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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

TRASTUZUMAB-DKST: 222 Adverse Event Reports & Safety Profile

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222
Total FAERS Reports
41 (18.5%)
Deaths Reported
74
Hospitalizations
222
As Primary/Secondary Suspect
12
Life-Threatening
2
Disabilities
Prescription
Status

FDA Application: 761074 ·

First Report: 2019 · Latest Report: 20250805

What Are the Most Common TRASTUZUMAB-DKST Side Effects?

#1 Most Reported
Death
27 reports (12.2%)
#2 Most Reported
Off label use
24 reports (10.8%)
#3 Most Reported
Chills
18 reports (8.1%)

All TRASTUZUMAB-DKST Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Death 27 12.2% 27 4
Off label use 24 10.8% 5 12
Chills 18 8.1% 0 9
Back pain 17 7.7% 0 5
Disease progression 17 7.7% 7 4
Diarrhoea 13 5.9% 1 8
Dyspnoea 13 5.9% 0 7
Malaise 13 5.9% 1 6
Nausea 13 5.9% 1 4
Hospitalisation 12 5.4% 1 12
Weight decreased 12 5.4% 0 6
Neutropenia 11 5.0% 0 3
Arthralgia 10 4.5% 0 1
Fatigue 10 4.5% 1 3
Tremor 10 4.5% 0 3
Vomiting 10 4.5% 0 5
Pyrexia 9 4.1% 1 6
Headache 8 3.6% 0 1
Infusion related reaction 8 3.6% 0 3
Pain 8 3.6% 1 2

Who Reports TRASTUZUMAB-DKST Side Effects? Age & Gender Data

Gender: 90.6% female, 9.4% male. Average age: 55.7 years. Most reports from: CA. View detailed demographics →

Is TRASTUZUMAB-DKST Getting Safer? Reports by Year

YearReportsDeathsHosp.
2019 5 0 1
2020 11 0 4
2021 18 3 4
2022 19 4 9
2023 29 3 12
2024 16 5 5
2025 16 0 5

View full timeline →

What Is TRASTUZUMAB-DKST Used For?

IndicationReports
Breast cancer metastatic 64
Breast cancer 42
Product used for unknown indication 26
Her2 positive breast cancer 22
Metastatic gastric cancer 7

TRASTUZUMAB-DKST vs Alternatives: Which Is Safer?

TRASTUZUMAB-DKST vs TRASTUZUMAB-DTTB TRASTUZUMAB-DKST vs TRASTUZUMAB EMTANSINE TRASTUZUMAB-DKST vs TRASTUZUMAB-PKRB TRASTUZUMAB-DKST vs TRASTUZUMAB-QYYP TRASTUZUMAB-DKST vs TRAVOPROST TRASTUZUMAB-DKST vs TRAZODONE TRASTUZUMAB-DKST vs TREANDA TRASTUZUMAB-DKST vs TREMELIMUMAB TRASTUZUMAB-DKST vs TREMELIMUMAB\TREMELIMUMAB-ACTL TRASTUZUMAB-DKST vs TRENBOLONE

Official FDA Label for TRASTUZUMAB-DKST

Official prescribing information from the FDA-approved drug label.