Trastuzumab-Qyyp side effects: what 381 FDA adverse event reports show

Trastuzumab-Qyyp · Trazimera · 15 reaction terms · 185 drug–reaction co-reports · data 2026-09-14

Drug class

HER2/neu Receptor Antagonist

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Trazimera

openFDA label

Who reports

381 reports · 75% serious · 40 with death outcome · 91% female

openFDA FAERS counts, all years, deduplication not applied

Used for

TRAZIMERA is a HER2/neu receptor antagonist indicated in adults for: • The treatment of HER2-overexpressing breast cancer. ( 1.1 , 1.2 ) • The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. ( 1.3 ) Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.

FDA label, Indications and Usage

What it is

Trastuzumab-qyyp is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab-qyyp is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture.

FDA label, Description section

Boxed warning

CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY See full prescribing information for comple.

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 13 strongest signals

Labeled — boxed warning 1Labeled adverse reaction 1Reporting / coding artifact 1Lab value / disease marker 2Not in label — unassessed 8

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.
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.
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. 2 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
Dry throat	11	59.7 33.3–106.9ROR 61.4 · χ² 577 / p 8e-128	54.3 EB05 32.4 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=11	no trial data cached
Blood iron decreased	12	56.1 32.1–97.9ROR 57.9 · χ² 595 / p 1e-131	51.7 EB05 31.5 · IC025 +3.2 3/3 methods agree	Lab value / disease marker	serious PRR 58.7	no trial data cached
Seasonal allergy	13	50.7 29.7–86.6ROR 52.5 · χ² 585 / p 2e-129	47.4 EB05 29.5 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=11	no trial data cached
Dysmenorrhoea	11	46.3 25.9–83.0ROR 47.7 · χ² 443 / p 9e-99	43.1 EB05 25.7 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=11	no trial data cached
Blood test abnormal	11	43.2 24.1–77.3ROR 44.4 · χ² 412 / p 8e-92	40.3 EB05 24.0 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious PRR 50.8	no trial data cached
Skin fissures	13	37.9 22.2–64.7ROR 39.2 · χ² 431 / p 5e-96	36.1 EB05 22.4 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=12	no trial data cached
Sneezing	13	32.0 18.8–54.6ROR 33.1 · χ² 360 / p 1e-80	30.7 EB05 19.0 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 61.6	no trial data cached
Ejection fraction decreased	9	31.8 16.7–60.7ROR 32.6 · χ² 239 / p 4e-54	29.9 EB05 16.7 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 27.0	no trial data cached
Hepatitis (liver inflammation)	12	25.8 14.8–45.1ROR 26.6 · χ² 262 / p 3e-59	24.8 EB05 14.9 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 20.2	no trial data cached
Neoplasm progression	16	25.1 15.5–40.5ROR 26.2 · χ² 347 / p 1e-77	24.4 EB05 15.9 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 16.7	no trial data cached
Infusion related reaction (reaction during infusion)	30	25.0 17.7–35.3ROR 27.1 · χ² 669 / p 7e-148	24.7 EB05 18.1 · IC025 +3.6 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 22.7 · 95% clinician	no trial data cached
Heart rate decreased	16	25.0 15.5–40.3ROR 26.0 · χ² 345 / p 3e-77	24.3 EB05 15.8 · IC025 +3.0 3/3 methods agree	Lab value / disease marker	serious PRR 24.0	no trial data cached
Injection site haemorrhage	10	6.9 3.8–12.8ROR 7.1 · χ² 45 / p 9e-12	5.5 EB05 3.1 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 39.7	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
Infusion related reaction (reaction during infusion)	30	25.0 17.7–35.3ROR 27.1 · χ² 669 / p 7e-148	24.7 EB05 18.1 · IC025 +3.6 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 22.7 · 95% clinician	no trial data cached
Heart rate decreased	16	25.0 15.5–40.3ROR 26.0 · χ² 345 / p 3e-77	24.3 EB05 15.8 · IC025 +3.0 3/3 methods agree	Lab value / disease marker	serious PRR 24.0	no trial data cached
Neoplasm progression	16	25.1 15.5–40.5ROR 26.2 · χ² 347 / p 1e-77	24.4 EB05 15.9 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 16.7	no trial data cached
Sneezing	13	32.0 18.8–54.6ROR 33.1 · χ² 360 / p 1e-80	30.7 EB05 19.0 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 61.6	no trial data cached
Skin fissures	13	37.9 22.2–64.7ROR 39.2 · χ² 431 / p 5e-96	36.1 EB05 22.4 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=12	no trial data cached
Seasonal allergy	13	50.7 29.7–86.6ROR 52.5 · χ² 585 / p 2e-129	47.4 EB05 29.5 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=11	no trial data cached
Hepatitis (liver inflammation)	12	25.8 14.8–45.1ROR 26.6 · χ² 262 / p 3e-59	24.8 EB05 14.9 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 20.2	no trial data cached
Blood iron decreased	12	56.1 32.1–97.9ROR 57.9 · χ² 595 / p 1e-131	51.7 EB05 31.5 · IC025 +3.2 3/3 methods agree	Lab value / disease marker	serious PRR 58.7	no trial data cached
Blood test abnormal	11	43.2 24.1–77.3ROR 44.4 · χ² 412 / p 8e-92	40.3 EB05 24.0 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious PRR 50.8	no trial data cached
Dysmenorrhoea	11	46.3 25.9–83.0ROR 47.7 · χ² 443 / p 9e-99	43.1 EB05 25.7 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=11	no trial data cached
Dry throat	11	59.7 33.3–106.9ROR 61.4 · χ² 577 / p 8e-128	54.3 EB05 32.4 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=11	no trial data cached
Injection site haemorrhage	10	6.9 3.8–12.8ROR 7.1 · χ² 45 / p 9e-12	5.5 EB05 3.1 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 39.7	no trial data cached
Ejection fraction decreased	9	31.8 16.7–60.7ROR 32.6 · χ² 239 / p 4e-54	29.9 EB05 16.7 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 27.0	no trial data cached
Myocarditis	4	19.4 7.3–51.6ROR 19.6 · χ² 53 / p 2e-13	13.4 EB05 3.7 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 15.0	no trial data cached
Poor venous access	4	21.3 8.0–56.6ROR 21.5 · χ² 59 / p 1e-14	15.3 EB05 4.1 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious n=4	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

✓ A hand-written Bradford Hill causality assessment exists for this drug: Trastuzumab ↔ Cardiotoxicity / heart failure.

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 Trastuzumab-Qyyp?

In FDA FAERS, the most frequently co-reported reaction terms for Trastuzumab-Qyyp are infusion related reaction, heart rate decreased, neoplasm progression, sneezing, skin fissures, seasonal allergy. 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 Trastuzumab-Qyyp have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO-FETAL TOXICITY, and PULMONARY TOXICITY See full prescribing information for comple.

Do FAERS signals prove that Trastuzumab-Qyyp 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 b9c5e894-27d2-4245-a653-df986fed3c56, effective 20260410; matched on openfda.generic_name.exact:"TRASTUZUMAB-QYYP")
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, 15 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.