Drug · FAERS side-effect profile with label screen
Tezepelumab-Ekko side effects: what 6,266 FDA adverse event reports show
Drug class
Thymic Stromal Lymphopoietin Blocker
FDA label (Established Pharmacologic Class)
Brand names
Tezspire
openFDA label
Who reports
6,266 reports · 46% serious · 236 with death outcome · 74% female
openFDA FAERS counts, all years, deduplication not applied
Used for
TEZSPIRE is a thymic stromal lymphopoietin (TSLP) blocker, human monoclonal antibody (IgG2λ), indicated: • for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. ( 1.1 ) Limitations of Use: Not for relief of acute bronchospasm or status asthmaticus.
FDA label, Indications and Usage
What it is
Tezepelumab-ekko, a thymic stromal lymphopoietin (TSLP) blocker, is a human monoclonal antibody immunoglobulin G2λ (IgG2λ) produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Tezepelumab-ekko has a molecular weight of approximately 147 kDa.
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) 2Likely indication confounding 2Reporting / coding artifact 11Lab value / disease marker 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.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- 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. 159 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 |
|---|---|---|---|---|---|---|
| Asthma | 953 | 28.6 26.9–30.3ROR 33.5 · χ² 25,252 / p <1e-300 | 28.3 EB05 26.8 · IC025 +4.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 29.2 | no trial data cached |
| Impaired quality of life | 58 | 13.5 10.4–17.4ROR 13.6 · χ² 656 / p 6e-145 | 13.3 EB05 10.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 18.3 | no trial data cached |
| Device leakage | 169 | 13.4 11.5–15.5ROR 13.7 · χ² 1,916 / p <1e-300 | 13.3 EB05 11.6 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious n=20 · 78% consumer | no trial data cached |
| Device delivery system issue | 96 | 12.3 10.1–15.0ROR 12.5 · χ² 982 / p 9e-216 | 12.1 EB05 10.2 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious n=17 | no trial data cached |
| Quality of life decreased | 42 | 10.5 7.7–14.1ROR 10.5 · χ² 349 / p 4e-78 | 10.0 EB05 7.5 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 13.5 | no trial data cached |
| Device use issue | 53 | 10.2 7.8–13.4ROR 10.3 · χ² 431 / p 4e-96 | 9.8 EB05 7.7 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious n=12 · 77% consumer | no trial data cached |
| Pharyngeal swelling | 25 | 8.7 5.9–12.9ROR 8.8 · χ² 163 / p 1e-37 | 7.9 EB05 5.5 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Wheezing | 149 | 8.4 7.2–9.9ROR 8.6 · χ² 966 / p 2e-212 | 8.3 EB05 7.2 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Secretion discharge | 31 | 8.4 5.9–11.9ROR 8.4 · χ² 194 / p 2e-44 | 7.7 EB05 5.6 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Device defective | 40 | 8.3 6.1–11.3ROR 8.3 · χ² 248 / p 5e-56 | 7.7 EB05 5.8 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious n=9 · 70% consumer | no trial data cached |
| Insurance issue | 35 | 7.9 5.7–11.0ROR 7.9 · χ² 203 / p 3e-46 | 7.3 EB05 5.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 12.9 | no trial data cached |
| Incorrect dose administered by device | 58 | 7.6 5.9–9.9ROR 7.7 · χ² 327 / p 2e-73 | 7.3 EB05 5.8 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious n=4 · 72% consumer | no trial data cached |
| Drug effect less than expected | 26 | 6.2 4.2–9.0ROR 6.2 · χ² 107 / p 2e-25 | 5.6 EB05 4.0 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious n=7 | no trial data cached |
| Needle issue | 51 | 6.0 4.5–7.8ROR 6.0 · χ² 205 / p 8e-47 | 5.7 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=7 · 78% consumer | no trial data cached |
