Pertuzumab, Trastuzumab and Hyaluronidase-Zzxf side effects: what 13,426 FDA adverse event reports show
Drug class
Brand names
Perjeta
Who reports
13,426 reports · 94% serious · 1,374 with death outcome · 96% female
Used for
PERJETA is a HER2/neu receptor antagonist indicated for: Use in combination with trastuzumab and docetaxel for treatment of adults with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
What it is
Pertuzumab is a recombinant humanized monoclonal antibody and HER2/neu receptor antagonist that targets the extracellular dimerization domain (Subdomain II) of the human epidermal growth factor receptor 2 protein (HER2).
Boxed warning
LEFT VENTRICULAR DYSFUNCTION and EMBRYO-FETAL TOXICITY Left Ventricular Dysfunction: PERJETA can cause subclinical and clinical cardiac failure manifesting as decreased LVEF and CHF. Evaluate cardiac function prior to and during treatment.
Causality screen of the 36 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.
- 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. 35 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 |
|---|---|---|---|---|---|---|
| No adverse event | 907 | 23.4 22.1–24.8ROR 28.9 · χ² 19,515 / p <1e-300 | 23.3 EB05 22.1 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Metastases to central nervous system | 48 | 17.1 12.9–22.7ROR 17.3 · χ² 711 / p 5e-157 | 16.9 EB05 13.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Ejection fraction decreased | 40 | 11.7 8.6–16.0ROR 11.8 · χ² 382 / p 3e-85 | 11.3 EB05 8.5 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | – | no trial data cached |
| Injection site reaction | 161 | 10.7 9.2–12.5ROR 11.1 · χ² 1,410 / p <1e-300 | 10.6 EB05 9.3 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Incorrect route of product administration | 23 | 6.2 4.2–9.4ROR 6.3 · χ² 96 / p 5e-23 | 5.6 EB05 3.9 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Metastases to bone | 20 | 5.6 3.6–8.6ROR 5.6 · χ² 71 / p 2e-17 | 5.0 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Full blood count abnormal | 12 | 5.2 2.9–9.1ROR 5.2 · χ² 37 / p 8e-10 | 4.4 EB05 2.7 · IC025 +1.2 3/3 methods agree | Lab value / disease marker | – | no trial data cached |
| Disease progression | 134 | 5.2 4.4–6.1ROR 5.3 · χ² 450 / p 3e-100 | 5.1 EB05 4.4 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Surgery | 64 | 5.0 3.9–6.4ROR 5.1 · χ² 203 / p 2e-46 | 4.9 EB05 3.9 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Off label use (used outside approved label) | 888 | 4.7 4.4–5.0ROR 5.5 · χ² 2,664 / p <1e-300 | 4.7 EB05 4.4 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Neoplasm | 11 | 4.4 2.4–7.9ROR 4.4 · χ² 25 / p 3e-7 | 3.8 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Breast cancer metastatic | 10 | 4.3 2.3–7.9ROR 4.3 · χ² 22 / p 2e-6 | 3.6 EB05 2.1 · IC025 +0.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | – | no trial data cached |
| Polyneuropathy | 11 | 4.2 2.3–7.6ROR 4.2 · χ² 24 / p 5e-7 | 3.7 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Metastases to liver | 16 | 4.2 2.6–6.8ROR 4.2 · χ² 35 / p 1e-9 | 3.8 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Ageusia (loss of taste) | 22 | 4.0 2.6–6.1ROR 4.0 · χ² 47 / p 4e-12 | 3.7 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Mouth ulceration | 17 | 3.7 2.3–5.9ROR 3.7 · χ² 31 / p 2e-8 | 3.4 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Product prescribing error | 19 | 3.7 2.3–5.7ROR 3.7 · χ² 34 / p 3e-9 | 3.4 EB05 2.3 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Product administration error | 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 | Reporting / coding artifact | – | no trial data cached |
