, PRR 9.5
- Dermatitis exfoliative generalised — n=38, PRR 6.6
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Guselkumab?
In FDA FAERS, the most frequently co-reported reaction terms for Guselkumab are needle issue, psoriasis, arthralgia. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Guselkumab have an FDA boxed warning?
No. The FDA label retrieved for Guselkumab has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Guselkumab causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 1e6dc9ae-1c4c-42d9-87aa-c315ecc51b56, effective 20260604; matched on
openfda.generic_name.exact:"GUSELKUMAB") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,026 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
GUSELKUMAB, results-bearing studies sorted by enrollment)
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.