ADO-TRASTUZUMAB EMTANSINE: 8,699 Adverse Event Reports & Safety Profile
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8,699
Total FAERS Reports
1,199 (13.8%)
Deaths Reported
2,608
Hospitalizations
8,699
As Primary/Secondary Suspect
219
Life-Threatening
125
Disabilities
Prescription
Status
FDA Application: 125427 ·
First Report: 200411 · Latest Report: 20250919
What Are the Most Common ADO-TRASTUZUMAB EMTANSINE Side Effects?
#1 Most Reported
Nausea
780 reports (9.0%)
#2 Most Reported
Fatigue
774 reports (8.9%)
#3 Most Reported
Disease progression
750 reports (8.6%)
All ADO-TRASTUZUMAB EMTANSINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Nausea | 780 | 9.0% | 97 | 339 |
| Fatigue | 774 | 8.9% | 81 | 285 |
| Disease progression | 750 | 8.6% | 223 | 181 |
| Diarrhoea | 654 | 7.5% | 113 | 396 |
| Off label use | 630 | 7.2% | 165 | 251 |
| Thrombocytopenia | 519 | 6.0% | 58 | 150 |
| Death | 509 | 5.9% | 508 | 70 |
| Neuropathy peripheral | 506 | 5.8% | 63 | 142 |
| Headache | 465 | 5.4% | 44 | 224 |
| Platelet count decreased | 453 | 5.2% | 48 | 168 |
| Metastases to central nervous system | 386 | 4.4% | 45 | 84 |
| Pyrexia | 386 | 4.4% | 72 | 215 |
| Vomiting | 380 | 4.4% | 73 | 242 |
| Drug ineffective | 373 | 4.3% | 46 | 58 |
| Dyspnoea | 346 | 4.0% | 49 | 192 |
| Pneumonia | 341 | 3.9% | 113 | 230 |
| Epistaxis | 327 | 3.8% | 19 | 91 |
| Pain | 317 | 3.6% | 35 | 140 |
| Asthenia | 313 | 3.6% | 47 | 132 |
| Weight decreased | 309 | 3.6% | 71 | 153 |
Who Reports ADO-TRASTUZUMAB EMTANSINE Side Effects? Age & Gender Data
Gender: 96.8% female, 3.2% male. Average age: 54.8 years. Most reports from: US. View detailed demographics →
Is ADO-TRASTUZUMAB EMTANSINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2004 | 1 | 0 | 0 |
| 2005 | 3 | 1 | 2 |
| 2007 | 3 | 0 | 0 |
| 2008 | 6 | 1 | 0 |
| 2009 | 23 | 1 | 3 |
| 2010 | 12 | 1 | 4 |
| 2011 | 13 | 1 | 7 |
| 2012 | 68 | 8 | 21 |
| 2013 | 179 | 27 | 76 |
| 2014 | 246 | 55 | 111 |
| 2015 | 426 | 85 | 233 |
| 2016 | 400 | 95 | 229 |
| 2017 | 368 | 60 | 196 |
| 2018 | 412 | 74 | 225 |
| 2019 | 448 | 68 | 214 |
| 2020 | 429 | 59 | 166 |
| 2021 | 449 | 51 | 188 |
| 2022 | 458 | 58 | 208 |
| 2023 | 358 | 50 | 150 |
| 2024 | 252 | 40 | 91 |
| 2025 | 72 | 10 | 26 |
What Is ADO-TRASTUZUMAB EMTANSINE Used For?
| Indication | Reports |
|---|---|
| Breast cancer | 2,342 |
| Breast cancer metastatic | 1,996 |
| Her2 positive breast cancer | 1,521 |
| Product used for unknown indication | 1,246 |
| Her-2 positive breast cancer | 868 |
| Invasive ductal breast carcinoma | 162 |
| Invasive breast carcinoma | 85 |
| Neoplasm malignant | 69 |
| Breast cancer female | 67 |
| Breast cancer stage iv | 46 |
ADO-TRASTUZUMAB EMTANSINE vs Alternatives: Which Is Safer?
ADO-TRASTUZUMAB EMTANSINE vs ADRIAMYCIN
ADO-TRASTUZUMAB EMTANSINE vs ADUCANUMAB
ADO-TRASTUZUMAB EMTANSINE vs ADUCANUMAB-AVWA
ADO-TRASTUZUMAB EMTANSINE vs ADVAIR
ADO-TRASTUZUMAB EMTANSINE vs ADVAIR HFA
ADO-TRASTUZUMAB EMTANSINE vs ADVIL
ADO-TRASTUZUMAB EMTANSINE vs AFATINIB
ADO-TRASTUZUMAB EMTANSINE vs AFINITOR
ADO-TRASTUZUMAB EMTANSINE vs AFLIBERCEPT
ADO-TRASTUZUMAB EMTANSINE vs AGALSIDASE ALFA
Official FDA Label for ADO-TRASTUZUMAB EMTANSINE
Official prescribing information from the FDA-approved drug label.