| Immunodeficiency | 11 | 3.4 1.9–6.1ROR 3.4 · χ² 16 / p 3e-5 | 3.1 EB05 1.9 · IC025 +0.6 | Not in label — unassessed | – | no trial data cached |
| Myelosuppression | 25 | 3.4 2.3–5.0ROR 3.4 · χ² 39 / p 2e-10 | 3.2 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Mucosal inflammation | 19 | 3.3 2.1–5.2ROR 3.3 · χ² 29 / p 4e-8 | 3.1 EB05 2.1 · IC025 +0.9 3/3 methods agree | Labeled adverse reaction exact term | – | no trial data cached |
| Central nervous system lesion | 10 | 3.3 1.8–6.1ROR 3.3 · χ² 14 / p 1e-4 | 2.9 EB05 1.7 · IC025 +0.5 | Not in label — unassessed | – | no trial data cached |
| Skin reaction | 10 | 3.2 1.7–6.0ROR 3.2 · χ² 13 / p 1e-4 | 2.9 EB05 1.7 · IC025 +0.5 | Labeled (related wording) related wording | – | no trial data cached |
| Neuropathy peripheral (nerve damage in hands/feet) | 67 | 3.2 2.5–4.1ROR 3.3 · χ² 101 / p 4e-24 | 3.2 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | – | no trial data cached |
| Injection site pain (pain where injected) | 210 | 3.2 2.8–3.6ROR 3.3 · χ² 311 / p 6e-70 | 3.1 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | – | no trial data cached |
| Diarrhoea (diarrhea) | 403 | 2.9 2.6–3.1ROR 3.0 · χ² 500 / p 5e-111 | 2.8 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | – | no trial data cached |
| Lymphadenopathy | 22 | 2.8 1.9–4.3ROR 2.8 · χ² 24 / p 4e-7 | 2.7 EB05 1.9 · IC025 +0.7 | Not in label — unassessed | – | no trial data cached |
| Interstitial lung disease | 29 | 2.7 1.9–3.9ROR 2.7 · χ² 30 / p 2e-8 | 2.7 EB05 1.9 · IC025 +0.8 | Not in label — unassessed | – | no trial data cached |
| Taste disorder | 12 | 2.7 1.6–4.8ROR 2.7 · χ² 11 / p 3e-4 | 2.5 EB05 1.6 · IC025 +0.4 | Not in label — unassessed | – | no trial data cached |
| Ill-defined disorder | 35 | 2.6 1.9–3.7ROR 2.6 · χ² 34 / p 3e-9 | 2.6 EB05 1.9 · IC025 +0.8 | Not in label — unassessed | – | no trial data cached |
| Infusion related reaction (reaction during infusion) | 38 | 2.6 1.9–3.6ROR 2.6 · χ² 37 / p 7e-10 | 2.6 EB05 2.0 · IC025 +0.8 | Labeled — boxed warning synonym match | – | no trial data cached |
| Gait inability | 19 | 2.6 1.7–4.1ROR 2.6 · χ² 17 / p 1e-5 | 2.5 EB05 1.7 · IC025 +0.6 | Not in label — unassessed | – | no trial data cached |
| Pneumonitis | 14 | 2.4 1.4–4.0ROR 2.4 · χ² 10 / p 9e-4 | 2.3 EB05 1.4 · IC025 +0.3 | Not in label — unassessed | – | no trial data cached |
| Feeding disorder | 10 | 2.3 1.2–4.2ROR 2.3 · χ² 6 / p 0.007 | 2.2 EB05 1.3 · IC025 +0.0 | Not in label — unassessed | – | no trial data cached |
| Product storage error | 41 | 2.2 1.6–2.9ROR 2.2 · χ² 24 / p 4e-7 | 2.1 EB05 1.6 · IC025 +0.6 | Reporting / coding artifact | – | no trial data cached |
| Product dispensing error | 10 | 2.1 1.1–3.9ROR 2.1 · χ² 5 / p 0.015 | 2.0 EB05 1.2 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | – | 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 |
|---|---|---|---|---|---|---|
| No adverse event | 907 | 23.4 22.1–24.8ROR 28.9 · χ² 19,515 / p <1e-300 | 23.3 EB05 22.1 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Off label use (used outside approved label) | 888 | 4.7 4.4–5.0ROR 5.5 · χ² 2,664 / p <1e-300 | 4.7 EB05 4.4 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Diarrhoea (diarrhea) | 403 | 2.9 2.6–3.1ROR 3.0 · χ² 500 / p 5e-111 | 2.8 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | – | no trial data cached |
