What the label lists and what reports show
Tildrakizumab side effects
Tildrakizumab's FDA label: “Most common (≥1%) adverse reactions associated with ILUMYA treatment are upper respiratory infections, injection site reactions, and diarrhea.” FAERS holds 2,321 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 self-medication (89 reports).
- No generic listed
Check it at the source: the tildrakizumab FDA label on DailyMed (effective July 29, 2026); 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 ILUMYA?ILUMYA may cause serious side effects. See “What is the most important information I should know about ILUMYA?” The most common side effects of ILUMYA include: upper respiratory infections injection site reactions diarrhea These are not all of the possible side effects of ILUMYA. 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, Sun Pharmaceutical Industries, Inc., effective July 29, 2026 (SPL set c6a322bb-51b9-4f0e-8642-62a9682ffcde), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common (≥1%) adverse reactions associated with ILUMYA treatment are upper respiratory infections, injection site reactions, and diarrhea.
From the label: adverse reactions, continuedThe following serious adverse reactions are discussed elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Infections [see Warnings and Precautions (5.2) ] Most common (≥1%) adverse reactions associated with ILUMYA treatment are upper respiratory infections, injection site reactions, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 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. Plaque Psoriasis In clinical trials, a total of 1994 subjects with plaque psoriasis were treated with ILUMYA, of which 1083 subjects were treated with ILUMYA 100 mg. Of these, 672 subjects were exposed for at least 12 months, 587 for 18 months, and 469 for 24 months. Data from three placebo-controlled trials (Trials 1, 2, and 3) in 705 subjects (mean age 46 years, 71% males, 81% white) were pooled to evaluate the safety of ILUMYA (100 mg administered subcutaneously at Weeks 0 and 4, followed by every 12 weeks [Q12W]) [see Clinical Studies (14) ]. …
Source: FDA drug label, Sun Pharmaceutical Industries, Inc., effective July 29, 2026 (SPL set c6a322bb-51b9-4f0e-8642-62a9682ffcde), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,321 reports list tildrakizumab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 159 are coded as a death and 92 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 15 reactions below, 4 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.
Reports received each year
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?
- Tildrakizumab: 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