What the label lists and what reports show
Ustekinumab side effects
Ustekinumab's FDA label: “Most common adverse reactions are: Psoriasis and Psoriatic Arthritis (≥3%): nasopharyngitis, upper respiratory tract infection, headache, and fatigue.” FAERS holds 102,257 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 fatigue (6,864 reports).
- No generic listed
Check it at the source: the ustekinumab FDA label on DailyMed (effective September 8, 2026, Janssen Biotech, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions are: Psoriasis and Psoriatic Arthritis (≥3%): nasopharyngitis, upper respiratory tract infection, headache, and fatigue.
Table 9: Adverse Reactions, Reported by ≥1% of Subjects with Plaque Psoriasis and at Higher Rates in the STELARA Groups through Week 12 in Ps STUDY 1 and Ps STUDY 2
| Reaction | Placebo | 45 mg | 90 mg |
|---|---|---|---|
| Subjects treated | 665 | 664 | 666 |
| Nasopharyngitis | 51 (8%) | 56 (8%) | 49 (7%) |
| Upper respiratory tract infection | 30 (5%) | 36 (5%) | 28 (4%) |
| Headache | 23 (3%) | 33 (5%) | 32 (5%) |
| Fatigue | 14 (2%) | 18 (3%) | 17 (3%) |
| Back pain | 8 (1%) | 9 (1%) | 14 (2%) |
| Dizziness | 8 (1%) | 8 (1%) | 14 (2%) |
| Pharyngolaryngeal pain | 7 (1%) | 9 (1%) | 12 (2%) |
| Pruritus | 9 (1%) | 10 (2%) | 9 (1%) |
| Injection site erythema | 3 (<1%) | 6 (1%) | 13 (2%) |
| Myalgia | 4 (1%) | 7 (1%) | 8 (1%) |
| Depression | 3 (<1%) | 8 (1%) | 4 (1%) |
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, continuedThe following serious adverse reactions are discussed elsewhere in the label: Infections [see Warnings and Precautions (5.1) ] Malignancies [see Warnings and Precautions (5.4) ] Serious Hypersensitivity Reactions [see Warnings and Precautions (5.5) ] Posterior Reversible Encephalopathy Syndrome (PRES) [see Warnings and Precautions (5.6) ] Noninfectious Pneumonia [see Warnings and Precautions (5.8) ] Most common adverse reactions are: Psoriasis and Psoriatic Arthritis (≥3%): nasopharyngitis, upper respiratory tract infection, headache, and fatigue. ( 6.1 ) Crohn's Disease induction (≥3%): vomiting. ( 6.1 ) maintenance (≥3%): nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis. ( 6.1 ) Ulcerative Colitis induction (≥3%): nasopharyngitis. ( 6.1 ) maintenance (≥3%): nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea. ( 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. …
Source: FDA drug label, Janssen Biotech, Inc., effective September 8, 2026 (SPL set c77a9664-e3bb-4023-b400-127aa53bca2b), via openFDA; the full label on DailyMed
What do FAERS reports show?
102,257 reports list ustekinumab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 5,976 are coded as a death and 22,444 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 19 reactions below, 8 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?
- Ustekinumab: 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