| Seasonal allergy | 25 | 5.9 4.0–8.7ROR 5.9 · χ² 97 / p 3e-23 | 5.4 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Pharyngitis | 22 | 5.9 3.9–8.9ROR 5.9 · χ² 84 / p 2e-20 | 5.3 EB05 3.7 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Device malfunction | 100 | 5.0 4.1–6.0ROR 5.0 · χ² 313 / p 2e-70 | 4.9 EB05 4.1 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 5.7 · 73% consumer | no trial data cached |
| Conjunctivitis | 27 | 4.9 3.4–7.1ROR 4.9 · χ² 80 / p 2e-19 | 4.5 EB05 3.3 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 | no trial data cached |
| Immune system disorder | 19 | 4.8 3.1–7.6ROR 4.8 · χ² 54 / p 1e-13 | 4.3 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Throat tightness | 39 | 4.8 3.5–6.6ROR 4.8 · χ² 114 / p 6e-27 | 4.6 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 79 | 4.8 3.9–6.0ROR 4.8 · χ² 234 / p 4e-53 | 4.7 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.9 | no trial data cached |
| Product administration error | 27 | 4.5 3.1–6.6ROR 4.5 · χ² 70 / p 2e-17 | 4.2 EB05 3.0 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 1.5 · 81% consumer | no trial data cached |
| Paraesthesia oral | 19 | 4.4 2.8–6.9ROR 4.4 · χ² 47 / p 4e-12 | 4.0 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 | no trial data cached |
| Illness | 132 | 4.4 3.7–5.2ROR 4.5 · χ² 343 / p 9e-77 | 4.3 EB05 3.7 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 6.4 · 77% consumer | no trial data cached |
| Wrong technique in device usage process | 60 | 4.4 3.4–5.6ROR 4.4 · χ² 153 / p 2e-35 | 4.2 EB05 3.4 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious n=4 · 85% consumer | no trial data cached |
| Decreased activity | 14 | 4.4 2.6–7.4ROR 4.4 · χ² 33 / p 5e-9 | 3.9 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Chest discomfort | 131 | 4.3 3.6–5.1ROR 4.4 · χ² 328 / p 1e-73 | 4.2 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Chronic obstructive pulmonary disease | 65 | 4.2 3.3–5.3ROR 4.2 · χ² 153 / p 2e-35 | 4.0 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Arthralgia (joint pain) | 514 | 4.1 3.8–4.5ROR 4.4 · χ² 1,244 / p 9e-273 | 4.1 EB05 3.8 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 | no trial data cached |
| Full blood count abnormal | 13 | 4.1 2.4–7.1ROR 4.1 · χ² 28 / p 8e-8 | 3.6 EB05 2.3 · IC025 +0.9 3/3 methods agree | Lab value / disease marker | serious PRR 6.4 | no trial data cached |
| Sputum discoloured | 11 | 3.9 2.2–7.0ROR 3.9 · χ² 21 / p 3e-6 | 3.4 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Atelectasis | 11 | 3.8 2.1–6.8ROR 3.8 · χ² 20 / p 4e-6 | 3.3 EB05 2.0 · IC025 +0.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 | no trial data cached |
| Eye pruritus | 37 | 3.7 2.7–5.2ROR 3.8 · χ² 72 / p 1e-17 | 3.6 EB05 2.7 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Bronchospasm (airway tightening) | 16 | 3.7 2.3–6.1ROR 3.7 · χ² 29 / p 3e-8 | 3.4 EB05 2.2 · IC025 +0.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.9 | no trial data cached |
| Respiratory tract infection | 29 | 3.7 2.6–5.4ROR 3.7 · χ² 55 / p 6e-14 | 3.5 EB05 2.6 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 | no trial data cached |
| Injection site urticaria | 27 | 3.7 2.5–5.4ROR 3.7 · χ² 51 / p 5e-13 | 3.5 EB05 2.5 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious n=4 | no trial data cached |
| Sleep disorder due to a general medical condition | 18 | 3.7 2.3–5.9ROR 3.7 · χ² 33 / p 5e-9 | 3.4 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Brain fog | 16 | 3.7 2.2–6.0ROR 3.7 · χ² 28 / p 5e-8 | 3.4 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 1.1 | no trial data cached |
| Product dose omission issue | 310 | 3.6 3.3–4.0ROR 3.8 · χ² 596 / p 5e-132 | 3.6 EB05 3.3 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 4.5 · 72% consumer | no trial data cached |
