Teplizumab-Mzwv side effects: what 566 FDA adverse event reports show

Teplizumab-Mzwv · Tzield · 9 reaction terms · 175 drug–reaction co-reports · data 2026-09-14

Drug class

CD3-directed Antibody

FDA label (Established Pharmacologic Class)

Brand names

Tzield

openFDA label

Who reports

566 reports · 13% serious · 1 with death outcome · 60% female

openFDA FAERS counts, all years, deduplication not applied

Used for

TZIELD is indicated to : Delay the onset of Stage 3 type 1 diabetes (T1D) in adult and pediatric patients 1 year of age and older with Stage 2 T1D. Delay the decline in endogenous insulin production in pediatric patients aged 8 to 17 years recently diagnosed with Stage 3 T1D.

FDA label, Indications and Usage

What it is

Teplizumab-mzwv is a CD3-directed monoclonal antibody (humanized IgG1 kappa) that has a molecular weight of approximately 150 kilodalton (kDa) and is expressed from a recombinant Chinese hamster ovary (CHO) cell line.

FDA label, Description section

Boxed warning

Viral Reactivation Serious, life-threatening cases of viral reactivation, including Epstein-Barr virus (EBV) and cytomegalovirus (CMV) reactivation have been reported with TZIELD. Patients who are immunocompromised are at increased risk.

FDA 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 8 strongest signals

Labeled — boxed warning 2Reporting / coding artifact 1Lab value / disease marker 3Not in label — unassessed 2

What the badges mean

Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
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. 1 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Lymphopenia	35	92.4 67.0–127.4ROR 98.4 · χ² 3,067 / p <1e-300	87.9 EB05 66.0 · IC025 +4.8 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 126.9	no trial data cached
Lymphocyte count decreased	40	84.0 62.3–113.2ROR 90.3 · χ² 3,192 / p <1e-300	80.7 EB05 61.8 · IC025 +4.8 3/3 methods agree	Lab value / disease marker	serious PRR 80.2	no trial data cached
Cytokine release syndrome	19	37.0 23.8–57.5ROR 38.2 · χ² 630 / p 3e-139	35.7 EB05 24.2 · IC025 +3.5 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 140.4	no trial data cached
Liver function test increased	16	27.8 17.2–45.1ROR 28.6 · χ² 387 / p 2e-86	27.0 EB05 17.6 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 36.3	no trial data cached
Rash pruritic	40	27.5 20.4–37.1ROR 29.5 · χ² 996 / p 5e-219	27.2 EB05 20.8 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 19.8	no trial data cached
Body temperature increased	12	21.7 12.4–38.0ROR 22.2 · χ² 217 / p 2e-49	20.8 EB05 12.3 · IC025 +2.6 3/3 methods agree	Lab value / disease marker	serious PRR 29.9	no trial data cached
Product preparation error	5	8.9 3.7–21.4ROR 9.0 · χ² 28 / p 7e-8	5.7 EB05 2.5 · IC025 +0.8 3/3 methods agree	Reporting / coding artifact	serious n=1	no trial data cached
Glycosylated haemoglobin increased	5	7.4 3.1–17.6ROR 7.4 · χ² 21 / p 2e-6	4.8 EB05 2.2 · IC025 +0.7 3/3 methods agree	Lab value / disease marker	serious PRR 44.7	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
Rash pruritic	40	27.5 20.4–37.1ROR 29.5 · χ² 996 / p 5e-219	27.2 EB05 20.8 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 19.8	no trial data cached
Lymphocyte count decreased	40	84.0 62.3–113.2ROR 90.3 · χ² 3,192 / p <1e-300	80.7 EB05 61.8 · IC025 +4.8 3/3 methods agree	Lab value / disease marker	serious PRR 80.2	no trial data cached
Lymphopenia	35	92.4 67.0–127.4ROR 98.4 · χ² 3,067 / p <1e-300	87.9 EB05 66.0 · IC025 +4.8 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 126.9	no trial data cached
Cytokine release syndrome	19	37.0 23.8–57.5ROR 38.2 · χ² 630 / p 3e-139	35.7 EB05 24.2 · IC025 +3.5 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 140.4	no trial data cached
Liver function test increased	16	27.8 17.2–45.1ROR 28.6 · χ² 387 / p 2e-86	27.0 EB05 17.6 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 36.3	no trial data cached
Body temperature increased	12	21.7 12.4–38.0ROR 22.2 · χ² 217 / p 2e-49	20.8 EB05 12.3 · IC025 +2.6 3/3 methods agree	Lab value / disease marker	serious PRR 29.9	no trial data cached
Glycosylated haemoglobin increased	5	7.4 3.1–17.6ROR 7.4 · χ² 21 / p 2e-6	4.8 EB05 2.2 · IC025 +0.7 3/3 methods agree	Lab value / disease marker	serious PRR 44.7	no trial data cached
Product preparation error	5	8.9 3.7–21.4ROR 9.0 · χ² 28 / p 7e-8	5.7 EB05 2.5 · IC025 +0.8 3/3 methods agree	Reporting / coding artifact	serious n=1	no trial data cached
Blood glucose fluctuation	3	10.1 3.3–31.3ROR 10.2 · χ² 16 / p 3e-5	5.2 EB05 1.8 · IC025 +0.1	Lab value / disease marker	–	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.

Rash pruritic — n=40, PRR 27.5

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 Teplizumab-Mzwv?

In FDA FAERS, the most frequently co-reported reaction terms for Teplizumab-Mzwv are rash pruritic, lymphocyte count decreased, lymphopenia, cytokine release syndrome, liver function test increased, body temperature increased. 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 Teplizumab-Mzwv have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: Viral Reactivation Serious, life-threatening cases of viral reactivation, including Epstein-Barr virus (EBV) and cytomegalovirus (CMV) reactivation have been reported with TZIELD. Patients who are immunocompromised are at increased risk.

Do FAERS signals prove that Teplizumab-Mzwv 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 e8a39a5f-139c-4510-9777-71cbb00138fa, effective 20260814; matched on openfda.generic_name.exact:"TEPLIZUMAB-MZWV")
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, field patient.drug.openfda.generic_name.exact, 9 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.