Drug · FAERS side-effect profile with label screen
Tralokinumab-Ldrm side effects: what 6,043 FDA adverse event reports show
Drug class
Interleukin-13 Antagonist
FDA label (Established Pharmacologic Class)
Brand names
Adbry
openFDA label
Who reports
6,043 reports · 14% serious · 83 with death outcome · 64% female
openFDA FAERS counts, all years, deduplication not applied
Used for
ADBRY is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and pediatric patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. ADBRY can be used with or without topical corticosteroids.
FDA label, Indications and Usage
What it is
Tralokinumab-ldrm, an interleukin-13 antagonist, is a human IgG4 monoclonal antibody. Tralokinumab-ldrm is produced in mouse myeloma cells by recombinant DNA technology, consists of 1326 amino acids, and has a molecular weight of approximately 147 kilodaltons.
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 adverse reaction 4Labeled (related wording) 13Likely indication confounding 2Reporting / coding artifact 1Not in label — unassessed 20
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- 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.
- 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. 58 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 |
|---|---|---|---|---|---|---|
| Dermatitis atopic | 841 | 59.4 55.8–63.3ROR 68.8 · χ² 47,520 / p <1e-300 | 58.3 EB05 55.1 · IC025 +5.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=48 | no trial data cached |
| Conjunctivitis | 137 | 26.1 22.1–30.8ROR 26.6 · χ² 3,254 / p <1e-300 | 25.8 EB05 22.4 · IC025 +4.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.8 | no trial data cached |
| Eczema | 366 | 25.4 23.0–28.1ROR 27.0 · χ² 8,520 / p <1e-300 | 25.2 EB05 23.1 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.2 | no trial data cached |
| Eye pruritus | 163 | 17.2 14.8–20.1ROR 17.7 · χ² 2,468 / p <1e-300 | 17.1 EB05 15.0 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 22.4 | no trial data cached |
| Skin fissures | 71 | 13.1 10.4–16.5ROR 13.2 · χ² 779 / p 1e-171 | 12.9 EB05 10.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Ocular hyperaemia | 163 | 12.1 10.4–14.1ROR 12.5 · χ² 1,654 / p <1e-300 | 12.0 EB05 10.5 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 12.5 | no trial data cached |
| Eye discharge | 32 | 10.9 7.7–15.4ROR 10.9 · χ² 277 / p 2e-62 | 10.3 EB05 7.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Dermatitis | 59 | 9.9 7.7–12.8ROR 10.0 · χ² 463 / p 7e-103 | 9.5 EB05 7.6 · IC025 +2.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 5.6 | no trial data cached |
| Dry eye | 134 | 9.6 8.1–11.4ROR 9.8 · χ² 1,026 / p 2e-225 | 9.4 EB05 8.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 | no trial data cached |
| Injection site pruritus | 183 | 9.6 8.3–11.0ROR 9.8 · χ² 1,395 / p <1e-300 | 9.4 EB05 8.3 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.5 | no trial data cached |
| Sleep disorder due to a general medical condition | 40 | 8.6 6.3–11.7ROR 8.7 · χ² 261 / p 6e-59 | 8.1 EB05 6.1 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 1.7 | no trial data cached |
| Eye inflammation | 23 | 8.5 5.6–12.8ROR 8.5 · χ² 144 / p 2e-33 | 7.6 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=3 | no trial data cached |
| Injection site swelling | 171 | 7.8 6.8–9.1ROR 8.0 · χ² 1,016 / p 3e-223 | 7.7 EB05 6.8 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.7 | no trial data cached |
| Eye irritation | 122 | 7.6 6.4–9.1ROR 7.7 · χ² 694 / p 3e-153 | 7.4 EB05 6.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 | no trial data cached |
| Eye infection | 24 | 7.4 5.0–11.1ROR 7.5 · χ² 127 / p 9e-30 | 6.7 EB05 4.6 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious n=5 | no trial data cached |
