Trastuzumab-Anns side effects: what 1,503 FDA adverse event reports show
Drug class
Brand names
Kanjinti
Who reports
1,503 reports · 24% serious · 24 with death outcome · 93% female
Used for
KANJINTI 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 ( 1 , 2.2 ).
What it is
Trastuzumab-anns 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.
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.
Causality screen of the 16 strongest signals
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.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- 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.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Circumstance or information capable of leading to medication error | 257 | 107.7 96.3–120.4ROR 129.7 · χ² 26,892 / p <1e-300 | 106.0 EB05 95.6 · IC025 +6.3 3/3 methods agree | Labeled (related wording) related wording | – | no trial data cached |
| Product storage error | 346 | 56.0 51.0–61.4ROR 72.5 · χ² 18,639 / p <1e-300 | 55.6 EB05 50.9 · IC025 +5.5 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Intercepted product preparation error | 42 | 48.3 35.8–65.1ROR 49.6 · χ² 1,892 / p <1e-300 | 47.1 EB05 36.4 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Product preparation error | 40 | 27.0 19.9–36.7ROR 27.7 · χ² 975 / p 3e-214 | 26.6 EB05 20.4 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Intentional dose omission | 25 | 12.8 8.7–18.8ROR 13.0 · χ² 260 / p 1e-58 | 12.2 EB05 8.3 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | 100% clinician | no trial data cached |
| Ejection fraction decreased | 12 | 10.8 6.1–18.9ROR 10.8 · χ² 97 / p 4e-23 | 9.0 EB05 5.0 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.8 | no trial data cached |
| Infusion related reaction (reaction during infusion) | 36 | 7.6 5.5–10.5ROR 7.8 · χ² 201 / p 8e-46 | 7.1 EB05 5.3 · IC025 +2.2 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 17.8 · 97% clinician | no trial data cached |
| Sars-cov-2 test positive | 7 | 7.3 3.5–15.3ROR 7.3 · χ² 32 / p 7e-9 | 5.3 EB05 2.7 · IC025 +1.1 3/3 methods agree | Lab value / disease marker | serious n=1 | no trial data cached |
| Chills | 58 | 6.9 5.4–8.9ROR 7.1 · χ² 288 / p 7e-65 | 6.6 EB05 5.3 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.3 | no trial data cached |
| Intestinal perforation | 5 | 6.2 2.6–14.9ROR 6.2 · χ² 17 / p 2e-5 | 4.2 EB05 2.0 · IC025 +0.5 | Not in label — unassessed | serious PRR 14.8 | no trial data cached |
| Acute hepatic failure | 6 | 6.2 2.8–13.7ROR 6.2 · χ² 21 / p 2e-6 | 4.4 EB05 2.2 · IC025 +0.7 3/3 methods agree | Not in label — unassessed | serious PRR 14.7 | no trial data cached |
| Accidental exposure to product | 40 | 5.6 4.1–7.6ROR 5.7 · χ² 147 / p 4e-34 | 5.3 EB05 4.0 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Adverse reaction | 5 | 5.3 2.2–12.6ROR 5.3 · χ² 13 / p 1e-4 | 3.8 EB05 1.8 · IC025 +0.4 | Reporting / coding artifact | serious n=1 | no trial data cached |
| Unevaluable event | 28 | 5.2 3.6–7.5ROR 5.2 · χ² 90 / p 1e-21 | 4.8 EB05 3.5 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 1.6 · 93% clinician | no trial data cached |
| Pneumonitis | 10 | 5.2 2.8–9.6ROR 5.2 · χ² 30 / p 3e-8 | 4.3 EB05 2.5 · IC025 +1.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 11.5 | no trial data cached |
| Palmar-plantar erythrodysaesthesia syndrome | 6 | 3.6 1.6–8.0ROR 3.6 · χ² 9 / p 0.002 | 3.0 EB05 1.5 · IC025 +0.2 | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Product storage error | 346 | 56.0 51.0–61.4ROR 72.5 · χ² 18,639 / p <1e-300 | 55.6 EB05 50.9 · IC025 +5.5 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Circumstance or information capable of leading to medication error | 257 | 107.7 96.3–120.4ROR 129.7 · χ² 26,892 / p <1e-300 | 106.0 EB05 95.6 · IC025 +6.3 3/3 methods agree | Labeled (related wording) related wording | – | no trial data cached |
| Chills | 58 | 6.9 5.4–8.9ROR 7.1 · χ² 288 / p 7e-65 | 6.6 EB05 5.3 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.3 | no trial data cached |
| Intercepted product preparation error | 42 | 48.3 35.8–65.1ROR 49.6 · χ² 1,892 / p <1e-300 | 47.1 EB05 36.4 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Accidental exposure to product | 40 | 5.6 4.1–7.6ROR 5.7 · χ² 147 / p 4e-34 | 5.3 EB05 4.0 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Product preparation error | 40 | 27.0 19.9–36.7ROR 27.7 · χ² 975 / p 3e-214 | 26.6 EB05 20.4 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Infusion related reaction (reaction during infusion) | 36 | 7.6 5.5–10.5ROR 7.8 · χ² 201 / p 8e-46 | 7.1 EB05 5.3 · IC025 +2.2 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 17.8 · 97% clinician | no trial data cached |
| Unevaluable event | 28 | 5.2 3.6–7.5ROR 5.2 · χ² 90 / p 1e-21 | 4.8 EB05 3.5 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 1.6 · 93% clinician | no trial data cached |
| Intentional dose omission | 25 | 12.8 8.7–18.8ROR 13.0 · χ² 260 / p 1e-58 | 12.2 EB05 8.3 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | 100% clinician | no trial data cached |
| Ejection fraction decreased | 12 | 10.8 6.1–18.9ROR 10.8 · χ² 97 / p 4e-23 | 9.0 EB05 5.0 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.8 | no trial data cached |
| Pneumonitis | 10 | 5.2 2.8–9.6ROR 5.2 · χ² 30 / p 3e-8 | 4.3 EB05 2.5 · IC025 +1.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 11.5 | no trial data cached |
| Sars-cov-2 test positive | 7 | 7.3 3.5–15.3ROR 7.3 · χ² 32 / p 7e-9 | 5.3 EB05 2.7 · IC025 +1.1 3/3 methods agree | Lab value / disease marker | serious n=1 | no trial data cached |
| Palmar-plantar erythrodysaesthesia syndrome | 6 | 3.6 1.6–8.0ROR 3.6 · χ² 9 / p 0.002 | 3.0 EB05 1.5 · IC025 +0.2 | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Acute hepatic failure | 6 | 6.2 2.8–13.7ROR 6.2 · χ² 21 / p 2e-6 | 4.4 EB05 2.2 · IC025 +0.7 3/3 methods agree | Not in label — unassessed | serious PRR 14.7 | no trial data cached |
| Adverse reaction | 5 | 5.3 2.2–12.6ROR 5.3 · χ² 13 / p 1e-4 | 3.8 EB05 1.8 · IC025 +0.4 | Reporting / coding artifact | serious n=1 | 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.
- Intercepted product preparation error — n=42, PRR 48.3
✓ 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-Anns?
In FDA FAERS, the most frequently co-reported reaction terms for Trastuzumab-Anns are circumstance or information capable of leading to medication error, chills, intercepted product preparation error, infusion related reaction, ejection fraction decreased, pneumonitis. 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-Anns 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-Anns 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 9a94f5b2-b84e-4987-8ea1-c4346db5a5fa, effective 20260623; matched on
openfda.generic_name.exact:"TRASTUZUMAB-ANNS") - 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, 18 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.