| Cough | 304 | 3.6 3.2–4.0ROR 3.8 · χ² 582 / p 6e-129 | 3.6 EB05 3.3 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | 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 |
|---|---|---|---|---|---|---|
| Asthma | 953 | 28.6 26.9–30.3ROR 33.5 · χ² 25,252 / p <1e-300 | 28.3 EB05 26.8 · IC025 +4.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 29.2 | no trial data cached |
| Dyspnoea (shortness of breath) | 583 | 3.4 3.2–3.7ROR 3.7 · χ² 1,033 / p 7e-227 | 3.4 EB05 3.2 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Arthralgia (joint pain) | 514 | 4.1 3.8–4.5ROR 4.4 · χ² 1,244 / p 9e-273 | 4.1 EB05 3.8 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 | no trial data cached |
| Product dose omission issue | 310 | 3.6 3.3–4.0ROR 3.8 · χ² 596 / p 5e-132 | 3.6 EB05 3.3 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 4.5 · 72% consumer | no trial data cached |
| Cough | 304 | 3.6 3.2–4.0ROR 3.8 · χ² 582 / p 6e-129 | 3.6 EB05 3.3 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Pneumonia (lung infection) | 271 | 2.8 2.5–3.1ROR 2.9 · χ² 316 / p 7e-71 | 2.8 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.4 | no trial data cached |
| Back pain | 226 | 3.2 2.9–3.7ROR 3.3 · χ² 352 / p 8e-79 | 3.2 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.9 | no trial data cached |
| Rash | 223 | 1.7 1.5–2.0ROR 1.7 · χ² 67 / p 1e-16 | 1.7 EB05 1.5 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.3 | no trial data cached |
| Injection site pain (pain where injected) | 193 | 2.1 1.8–2.4ROR 2.2 · χ² 115 / p 4e-27 | 2.1 EB05 1.9 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 3.5 | no trial data cached |
| Device leakage | 169 | 13.4 11.5–15.5ROR 13.7 · χ² 1,916 / p <1e-300 | 13.3 EB05 11.6 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious n=20 · 78% consumer | no trial data cached |
| Wheezing | 149 | 8.4 7.2–9.9ROR 8.6 · χ² 966 / p 2e-212 | 8.3 EB05 7.2 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Hypersensitivity (allergic reaction) | 146 | 2.6 2.2–3.1ROR 2.7 · χ² 147 / p 5e-34 | 2.6 EB05 2.3 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 | no trial data cached |
| Urticaria (hives) | 139 | 2.8 2.4–3.3ROR 2.8 · χ² 158 / p 1e-36 | 2.8 EB05 2.4 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.5 | no trial data cached |
| Illness | 132 | 4.4 3.7–5.2ROR 4.5 · χ² 343 / p 9e-77 | 4.3 EB05 3.7 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 6.4 · 77% consumer | no trial data cached |
| Chest discomfort | 131 | 4.3 3.6–5.1ROR 4.4 · χ² 328 / p 1e-73 | 4.2 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | 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.
- Impaired quality of life — n=58, PRR 13.5
- Quality of life decreased — n=42, PRR 10.5
- Pharyngeal swelling — n=25, PRR 8.7
- Wheezing — n=149, PRR 8.4
- Secretion discharge — n=31, PRR 8.4
- Insurance issue — n=35, PRR 7.9
- Needle issue — n=51, PRR 6.0
- Seasonal allergy — n=25, PRR 5.9
- Throat tightness — n=39, PRR 4.8
- Chest discomfort — n=131, PRR 4.3
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 Tezepelumab-Ekko?
In FDA FAERS, the most frequently co-reported reaction terms for Tezepelumab-Ekko are asthma, dyspnoea, arthralgia, cough, pneumonia, back pain. 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 Tezepelumab-Ekko have an FDA boxed warning?
No. The FDA label retrieved for Tezepelumab-Ekko has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Tezepelumab-Ekko 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 60f0aa03-ad25-4d48-80ce-7fcfa76f325f, effective 20251017; matched on
openfda.generic_name.exact:"TEZEPELUMAB-EKKO") - 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, 199 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.