| Injection site pain (pain where injected) | 210 | 3.2 2.8–3.6ROR 3.3 · χ² 311 / p 6e-70 | 3.1 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | – | no trial data cached |
| Injection site reaction | 161 | 10.7 9.2–12.5ROR 11.1 · χ² 1,410 / p <1e-300 | 10.6 EB05 9.3 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Disease progression | 134 | 5.2 4.4–6.1ROR 5.3 · χ² 450 / p 3e-100 | 5.1 EB05 4.4 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Erythema (skin redness) | 87 | 1.9 1.6–2.4ROR 2.0 · χ² 39 / p 3e-10 | 1.9 EB05 1.6 · IC025 +0.6 | Not in label — unassessed | – | no trial data cached |
| Neuropathy peripheral (nerve damage in hands/feet) | 67 | 3.2 2.5–4.1ROR 3.3 · χ² 101 / p 4e-24 | 3.2 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | – | no trial data cached |
| Surgery | 64 | 5.0 3.9–6.4ROR 5.1 · χ² 203 / p 2e-46 | 4.9 EB05 3.9 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Metastases to central nervous system | 48 | 17.1 12.9–22.7ROR 17.3 · χ² 711 / p 5e-157 | 16.9 EB05 13.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Product storage error | 41 | 2.2 1.6–2.9ROR 2.2 · χ² 24 / p 4e-7 | 2.1 EB05 1.6 · IC025 +0.6 | Reporting / coding artifact | – | no trial data cached |
| Ejection fraction decreased | 40 | 11.7 8.6–16.0ROR 11.8 · χ² 382 / p 3e-85 | 11.3 EB05 8.5 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | – | no trial data cached |
| Infusion related reaction (reaction during infusion) | 38 | 2.6 1.9–3.6ROR 2.6 · χ² 37 / p 7e-10 | 2.6 EB05 2.0 · IC025 +0.8 | Labeled — boxed warning synonym match | – | no trial data cached |
| Ill-defined disorder | 35 | 2.6 1.9–3.7ROR 2.6 · χ² 34 / p 3e-9 | 2.6 EB05 1.9 · IC025 +0.8 | Not in label — unassessed | – | no trial data cached |
| Malignant neoplasm progression | 29 | 1.3 0.9–1.9ROR 1.3 · χ² 2 / p 0.096 | 1.3 EB05 1.0 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | – | 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.
- Metastases to central nervous system — n=48, PRR 17.1
- Injection site reaction — n=161, PRR 10.7
- Metastases to bone — n=20, PRR 5.6
- Ageusia — n=22, PRR 4.0
- Myelosuppression — n=25, PRR 3.4
- Lymphadenopathy — n=22, PRR 2.8
- Interstitial lung disease — n=29, PRR 2.7
- Ill-defined disorder — n=35, PRR 2.6
✓ 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 Pertuzumab?
In FDA FAERS, the most frequently co-reported reaction terms for Pertuzumab are diarrhoea, injection site pain, injection site reaction, erythema, neuropathy peripheral, metastases to central nervous system. 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 Pertuzumab have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: LEFT VENTRICULAR DYSFUNCTION and EMBRYO-FETAL TOXICITY Left Ventricular Dysfunction: PERJETA can cause subclinical and clinical cardiac failure manifesting as decreased LVEF and CHF. Evaluate cardiac function prior to and during treatment.
Do FAERS signals prove that Pertuzumab 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 17f85d17-ab71-4f5b-9fe3-0b8c822f69ff, effective 20260430; matched on
openfda.generic_name.exact:"PERTUZUMAB") - 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, 71 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.