What the label lists and what reports show
Tralokinumab side effects
Tralokinumab's FDA label: “Most common adverse reactions (incidence ≥ 1%) are upper respiratory tract infections, conjunctivitis, injection site reactions, and eosinophilia.” FAERS holds 6,044 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 dermatitis atopic (841 reports).
- No generic listed
Check it at the source: the tralokinumab FDA label on DailyMed (effective December 17, 2025, LEO Pharma 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 ADBRY?ADBRY can cause serious side effects, including: Allergic reactions (hypersensitivity), including a severe reaction known as anaphylaxis. Stop using ADBRY and tell your healthcare provider or get emergency help right away if you get any of the following symptoms: breathing problems swelling of the face, mouth, and tongue hives itching fainting, dizziness, feeling lightheaded (low blood pressure) skin rash Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision. The most common side effects of ADBRY include: upper respiratory tract infections eye and eyelid inflammation, including redness, swelling, and itching injection site reactions high count of a certain white blood cell (eosinophilia) These are not all of the possible side effects of ADBRY. Call your doctor for medical advice about side effects. […]
Source: FDA drug label, LEO Pharma Inc., effective December 17, 2025 (SPL set d8020b69-3001-44e2-9b5d-5f93d9aaf6e1), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥ 1%) are upper respiratory tract infections, conjunctivitis, injection site reactions, and eosinophilia.
Table 1: Adverse Reactions Occurring in ≥1% of the ADBRY Monotherapy Group or the ADBRY + TCS Group in the Atopic Dermatitis Trials through Week 16
| Reaction | ADBRY 300 mg Q2W ADBRY 600 mg at Week 0, followed by 300 mg every other week. N=1180 n (%) | PLACEBO N=388 n (%) | ADBRY 300 mg Q2W + TCS N=243 n (%) | PLACEBO + TCS N=123 n (%) |
|---|---|---|---|---|
| Upper respiratory tract infections Upper respiratory tract infections cluster includes… | 281 (23.8) | 79 (20.4) | 73 (30.0) | 19 (15.4) |
| Conjunctivitis Conjunctivitis cluster includes conjunctivitis and allergic conjunctivitis. | 88 (7.5) | 12 (3.1) | 33 (13.6) | 6 (4.9) |
| Injection site reactions Injection site reactions cluster includes pain, erythema, and… | 87 (7.4) | 16 (4.1) | 27 (11.1) | 1 (0.8) |
| Eosinophilia Eosinophilia cluster includes eosinophilia and eosinophil count increased. | 17 (1.4) | 2 (0.5) | 3 (1.2) | 0 |
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 adverse reactions are discussed in greater detail elsewhere in the labeling: Hypersensitivity [see Warnings and Precautions (5.1) ] Conjunctivitis and Keratitis [see Warnings and Precautions (5.2) ] Most common adverse reactions (incidence ≥ 1%) are upper respiratory tract infections, conjunctivitis, injection site reactions, and eosinophilia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact LEO Pharma Inc. at 1-877-494-4536 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. Adverse Reactions from Clinical Trials in Adults The safety of ADBRY was evaluated in a pool of 5 randomized, double-blind, placebo-controlled trials in subjects with moderate-to-severe atopic dermatitis including three phase 3 Eczema Tralokinumab trials (ECZTRA 1, ECZTRA 2, and ECZTRA 3), a dose-finding trial, and a vaccine response trial. The safety population had a mean age of 37 years; 43% of subjects were female, 67% were White, 21% were Asian, and 9% were Black. …
Source: FDA drug label, LEO Pharma Inc., effective December 17, 2025 (SPL set d8020b69-3001-44e2-9b5d-5f93d9aaf6e1), via openFDA; the full label on DailyMed
What do FAERS reports show?
6,044 reports list tralokinumab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 83 are coded as a death and 315 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. Reports rose sharply in 2025 (1,894, against a median of 1 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 23 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.
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?
- Tralokinumab: 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