| Skin haemorrhage | 30 | 7.2 5.1–10.3ROR 7.3 · χ² 155 / p 9e-36 | 6.6 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=1 · ♀ 38% (drug 64%) | no trial data cached |
| Dry skin | 264 | 7.0 6.2–7.8ROR 7.2 · χ² 1,351 / p 5e-296 | 6.9 EB05 6.2 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Lacrimation increased | 57 | 6.6 5.1–8.6ROR 6.7 · χ² 267 / p 3e-60 | 6.3 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Eye swelling | 69 | 6.5 5.1–8.2ROR 6.5 · χ² 315 / p 1e-70 | 6.2 EB05 5.1 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.5 | no trial data cached |
| Injection site rash | 56 | 6.4 4.9–8.3ROR 6.5 · χ² 250 / p 1e-56 | 6.1 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | – | no trial data cached |
| Skin exfoliation | 152 | 6.4 5.4–7.4ROR 6.5 · χ² 682 / p 1e-150 | 6.2 EB05 5.4 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Pruritus (itching) | 668 | 6.1 5.7–6.6ROR 6.8 · χ² 2,918 / p <1e-300 | 6.1 EB05 5.7 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Ocular discomfort | 19 | 6.1 3.9–9.5ROR 6.1 · χ² 76 / p 2e-18 | 5.4 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious n=1 | no trial data cached |
| Injection site erythema (redness where injected) | 207 | 5.8 5.1–6.7ROR 6.0 · χ² 826 / p 6e-182 | 5.7 EB05 5.1 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.9 | no trial data cached |
| Injection site reaction | 107 | 5.4 4.5–6.5ROR 5.5 · χ² 382 / p 3e-85 | 5.3 EB05 4.5 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.4 | no trial data cached |
| Mood altered | 42 | 5.4 4.0–7.3ROR 5.4 · χ² 145 / p 1e-33 | 5.1 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 2.8 · 98% clinician | no trial data cached |
| Drug effect less than expected | 21 | 5.2 3.4–7.9ROR 5.2 · χ² 67 / p 2e-16 | 4.7 EB05 3.2 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Rash macular | 50 | 5.0 3.8–6.6ROR 5.0 · χ² 155 / p 6e-36 | 4.8 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 1.0 | no trial data cached |
| Injection site urticaria | 33 | 4.7 3.4–6.6ROR 4.7 · χ² 93 / p 2e-22 | 4.4 EB05 3.3 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious n=1 | no trial data cached |
| Injection site discomfort | 14 | 4.7 2.8–7.9ROR 4.7 · χ² 37 / p 5e-10 | 4.1 EB05 2.6 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | – | no trial data cached |
| Eye disorder | 44 | 4.7 3.5–6.3ROR 4.7 · χ² 123 / p 7e-29 | 4.5 EB05 3.5 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.7 | no trial data cached |
| Scab | 15 | 4.6 2.8–7.6ROR 4.6 · χ² 39 / p 3e-10 | 4.1 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious n=2 | no trial data cached |
| Injection site warmth | 25 | 4.2 2.8–6.2ROR 4.2 · χ² 58 / p 1e-14 | 3.9 EB05 2.8 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | – | no trial data cached |
| Injection site pain (pain where injected) | 355 | 4.1 3.7–4.5ROR 4.3 · χ² 827 / p 3e-182 | 4.0 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.7 | no trial data cached |
| Injection site mass | 41 | 3.9 2.8–5.2ROR 3.9 · χ² 84 / p 2e-20 | 3.7 EB05 2.9 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.0 | no trial data cached |
| Injection site irritation | 14 | 3.8 2.3–6.5ROR 3.8 · χ² 27 / p 1e-7 | 3.5 EB05 2.2 · IC025 +0.9 3/3 methods agree | Labeled (related wording) related wording | – | no trial data cached |
| Initial insomnia | 11 | 3.7 2.1–6.8ROR 3.8 · χ² 19 / p 5e-6 | 3.3 EB05 2.0 · IC025 +0.7 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Injection site bruising | 85 | 3.7 3.0–4.6ROR 3.8 · χ² 169 / p 8e-39 | 3.7 EB05 3.1 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.2 | no trial data cached |
| Sleep disorder | 75 | 3.7 3.0–4.7ROR 3.8 · χ² 147 / p 4e-34 | 3.6 EB05 3.0 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 1.7 | no trial data cached |
| Rash | 455 | 3.6 3.3–4.0ROR 3.9 · χ² 887 / p 3e-195 | 3.6 EB05 3.4 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
