What the label lists and what reports show
Icotrokinra side effects
Icotrokinra's FDA label: “Most common adverse reactions (≥1%) are headache, nausea, cough, fungal infection, and fatigue.” FAERS holds 121 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is headache (18 reports).
- No generic listed
Check it at the source: the icotrokinra FDA label on DailyMed (effective March 17, 2026, Janssen Biotech, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of ICOTYDE?ICOTYDE may cause serious side effects. See "What is the most important information I should know about ICOTYDE?" The most common side effects of ICOTYDE include: headache nausea cough fungal infection tiredness These are not all the possible side effects of ICOTYDE. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label, Janssen Biotech, Inc., effective March 17, 2026 (SPL set aee3c963-edc0-4252-8769-cdf6c7cdc21a), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥1%) are headache, nausea, cough, fungal infection, and fatigue.
Table 1: Adverse Reactions that Occurred in ≥1% of Subjects in the ICOTYDE Group and More Frequently than in the Placebo Group in Trials PSO-1, PSO-2, PSO-3, and PSO-4 through Week 16 percentages based on…
| Adverse Reactions | ICOTYDE N=1296 n (%) | Placebo N=568 n (%) |
|---|---|---|
| Headache | 51 (4.1) | 19 (3.3) |
| Nausea | 15 (1.2) | 3 (0.5) |
| Cough | 15 (1.2) | 1 (0.2) |
| Fungal Infection Fungal infection includes tinea pedis (n=4), tinea versicolor (n=2),… | 14 (1.1) | 0 (0) |
| Fatigue | 15 (1.0) | 3 (0.5) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedMost common adverse reactions (≥1%) are headache, nausea, cough, fungal infection, and fatigue. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Biotech, Inc. at 1-800-526-7736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of ICOTYDE was evaluated in two placebo-controlled trials (Trial PSO-3 and Trial PSO-4) and two placebo- and active-controlled trials (Trial PSO-1 and Trial PSO-2) [see Clinical Studies (14) ]. A total of 2367 adults and pediatric subjects 12 years of age and older who weigh at least 40 kg with moderate-to-severe plaque psoriasis received ICOTYDE 200 mg orally once daily. Of these, 648 subjects were treated with ICOTYDE for at least one year. Data from these four trials were pooled to evaluate the safety of ICOTYDE compared to placebo for 16 weeks. Adverse Reactions Weeks 0 to 16 Table 1: Adverse Reactions that Occurred in ≥1% of Subjects in the ICOTYDE Group and More Frequently than in the Placebo Group in Trials PSO-1, PSO-2, PSO-3, and PSO-4 through Week 16 percentages based on Cochran-Mantel-Haenszel (CMH) adjusted proportions.
Source: FDA drug label, Janssen Biotech, Inc., effective March 17, 2026 (SPL set aee3c963-edc0-4252-8769-cdf6c7cdc21a), via openFDA; the full label on DailyMed
What do FAERS reports show?
121 reports list icotrokinra among the medicines taken, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 6 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 6 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Icotrokinra: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions