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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-DTTB: 497 Adverse Event Reports & Safety Profile

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497
Total FAERS Reports
28 (5.6%)
Deaths Reported
323
Hospitalizations
497
As Primary/Secondary Suspect
49
Life-Threatening
1
Disabilities
Prescription
Status

FDA Application: 761100 ·

First Report: 20160715 · Latest Report: 20250130

What Are the Most Common TRASTUZUMAB-DTTB Side Effects?

#1 Most Reported
Diarrhoea
150 reports (30.2%)
#2 Most Reported
Product use in unapproved indication
89 reports (17.9%)
#3 Most Reported
Nausea
66 reports (13.3%)

All TRASTUZUMAB-DTTB Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Diarrhoea 150 30.2% 1 133
Product use in unapproved indication 89 17.9% 4 83
Nausea 66 13.3% 0 54
Pyrexia 65 13.1% 1 62
Off label use 63 12.7% 3 56
Anaemia 61 12.3% 0 55
Vomiting 46 9.3% 0 38
Hypokalaemia 43 8.7% 0 43
Chills 40 8.1% 1 22
Dyspnoea 37 7.4% 0 21
Acute kidney injury 31 6.2% 0 31
Abdominal pain 26 5.2% 0 21
General physical health deterioration 26 5.2% 3 23
Fatigue 25 5.0% 0 19
Headache 25 5.0% 0 16
Neutropenia 24 4.8% 0 16
Dysphagia 21 4.2% 0 19
Infusion related reaction 21 4.2% 0 12
Sepsis 21 4.2% 4 21
C-reactive protein increased 20 4.0% 0 20

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

Gender: 73.5% female, 26.5% male. Average age: 63.0 years. Most reports from: DE. View detailed demographics →

Is TRASTUZUMAB-DTTB Getting Safer? Reports by Year

YearReportsDeathsHosp.
2016 4 0 2
2017 7 0 5
2018 39 0 20
2019 75 0 33
2020 31 7 17
2021 37 5 23
2022 62 0 41
2023 140 6 124
2024 50 0 40
2025 4 1 3

View full timeline →

What Is TRASTUZUMAB-DTTB Used For?

IndicationReports
Breast cancer 143
Oesophageal adenocarcinoma 98
Breast cancer female 61
Her2 positive breast cancer 59
Product used for unknown indication 38
Breast cancer metastatic 34
Her2 positive gastric cancer 10
Invasive ductal breast carcinoma 8
Neoplasm malignant 8
Adenocarcinoma gastric 6

TRASTUZUMAB-DTTB vs Alternatives: Which Is Safer?

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

Official FDA Label for TRASTUZUMAB-DTTB

Official prescribing information from the FDA-approved drug label.