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 |
|---|---|---|---|---|---|---|
| Dermatitis atopic | 841 | 59.4 55.8–63.3ROR 68.8 · χ² 47,520 / p <1e-300 | 58.3 EB05 55.1 · IC025 +5.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=48 | no trial data cached |
| Drug ineffective (drug did not work) | 782 | 2.1 1.9–2.2ROR 2.2 · χ² 454 / p 4e-101 | 2.1 EB05 1.9 · IC025 +0.9 | Reporting / coding artifact | serious PRR 1.2 | no trial data cached |
| Pruritus (itching) | 668 | 6.1 5.7–6.6ROR 6.8 · χ² 2,918 / p <1e-300 | 6.1 EB05 5.7 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Rash | 455 | 3.6 3.3–4.0ROR 3.9 · χ² 887 / p 3e-195 | 3.6 EB05 3.4 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 | no trial data cached |
| Eczema | 366 | 25.4 23.0–28.1ROR 27.0 · χ² 8,520 / p <1e-300 | 25.2 EB05 23.1 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.2 | no trial data cached |
| Injection site pain (pain where injected) | 355 | 4.1 3.7–4.5ROR 4.3 · χ² 827 / p 3e-182 | 4.0 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.7 | no trial data cached |
| Dry skin | 264 | 7.0 6.2–7.8ROR 7.2 · χ² 1,351 / p 5e-296 | 6.9 EB05 6.2 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Injection site erythema (redness where injected) | 207 | 5.8 5.1–6.7ROR 6.0 · χ² 826 / p 6e-182 | 5.7 EB05 5.1 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.9 | no trial data cached |
| Erythema (skin redness) | 206 | 3.5 3.0–4.0ROR 3.6 · χ² 366 / p 9e-82 | 3.5 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.7 | no trial data cached |
| Product use in unapproved indication | 193 | 2.7 2.4–3.2ROR 2.8 · χ² 214 / p 8e-49 | 2.7 EB05 2.4 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 4.0 | no trial data cached |
| Injection site pruritus | 183 | 9.6 8.3–11.0ROR 9.8 · χ² 1,395 / p <1e-300 | 9.4 EB05 8.3 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.5 | no trial data cached |
| Injection site swelling | 171 | 7.8 6.8–9.1ROR 8.0 · χ² 1,016 / p 3e-223 | 7.7 EB05 6.8 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.7 | no trial data cached |
| Ocular hyperaemia | 163 | 12.1 10.4–14.1ROR 12.5 · χ² 1,654 / p <1e-300 | 12.0 EB05 10.5 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 12.5 | no trial data cached |
| Eye pruritus | 163 | 17.2 14.8–20.1ROR 17.7 · χ² 2,468 / p <1e-300 | 17.1 EB05 15.0 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 22.4 | no trial data cached |
| Skin exfoliation | 152 | 6.4 5.4–7.4ROR 6.5 · χ² 682 / p 1e-150 | 6.2 EB05 5.4 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
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.
- Eye pruritus — n=163, PRR 17.2
- Skin fissures — n=71, PRR 13.1
- Ocular hyperaemia — n=163, PRR 12.1
- Eye discharge — n=32, PRR 10.9
- Dry eye — n=134, PRR 9.6
- Sleep disorder due to a general medical condition — n=40, PRR 8.6
- Eye inflammation — n=23, PRR 8.5
- Eye irritation — n=122, PRR 7.6
- Skin haemorrhage — n=30, PRR 7.2
- Dry skin — n=264, PRR 7.0
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 Tralokinumab-Ldrm?
In FDA FAERS, the most frequently co-reported reaction terms for Tralokinumab-Ldrm are dermatitis atopic, pruritus, rash, eczema, injection site pain, dry skin. 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 Tralokinumab-Ldrm have an FDA boxed warning?
No. The FDA label retrieved for Tralokinumab-Ldrm has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Tralokinumab-Ldrm 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 d8020b69-3001-44e2-9b5d-5f93d9aaf6e1, effective 20251217; matched on
openfda.generic_name.exact:"TRALOKINUMAB-LDRM") - 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, 98 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
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.