HER2/neu Receptor Antagonist side effects compared: 5 drugs, 42,853 FDA adverse event reports
Members
| Drug | FAERS reports | Serious | Death outcome | Boxed warning | Top labeled signals | Unlabeled (unassessed) |
|---|---|---|---|---|---|---|
| Pertuzumab (Perjeta) | 27,021 | 85% | 2,685 | boxed | Ejection fraction decreased; Radiation skin injury; Nail bed inflammation | Myelosuppression; Metastases to central nervous system |
| Pertuzumab (Perjeta) | 13,426 | 94% | 1,374 | boxed | Diarrhoea; Injection site pain; Neuropathy peripheral | Injection site reaction; Metastases to central nervous system |
| Trastuzumab-Anns (Kanjinti) | 1,503 | 24% | 24 | boxed | Circumstance or information capable of leading to medication error; Chills; Infusion related reaction | Intercepted product preparation error |
| Ontruzant | 522 | 93% | 28 | boxed | Hypokalaemia; Ejection fraction decreased; Cardiovascular disorder | – |
| Trastuzumab-Qyyp (Trazimera) | 381 | 75% | 40 | boxed | Infusion related reaction | – |
Class-wide signals (flagged in at least 3 of 5 members)
| Reaction | Members flagged | Median PRR | Reports (sum) | In label |
|---|---|---|---|---|
| Infusion related reaction | 3/5 | 7.6 | 104 | 3/3 members' labels |
Member-specific signals (flagged in exactly one drug)
| Reaction | Drug | Reports | PRR | Label screen |
|---|---|---|---|---|
| Her2 positive breast cancer | Pertuzumab | 117 | 362.2 | Likely indication confounding |
| Lacrimal structure injury | Pertuzumab | 59 | 143.7 | Not in label — unassessed |
| Delusion of grandeur | Pertuzumab | 63 | 127.1 | Not in label — unassessed |
| Circumstance or information capable of leading to medication error | Trastuzumab-Anns | 257 | 107.7 | Labeled (related wording) |
| Dacryostenosis acquired | Pertuzumab | 77 | 48.9 | Not in label — unassessed |
| Metastases to skin | Pertuzumab | 58 | 46.5 | Not in label — unassessed |
| Streptococcal sepsis | Pertuzumab | 57 | 38.9 | Not in label — unassessed |
| Radiation skin injury | Pertuzumab | 55 | 38.5 | Labeled adverse reaction |
| Breast cancer recurrent | Pertuzumab | 138 | 35.5 | Not in label — unassessed |
| Mastectomy | Pertuzumab | 75 | 34.8 | Not in label — unassessed |
| Injection site reaction | Pertuzumab | 161 | 10.7 | Not in label — unassessed |
| Chills | Trastuzumab-Anns | 58 | 6.9 | Labeled adverse reaction |
| Neuropathy peripheral | Pertuzumab | 67 | 3.2 | Labeled adverse reaction |
| Injection site pain | Pertuzumab | 210 | 3.2 | Labeled (related wording) |
| Diarrhoea | Pertuzumab | 403 | 2.9 | Labeled adverse reaction |
Common questions
Which her2/neu receptor antagonist has the most FDA adverse event reports?
Pertuzumab has the most FAERS co-reports in this class (27,021), followed by Pertuzumab (13,426). Report volume tracks how widely and how long a drug has been used, and how much attention it has had, far more than its risk.
Which side effects are shared across her2/neu receptor antagonist drugs?
Reaction terms flagged in at least half of the 5 members include infusion related reaction. A term shared across a class usually reflects the shared mechanism (or the shared patient population) rather than one product.
Does a FAERS signal mean the drug causes the reaction?
No. These are disproportionality signals from voluntary reports with no denominator. Each is screened against the FDA label (known vs unlabeled) on the drug pages; causality needs temporality, dose-response, plausibility and trial or cohort evidence.
Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, seriousness and death counts from openFDA count queries. Generated 2026-10-08. Not medical advice.